Gynecology

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

A version of this article first appeared on Medscape.com.

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

A version of this article first appeared on Medscape.com.

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

A version of this article first appeared on Medscape.com.

Data from a large French cohort study suggest that women who have a hysterectomy before 40-45 years of age may be at particular risk of subsequently developing type 2 diabetes.

A 20% increase in the risk for incident diabetes was found comparing women of all ages who had and had not had a hysterectomy (P = .0003).

This risk jumped to a 52% increase when only women below the age of 45 were considered (P < .0001) and was still 38% higher if only women under 40 years were analyzed (P = .005).

Dr. Fabrice Bonnet

“Our findings clearly show that hysterectomy is a risk marker for diabetes,” Fabrice Bonnet, MD, PhD, of Centre Hospitalier Universitaire (CHU) de Rennes (France), said at the annual meeting of the European Association for the Study of Diabetes.

Importantly, this risk appears to occur “independently of any hormonal therapy, any reproductive factors, physical activity, and diet,” Dr. Bonnet added.
 

Findings challenged

“I would like to challenge your findings,” said Peter Nilsson, MD, PhD, a professor at Lund (Sweden) University, during the postpresentation discussion period.

“Could there be a detection bias?” queried Dr. Nilsson. “If you undergo surgery like this, there will be several postoperative visits to a physician and there’s a higher likelihood of somebody taking blood samples and detecting diabetes.

“So, if this is true, it could mean that postoperative controls of goiter or thyroid surgery would bring the same findings,” Dr. Nilsson suggested.

“It is an epidemiological cohort of woman followed for a long time,” Dr. Bonnet responded. “So of course, there probably was more blood testing than in the usual population, but we did not observe the association for another type of surgery and type 2 diabetes.”

Clarifying further, Dr. Bonnet said that they had looked at thyroid surgery but not any other types of abdominal surgery.
 

Assessing the risk of incident diabetes

Hysterectomy is a common surgery among women – more than 400,000 are estimated to be performed every year in the United States, and 80,000 in France, with a rising rate in developing countries, Dr. Bonnet said in an interview.

“We don’t know exactly why that is, but it could have long-term consequences in terms of metabolic effects and the incidence of diabetes,” he said.

Prior research has linked having a hysterectomy with an increased rate of hypertension and cardiovascular risk, and there have also been a few studies linking it to diabetes.

“Our aim was to analyze the relationship between the past history of hysterectomies and the risk of incident diabetes; and specifically, we assessed the influence of age,” Dr. Bonnet said.

To do so, data on more than 83,000 women who had participated in The French E3N Prospective Cohort Study (E3N) were obtained. This large epidemiologic study is the French component of the long-running EPIC study.

For inclusion in the analysis, women had to have no diabetes at baseline, to have had their uterus, ovaries, or both removed for benign gynecologic reasons, and to have had their surgeries performed before any diagnosis of diabetes had been made. A diagnosis of diabetes was identified through the women’s responses to self-report questionnaires and prescriptions for antidiabetic medications.

In all, 2,672 women were found to have developed diabetes during the 16-year follow-up period.

The hazard ratio for the risk of diabetes in women who had and had not had a hysterectomy was 1.30 (95% confidence interval, 1.17-1.43; P < .0001), taking age into account and stratifying for birth generation.

The association held, when there was adjustment for other factors such as smoking status, physical activity, history of diabetes, weight, and adherence to a Mediterranean diet (HR 1.27; 95% CI 1.02-1.05; P = .02).

And, after adjustment for age at menarche, menopausal status, age at which menopause was reached, oral contraceptive and hormone therapy use, and the number of pregnancies, the risk for type 2 diabetes was still apparent in those who had undergoing a hysterectomy (HR, 1.20; 95% CI, 1.09-1.33; P = .0003).
 

Risk increased with oophorectomy

“Women who had both hysterectomy with bilateral oophorectomy had the highest rates of incident diabetes, as compared to women without hysterectomy and no oophorectomy,” said Dr. Bonnet (HR, 1.26; 95% CI, 1.11-1.42; P = .0003).

“This suggests preserving ovarian function is of importance,” he added. “Try to keep the ovaries in place, so just have hysterectomy alone,” he suggested might be the advice to fellow clinicians.

“So, identifying women at higher risk could be followed by a prevention program,” he suggested. “We do this for women who have gestational diabetes,” but for women who have had a hysterectomy, “we didn’t pay attention to this until now.”
 

No increased risk for endometriosis

While hysterectomy appears to up the risk for diabetes, having endometriosis does not. In a separate analysis of data from the E3N cohort, no effect was seen despite the association between endometriosis and other cardiometabolic risk factors.

The HR for incident type 2 diabetes comparing women with and without endometriosis was 10.06 in a fully adjusted statistical model (95% CI, 0.87-1.29). While there was an increase in the risk for diabetes if a woman had endometriosis and had also had a hysterectomy, this was not significant (HR, 1.22; 95% CI, 0.96-1.54).

The E3N study was sponsored by the French Institute for Health and Research. Dr. Bonnet and Dr. Nilsson had no relevant conflicts of interest to disclose.

Data from a large French cohort study suggest that women who have a hysterectomy before 40-45 years of age may be at particular risk of subsequently developing type 2 diabetes.

A 20% increase in the risk for incident diabetes was found comparing women of all ages who had and had not had a hysterectomy (P = .0003).

This risk jumped to a 52% increase when only women below the age of 45 were considered (P < .0001) and was still 38% higher if only women under 40 years were analyzed (P = .005).

Dr. Fabrice Bonnet

“Our findings clearly show that hysterectomy is a risk marker for diabetes,” Fabrice Bonnet, MD, PhD, of Centre Hospitalier Universitaire (CHU) de Rennes (France), said at the annual meeting of the European Association for the Study of Diabetes.

Importantly, this risk appears to occur “independently of any hormonal therapy, any reproductive factors, physical activity, and diet,” Dr. Bonnet added.
 

Findings challenged

“I would like to challenge your findings,” said Peter Nilsson, MD, PhD, a professor at Lund (Sweden) University, during the postpresentation discussion period.

“Could there be a detection bias?” queried Dr. Nilsson. “If you undergo surgery like this, there will be several postoperative visits to a physician and there’s a higher likelihood of somebody taking blood samples and detecting diabetes.

“So, if this is true, it could mean that postoperative controls of goiter or thyroid surgery would bring the same findings,” Dr. Nilsson suggested.

“It is an epidemiological cohort of woman followed for a long time,” Dr. Bonnet responded. “So of course, there probably was more blood testing than in the usual population, but we did not observe the association for another type of surgery and type 2 diabetes.”

Clarifying further, Dr. Bonnet said that they had looked at thyroid surgery but not any other types of abdominal surgery.
 

Assessing the risk of incident diabetes

Hysterectomy is a common surgery among women – more than 400,000 are estimated to be performed every year in the United States, and 80,000 in France, with a rising rate in developing countries, Dr. Bonnet said in an interview.

“We don’t know exactly why that is, but it could have long-term consequences in terms of metabolic effects and the incidence of diabetes,” he said.

Prior research has linked having a hysterectomy with an increased rate of hypertension and cardiovascular risk, and there have also been a few studies linking it to diabetes.

“Our aim was to analyze the relationship between the past history of hysterectomies and the risk of incident diabetes; and specifically, we assessed the influence of age,” Dr. Bonnet said.

To do so, data on more than 83,000 women who had participated in The French E3N Prospective Cohort Study (E3N) were obtained. This large epidemiologic study is the French component of the long-running EPIC study.

For inclusion in the analysis, women had to have no diabetes at baseline, to have had their uterus, ovaries, or both removed for benign gynecologic reasons, and to have had their surgeries performed before any diagnosis of diabetes had been made. A diagnosis of diabetes was identified through the women’s responses to self-report questionnaires and prescriptions for antidiabetic medications.

In all, 2,672 women were found to have developed diabetes during the 16-year follow-up period.

The hazard ratio for the risk of diabetes in women who had and had not had a hysterectomy was 1.30 (95% confidence interval, 1.17-1.43; P < .0001), taking age into account and stratifying for birth generation.

The association held, when there was adjustment for other factors such as smoking status, physical activity, history of diabetes, weight, and adherence to a Mediterranean diet (HR 1.27; 95% CI 1.02-1.05; P = .02).

And, after adjustment for age at menarche, menopausal status, age at which menopause was reached, oral contraceptive and hormone therapy use, and the number of pregnancies, the risk for type 2 diabetes was still apparent in those who had undergoing a hysterectomy (HR, 1.20; 95% CI, 1.09-1.33; P = .0003).
 

Risk increased with oophorectomy

“Women who had both hysterectomy with bilateral oophorectomy had the highest rates of incident diabetes, as compared to women without hysterectomy and no oophorectomy,” said Dr. Bonnet (HR, 1.26; 95% CI, 1.11-1.42; P = .0003).

“This suggests preserving ovarian function is of importance,” he added. “Try to keep the ovaries in place, so just have hysterectomy alone,” he suggested might be the advice to fellow clinicians.

“So, identifying women at higher risk could be followed by a prevention program,” he suggested. “We do this for women who have gestational diabetes,” but for women who have had a hysterectomy, “we didn’t pay attention to this until now.”
 

No increased risk for endometriosis

While hysterectomy appears to up the risk for diabetes, having endometriosis does not. In a separate analysis of data from the E3N cohort, no effect was seen despite the association between endometriosis and other cardiometabolic risk factors.

The HR for incident type 2 diabetes comparing women with and without endometriosis was 10.06 in a fully adjusted statistical model (95% CI, 0.87-1.29). While there was an increase in the risk for diabetes if a woman had endometriosis and had also had a hysterectomy, this was not significant (HR, 1.22; 95% CI, 0.96-1.54).

The E3N study was sponsored by the French Institute for Health and Research. Dr. Bonnet and Dr. Nilsson had no relevant conflicts of interest to disclose.

Data from a large French cohort study suggest that women who have a hysterectomy before 40-45 years of age may be at particular risk of subsequently developing type 2 diabetes.

A 20% increase in the risk for incident diabetes was found comparing women of all ages who had and had not had a hysterectomy (P = .0003).

This risk jumped to a 52% increase when only women below the age of 45 were considered (P < .0001) and was still 38% higher if only women under 40 years were analyzed (P = .005).

Dr. Fabrice Bonnet

“Our findings clearly show that hysterectomy is a risk marker for diabetes,” Fabrice Bonnet, MD, PhD, of Centre Hospitalier Universitaire (CHU) de Rennes (France), said at the annual meeting of the European Association for the Study of Diabetes.

Importantly, this risk appears to occur “independently of any hormonal therapy, any reproductive factors, physical activity, and diet,” Dr. Bonnet added.
 

Findings challenged

“I would like to challenge your findings,” said Peter Nilsson, MD, PhD, a professor at Lund (Sweden) University, during the postpresentation discussion period.

“Could there be a detection bias?” queried Dr. Nilsson. “If you undergo surgery like this, there will be several postoperative visits to a physician and there’s a higher likelihood of somebody taking blood samples and detecting diabetes.

“So, if this is true, it could mean that postoperative controls of goiter or thyroid surgery would bring the same findings,” Dr. Nilsson suggested.

“It is an epidemiological cohort of woman followed for a long time,” Dr. Bonnet responded. “So of course, there probably was more blood testing than in the usual population, but we did not observe the association for another type of surgery and type 2 diabetes.”

Clarifying further, Dr. Bonnet said that they had looked at thyroid surgery but not any other types of abdominal surgery.
 

Assessing the risk of incident diabetes

Hysterectomy is a common surgery among women – more than 400,000 are estimated to be performed every year in the United States, and 80,000 in France, with a rising rate in developing countries, Dr. Bonnet said in an interview.

“We don’t know exactly why that is, but it could have long-term consequences in terms of metabolic effects and the incidence of diabetes,” he said.

Prior research has linked having a hysterectomy with an increased rate of hypertension and cardiovascular risk, and there have also been a few studies linking it to diabetes.

“Our aim was to analyze the relationship between the past history of hysterectomies and the risk of incident diabetes; and specifically, we assessed the influence of age,” Dr. Bonnet said.

To do so, data on more than 83,000 women who had participated in The French E3N Prospective Cohort Study (E3N) were obtained. This large epidemiologic study is the French component of the long-running EPIC study.

For inclusion in the analysis, women had to have no diabetes at baseline, to have had their uterus, ovaries, or both removed for benign gynecologic reasons, and to have had their surgeries performed before any diagnosis of diabetes had been made. A diagnosis of diabetes was identified through the women’s responses to self-report questionnaires and prescriptions for antidiabetic medications.

In all, 2,672 women were found to have developed diabetes during the 16-year follow-up period.

The hazard ratio for the risk of diabetes in women who had and had not had a hysterectomy was 1.30 (95% confidence interval, 1.17-1.43; P < .0001), taking age into account and stratifying for birth generation.

The association held, when there was adjustment for other factors such as smoking status, physical activity, history of diabetes, weight, and adherence to a Mediterranean diet (HR 1.27; 95% CI 1.02-1.05; P = .02).

And, after adjustment for age at menarche, menopausal status, age at which menopause was reached, oral contraceptive and hormone therapy use, and the number of pregnancies, the risk for type 2 diabetes was still apparent in those who had undergoing a hysterectomy (HR, 1.20; 95% CI, 1.09-1.33; P = .0003).
 

Risk increased with oophorectomy

“Women who had both hysterectomy with bilateral oophorectomy had the highest rates of incident diabetes, as compared to women without hysterectomy and no oophorectomy,” said Dr. Bonnet (HR, 1.26; 95% CI, 1.11-1.42; P = .0003).

“This suggests preserving ovarian function is of importance,” he added. “Try to keep the ovaries in place, so just have hysterectomy alone,” he suggested might be the advice to fellow clinicians.

“So, identifying women at higher risk could be followed by a prevention program,” he suggested. “We do this for women who have gestational diabetes,” but for women who have had a hysterectomy, “we didn’t pay attention to this until now.”
 

No increased risk for endometriosis

While hysterectomy appears to up the risk for diabetes, having endometriosis does not. In a separate analysis of data from the E3N cohort, no effect was seen despite the association between endometriosis and other cardiometabolic risk factors.

The HR for incident type 2 diabetes comparing women with and without endometriosis was 10.06 in a fully adjusted statistical model (95% CI, 0.87-1.29). While there was an increase in the risk for diabetes if a woman had endometriosis and had also had a hysterectomy, this was not significant (HR, 1.22; 95% CI, 0.96-1.54).

The E3N study was sponsored by the French Institute for Health and Research. Dr. Bonnet and Dr. Nilsson had no relevant conflicts of interest to disclose.

In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.

COVID-19 vaccination had minimal effects on menstrual cycle length

Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.

Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,^1,2 as the menstrual cycle is often considered a sign of health and fertility.

To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.³ Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.

The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the  2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)

Increase in cycle length clinically negligible

The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).

An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.

Counseling takeaway

This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.

Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...

Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel

Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.

A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as  combined oral contraceptives (COCs).

Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG)  0.075 mg, which is commonly used in Europe.⁴ Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.

Top reasons for stopping a POP

The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.

New oral contraception option

This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.

Continue to: Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy...

Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy

Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.

Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.

Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.⁵ These included 4 retrospective cohort studies with control groups,  2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.

Promising results  for combined therapy

Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first  6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.

The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an  LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.

Bottom line

The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.

 Continue to: LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...

LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows

van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.

To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.⁶

Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.

Cost-effectiveness and noninferiority assessed

A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.

At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.

Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).

Key takeaway

Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial  ablation. ●

In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.

COVID-19 vaccination had minimal effects on menstrual cycle length

Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.

Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,^1,2 as the menstrual cycle is often considered a sign of health and fertility.

To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.³ Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.

The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the  2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)

Increase in cycle length clinically negligible

The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).

An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.

Counseling takeaway

This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.

Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...

Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel

Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.

A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as  combined oral contraceptives (COCs).

Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG)  0.075 mg, which is commonly used in Europe.⁴ Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.

Top reasons for stopping a POP

The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.

New oral contraception option

This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.

Continue to: Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy...

Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy

Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.

Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.

Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.⁵ These included 4 retrospective cohort studies with control groups,  2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.

Promising results  for combined therapy

Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first  6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.

The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an  LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.

Bottom line

The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.

 Continue to: LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...

LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows

van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.

To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.⁶

Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.

Cost-effectiveness and noninferiority assessed

A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.

At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.

Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).

Key takeaway

Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial  ablation. ●

In this Update, we focus on therapies for abnormal uterine bleeding (AUB) that include a new formulation of a progesterone-only pill (POP), drospirenone 4 mg in a 24/4 regimen (24 days of drospirenone/4 days of inert tablets), which recently showed benefit over the use of desogestrel in a European randomized clinical trial (RCT). Two other commonly used treatments for AUB— the levonorgestrel-releasing intrauterine system (LNG IUS) and endometrial ablation—were studied in terms of cost-effectiveness as well as whether they should be used in combination for added efficacy. In addition, although at times either COVID-19 disease or the COVID-19 vaccine has been blamed for societal and medical problems, one study showed that it is unlikely that significant changes in the menstrual cycle are a result of the COVID-19 vaccine.

COVID-19 vaccination had minimal effects on menstrual cycle length

Edelman A, Boniface ER, Benhar W, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a US cohort. Obstet Gynecol. 2022;139:481-489.

Does receiving the COVID-19 vaccination result in abnormal menstrual cycles? Patients often ask this question, and it has been a topic of social media discussion (including NPR) and concerns about the possibility of vaccine hesitancy,^1,2 as the menstrual cycle is often considered a sign of health and fertility.

To better understand this possible association, Edelman and colleagues conducted a study that prospectively tracked menstrual cycle data using the digital app Natural Cycles in US residents aged 18 to 45 years for 3 consecutive cycles in both a vaccinated and an unvaccinated cohort.³ Almost 4,000 individuals were studied; 2,403 were vaccinated and 1,556 were unvaccinated. The study vaccine types included the BioNTech (Pfizer), Moderna, Johnson & Johnson/Janssen, and unspecified vaccines.

The primary outcome was the within-individual change in cycle length in days, comparing a 3-cycle postvaccine average to a 3-cycle prevaccination average in the  2 groups. (For the unvaccinated group, cycles 1, 2, and 3 were considered the equivalent of prevaccination cycles; cycle 4 was designated as the artificial first vaccine dose-cycle and cycle 5 as the artificial second-dose cycle.)

Increase in cycle length clinically negligible

The investigators found that the vaccinated cohort had less than a 1-day unadjusted increase in the length of their menstrual cycle, which was essentially a 0.71-day increase (98.75% confidence interval [CI], 0.47–0.94). Although this is considered statistically significant, it is likely clinically insignificant in that the overlaid histograms comparing the distribution of change showed a cycle length distribution in vaccinated individuals that is essentially equivalent to that in unvaccinated individuals. After adjusting for confounders, the difference in cycle length was reduced to a 0.64 day (98.75% CI, 0.27–1.01).

An interesting finding was that a subset of individuals who received both vaccine doses in a single cycle had, on average, an adjusted 2-day increase in their menstrual cycle compared with unvaccinated individuals. To explain this slightly longer cycle length, the authors postulated that mRNA vaccines create an immune response, or stressor, which could temporarily affect the hypothalamic-pituitary-ovarian axis if timed correctly. It is certainly possible for an individual to receive 2 doses in a single cycle, which could have both been administered in the early follicular phase. Such cycle length variability can be caused by events, including stressors, that affect the recruitment and maturation of the dominant follicle.

Counseling takeaway

This study provides reassurance to most individuals who receive a COVID-19 vaccine that it likely will not affect their menstrual cycle in a clinically significant manner.

Continue to: Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel...

Drospirenone improved bleeding profiles, lowered discontinuation rates compared with desogestrel

Regidor PA, Colli E, Palacios S. Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel. Gynecol Endocrinol. 2021;37:1121-1127.

A new POP, marketed under the name Slynd, recently came to market. It contains the progestin drospirenone (DRSP) 4 mg in a 24/4 regimen. This formulation has the advantage of being an antiandrogenic progestin, with a long enough half-life to allow for managing a missed pill in the same fashion as  combined oral contraceptives (COCs).

Investigators in Europe conducted a double-blind, randomized trial to assess discontinuation rates due to adverse events (mainly bleeding disorders) in participants taking DRSP 4 mg in a 24/4 regimen compared with those taking the POP desogestrel (DSG)  0.075 mg, which is commonly used in Europe.⁴ Regidor and colleagues compared 858 women with 6,691 DRSP treatment cycles with 332 women with 2,487 DSG treatment cycles.

Top reasons for stopping a POP

The discontinuation rate for abnormal bleeding was 3.7% in the DRSP group versus 7.3% in the DSG group (55.7% lower). The most common reasons for stopping either POP formulation were vaginal bleeding and acne. Both of these adverse events were less common in the DRSP group. Pill discontinuation due to vaginal bleeding was 2.6% in the DRSP group versus 5.4% in the DSG group, while discontinuation due to acne occurred in 1% in the DRSP group versus 2.7% in the DSG group.

New oral contraception option

This study shows improved acceptability and bleeding profiles in women using this new DRSP contraception pill regimen.

Continue to: Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy...

Placing an LNG IUS after  endometrial ablation for heavy  menstrual bleeding reduced risk  of hysterectomy

Oderkerk TJ, van de Kar MMA, van der Zanden CHM, et al. The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: a systematic review. Acta Obstet Gynecol Scand. 2021;100:1779-1787.

Over the years, a smattering of articles have suggested that a reduction in uterine bleeding was associated with placement of an LNG IUS at the conclusion of endometrial ablation. We now have a systematic review of this surgical modification.

Oderkerk and colleagues sifted through 747 articles to find 7 publications that could provide meaningful data on the impact of combined use of endometrial ablation and LNG IUS insertion for women with heavy menstrual bleeding.⁵ These included 4 retrospective cohort studies with control groups,  2 retrospective studies without control groups, and 1 case series. The primary outcome was the hysterectomy rate after therapy.

Promising results  for combined therapy

Although no statistically significant intergroup differences were seen in the combined treatment group versus the endometrial ablation alone group for the first  6 months of treatment, significant differences existed at the 12- and 24-month mark. Hysterectomy rates after combined treatment varied from 0% to 11% versus 9.4% to 24% after endometrial ablation alone. Complication rates for combined treatment did not appear higher than those for endometrial ablation alone.

The authors postulated that the failure of endometrial ablation is generally caused by either remaining or regenerating endometrial tissue and that the addition of an  LNG IUS allows for suppression of endometrial tissue. Also encouraging was that, in general, the removal of the LNG IUS was relatively simple. A single difficult removal was described due to uterine synechiae, but hysteroscopic resection was not necessary. The authors acknowledged that the data from these 7 retrospective studies are limited and that high-quality research from prospective studies is needed.

Bottom line

The data available from this systematic review suggest that placement of an LNG IUS at the completion of an endometrial ablation may result in lower hysterectomy rates, without apparent risk, and without significantly difficult LNG IUS removal when needed.

 Continue to: LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows...

LNG IUS is less expensive, and  less effective, than endometrial ablation for heavy menstrual bleeding, cost analysis shows

van den Brink MJ, Beelen P, Herman MC, et al. The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis. BJOG. 2021;128:2003-2011.

To assess the cost-effectiveness of the LNG IUS versus endometrial ablation in the treatment of heavy menstrual bleeding, van den Brink and colleagues conducted a randomized, noninferiority trial.⁶

Part of the rationale for this study was to better understand the cost differences between the LNG IUS and second-generation endometrial ablation. Some data have suggested that the LNG IUS is cost-effective when compared with first-generation endometrial ablation; however, definitive evidence about its cost compared with second-generation endometrial ablation is lacking, as these procedures should be less expensive than first-generation endometrial ablation since they frequently are performed in the office rather than in an operating room.

Cost-effectiveness and noninferiority assessed

A total of 270 women were randomly assigned to 1 of 2 treatment strategies. Eventually, 132 women were treated first with the 52-mg LNG IUS, and 138 were treated first with endometrial ablation by radiofrequency ablation. Menstrual blood loss after 24 months was the primary outcome.

At 24 months, the mean pictorial blood loss assessment chart (PBAC) scores were 64.8 in the LNG IUS group compared with 14.2 in the endometrial ablation group. Given that the noninferiority margin was defined as 25 points, noninferiority could not be demonstrated. However, when looking at PBAC scores less than 75 points, the LNG IUS group met this secondary end point in 87% of women versus 94% in the endometrial ablation group. When satisfaction was assessed, 74% of women in the LNG IUS group were satisfied compared with 84% in the endometrial ablation group.

Overall, the total costs per patient were €2,285 in the LNG IUS strategy and €3,465 in the endometrial ablation strategy (costs convert to $2,285 and $3,465 as of this writing).

Key takeaway

Treatment of heavy menstrual bleeding starting with the LNG IUS is cheaper, but it is slightly less effective than endometrial  ablation. ●

Fort Worth, Tex. – A case decision made by Texas U.S. District Judge Reed Charles O’Connor that will allow employers to deny health care insurance coverage for HIV preexposure prophylaxis (PrEP) is already provoking HIV activists, medical associations, nonprofits, and patients.

As this news organization first reported in August, the class action suit (Kelley v. Azar) has a broader goal – to dismantle the Affordable Care Act using the argument that many of the preventive services it covers, including PrEP, violate the Religious Freedom Restoration Act.

“Judge O’Connor has a long history of issuing rulings against the Affordable Care Act and LGBT individuals, and we expect the case to be successfully appealed as has been the case with his previous discriminatory decisions,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington, in a prepared statement issued shortly after the ruling.

“To single out PrEP, which are FDA approved drugs that effectively prevent HIV, and conclude that its coverage violates the religious freedom of certain individuals, is plain wrong, highly discriminatory, and impedes the public health of our nation,” he said. 

PrEP is not just for men who have sex with men. According to the Centers for Disease Control and Prevention, more than 1 million Americans could benefit from PrEP, and roughly 20% are heterosexual women – a fact both Mr. Schmid and the HIV Medicine Association pointed out in response to Judge O’Connor’s ruling.

“Denying access to PrEP threatens the health of more than 1.2 million Americans who could benefit from this potentially life saving intervention,” stated Marwan Haddad, MD, MPH, chair of the HIV Medicine Association, in a press release issued by the organization.

“This ruling is yet one more instance of unacceptable interference in scientific, evidence-based health care practices that must remain within the sanctity of the provider-patient relationship,” she said.

The ruling is also outside what is normally considered religious “conscientious objection.”

While the American Medical Association supports the rights of physicians to act in accordance with conscience, medical ethicists like Abram Brummett, PhD, assistant professor, department of foundational medical studies, Oakland University, Rochester, Mich., previously told this news organization that this ruling actually reflects a phenomenon known as “conscience creep” – that is, the way conscientious objection creeps outside traditional contexts like abortion, sterilization, and organ transplantation.

Incidentally, the case is not yet completed; Judge O’Connor still has to decide on challenges to contraceptives and HPV mandates. He has requested that defendants and plaintiffs file a supplemental briefing before he makes a final decision.

Regardless of how it plays out, it is unclear whether the U.S. Department of Health and Human Services will appeal.

A version of this article first appeared on Medscape.com.

Fort Worth, Tex. – A case decision made by Texas U.S. District Judge Reed Charles O’Connor that will allow employers to deny health care insurance coverage for HIV preexposure prophylaxis (PrEP) is already provoking HIV activists, medical associations, nonprofits, and patients.

As this news organization first reported in August, the class action suit (Kelley v. Azar) has a broader goal – to dismantle the Affordable Care Act using the argument that many of the preventive services it covers, including PrEP, violate the Religious Freedom Restoration Act.

“Judge O’Connor has a long history of issuing rulings against the Affordable Care Act and LGBT individuals, and we expect the case to be successfully appealed as has been the case with his previous discriminatory decisions,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington, in a prepared statement issued shortly after the ruling.

“To single out PrEP, which are FDA approved drugs that effectively prevent HIV, and conclude that its coverage violates the religious freedom of certain individuals, is plain wrong, highly discriminatory, and impedes the public health of our nation,” he said. 

PrEP is not just for men who have sex with men. According to the Centers for Disease Control and Prevention, more than 1 million Americans could benefit from PrEP, and roughly 20% are heterosexual women – a fact both Mr. Schmid and the HIV Medicine Association pointed out in response to Judge O’Connor’s ruling.

“Denying access to PrEP threatens the health of more than 1.2 million Americans who could benefit from this potentially life saving intervention,” stated Marwan Haddad, MD, MPH, chair of the HIV Medicine Association, in a press release issued by the organization.

“This ruling is yet one more instance of unacceptable interference in scientific, evidence-based health care practices that must remain within the sanctity of the provider-patient relationship,” she said.

The ruling is also outside what is normally considered religious “conscientious objection.”

While the American Medical Association supports the rights of physicians to act in accordance with conscience, medical ethicists like Abram Brummett, PhD, assistant professor, department of foundational medical studies, Oakland University, Rochester, Mich., previously told this news organization that this ruling actually reflects a phenomenon known as “conscience creep” – that is, the way conscientious objection creeps outside traditional contexts like abortion, sterilization, and organ transplantation.

Incidentally, the case is not yet completed; Judge O’Connor still has to decide on challenges to contraceptives and HPV mandates. He has requested that defendants and plaintiffs file a supplemental briefing before he makes a final decision.

Regardless of how it plays out, it is unclear whether the U.S. Department of Health and Human Services will appeal.

A version of this article first appeared on Medscape.com.

Fort Worth, Tex. – A case decision made by Texas U.S. District Judge Reed Charles O’Connor that will allow employers to deny health care insurance coverage for HIV preexposure prophylaxis (PrEP) is already provoking HIV activists, medical associations, nonprofits, and patients.

As this news organization first reported in August, the class action suit (Kelley v. Azar) has a broader goal – to dismantle the Affordable Care Act using the argument that many of the preventive services it covers, including PrEP, violate the Religious Freedom Restoration Act.

“Judge O’Connor has a long history of issuing rulings against the Affordable Care Act and LGBT individuals, and we expect the case to be successfully appealed as has been the case with his previous discriminatory decisions,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington, in a prepared statement issued shortly after the ruling.

“To single out PrEP, which are FDA approved drugs that effectively prevent HIV, and conclude that its coverage violates the religious freedom of certain individuals, is plain wrong, highly discriminatory, and impedes the public health of our nation,” he said. 

PrEP is not just for men who have sex with men. According to the Centers for Disease Control and Prevention, more than 1 million Americans could benefit from PrEP, and roughly 20% are heterosexual women – a fact both Mr. Schmid and the HIV Medicine Association pointed out in response to Judge O’Connor’s ruling.

“Denying access to PrEP threatens the health of more than 1.2 million Americans who could benefit from this potentially life saving intervention,” stated Marwan Haddad, MD, MPH, chair of the HIV Medicine Association, in a press release issued by the organization.

“This ruling is yet one more instance of unacceptable interference in scientific, evidence-based health care practices that must remain within the sanctity of the provider-patient relationship,” she said.

The ruling is also outside what is normally considered religious “conscientious objection.”

While the American Medical Association supports the rights of physicians to act in accordance with conscience, medical ethicists like Abram Brummett, PhD, assistant professor, department of foundational medical studies, Oakland University, Rochester, Mich., previously told this news organization that this ruling actually reflects a phenomenon known as “conscience creep” – that is, the way conscientious objection creeps outside traditional contexts like abortion, sterilization, and organ transplantation.

Incidentally, the case is not yet completed; Judge O’Connor still has to decide on challenges to contraceptives and HPV mandates. He has requested that defendants and plaintiffs file a supplemental briefing before he makes a final decision.

Regardless of how it plays out, it is unclear whether the U.S. Department of Health and Human Services will appeal.

A version of this article first appeared on Medscape.com.

As life-preserving medical technology advanced in the second half of the 20th century, doctors and families were faced with a thorny decision, one with weighty legal and moral implications: How should we define when life ends? Cardiopulmonary bypass machines could keep the blood pumping and ventilators could maintain breathing long after a patient’s natural ability to perform those vital functions had ceased.

After decades of deliberations involving physicians, bioethicists, attorneys, and theologians, a U.S. presidential commission in 1981 settled on a scientifically derived dividing line between life and death that has endured, more or less, ever since: A person was considered dead when the entire brain – including the brain stem, its most primitive portion – was no longer functioning, even if other vital functions could be maintained indefinitely through artificial life support.

In the decades since, the committee’s criteria have served as a foundation for laws in most states adopting brain death as a standard for legal death.

Now, with the overturning of Roe v. Wade and dozens of states rushing to impose abortion restrictions, American society is engaged in a chaotic race to define the other pole of human existence: When exactly does human life begin? At conception, the hint of a heartbeat, a first breath, the ability to survive outside the womb with the help of the latest technology?

That we’ve been able to devise and apply uniform clinical standards for when life ends, but not when it begins, is due largely to the legal and political maelstrom around abortion. And in the 2 months since the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, eliminating a longstanding federal right to abortion, state legislators are eagerly bounding into that void, looking to codify into law assorted definitions of life that carry profound repercussions for abortion rights, birth control, and assisted reproduction, as well as civil and criminal law.

“The court said that when life begins is up to whoever is running your state – whether they are wrong or not, or you agree with them or not,” said Mary Ziegler, a law professor at the University of California, Davis, who has written several books on the history of abortion.

Unlike the debate over death, which delved into exquisite medical and scientific detail, the legislative scramble to determine when life’s building blocks reach a threshold that warrants government protection as human life has generally ignored the input of mainstream medical professionals.

Instead, red states across much of the South and portions of the Midwest are adopting language drafted by elected officials that is informed by conservative Christian doctrine, often with little scientific underpinning.

A handful of Republican-led states, including Arkansas, Kentucky, Missouri, and Oklahoma, have passed laws declaring that life begins at fertilization, a contention that opens the door to a host of pregnancy-related litigation. This includes wrongful death lawsuits brought on behalf of the estate of an embryo by disgruntled ex-partners against physicians and women who end a pregnancy or even miscarry. (One such lawsuit is underway in Arizona. Another reached the Alabama Supreme Court.)

In Kentucky, the law outlawing abortion uses morally explosive terms to define pregnancy as “the human female reproductive condition of having a living unborn human being within her body throughout the entire embryonic and fetal stages of the unborn child from fertilization to full gestation and childbirth.”

Several other states, including Georgia, have adopted measures equating life with the point at which an embryo’s nascent cardiac activity can be detected by an ultrasound, at around 6 weeks of gestation. Many such laws mischaracterize the flickering electrical impulses detectable at that stage as a heartbeat, including in Georgia, whose Department of Revenue recently announced that “any unborn child with a detectable human heartbeat” can be claimed as a dependent.

The Supreme Court’s 1973 decision in Roe v. Wade that established a constitutional right to abortion did not define a moment when life begins. The opinion, written by Justice Harry Blackmun, observed that the Constitution does not provide a definition of “person,” though it extends protections to those born or naturalized in the United States. The court majority made note of the many disparate views among religions and scientists on when life begins, and concluded it was not up to the states to adopt one theory of life.

Instead, Roe created a framework intended to balance a pregnant woman’s right to make decisions about her body with a public interest in protecting potential human life. That decision and a key ruling that followed generally recognized a woman’s right to abortion up to the point medical professionals judge a fetus viable to survive outside the uterus, at about 24 weeks of gestation.

In decisively overturning Roe in June, the Supreme Court’s conservative majority drew on legal arguments that have shaped another contentious end-of-life issue. The legal standard employed in Dobbs – that there is no right to abortion in the federal Constitution and that states can decide on their own – is the same rationale used in 1997 when the Supreme Court said terminally ill people did not have a constitutional right to medically assisted death. That decision, Washington v. Glucksberg, is mentioned 15 times in the majority opinion for Dobbs and a concurrence by Justice Clarence Thomas.

Often, the same groups that have led the fight to outlaw abortion have also challenged medical aid-in-dying laws. Even after Dobbs, so-called right-to-die laws remain far less common than those codifying state abortion rights. Ten states allow physicians to prescribe lethal doses of medicine for terminally ill patients. Doctors are still prohibited from administering the drugs.

James Bopp, general counsel for the National Right to Life Committee who has been central to the efforts to outlaw abortion, said that both abortion and medically assisted death, which he refers to as physician-assisted suicide, endanger society.

“Every individual human life has inherent value and is sacred,” said Mr. Bopp. “The government has the duty to protect that life.”

Both issues raise profound societal questions: Can the government keep a patient on life support against his wishes, or force a woman to give birth? Can states bar their own residents from going to other states to end a pregnancy, or prohibit out-of-state patients from coming in to seek medically assisted death? And who gets to decide, particularly if the answer imposes a singular religious viewpoint?

Just as there are legal implications that flow from determining a person’s death, from organ donation to inheritance, the implied rights held by a legally recognized zygote are potentially vast. Will death certificates be issued for every lost pregnancy? Will miscarriages be investigated? When will Social Security numbers be issued? How will census counts be tallied and congressional districts drawn?

Medical professionals and bioethicists caution that both the beginning and end of life are complicated biological processes that are not defined by a single identifiable moment – and are ill suited to the political arena.

“Unfortunately, biological occurrences are not events, they are processes,” said David Magnus, PhD, director of the Stanford (Calif.) Center for Biomedical Ethics.

Moreover, asking doctors “What is life?” or “What is death?” may miss the point, said Dr. Magnus: “Medicine can answer the question ‘When does a biological organism cease to exist?’ But they can’t answer the question ‘When does a person begin or end?’ because those are metaphysical issues.”

Ben Sarbey, a doctoral candidate in the department of philosophy at Duke University, Durham, N.C., who studies medical ethics, echoed that perspective, recounting the Paradox of the Heap, a thought experiment that involves placing grains of sand one on top of the next. The philosophical quandary is this: At what point do those grains of sand become something more – a heap?

“We’re going to have a rough time placing a dividing line that this counts as a person and this does not count as a person,” he said. “Many things count as life – a sperm counts as life, a person in a persistent vegetative state counts as life – but does that constitute a person that we should be protecting?”

Even as debate over the court’s abortion decision percolates, the 1981 federal statute that grew out of the presidential committee’s findings, the Uniform Determination of Death Act, is also under review. In 2022, the Uniform Law Commission, a nonpartisan group of legal experts that drafts laws intended for adoption in multiple states, has taken up the work to revisit the definition of death.

The group will consider sharpening the medical standards for brain death in light of advances in the understanding of brain function. And they will look to address lingering questions raised in recent years as families and religious groups have waged heated legal battles over terminating artificial life support for patients with no brain wave activity.

Mr. Bopp, with the National Right to Life Committee, is among those serving on advisory panels for the effort, along with an array of doctors, philosophers, and medical ethicists. The concept of “personhood” that infuses the antiabortion movement’s broader push for fetal rights is expected to be an underlying topic, albeit in mirror image: When does a life form cease being a person?

Dr. Magnus, who is also serving on an advisory panel, has no doubt the commission will reach a consensus, a sober resolution rooted in science. What’s less clear, he said, is whether in today’s political environment that updated definition will hold the same sway, an enduring legal standard embraced across states.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

As life-preserving medical technology advanced in the second half of the 20th century, doctors and families were faced with a thorny decision, one with weighty legal and moral implications: How should we define when life ends? Cardiopulmonary bypass machines could keep the blood pumping and ventilators could maintain breathing long after a patient’s natural ability to perform those vital functions had ceased.

After decades of deliberations involving physicians, bioethicists, attorneys, and theologians, a U.S. presidential commission in 1981 settled on a scientifically derived dividing line between life and death that has endured, more or less, ever since: A person was considered dead when the entire brain – including the brain stem, its most primitive portion – was no longer functioning, even if other vital functions could be maintained indefinitely through artificial life support.

In the decades since, the committee’s criteria have served as a foundation for laws in most states adopting brain death as a standard for legal death.

Now, with the overturning of Roe v. Wade and dozens of states rushing to impose abortion restrictions, American society is engaged in a chaotic race to define the other pole of human existence: When exactly does human life begin? At conception, the hint of a heartbeat, a first breath, the ability to survive outside the womb with the help of the latest technology?

That we’ve been able to devise and apply uniform clinical standards for when life ends, but not when it begins, is due largely to the legal and political maelstrom around abortion. And in the 2 months since the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, eliminating a longstanding federal right to abortion, state legislators are eagerly bounding into that void, looking to codify into law assorted definitions of life that carry profound repercussions for abortion rights, birth control, and assisted reproduction, as well as civil and criminal law.

“The court said that when life begins is up to whoever is running your state – whether they are wrong or not, or you agree with them or not,” said Mary Ziegler, a law professor at the University of California, Davis, who has written several books on the history of abortion.

Unlike the debate over death, which delved into exquisite medical and scientific detail, the legislative scramble to determine when life’s building blocks reach a threshold that warrants government protection as human life has generally ignored the input of mainstream medical professionals.

Instead, red states across much of the South and portions of the Midwest are adopting language drafted by elected officials that is informed by conservative Christian doctrine, often with little scientific underpinning.

A handful of Republican-led states, including Arkansas, Kentucky, Missouri, and Oklahoma, have passed laws declaring that life begins at fertilization, a contention that opens the door to a host of pregnancy-related litigation. This includes wrongful death lawsuits brought on behalf of the estate of an embryo by disgruntled ex-partners against physicians and women who end a pregnancy or even miscarry. (One such lawsuit is underway in Arizona. Another reached the Alabama Supreme Court.)

In Kentucky, the law outlawing abortion uses morally explosive terms to define pregnancy as “the human female reproductive condition of having a living unborn human being within her body throughout the entire embryonic and fetal stages of the unborn child from fertilization to full gestation and childbirth.”

Several other states, including Georgia, have adopted measures equating life with the point at which an embryo’s nascent cardiac activity can be detected by an ultrasound, at around 6 weeks of gestation. Many such laws mischaracterize the flickering electrical impulses detectable at that stage as a heartbeat, including in Georgia, whose Department of Revenue recently announced that “any unborn child with a detectable human heartbeat” can be claimed as a dependent.

The Supreme Court’s 1973 decision in Roe v. Wade that established a constitutional right to abortion did not define a moment when life begins. The opinion, written by Justice Harry Blackmun, observed that the Constitution does not provide a definition of “person,” though it extends protections to those born or naturalized in the United States. The court majority made note of the many disparate views among religions and scientists on when life begins, and concluded it was not up to the states to adopt one theory of life.

Instead, Roe created a framework intended to balance a pregnant woman’s right to make decisions about her body with a public interest in protecting potential human life. That decision and a key ruling that followed generally recognized a woman’s right to abortion up to the point medical professionals judge a fetus viable to survive outside the uterus, at about 24 weeks of gestation.

In decisively overturning Roe in June, the Supreme Court’s conservative majority drew on legal arguments that have shaped another contentious end-of-life issue. The legal standard employed in Dobbs – that there is no right to abortion in the federal Constitution and that states can decide on their own – is the same rationale used in 1997 when the Supreme Court said terminally ill people did not have a constitutional right to medically assisted death. That decision, Washington v. Glucksberg, is mentioned 15 times in the majority opinion for Dobbs and a concurrence by Justice Clarence Thomas.

Often, the same groups that have led the fight to outlaw abortion have also challenged medical aid-in-dying laws. Even after Dobbs, so-called right-to-die laws remain far less common than those codifying state abortion rights. Ten states allow physicians to prescribe lethal doses of medicine for terminally ill patients. Doctors are still prohibited from administering the drugs.

James Bopp, general counsel for the National Right to Life Committee who has been central to the efforts to outlaw abortion, said that both abortion and medically assisted death, which he refers to as physician-assisted suicide, endanger society.

“Every individual human life has inherent value and is sacred,” said Mr. Bopp. “The government has the duty to protect that life.”

Both issues raise profound societal questions: Can the government keep a patient on life support against his wishes, or force a woman to give birth? Can states bar their own residents from going to other states to end a pregnancy, or prohibit out-of-state patients from coming in to seek medically assisted death? And who gets to decide, particularly if the answer imposes a singular religious viewpoint?

Just as there are legal implications that flow from determining a person’s death, from organ donation to inheritance, the implied rights held by a legally recognized zygote are potentially vast. Will death certificates be issued for every lost pregnancy? Will miscarriages be investigated? When will Social Security numbers be issued? How will census counts be tallied and congressional districts drawn?

Medical professionals and bioethicists caution that both the beginning and end of life are complicated biological processes that are not defined by a single identifiable moment – and are ill suited to the political arena.

“Unfortunately, biological occurrences are not events, they are processes,” said David Magnus, PhD, director of the Stanford (Calif.) Center for Biomedical Ethics.

Moreover, asking doctors “What is life?” or “What is death?” may miss the point, said Dr. Magnus: “Medicine can answer the question ‘When does a biological organism cease to exist?’ But they can’t answer the question ‘When does a person begin or end?’ because those are metaphysical issues.”

Ben Sarbey, a doctoral candidate in the department of philosophy at Duke University, Durham, N.C., who studies medical ethics, echoed that perspective, recounting the Paradox of the Heap, a thought experiment that involves placing grains of sand one on top of the next. The philosophical quandary is this: At what point do those grains of sand become something more – a heap?

“We’re going to have a rough time placing a dividing line that this counts as a person and this does not count as a person,” he said. “Many things count as life – a sperm counts as life, a person in a persistent vegetative state counts as life – but does that constitute a person that we should be protecting?”

Even as debate over the court’s abortion decision percolates, the 1981 federal statute that grew out of the presidential committee’s findings, the Uniform Determination of Death Act, is also under review. In 2022, the Uniform Law Commission, a nonpartisan group of legal experts that drafts laws intended for adoption in multiple states, has taken up the work to revisit the definition of death.

The group will consider sharpening the medical standards for brain death in light of advances in the understanding of brain function. And they will look to address lingering questions raised in recent years as families and religious groups have waged heated legal battles over terminating artificial life support for patients with no brain wave activity.

Mr. Bopp, with the National Right to Life Committee, is among those serving on advisory panels for the effort, along with an array of doctors, philosophers, and medical ethicists. The concept of “personhood” that infuses the antiabortion movement’s broader push for fetal rights is expected to be an underlying topic, albeit in mirror image: When does a life form cease being a person?

Dr. Magnus, who is also serving on an advisory panel, has no doubt the commission will reach a consensus, a sober resolution rooted in science. What’s less clear, he said, is whether in today’s political environment that updated definition will hold the same sway, an enduring legal standard embraced across states.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

As life-preserving medical technology advanced in the second half of the 20th century, doctors and families were faced with a thorny decision, one with weighty legal and moral implications: How should we define when life ends? Cardiopulmonary bypass machines could keep the blood pumping and ventilators could maintain breathing long after a patient’s natural ability to perform those vital functions had ceased.

After decades of deliberations involving physicians, bioethicists, attorneys, and theologians, a U.S. presidential commission in 1981 settled on a scientifically derived dividing line between life and death that has endured, more or less, ever since: A person was considered dead when the entire brain – including the brain stem, its most primitive portion – was no longer functioning, even if other vital functions could be maintained indefinitely through artificial life support.

In the decades since, the committee’s criteria have served as a foundation for laws in most states adopting brain death as a standard for legal death.

Now, with the overturning of Roe v. Wade and dozens of states rushing to impose abortion restrictions, American society is engaged in a chaotic race to define the other pole of human existence: When exactly does human life begin? At conception, the hint of a heartbeat, a first breath, the ability to survive outside the womb with the help of the latest technology?

That we’ve been able to devise and apply uniform clinical standards for when life ends, but not when it begins, is due largely to the legal and political maelstrom around abortion. And in the 2 months since the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, eliminating a longstanding federal right to abortion, state legislators are eagerly bounding into that void, looking to codify into law assorted definitions of life that carry profound repercussions for abortion rights, birth control, and assisted reproduction, as well as civil and criminal law.

“The court said that when life begins is up to whoever is running your state – whether they are wrong or not, or you agree with them or not,” said Mary Ziegler, a law professor at the University of California, Davis, who has written several books on the history of abortion.

Unlike the debate over death, which delved into exquisite medical and scientific detail, the legislative scramble to determine when life’s building blocks reach a threshold that warrants government protection as human life has generally ignored the input of mainstream medical professionals.

Instead, red states across much of the South and portions of the Midwest are adopting language drafted by elected officials that is informed by conservative Christian doctrine, often with little scientific underpinning.

A handful of Republican-led states, including Arkansas, Kentucky, Missouri, and Oklahoma, have passed laws declaring that life begins at fertilization, a contention that opens the door to a host of pregnancy-related litigation. This includes wrongful death lawsuits brought on behalf of the estate of an embryo by disgruntled ex-partners against physicians and women who end a pregnancy or even miscarry. (One such lawsuit is underway in Arizona. Another reached the Alabama Supreme Court.)

In Kentucky, the law outlawing abortion uses morally explosive terms to define pregnancy as “the human female reproductive condition of having a living unborn human being within her body throughout the entire embryonic and fetal stages of the unborn child from fertilization to full gestation and childbirth.”

Several other states, including Georgia, have adopted measures equating life with the point at which an embryo’s nascent cardiac activity can be detected by an ultrasound, at around 6 weeks of gestation. Many such laws mischaracterize the flickering electrical impulses detectable at that stage as a heartbeat, including in Georgia, whose Department of Revenue recently announced that “any unborn child with a detectable human heartbeat” can be claimed as a dependent.

The Supreme Court’s 1973 decision in Roe v. Wade that established a constitutional right to abortion did not define a moment when life begins. The opinion, written by Justice Harry Blackmun, observed that the Constitution does not provide a definition of “person,” though it extends protections to those born or naturalized in the United States. The court majority made note of the many disparate views among religions and scientists on when life begins, and concluded it was not up to the states to adopt one theory of life.

Instead, Roe created a framework intended to balance a pregnant woman’s right to make decisions about her body with a public interest in protecting potential human life. That decision and a key ruling that followed generally recognized a woman’s right to abortion up to the point medical professionals judge a fetus viable to survive outside the uterus, at about 24 weeks of gestation.

In decisively overturning Roe in June, the Supreme Court’s conservative majority drew on legal arguments that have shaped another contentious end-of-life issue. The legal standard employed in Dobbs – that there is no right to abortion in the federal Constitution and that states can decide on their own – is the same rationale used in 1997 when the Supreme Court said terminally ill people did not have a constitutional right to medically assisted death. That decision, Washington v. Glucksberg, is mentioned 15 times in the majority opinion for Dobbs and a concurrence by Justice Clarence Thomas.

Often, the same groups that have led the fight to outlaw abortion have also challenged medical aid-in-dying laws. Even after Dobbs, so-called right-to-die laws remain far less common than those codifying state abortion rights. Ten states allow physicians to prescribe lethal doses of medicine for terminally ill patients. Doctors are still prohibited from administering the drugs.

James Bopp, general counsel for the National Right to Life Committee who has been central to the efforts to outlaw abortion, said that both abortion and medically assisted death, which he refers to as physician-assisted suicide, endanger society.

“Every individual human life has inherent value and is sacred,” said Mr. Bopp. “The government has the duty to protect that life.”

Both issues raise profound societal questions: Can the government keep a patient on life support against his wishes, or force a woman to give birth? Can states bar their own residents from going to other states to end a pregnancy, or prohibit out-of-state patients from coming in to seek medically assisted death? And who gets to decide, particularly if the answer imposes a singular religious viewpoint?

Just as there are legal implications that flow from determining a person’s death, from organ donation to inheritance, the implied rights held by a legally recognized zygote are potentially vast. Will death certificates be issued for every lost pregnancy? Will miscarriages be investigated? When will Social Security numbers be issued? How will census counts be tallied and congressional districts drawn?

Medical professionals and bioethicists caution that both the beginning and end of life are complicated biological processes that are not defined by a single identifiable moment – and are ill suited to the political arena.

“Unfortunately, biological occurrences are not events, they are processes,” said David Magnus, PhD, director of the Stanford (Calif.) Center for Biomedical Ethics.

Moreover, asking doctors “What is life?” or “What is death?” may miss the point, said Dr. Magnus: “Medicine can answer the question ‘When does a biological organism cease to exist?’ But they can’t answer the question ‘When does a person begin or end?’ because those are metaphysical issues.”

Ben Sarbey, a doctoral candidate in the department of philosophy at Duke University, Durham, N.C., who studies medical ethics, echoed that perspective, recounting the Paradox of the Heap, a thought experiment that involves placing grains of sand one on top of the next. The philosophical quandary is this: At what point do those grains of sand become something more – a heap?

“We’re going to have a rough time placing a dividing line that this counts as a person and this does not count as a person,” he said. “Many things count as life – a sperm counts as life, a person in a persistent vegetative state counts as life – but does that constitute a person that we should be protecting?”

Even as debate over the court’s abortion decision percolates, the 1981 federal statute that grew out of the presidential committee’s findings, the Uniform Determination of Death Act, is also under review. In 2022, the Uniform Law Commission, a nonpartisan group of legal experts that drafts laws intended for adoption in multiple states, has taken up the work to revisit the definition of death.

The group will consider sharpening the medical standards for brain death in light of advances in the understanding of brain function. And they will look to address lingering questions raised in recent years as families and religious groups have waged heated legal battles over terminating artificial life support for patients with no brain wave activity.

Mr. Bopp, with the National Right to Life Committee, is among those serving on advisory panels for the effort, along with an array of doctors, philosophers, and medical ethicists. The concept of “personhood” that infuses the antiabortion movement’s broader push for fetal rights is expected to be an underlying topic, albeit in mirror image: When does a life form cease being a person?

Dr. Magnus, who is also serving on an advisory panel, has no doubt the commission will reach a consensus, a sober resolution rooted in science. What’s less clear, he said, is whether in today’s political environment that updated definition will hold the same sway, an enduring legal standard embraced across states.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The first major revision in the systematic description of ovulatory disorders in nearly 50 years has been proposed by a consensus of experts organized by the International Federation of Gynecology and Obstetrics.

“The FIGO HyPO-P system for the classification of ovulatory disorders is submitted for consideration as a worldwide standard,” according to the writing committee, who published their methodology and their proposed applications in the International Journal of Gynecology and Obstetrics.

The classification system was created to replace the much-modified World Health Organization system first described in 1973. Since that time, many modifications have been proposed to accommodate advances in imaging and new information about underlying pathologies, but there has been no subsequent authoritative reference with these modifications or any other newer organizing system.

The new system “provides a different structure for determining the diagnosis. Blood tests are not a necessary first step,” explained Malcolm G. Munro, MD, clinical professor, department of obstetrics and gynecology, University of California, Los Angeles. Dr. Munro was the first author of the publication.

The classification system “is not as focused on the specific steps for investigation of ovulatory dysfunction as much as it explains how to structure an investigation of the girl or woman with an ovulatory disorder and then how to characterize the underlying cause,” Dr. Munro said in an interview. “It is designed to allow everyone, whether clinicians, researchers, or patients, to speak the same language.”
 

New system employs four categories

The four primary categories provide just the first level of classification. The next step is encapsulated in the GAIN-FIT-PIE acronym, which frames the presumed or documented categories of etiologies for the primary categories. GAIN stands for genetic, autoimmune, iatrogenic, or neoplasm etiologies. FIT stands for functional, infectious/inflammatory, or trauma and vascular etiologies. PIE stands for physiological, idiopathic, and endocrine etiologies.

By this methodology, a patient with irregular menses, galactorrhea, and elevated prolactin and an MRI showing a pituitary tumor would be identified a type 2-N, signifying pituitary (type 2) involvement with a neoplasm (N).

A third level of classification permits specific diagnostic entities to be named, allowing the patient in the example above to receive a diagnosis of a prolactin-secreting adenoma.

Not all etiologies can be identified with current diagnostic studies, even assuming clinicians have access to the resources, such as advanced imaging, that will increase diagnostic yield. As a result, the authors acknowledged that the classification system will be “aspirational” in at least some patients, but the structure of this system is expected to lead to greater precision in understanding the causes and defining features of ovulatory disorders, which, in turn, might facilitate new research initiatives.

In the published report, diagnostic protocols based on symptoms were described as being “beyond the spectrum” of this initial description. Rather, Dr. Munro explained that the most important contribution of this new classification system are standardization and communication. The system will be amenable for educating trainees and patients, for communicating between clinicians, and as a framework for research where investigators focus on more homogeneous populations of patients.

“There are many causes of ovulatory disorders that are not related to ovarian function. This is one message. Another is that ovulatory disorders are not binary. They occur on a spectrum. These range from transient instances of delayed or failed ovulation to chronic anovulation,” he said.

The new system is “ a welcome update,” according to Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, both in Orlando.

Dr. Trolice pointed to the clinical value of placing PCOS in a separate category. He noted that it affects 8%-13% of women, making it the most common single cause of ovulatory dysfunction.

“Another area that required clarification from prior WHO classifications was hyperprolactinemia, which is now placed in the type II category,” Dr. Trolice said in an interview.

Better terminology can help address a complex set of disorders with multiple causes and variable manifestations.

“In the evaluation of ovulation dysfunction, it is important to remember that regular menstrual intervals do not ensure ovulation,” Dr. Trolice pointed out. Even though a serum progesterone level of higher than 3 ng/mL is one of the simplest laboratory markers for ovulation, this level, he noted, “can vary through the luteal phase and even throughout the day.”

The proposed classification system, while providing a framework for describing ovulatory disorders, is designed to be adaptable, permitting advances in the understanding of the causes of ovulatory dysfunction, in the diagnosis of the causes, and in the treatments to be incorporated.

“No system should be considered permanent,” according to Dr. Munro and his coauthors. “Review and careful modification and revision should be carried out regularly.”

Dr. Munro reports financial relationships with AbbVie, American Regent, Daiichi Sankyo, Hologic, Myovant, and Pharmacosmos. Dr. Trolice reports no potential conflicts of interest.
 

The first major revision in the systematic description of ovulatory disorders in nearly 50 years has been proposed by a consensus of experts organized by the International Federation of Gynecology and Obstetrics.

“The FIGO HyPO-P system for the classification of ovulatory disorders is submitted for consideration as a worldwide standard,” according to the writing committee, who published their methodology and their proposed applications in the International Journal of Gynecology and Obstetrics.

The classification system was created to replace the much-modified World Health Organization system first described in 1973. Since that time, many modifications have been proposed to accommodate advances in imaging and new information about underlying pathologies, but there has been no subsequent authoritative reference with these modifications or any other newer organizing system.

The new system “provides a different structure for determining the diagnosis. Blood tests are not a necessary first step,” explained Malcolm G. Munro, MD, clinical professor, department of obstetrics and gynecology, University of California, Los Angeles. Dr. Munro was the first author of the publication.

The classification system “is not as focused on the specific steps for investigation of ovulatory dysfunction as much as it explains how to structure an investigation of the girl or woman with an ovulatory disorder and then how to characterize the underlying cause,” Dr. Munro said in an interview. “It is designed to allow everyone, whether clinicians, researchers, or patients, to speak the same language.”
 

New system employs four categories

The four primary categories provide just the first level of classification. The next step is encapsulated in the GAIN-FIT-PIE acronym, which frames the presumed or documented categories of etiologies for the primary categories. GAIN stands for genetic, autoimmune, iatrogenic, or neoplasm etiologies. FIT stands for functional, infectious/inflammatory, or trauma and vascular etiologies. PIE stands for physiological, idiopathic, and endocrine etiologies.

By this methodology, a patient with irregular menses, galactorrhea, and elevated prolactin and an MRI showing a pituitary tumor would be identified a type 2-N, signifying pituitary (type 2) involvement with a neoplasm (N).

A third level of classification permits specific diagnostic entities to be named, allowing the patient in the example above to receive a diagnosis of a prolactin-secreting adenoma.

Not all etiologies can be identified with current diagnostic studies, even assuming clinicians have access to the resources, such as advanced imaging, that will increase diagnostic yield. As a result, the authors acknowledged that the classification system will be “aspirational” in at least some patients, but the structure of this system is expected to lead to greater precision in understanding the causes and defining features of ovulatory disorders, which, in turn, might facilitate new research initiatives.

In the published report, diagnostic protocols based on symptoms were described as being “beyond the spectrum” of this initial description. Rather, Dr. Munro explained that the most important contribution of this new classification system are standardization and communication. The system will be amenable for educating trainees and patients, for communicating between clinicians, and as a framework for research where investigators focus on more homogeneous populations of patients.

“There are many causes of ovulatory disorders that are not related to ovarian function. This is one message. Another is that ovulatory disorders are not binary. They occur on a spectrum. These range from transient instances of delayed or failed ovulation to chronic anovulation,” he said.

The new system is “ a welcome update,” according to Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, both in Orlando.

Dr. Trolice pointed to the clinical value of placing PCOS in a separate category. He noted that it affects 8%-13% of women, making it the most common single cause of ovulatory dysfunction.

“Another area that required clarification from prior WHO classifications was hyperprolactinemia, which is now placed in the type II category,” Dr. Trolice said in an interview.

Better terminology can help address a complex set of disorders with multiple causes and variable manifestations.

“In the evaluation of ovulation dysfunction, it is important to remember that regular menstrual intervals do not ensure ovulation,” Dr. Trolice pointed out. Even though a serum progesterone level of higher than 3 ng/mL is one of the simplest laboratory markers for ovulation, this level, he noted, “can vary through the luteal phase and even throughout the day.”

The proposed classification system, while providing a framework for describing ovulatory disorders, is designed to be adaptable, permitting advances in the understanding of the causes of ovulatory dysfunction, in the diagnosis of the causes, and in the treatments to be incorporated.

“No system should be considered permanent,” according to Dr. Munro and his coauthors. “Review and careful modification and revision should be carried out regularly.”

Dr. Munro reports financial relationships with AbbVie, American Regent, Daiichi Sankyo, Hologic, Myovant, and Pharmacosmos. Dr. Trolice reports no potential conflicts of interest.
 

The first major revision in the systematic description of ovulatory disorders in nearly 50 years has been proposed by a consensus of experts organized by the International Federation of Gynecology and Obstetrics.

“The FIGO HyPO-P system for the classification of ovulatory disorders is submitted for consideration as a worldwide standard,” according to the writing committee, who published their methodology and their proposed applications in the International Journal of Gynecology and Obstetrics.

The classification system was created to replace the much-modified World Health Organization system first described in 1973. Since that time, many modifications have been proposed to accommodate advances in imaging and new information about underlying pathologies, but there has been no subsequent authoritative reference with these modifications or any other newer organizing system.

The new system “provides a different structure for determining the diagnosis. Blood tests are not a necessary first step,” explained Malcolm G. Munro, MD, clinical professor, department of obstetrics and gynecology, University of California, Los Angeles. Dr. Munro was the first author of the publication.

The classification system “is not as focused on the specific steps for investigation of ovulatory dysfunction as much as it explains how to structure an investigation of the girl or woman with an ovulatory disorder and then how to characterize the underlying cause,” Dr. Munro said in an interview. “It is designed to allow everyone, whether clinicians, researchers, or patients, to speak the same language.”
 

New system employs four categories

The four primary categories provide just the first level of classification. The next step is encapsulated in the GAIN-FIT-PIE acronym, which frames the presumed or documented categories of etiologies for the primary categories. GAIN stands for genetic, autoimmune, iatrogenic, or neoplasm etiologies. FIT stands for functional, infectious/inflammatory, or trauma and vascular etiologies. PIE stands for physiological, idiopathic, and endocrine etiologies.

By this methodology, a patient with irregular menses, galactorrhea, and elevated prolactin and an MRI showing a pituitary tumor would be identified a type 2-N, signifying pituitary (type 2) involvement with a neoplasm (N).

A third level of classification permits specific diagnostic entities to be named, allowing the patient in the example above to receive a diagnosis of a prolactin-secreting adenoma.

Not all etiologies can be identified with current diagnostic studies, even assuming clinicians have access to the resources, such as advanced imaging, that will increase diagnostic yield. As a result, the authors acknowledged that the classification system will be “aspirational” in at least some patients, but the structure of this system is expected to lead to greater precision in understanding the causes and defining features of ovulatory disorders, which, in turn, might facilitate new research initiatives.

In the published report, diagnostic protocols based on symptoms were described as being “beyond the spectrum” of this initial description. Rather, Dr. Munro explained that the most important contribution of this new classification system are standardization and communication. The system will be amenable for educating trainees and patients, for communicating between clinicians, and as a framework for research where investigators focus on more homogeneous populations of patients.

“There are many causes of ovulatory disorders that are not related to ovarian function. This is one message. Another is that ovulatory disorders are not binary. They occur on a spectrum. These range from transient instances of delayed or failed ovulation to chronic anovulation,” he said.

The new system is “ a welcome update,” according to Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, both in Orlando.

Dr. Trolice pointed to the clinical value of placing PCOS in a separate category. He noted that it affects 8%-13% of women, making it the most common single cause of ovulatory dysfunction.

“Another area that required clarification from prior WHO classifications was hyperprolactinemia, which is now placed in the type II category,” Dr. Trolice said in an interview.

Better terminology can help address a complex set of disorders with multiple causes and variable manifestations.

“In the evaluation of ovulation dysfunction, it is important to remember that regular menstrual intervals do not ensure ovulation,” Dr. Trolice pointed out. Even though a serum progesterone level of higher than 3 ng/mL is one of the simplest laboratory markers for ovulation, this level, he noted, “can vary through the luteal phase and even throughout the day.”

The proposed classification system, while providing a framework for describing ovulatory disorders, is designed to be adaptable, permitting advances in the understanding of the causes of ovulatory dysfunction, in the diagnosis of the causes, and in the treatments to be incorporated.

“No system should be considered permanent,” according to Dr. Munro and his coauthors. “Review and careful modification and revision should be carried out regularly.”

Dr. Munro reports financial relationships with AbbVie, American Regent, Daiichi Sankyo, Hologic, Myovant, and Pharmacosmos. Dr. Trolice reports no potential conflicts of interest.
 

Polycystic ovary syndrome (PCOS) affects an estimated 8%-13% of women, and yet “it has been quite a black box for many years,” as Margo Hudson, MD, an assistant professor of endocrinology, diabetes, and hypertension at Harvard Medical School, Boston, puts it. That black box encompasses not only uncertainty about the etiology and pathophysiology of the condition but even what constitutes a diagnosis.

Even the international guidelines on PCOS management endorsed by the American Society for Reproductive Medicine – a document developed over 15 months with the input of 37 medical organizations covering 71 countries – notes that PCOS diagnosis is “controversial and assessment and management are inconsistent.” The result, the guidelines note, is that “the needs of women with PCOS are not being adequately met.”

One of the earliest diagnostic criteria, defined in 1990 by the National Institutes of Health, required only hyperandrogenism and irregular menstruation. Then the 2003 Rotterdam Criteria added presence of polycystic ovaries on ultrasound as a third criterion. Then the Androgen Excess Society determined that PCOS required presence of hyperandrogenism with either polycystic ovaries or oligo/amenorrhea anovulation. Yet the Endocrine Society notes that excess androgen levels are seen in 60%-80% of those with PCOS, suggesting it’s not an essential requirement for diagnosis, leaving most to diagnose it in people who have two of the three key criteria. The only real agreement on diagnosis is the need to eliminate other potential diagnoses first, making PCOS always a diagnosis of exclusion.

Further, though PCOS is known as the leading cause of infertility in women, it is more than a reproductive condition, with metabolic and psychological features as well. Then there is the range of comorbidities, none of which occur in all patients with PCOS but all of which occur in a majority and which are themselves interrelated. Insulin resistance is a common feature, occurring in 50%-70% of people with PCOS. Accordingly, metabolic syndrome occurs in at least a third of people with PCOS and type 2 diabetes prevalence is higher in those with PCOS as well.

Obesity occurs in an estimated 80% of women with PCOS in the United States, though it affects only about 50% of women with PCOS outside the United States, and those with PCOS have an increased risk of hypertension. Mood disorders, particularly anxiety and depression but also, to a lesser extent, bipolar disorder and obsessive-compulsive disorder, are more likely in people with PCOS. And given that these comorbidities are all cardiovascular risk factors, it’s unsurprising that recent studies are finding those with PCOS to be at greater risk for cardiometabolic disease and major cardiovascular events.

“The reality is that PCOS is a heterogenous entity. It’s not one thing – it’s a syndrome,” Lubna Pal, MBBS, a professor of ob.gyn. and director of the PCOS Program at Yale University, New Haven, Conn., said in an interview. A whole host of factors are likely playing a role in the causes of PCOS, and those factors interact differently within different people. “We’re looking at things like lipid metabolism, fetal origins, the gut microbiome, genetics, epigenetics, and then dietary and environmental factors,” Nichole Tyson, MD, division chief of pediatric and adolescent gynecology and a clinical associate professor at Stanford (Calif.) Medicine Children’s Health, said in an interview. And most studies have identified associations that may or may not be causal. Take, for example, endocrine disruptors. BPA levels have been shown to be higher in women with PCOS than women without, but that correlation may or may not be related to the etiology of the condition.
 

The hypothalamic-pituitary-gonadal axis

In trying to understand the pathophysiology of the condition, much of the latest research has zeroed in on potential mechanisms in the hypothalamic-pituitary-gonadal axis. “A consistent feature of PCOS is disordered gonadotropin secretion with elevated mean LH [luteinizing hormone], low or low normal FSH [follicle-stimulating hormone], and a persistently rapid frequency of GnRH [gonadotropin-releasing hormone] pulse secretion,” wrote authors of a scientific statement on aspects of PCOS.

“I think the balance is heading more to central neurologic control of the reproductive system and that disturbances there impact the GnRH cells in the hypothalamus, which then go on to give us the findings that we can measure peripherally with the LH-FSH ratio,” Dr. Hudson said in an interview.

The increased LH levels are thought to be a major driver of increased androgen levels. Current thinking suggests that the primary driver of increased LH is GnRH pulsatility, supported not only by human studies but by animal models as well. This leads to the question of what drives GnRH dysregulation. One hypothesis posits that GABA neurons play a role here, given findings that GABA levels in cerebrospinal fluid were higher in women with PCOS than those with normal ovulation.

But the culprit garnering the most attention is kisspeptin, a protein encoded by the KISS1 gene that stimulates GnRH neurons and has been linked to regulation of LH and FSH secretion. Kisspeptin, along with neurokinin B and dynorphin, is part of the triumvirate that comprises KNDy neurons, also recently implicated in menopausal vasomotor symptoms. Multiple systematic reviewsand meta-analyses have found a correlation between higher kisspeptin levels in the blood and higher circulating LH levels, regardless of body mass index. While kisspeptin is expressed in several tissues, including liver, pancreas, gonad, and adipose, it’s neural kisspeptin signaling that appears most likely to play a role in activating GnRH hormones and disrupting normal function of the hypothalamic-pituitary-gonadal axis.

But as noted, in at least one systematic review of kisspeptin and PCOS, “findings from animal studies suggest that kisspeptin levels are not increased in all subtypes of PCOS.” And another review found “altered” levels of kisspeptin levels in non-PCOS patients who had obesity, potentially raising questions about any associations between kisspeptin and obesity or insulin resistance.
 

Remaining chicken-and-egg questions

A hallmark of PCOS has long been, and continues to be, the string of chicken-or-egg questions that plague understanding of it. One of these is how depression and anxiety fit into the etiology of PCOS. Exploring the role of specific neurons that may overstimulate GnRH pulsatility may hold clues to a common underlying mechanism for the involvement of depression and anxiety in patients with PCOS, Dr. Hudson speculated. While previous assumptions often attributed depression and anxiety in PCOS to the symptoms – such as thin scalp hair and increased facial hair, excess weight, acne, and irregular periods – Dr. Hudson pointed out that women can address many of these symptoms with laser hair removal, weight loss, acne treatment, and similar interventions, yet they still have a lot of underlying mental health issues.

It’s also unclear whether metabolic factors so common with PCOS, particularly insulin resistance and obesity, are a result of the condition or are contributors to it. Is insulin resistance contributing to dysregulation in the neurons that interferes with normal functioning of the hypothalamic-pituitary-adrenal axis? Is abnormal functioning along this axis contributing to insulin resistance? Or neither? Or both? Or does it depend? The authors of one paper wrote that “insulin may play both direct and indirect roles in the pathogenesis of androgen excess in PCOS,” since insulin can “stimulate ovarian androgen production” and “enhance ovarian growth and follicular cyst formation in rats.”

Dr. Pal noted that “obesity itself can evolve into a PCOS-like picture,” raising questions about whether obesity or insulin resistance might be part of the causal pathway to PCOS, or whether either can trigger its development in those genetically predisposed.

“Obesity does appear to exacerbate many aspects of the PCOS phenotype, particularly those risk factors related to metabolic syndrome,” wrote the authors of a scientific statement on aspects of PCOS, but they add that “it is currently debated whether obesity per se can cause PCOS.” While massive weight loss in those with PCOS and obesity has improved multiple reproductive and metabolic issues, it hasn’t resolved all of them, they write.

Dr. Hudson said she expects there’s “some degree of appetite dysregulation and metabolic dysregulation” that contributes, but then there are other women who don’t have much of an appetite or overeat and still struggle with their weight. Evidence has also found insulin resistance in women of normal weight with PCOS. “There may be some kind of metabolic dysregulation that they have at some level, and others are clearly bothered by overeating,” Dr. Hudson said.

Similarly, it’s not clear whether the recent discovery of increased cardiovascular risks in people with PCOS is a result of the comorbidities so common with PCOS, such as obesity, or whether an underlying mechanism links the cardiovascular risk and the dysregulation of hormones. Dr. Pal would argue that, again, it’s probably both, depending on the patient.

Then there is the key feature of hyperandrogenemia. “An outstanding debate is whether the elevated androgens in PCOS women are merely a downstream endocrine response to hyperactive GnRH and LH secretion driving the ovary, or do the elevated androgens themselves act in the brain (or pituitary) during development and/or adulthood to sculpt and maintain the hypersecretion of GnRH and LH?” wrote Eulalia A. Coutinho, PhD, and Alexander S. Kauffman, PhD, in a 2019 review of the brain’s role in PCOS.

These problems may be bidirectional or part of various feedback loops. Sleep apnea is more common in people with PCOS, Dr. Tyson noted, but sleep apnea is also linked to cardiovascular, metabolic, and depression risks, and depression can play a role in obesity, which increases the risk of obstructive sleep apnea. “So you’re in this vicious cycle,” Dr. Tyson said. That’s why she also believes it’s important to change the dialogue and perspective on PCOS, to reduce the stigma attached to it, and work with patients to empower them in treating its symptoms and reducing their risk of comorbidities.
 

Recent and upcoming changes in treatment

Current treatment of PCOS already changes according to the symptoms posing the greatest problems at each stage of a person’s life, Dr. Hudson said. Younger women tend to be more bothered about the cosmetic effects of PCOS, including hair growth patterns and acne, but as they grow out of adolescence and into their 20s and 30s, infertility becomes a bigger concern for many. Then, as they start approaching menopause, metabolic and cardiovascular issues take the lead, with more of a focus on lipids, diabetes risk, and heart health.

In some ways, management of PCOS hasn’t changed much in the past several decades, except in an increased awareness of the metabolic and cardiovascular risks, which has led to more frequent screening to catch potential conditions earlier in life. What has changed, however, is improvements in the treatments used for symptoms, such as expanded bariatric surgery options and GLP-1 agonists for treating obesity. Other examples include better options for menstrual management, such as new progesterone IUDs, and optimized fertility treatments, Dr. Tyson said.

“I think with more of these large-scale studies about the pathophysiology of PCOS and how it may look in different people and the different outcomes, we may be able to tailor our treatments even further,” Dr. Tyson said. She emphasized the importance of identifying the condition early, particularly in adolescents, even if it’s identifying young people at risk for the condition rather than actually having it yet.

Early identification “gives us this chance to do a lot of preventative care and motivate older teens to have a great lifestyle, work on their diet and exercise, and manage cardiovascular” risk factors, Dr. Tyson said.

“What we do know and recognize is that there’s so many spokes to this PCOS wheel that there really should be a multidisciplinary approach to care,” Dr. Tyson said. “When I think about who would be the real doctors for patients with PCOS, these would be gynecologists, endocrinologists, dermatologists, nutritionists, psychologists, sleep specialists, and primary care at a minimum.”

Dr. Pal worries that the label of PCOS leaves it in the laps of ob.gyns. whereas, “if it was called something else, everybody would be involved in being vigilant and managing those patients.” She frequently reiterated that the label of PCOS is less important than ensuring clinicians treat the symptoms that most bother the patient.

And even if kisspeptin does play a causal role in PCOS for some patients, it’s only a subset of individuals with PCOS who would benefit from therapies developed to target it. Given the complexity of the syndrome and its many manifestations, a “galaxy of pathways” are involved in different potential subtypes of the condition. “You can’t treat PCOS as one entity,” Dr. Pal said.

Still, Dr. Hudson is optimistic that the research into potential neuroendocrine contributions to PCOS will yield therapies that go beyond just managing symptoms.

“There aren’t a lot of treatments available yet, but there may be some on the horizon,” Dr. Hudson said. “We’re still in this very primitive stage in terms of therapeutics, where we’re only addressing specific symptoms, and we haven’t been able to really address the underlying cause because we haven’t understood it as well and because we don’t have therapies that can target it,” Dr. Hudson said. “But once there are therapies developed that will target some of these central mechanisms, I think it will change completely the approach to treating PCOS for patients.”

This story was updated on Sept. 6, 2022.

Polycystic ovary syndrome (PCOS) affects an estimated 8%-13% of women, and yet “it has been quite a black box for many years,” as Margo Hudson, MD, an assistant professor of endocrinology, diabetes, and hypertension at Harvard Medical School, Boston, puts it. That black box encompasses not only uncertainty about the etiology and pathophysiology of the condition but even what constitutes a diagnosis.

Even the international guidelines on PCOS management endorsed by the American Society for Reproductive Medicine – a document developed over 15 months with the input of 37 medical organizations covering 71 countries – notes that PCOS diagnosis is “controversial and assessment and management are inconsistent.” The result, the guidelines note, is that “the needs of women with PCOS are not being adequately met.”

One of the earliest diagnostic criteria, defined in 1990 by the National Institutes of Health, required only hyperandrogenism and irregular menstruation. Then the 2003 Rotterdam Criteria added presence of polycystic ovaries on ultrasound as a third criterion. Then the Androgen Excess Society determined that PCOS required presence of hyperandrogenism with either polycystic ovaries or oligo/amenorrhea anovulation. Yet the Endocrine Society notes that excess androgen levels are seen in 60%-80% of those with PCOS, suggesting it’s not an essential requirement for diagnosis, leaving most to diagnose it in people who have two of the three key criteria. The only real agreement on diagnosis is the need to eliminate other potential diagnoses first, making PCOS always a diagnosis of exclusion.

Further, though PCOS is known as the leading cause of infertility in women, it is more than a reproductive condition, with metabolic and psychological features as well. Then there is the range of comorbidities, none of which occur in all patients with PCOS but all of which occur in a majority and which are themselves interrelated. Insulin resistance is a common feature, occurring in 50%-70% of people with PCOS. Accordingly, metabolic syndrome occurs in at least a third of people with PCOS and type 2 diabetes prevalence is higher in those with PCOS as well.

Obesity occurs in an estimated 80% of women with PCOS in the United States, though it affects only about 50% of women with PCOS outside the United States, and those with PCOS have an increased risk of hypertension. Mood disorders, particularly anxiety and depression but also, to a lesser extent, bipolar disorder and obsessive-compulsive disorder, are more likely in people with PCOS. And given that these comorbidities are all cardiovascular risk factors, it’s unsurprising that recent studies are finding those with PCOS to be at greater risk for cardiometabolic disease and major cardiovascular events.

“The reality is that PCOS is a heterogenous entity. It’s not one thing – it’s a syndrome,” Lubna Pal, MBBS, a professor of ob.gyn. and director of the PCOS Program at Yale University, New Haven, Conn., said in an interview. A whole host of factors are likely playing a role in the causes of PCOS, and those factors interact differently within different people. “We’re looking at things like lipid metabolism, fetal origins, the gut microbiome, genetics, epigenetics, and then dietary and environmental factors,” Nichole Tyson, MD, division chief of pediatric and adolescent gynecology and a clinical associate professor at Stanford (Calif.) Medicine Children’s Health, said in an interview. And most studies have identified associations that may or may not be causal. Take, for example, endocrine disruptors. BPA levels have been shown to be higher in women with PCOS than women without, but that correlation may or may not be related to the etiology of the condition.
 

The hypothalamic-pituitary-gonadal axis

In trying to understand the pathophysiology of the condition, much of the latest research has zeroed in on potential mechanisms in the hypothalamic-pituitary-gonadal axis. “A consistent feature of PCOS is disordered gonadotropin secretion with elevated mean LH [luteinizing hormone], low or low normal FSH [follicle-stimulating hormone], and a persistently rapid frequency of GnRH [gonadotropin-releasing hormone] pulse secretion,” wrote authors of a scientific statement on aspects of PCOS.

“I think the balance is heading more to central neurologic control of the reproductive system and that disturbances there impact the GnRH cells in the hypothalamus, which then go on to give us the findings that we can measure peripherally with the LH-FSH ratio,” Dr. Hudson said in an interview.

The increased LH levels are thought to be a major driver of increased androgen levels. Current thinking suggests that the primary driver of increased LH is GnRH pulsatility, supported not only by human studies but by animal models as well. This leads to the question of what drives GnRH dysregulation. One hypothesis posits that GABA neurons play a role here, given findings that GABA levels in cerebrospinal fluid were higher in women with PCOS than those with normal ovulation.

But the culprit garnering the most attention is kisspeptin, a protein encoded by the KISS1 gene that stimulates GnRH neurons and has been linked to regulation of LH and FSH secretion. Kisspeptin, along with neurokinin B and dynorphin, is part of the triumvirate that comprises KNDy neurons, also recently implicated in menopausal vasomotor symptoms. Multiple systematic reviewsand meta-analyses have found a correlation between higher kisspeptin levels in the blood and higher circulating LH levels, regardless of body mass index. While kisspeptin is expressed in several tissues, including liver, pancreas, gonad, and adipose, it’s neural kisspeptin signaling that appears most likely to play a role in activating GnRH hormones and disrupting normal function of the hypothalamic-pituitary-gonadal axis.

But as noted, in at least one systematic review of kisspeptin and PCOS, “findings from animal studies suggest that kisspeptin levels are not increased in all subtypes of PCOS.” And another review found “altered” levels of kisspeptin levels in non-PCOS patients who had obesity, potentially raising questions about any associations between kisspeptin and obesity or insulin resistance.
 

Remaining chicken-and-egg questions

A hallmark of PCOS has long been, and continues to be, the string of chicken-or-egg questions that plague understanding of it. One of these is how depression and anxiety fit into the etiology of PCOS. Exploring the role of specific neurons that may overstimulate GnRH pulsatility may hold clues to a common underlying mechanism for the involvement of depression and anxiety in patients with PCOS, Dr. Hudson speculated. While previous assumptions often attributed depression and anxiety in PCOS to the symptoms – such as thin scalp hair and increased facial hair, excess weight, acne, and irregular periods – Dr. Hudson pointed out that women can address many of these symptoms with laser hair removal, weight loss, acne treatment, and similar interventions, yet they still have a lot of underlying mental health issues.

It’s also unclear whether metabolic factors so common with PCOS, particularly insulin resistance and obesity, are a result of the condition or are contributors to it. Is insulin resistance contributing to dysregulation in the neurons that interferes with normal functioning of the hypothalamic-pituitary-adrenal axis? Is abnormal functioning along this axis contributing to insulin resistance? Or neither? Or both? Or does it depend? The authors of one paper wrote that “insulin may play both direct and indirect roles in the pathogenesis of androgen excess in PCOS,” since insulin can “stimulate ovarian androgen production” and “enhance ovarian growth and follicular cyst formation in rats.”

Dr. Pal noted that “obesity itself can evolve into a PCOS-like picture,” raising questions about whether obesity or insulin resistance might be part of the causal pathway to PCOS, or whether either can trigger its development in those genetically predisposed.

“Obesity does appear to exacerbate many aspects of the PCOS phenotype, particularly those risk factors related to metabolic syndrome,” wrote the authors of a scientific statement on aspects of PCOS, but they add that “it is currently debated whether obesity per se can cause PCOS.” While massive weight loss in those with PCOS and obesity has improved multiple reproductive and metabolic issues, it hasn’t resolved all of them, they write.

Dr. Hudson said she expects there’s “some degree of appetite dysregulation and metabolic dysregulation” that contributes, but then there are other women who don’t have much of an appetite or overeat and still struggle with their weight. Evidence has also found insulin resistance in women of normal weight with PCOS. “There may be some kind of metabolic dysregulation that they have at some level, and others are clearly bothered by overeating,” Dr. Hudson said.

Similarly, it’s not clear whether the recent discovery of increased cardiovascular risks in people with PCOS is a result of the comorbidities so common with PCOS, such as obesity, or whether an underlying mechanism links the cardiovascular risk and the dysregulation of hormones. Dr. Pal would argue that, again, it’s probably both, depending on the patient.

Then there is the key feature of hyperandrogenemia. “An outstanding debate is whether the elevated androgens in PCOS women are merely a downstream endocrine response to hyperactive GnRH and LH secretion driving the ovary, or do the elevated androgens themselves act in the brain (or pituitary) during development and/or adulthood to sculpt and maintain the hypersecretion of GnRH and LH?” wrote Eulalia A. Coutinho, PhD, and Alexander S. Kauffman, PhD, in a 2019 review of the brain’s role in PCOS.

These problems may be bidirectional or part of various feedback loops. Sleep apnea is more common in people with PCOS, Dr. Tyson noted, but sleep apnea is also linked to cardiovascular, metabolic, and depression risks, and depression can play a role in obesity, which increases the risk of obstructive sleep apnea. “So you’re in this vicious cycle,” Dr. Tyson said. That’s why she also believes it’s important to change the dialogue and perspective on PCOS, to reduce the stigma attached to it, and work with patients to empower them in treating its symptoms and reducing their risk of comorbidities.
 

Recent and upcoming changes in treatment

Current treatment of PCOS already changes according to the symptoms posing the greatest problems at each stage of a person’s life, Dr. Hudson said. Younger women tend to be more bothered about the cosmetic effects of PCOS, including hair growth patterns and acne, but as they grow out of adolescence and into their 20s and 30s, infertility becomes a bigger concern for many. Then, as they start approaching menopause, metabolic and cardiovascular issues take the lead, with more of a focus on lipids, diabetes risk, and heart health.

In some ways, management of PCOS hasn’t changed much in the past several decades, except in an increased awareness of the metabolic and cardiovascular risks, which has led to more frequent screening to catch potential conditions earlier in life. What has changed, however, is improvements in the treatments used for symptoms, such as expanded bariatric surgery options and GLP-1 agonists for treating obesity. Other examples include better options for menstrual management, such as new progesterone IUDs, and optimized fertility treatments, Dr. Tyson said.

“I think with more of these large-scale studies about the pathophysiology of PCOS and how it may look in different people and the different outcomes, we may be able to tailor our treatments even further,” Dr. Tyson said. She emphasized the importance of identifying the condition early, particularly in adolescents, even if it’s identifying young people at risk for the condition rather than actually having it yet.

Early identification “gives us this chance to do a lot of preventative care and motivate older teens to have a great lifestyle, work on their diet and exercise, and manage cardiovascular” risk factors, Dr. Tyson said.

“What we do know and recognize is that there’s so many spokes to this PCOS wheel that there really should be a multidisciplinary approach to care,” Dr. Tyson said. “When I think about who would be the real doctors for patients with PCOS, these would be gynecologists, endocrinologists, dermatologists, nutritionists, psychologists, sleep specialists, and primary care at a minimum.”

Dr. Pal worries that the label of PCOS leaves it in the laps of ob.gyns. whereas, “if it was called something else, everybody would be involved in being vigilant and managing those patients.” She frequently reiterated that the label of PCOS is less important than ensuring clinicians treat the symptoms that most bother the patient.

And even if kisspeptin does play a causal role in PCOS for some patients, it’s only a subset of individuals with PCOS who would benefit from therapies developed to target it. Given the complexity of the syndrome and its many manifestations, a “galaxy of pathways” are involved in different potential subtypes of the condition. “You can’t treat PCOS as one entity,” Dr. Pal said.

Still, Dr. Hudson is optimistic that the research into potential neuroendocrine contributions to PCOS will yield therapies that go beyond just managing symptoms.

“There aren’t a lot of treatments available yet, but there may be some on the horizon,” Dr. Hudson said. “We’re still in this very primitive stage in terms of therapeutics, where we’re only addressing specific symptoms, and we haven’t been able to really address the underlying cause because we haven’t understood it as well and because we don’t have therapies that can target it,” Dr. Hudson said. “But once there are therapies developed that will target some of these central mechanisms, I think it will change completely the approach to treating PCOS for patients.”

This story was updated on Sept. 6, 2022.

Polycystic ovary syndrome (PCOS) affects an estimated 8%-13% of women, and yet “it has been quite a black box for many years,” as Margo Hudson, MD, an assistant professor of endocrinology, diabetes, and hypertension at Harvard Medical School, Boston, puts it. That black box encompasses not only uncertainty about the etiology and pathophysiology of the condition but even what constitutes a diagnosis.

Even the international guidelines on PCOS management endorsed by the American Society for Reproductive Medicine – a document developed over 15 months with the input of 37 medical organizations covering 71 countries – notes that PCOS diagnosis is “controversial and assessment and management are inconsistent.” The result, the guidelines note, is that “the needs of women with PCOS are not being adequately met.”

One of the earliest diagnostic criteria, defined in 1990 by the National Institutes of Health, required only hyperandrogenism and irregular menstruation. Then the 2003 Rotterdam Criteria added presence of polycystic ovaries on ultrasound as a third criterion. Then the Androgen Excess Society determined that PCOS required presence of hyperandrogenism with either polycystic ovaries or oligo/amenorrhea anovulation. Yet the Endocrine Society notes that excess androgen levels are seen in 60%-80% of those with PCOS, suggesting it’s not an essential requirement for diagnosis, leaving most to diagnose it in people who have two of the three key criteria. The only real agreement on diagnosis is the need to eliminate other potential diagnoses first, making PCOS always a diagnosis of exclusion.

Further, though PCOS is known as the leading cause of infertility in women, it is more than a reproductive condition, with metabolic and psychological features as well. Then there is the range of comorbidities, none of which occur in all patients with PCOS but all of which occur in a majority and which are themselves interrelated. Insulin resistance is a common feature, occurring in 50%-70% of people with PCOS. Accordingly, metabolic syndrome occurs in at least a third of people with PCOS and type 2 diabetes prevalence is higher in those with PCOS as well.

Obesity occurs in an estimated 80% of women with PCOS in the United States, though it affects only about 50% of women with PCOS outside the United States, and those with PCOS have an increased risk of hypertension. Mood disorders, particularly anxiety and depression but also, to a lesser extent, bipolar disorder and obsessive-compulsive disorder, are more likely in people with PCOS. And given that these comorbidities are all cardiovascular risk factors, it’s unsurprising that recent studies are finding those with PCOS to be at greater risk for cardiometabolic disease and major cardiovascular events.

“The reality is that PCOS is a heterogenous entity. It’s not one thing – it’s a syndrome,” Lubna Pal, MBBS, a professor of ob.gyn. and director of the PCOS Program at Yale University, New Haven, Conn., said in an interview. A whole host of factors are likely playing a role in the causes of PCOS, and those factors interact differently within different people. “We’re looking at things like lipid metabolism, fetal origins, the gut microbiome, genetics, epigenetics, and then dietary and environmental factors,” Nichole Tyson, MD, division chief of pediatric and adolescent gynecology and a clinical associate professor at Stanford (Calif.) Medicine Children’s Health, said in an interview. And most studies have identified associations that may or may not be causal. Take, for example, endocrine disruptors. BPA levels have been shown to be higher in women with PCOS than women without, but that correlation may or may not be related to the etiology of the condition.
 

The hypothalamic-pituitary-gonadal axis

In trying to understand the pathophysiology of the condition, much of the latest research has zeroed in on potential mechanisms in the hypothalamic-pituitary-gonadal axis. “A consistent feature of PCOS is disordered gonadotropin secretion with elevated mean LH [luteinizing hormone], low or low normal FSH [follicle-stimulating hormone], and a persistently rapid frequency of GnRH [gonadotropin-releasing hormone] pulse secretion,” wrote authors of a scientific statement on aspects of PCOS.

“I think the balance is heading more to central neurologic control of the reproductive system and that disturbances there impact the GnRH cells in the hypothalamus, which then go on to give us the findings that we can measure peripherally with the LH-FSH ratio,” Dr. Hudson said in an interview.

The increased LH levels are thought to be a major driver of increased androgen levels. Current thinking suggests that the primary driver of increased LH is GnRH pulsatility, supported not only by human studies but by animal models as well. This leads to the question of what drives GnRH dysregulation. One hypothesis posits that GABA neurons play a role here, given findings that GABA levels in cerebrospinal fluid were higher in women with PCOS than those with normal ovulation.

But the culprit garnering the most attention is kisspeptin, a protein encoded by the KISS1 gene that stimulates GnRH neurons and has been linked to regulation of LH and FSH secretion. Kisspeptin, along with neurokinin B and dynorphin, is part of the triumvirate that comprises KNDy neurons, also recently implicated in menopausal vasomotor symptoms. Multiple systematic reviewsand meta-analyses have found a correlation between higher kisspeptin levels in the blood and higher circulating LH levels, regardless of body mass index. While kisspeptin is expressed in several tissues, including liver, pancreas, gonad, and adipose, it’s neural kisspeptin signaling that appears most likely to play a role in activating GnRH hormones and disrupting normal function of the hypothalamic-pituitary-gonadal axis.

But as noted, in at least one systematic review of kisspeptin and PCOS, “findings from animal studies suggest that kisspeptin levels are not increased in all subtypes of PCOS.” And another review found “altered” levels of kisspeptin levels in non-PCOS patients who had obesity, potentially raising questions about any associations between kisspeptin and obesity or insulin resistance.
 

Remaining chicken-and-egg questions

A hallmark of PCOS has long been, and continues to be, the string of chicken-or-egg questions that plague understanding of it. One of these is how depression and anxiety fit into the etiology of PCOS. Exploring the role of specific neurons that may overstimulate GnRH pulsatility may hold clues to a common underlying mechanism for the involvement of depression and anxiety in patients with PCOS, Dr. Hudson speculated. While previous assumptions often attributed depression and anxiety in PCOS to the symptoms – such as thin scalp hair and increased facial hair, excess weight, acne, and irregular periods – Dr. Hudson pointed out that women can address many of these symptoms with laser hair removal, weight loss, acne treatment, and similar interventions, yet they still have a lot of underlying mental health issues.

It’s also unclear whether metabolic factors so common with PCOS, particularly insulin resistance and obesity, are a result of the condition or are contributors to it. Is insulin resistance contributing to dysregulation in the neurons that interferes with normal functioning of the hypothalamic-pituitary-adrenal axis? Is abnormal functioning along this axis contributing to insulin resistance? Or neither? Or both? Or does it depend? The authors of one paper wrote that “insulin may play both direct and indirect roles in the pathogenesis of androgen excess in PCOS,” since insulin can “stimulate ovarian androgen production” and “enhance ovarian growth and follicular cyst formation in rats.”

Dr. Pal noted that “obesity itself can evolve into a PCOS-like picture,” raising questions about whether obesity or insulin resistance might be part of the causal pathway to PCOS, or whether either can trigger its development in those genetically predisposed.

“Obesity does appear to exacerbate many aspects of the PCOS phenotype, particularly those risk factors related to metabolic syndrome,” wrote the authors of a scientific statement on aspects of PCOS, but they add that “it is currently debated whether obesity per se can cause PCOS.” While massive weight loss in those with PCOS and obesity has improved multiple reproductive and metabolic issues, it hasn’t resolved all of them, they write.

Dr. Hudson said she expects there’s “some degree of appetite dysregulation and metabolic dysregulation” that contributes, but then there are other women who don’t have much of an appetite or overeat and still struggle with their weight. Evidence has also found insulin resistance in women of normal weight with PCOS. “There may be some kind of metabolic dysregulation that they have at some level, and others are clearly bothered by overeating,” Dr. Hudson said.

Similarly, it’s not clear whether the recent discovery of increased cardiovascular risks in people with PCOS is a result of the comorbidities so common with PCOS, such as obesity, or whether an underlying mechanism links the cardiovascular risk and the dysregulation of hormones. Dr. Pal would argue that, again, it’s probably both, depending on the patient.

Then there is the key feature of hyperandrogenemia. “An outstanding debate is whether the elevated androgens in PCOS women are merely a downstream endocrine response to hyperactive GnRH and LH secretion driving the ovary, or do the elevated androgens themselves act in the brain (or pituitary) during development and/or adulthood to sculpt and maintain the hypersecretion of GnRH and LH?” wrote Eulalia A. Coutinho, PhD, and Alexander S. Kauffman, PhD, in a 2019 review of the brain’s role in PCOS.

These problems may be bidirectional or part of various feedback loops. Sleep apnea is more common in people with PCOS, Dr. Tyson noted, but sleep apnea is also linked to cardiovascular, metabolic, and depression risks, and depression can play a role in obesity, which increases the risk of obstructive sleep apnea. “So you’re in this vicious cycle,” Dr. Tyson said. That’s why she also believes it’s important to change the dialogue and perspective on PCOS, to reduce the stigma attached to it, and work with patients to empower them in treating its symptoms and reducing their risk of comorbidities.
 

Recent and upcoming changes in treatment

Current treatment of PCOS already changes according to the symptoms posing the greatest problems at each stage of a person’s life, Dr. Hudson said. Younger women tend to be more bothered about the cosmetic effects of PCOS, including hair growth patterns and acne, but as they grow out of adolescence and into their 20s and 30s, infertility becomes a bigger concern for many. Then, as they start approaching menopause, metabolic and cardiovascular issues take the lead, with more of a focus on lipids, diabetes risk, and heart health.

In some ways, management of PCOS hasn’t changed much in the past several decades, except in an increased awareness of the metabolic and cardiovascular risks, which has led to more frequent screening to catch potential conditions earlier in life. What has changed, however, is improvements in the treatments used for symptoms, such as expanded bariatric surgery options and GLP-1 agonists for treating obesity. Other examples include better options for menstrual management, such as new progesterone IUDs, and optimized fertility treatments, Dr. Tyson said.

“I think with more of these large-scale studies about the pathophysiology of PCOS and how it may look in different people and the different outcomes, we may be able to tailor our treatments even further,” Dr. Tyson said. She emphasized the importance of identifying the condition early, particularly in adolescents, even if it’s identifying young people at risk for the condition rather than actually having it yet.

Early identification “gives us this chance to do a lot of preventative care and motivate older teens to have a great lifestyle, work on their diet and exercise, and manage cardiovascular” risk factors, Dr. Tyson said.

“What we do know and recognize is that there’s so many spokes to this PCOS wheel that there really should be a multidisciplinary approach to care,” Dr. Tyson said. “When I think about who would be the real doctors for patients with PCOS, these would be gynecologists, endocrinologists, dermatologists, nutritionists, psychologists, sleep specialists, and primary care at a minimum.”

Dr. Pal worries that the label of PCOS leaves it in the laps of ob.gyns. whereas, “if it was called something else, everybody would be involved in being vigilant and managing those patients.” She frequently reiterated that the label of PCOS is less important than ensuring clinicians treat the symptoms that most bother the patient.

And even if kisspeptin does play a causal role in PCOS for some patients, it’s only a subset of individuals with PCOS who would benefit from therapies developed to target it. Given the complexity of the syndrome and its many manifestations, a “galaxy of pathways” are involved in different potential subtypes of the condition. “You can’t treat PCOS as one entity,” Dr. Pal said.

Still, Dr. Hudson is optimistic that the research into potential neuroendocrine contributions to PCOS will yield therapies that go beyond just managing symptoms.

“There aren’t a lot of treatments available yet, but there may be some on the horizon,” Dr. Hudson said. “We’re still in this very primitive stage in terms of therapeutics, where we’re only addressing specific symptoms, and we haven’t been able to really address the underlying cause because we haven’t understood it as well and because we don’t have therapies that can target it,” Dr. Hudson said. “But once there are therapies developed that will target some of these central mechanisms, I think it will change completely the approach to treating PCOS for patients.”

This story was updated on Sept. 6, 2022.

In their peer-to-peer interview, “Cervical cancer: A path to eradication,” (OBG Manag. May 2022;34:30-34.) David G. Mutch, MD, and Warner Huh, MD, discussed the varying guidelines for cervical cancer screening. Dr. Huh pointed out that the 2020 guidelines for the American Cancer Society recommend cervical cancer screening to begin at age 25 years, although the current guidelines for the American College of Obstetricians and Gynecologists continue to recommend age 21. He noted that “the rate of cervical cancer is extremely low under age 25, and other countries like the United Kingdom already” screen beginning at age 25. OBG Management followed up with a poll for readers to ask: “Guidelines vary on what age to begin screening for cervical cancer. What age do you typically recommend for patients?”

In their peer-to-peer interview, “Cervical cancer: A path to eradication,” (OBG Manag. May 2022;34:30-34.) David G. Mutch, MD, and Warner Huh, MD, discussed the varying guidelines for cervical cancer screening. Dr. Huh pointed out that the 2020 guidelines for the American Cancer Society recommend cervical cancer screening to begin at age 25 years, although the current guidelines for the American College of Obstetricians and Gynecologists continue to recommend age 21. He noted that “the rate of cervical cancer is extremely low under age 25, and other countries like the United Kingdom already” screen beginning at age 25. OBG Management followed up with a poll for readers to ask: “Guidelines vary on what age to begin screening for cervical cancer. What age do you typically recommend for patients?”

In their peer-to-peer interview, “Cervical cancer: A path to eradication,” (OBG Manag. May 2022;34:30-34.) David G. Mutch, MD, and Warner Huh, MD, discussed the varying guidelines for cervical cancer screening. Dr. Huh pointed out that the 2020 guidelines for the American Cancer Society recommend cervical cancer screening to begin at age 25 years, although the current guidelines for the American College of Obstetricians and Gynecologists continue to recommend age 21. He noted that “the rate of cervical cancer is extremely low under age 25, and other countries like the United Kingdom already” screen beginning at age 25. OBG Management followed up with a poll for readers to ask: “Guidelines vary on what age to begin screening for cervical cancer. What age do you typically recommend for patients?”

Mothers who have a family history of any psychiatric disorder have almost two times the risk of postpartum depression as do mothers without such history, according to a new study.

Mette-Marie Zacher Kjeldsen, MSc, with the National Centre for Register-based Research at Aarhus (Denmark) University, led the study, a meta-analysis that included 26 studies with information on 100,877 women.

Findings were published online in JAMA Psychiatry.

When mothers had a family history of psychiatric disorders, the odds ratio for PPD was 2.08 (95% confidence interval, 1.67-2.59). That corresponds to a risk ratio of 1.79 (95% CI, 1.52-2.09), assuming a 15% postpartum depression prevalence in the general population.
 

Not doomed to develop PPD

Polina Teslyar, MD, a perinatal psychiatrist at Brigham and Women’s Hospital in Boston told this news organization it’s important to point out that though the risk is higher, women with a family psychiatric history should not feel as though they are destined to develop PPD.

“You are still more likely to not have postpartum depression, but it is important to be aware of personal risk factors so that if a person is experiencing that, they ask for help quickly rather than suffering and not knowing something is amiss,” she emphasized. Dr. Teslyar says she does see the higher risk for PPD, which is preventable and treatable, in her own practice when women have had a family history of psychiatric disorders.

The association makes sense, but literature on why that is has been varied, she said, and likely involves both genetics and socioeconomic factors. It’s difficult to tease apart how big a part each plays.

In her perinatal practice she sees women even before they are pregnant to discuss risk factors for PPD so she does ask about family history of psychiatric disorders, specifically about history of PPD and anxiety.

The researchers suggest routine perinatal care should include an easy low-cost, two-part question about both personal and family history of psychiatric disorders.

“As the assessment is possible even prior to conception, this would leave time for planning preventive efforts, such as psychosocial and psychological interventions targeting these at-risk women,” the authors write.
 

Asking about family history a challenge

Dr. Teslyar noted though that one of the challenges in asking about family history is that families may not have openly shared psychiatric history details with offspring. Family members may also report conditions they suspect a family member had rather than having a documented diagnosis.

In places where there is universal health care, she noted, finding documented diagnoses is easier, but otherwise “you’re really taking a subjective interpretation.”

The researchers found that subgroup, sensitivity, and meta–regression analyses aligned with the primary findings. The overall certainty of evidence was graded as moderate.

This study was not able to make clear how the specific diagnoses of family members affect the risk of developing PPD because much of the data from the studies came from self-report and questions were not consistent across the studies.

For instance, only 7 studies asked specifically about first-degree family members and 10 asked about specific diagnoses. Diagnoses ranged from mild affective disorders to more intrusive disorders, such as schizophrenia.

And while this study doesn’t seek to determine why the family history and risk of PPD appear to be connected, the authors offer some possible explanations.

“Growing up in an environment with parents struggling with mental health problems potentially influences the social support received from these parents when going into motherhood,” the authors write. “This particular explanation is supported by umbrella reviews concluding that lack of social support is a significant PPD risk factor.”

Screening, extraction, and assessment of studies included was done independently by two reviewers, increasing validity, the authors note.

The authors state that approximately 10%-15% of new mothers experience PPD, but Dr. Teslyar points out the numbers in the United States are typically quoted at up to 20%-30%. PPD ranges from mild to severe episodes and includes symptoms like those for major depression outside the postpartum period.

Study authors received funding from The Lundbeck Foundation and the European Union’s Horizon 2020 Research and Innovation Programme. A coauthor, Vibe G. Frokjaer, MD, PhD, has served as consultant and lecturer for H. Lundbeck and Sage Therapeutics. No other disclosures were reported. Dr. Teslyar reports no relevant financial relationships.

Mothers who have a family history of any psychiatric disorder have almost two times the risk of postpartum depression as do mothers without such history, according to a new study.

Mette-Marie Zacher Kjeldsen, MSc, with the National Centre for Register-based Research at Aarhus (Denmark) University, led the study, a meta-analysis that included 26 studies with information on 100,877 women.

Findings were published online in JAMA Psychiatry.

When mothers had a family history of psychiatric disorders, the odds ratio for PPD was 2.08 (95% confidence interval, 1.67-2.59). That corresponds to a risk ratio of 1.79 (95% CI, 1.52-2.09), assuming a 15% postpartum depression prevalence in the general population.
 

Not doomed to develop PPD

Polina Teslyar, MD, a perinatal psychiatrist at Brigham and Women’s Hospital in Boston told this news organization it’s important to point out that though the risk is higher, women with a family psychiatric history should not feel as though they are destined to develop PPD.

“You are still more likely to not have postpartum depression, but it is important to be aware of personal risk factors so that if a person is experiencing that, they ask for help quickly rather than suffering and not knowing something is amiss,” she emphasized. Dr. Teslyar says she does see the higher risk for PPD, which is preventable and treatable, in her own practice when women have had a family history of psychiatric disorders.

The association makes sense, but literature on why that is has been varied, she said, and likely involves both genetics and socioeconomic factors. It’s difficult to tease apart how big a part each plays.

In her perinatal practice she sees women even before they are pregnant to discuss risk factors for PPD so she does ask about family history of psychiatric disorders, specifically about history of PPD and anxiety.

The researchers suggest routine perinatal care should include an easy low-cost, two-part question about both personal and family history of psychiatric disorders.

“As the assessment is possible even prior to conception, this would leave time for planning preventive efforts, such as psychosocial and psychological interventions targeting these at-risk women,” the authors write.
 

Asking about family history a challenge

Dr. Teslyar noted though that one of the challenges in asking about family history is that families may not have openly shared psychiatric history details with offspring. Family members may also report conditions they suspect a family member had rather than having a documented diagnosis.

In places where there is universal health care, she noted, finding documented diagnoses is easier, but otherwise “you’re really taking a subjective interpretation.”

The researchers found that subgroup, sensitivity, and meta–regression analyses aligned with the primary findings. The overall certainty of evidence was graded as moderate.

This study was not able to make clear how the specific diagnoses of family members affect the risk of developing PPD because much of the data from the studies came from self-report and questions were not consistent across the studies.

For instance, only 7 studies asked specifically about first-degree family members and 10 asked about specific diagnoses. Diagnoses ranged from mild affective disorders to more intrusive disorders, such as schizophrenia.

And while this study doesn’t seek to determine why the family history and risk of PPD appear to be connected, the authors offer some possible explanations.

“Growing up in an environment with parents struggling with mental health problems potentially influences the social support received from these parents when going into motherhood,” the authors write. “This particular explanation is supported by umbrella reviews concluding that lack of social support is a significant PPD risk factor.”

Screening, extraction, and assessment of studies included was done independently by two reviewers, increasing validity, the authors note.

The authors state that approximately 10%-15% of new mothers experience PPD, but Dr. Teslyar points out the numbers in the United States are typically quoted at up to 20%-30%. PPD ranges from mild to severe episodes and includes symptoms like those for major depression outside the postpartum period.

Study authors received funding from The Lundbeck Foundation and the European Union’s Horizon 2020 Research and Innovation Programme. A coauthor, Vibe G. Frokjaer, MD, PhD, has served as consultant and lecturer for H. Lundbeck and Sage Therapeutics. No other disclosures were reported. Dr. Teslyar reports no relevant financial relationships.

Mothers who have a family history of any psychiatric disorder have almost two times the risk of postpartum depression as do mothers without such history, according to a new study.

Mette-Marie Zacher Kjeldsen, MSc, with the National Centre for Register-based Research at Aarhus (Denmark) University, led the study, a meta-analysis that included 26 studies with information on 100,877 women.

Findings were published online in JAMA Psychiatry.

When mothers had a family history of psychiatric disorders, the odds ratio for PPD was 2.08 (95% confidence interval, 1.67-2.59). That corresponds to a risk ratio of 1.79 (95% CI, 1.52-2.09), assuming a 15% postpartum depression prevalence in the general population.
 

Not doomed to develop PPD

Polina Teslyar, MD, a perinatal psychiatrist at Brigham and Women’s Hospital in Boston told this news organization it’s important to point out that though the risk is higher, women with a family psychiatric history should not feel as though they are destined to develop PPD.

“You are still more likely to not have postpartum depression, but it is important to be aware of personal risk factors so that if a person is experiencing that, they ask for help quickly rather than suffering and not knowing something is amiss,” she emphasized. Dr. Teslyar says she does see the higher risk for PPD, which is preventable and treatable, in her own practice when women have had a family history of psychiatric disorders.

The association makes sense, but literature on why that is has been varied, she said, and likely involves both genetics and socioeconomic factors. It’s difficult to tease apart how big a part each plays.

In her perinatal practice she sees women even before they are pregnant to discuss risk factors for PPD so she does ask about family history of psychiatric disorders, specifically about history of PPD and anxiety.

The researchers suggest routine perinatal care should include an easy low-cost, two-part question about both personal and family history of psychiatric disorders.

“As the assessment is possible even prior to conception, this would leave time for planning preventive efforts, such as psychosocial and psychological interventions targeting these at-risk women,” the authors write.
 

Asking about family history a challenge

Dr. Teslyar noted though that one of the challenges in asking about family history is that families may not have openly shared psychiatric history details with offspring. Family members may also report conditions they suspect a family member had rather than having a documented diagnosis.

In places where there is universal health care, she noted, finding documented diagnoses is easier, but otherwise “you’re really taking a subjective interpretation.”

The researchers found that subgroup, sensitivity, and meta–regression analyses aligned with the primary findings. The overall certainty of evidence was graded as moderate.

This study was not able to make clear how the specific diagnoses of family members affect the risk of developing PPD because much of the data from the studies came from self-report and questions were not consistent across the studies.

For instance, only 7 studies asked specifically about first-degree family members and 10 asked about specific diagnoses. Diagnoses ranged from mild affective disorders to more intrusive disorders, such as schizophrenia.

And while this study doesn’t seek to determine why the family history and risk of PPD appear to be connected, the authors offer some possible explanations.

“Growing up in an environment with parents struggling with mental health problems potentially influences the social support received from these parents when going into motherhood,” the authors write. “This particular explanation is supported by umbrella reviews concluding that lack of social support is a significant PPD risk factor.”

Screening, extraction, and assessment of studies included was done independently by two reviewers, increasing validity, the authors note.

The authors state that approximately 10%-15% of new mothers experience PPD, but Dr. Teslyar points out the numbers in the United States are typically quoted at up to 20%-30%. PPD ranges from mild to severe episodes and includes symptoms like those for major depression outside the postpartum period.

Study authors received funding from The Lundbeck Foundation and the European Union’s Horizon 2020 Research and Innovation Programme. A coauthor, Vibe G. Frokjaer, MD, PhD, has served as consultant and lecturer for H. Lundbeck and Sage Therapeutics. No other disclosures were reported. Dr. Teslyar reports no relevant financial relationships.

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●