Adolescent Medicine

BROOKLYN, N.Y. – The legalization of marijuana almost certainly will complicate the treatment of substance use disorder in adolescents, particularly when SUD occurs as a comorbidity of bipolar disorder or other psychiatric diseases, according to an expert review at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

The full effects of marijuana legalization on SUD have not yet been comprehensively studied in children or adults, but the consequences of easier access, diminished stigma, and potential for a diminished sense of harm are widely considered to be an important obstacle to successful therapy in children, said Timothy E. Wilens, MD, chief of the division of child and adolescent psychiatry at Massachusetts General Hospital, Boston.

Comorbid substance use in children with mood disorders or ADHD has long been understood as a form of self-medication. However, use of marijuana, alcohol, or other mood-altering drugs also are known to interfere with treatment, Dr. Wilens said.

The problem is common among adults as well, but adolescents pose a greater challenge.

“Youths are more vulnerable to developing a substance use disorder because reward pathways develop before control pathways,” Dr. Wilens said. He cited data showing that about half of individuals who develop SUD, many of whom have other psychiatric diagnoses, do so by age 18 years, and 80% do so by age 26 years.

“Substance use disorder is a pediatric issue,” he emphasized.

The problem with legalization of marijuana is that adolescents are likely to conclude that what is safe for adults is safe for children. Citing a study that associated increased use of marijuana with reduced perception of harm (and the opposite), Dr. Wilens predicted that adolescents with comorbid SUD would resist treatment.

Because of those concerns, Massachusetts General Hospital, which is based in a state where recreational marijuana use is permitted, has issued a position statement. The statement endorses the study of marijuana for benefit and for harm but expresses specific concern about “the recreational use of marijuana at any age because of the potential downstream effects on children.”

Dr. Wilens expressed particular concern about parental use of marijuana in front of children because of the implication that it is safe and acceptable. For children at risk of comorbid substance use because of a mood disorder, he cautioned parents against even concealed use of marijuana because of the low likelihood that it will go unnoticed.

“Substance use disorders are associated with a more pernicious and longer course in adolescents than children,” said Dr. Wilens, paraphrasing one of the bullet points from the Massachusetts General position statement, which outlines the potential harms for children. Another of the bullet points maintains, “there are known structural and functional brain changes” that have been documented when marijuana use begins in childhood.

Citing a correlation between parental and adolescent marijuana use, Dr. Wilens said the legalization of marijuana appears destined to exacerbate the already considerable challenge of substance use in children. He noted that a very high proportion of adolescents with or without mood disorders experiment with marijuana at some point in high school, so there already is resistance to a characterization that it is harmful.

A realistic approach is therefore required in helping adolescents with comorbid substance use to curb this form of self-medication. It is essential to set priorities, he said, when treating adolescents with SUD and comorbid psychiatric disorders. “Don’t even think about treating substance use disorder until you treat the bipolar disease,” he said.

As the symptoms are relieved, the need for self-medication is likely to diminish, but Dr. Wilens cautioned against being too rigid when helping adolescents move away from marijuana and alcohol. He believes a zero tolerance approach can be counterproductive. Rather, he advocates a “harm reduction” approach in which adolescents agree to reasonable reductions, like avoiding marijuana during the week, while they eliminate dependence.

In an overview of pharmacotherapy to reduce cravings for drugs, he cited evidence, as well as personal experience, that over-the-counter N-acetylcysteine can be a useful tool. However, adolescents in particular should be warned about the pungent smell, which has been a barrier to adherence. He also suggested that psychotherapy, with or without pharmacotherapy, is helpful.

Treatment of comorbid SUD is a critical part of achieving control of accompanying psychiatric diseases, but this task might be complicated by legalized recreational marijuana, Dr. Wilens concluded. He encouraged clinicians to recognize that challenge.

Dr. Wilens reported financial relationships with Ironshore Pharmaceuticals, Janssen, KemPharm, and Otsuka Pharmaceutical.
 

BROOKLYN, N.Y. – The legalization of marijuana almost certainly will complicate the treatment of substance use disorder in adolescents, particularly when SUD occurs as a comorbidity of bipolar disorder or other psychiatric diseases, according to an expert review at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

The full effects of marijuana legalization on SUD have not yet been comprehensively studied in children or adults, but the consequences of easier access, diminished stigma, and potential for a diminished sense of harm are widely considered to be an important obstacle to successful therapy in children, said Timothy E. Wilens, MD, chief of the division of child and adolescent psychiatry at Massachusetts General Hospital, Boston.

Comorbid substance use in children with mood disorders or ADHD has long been understood as a form of self-medication. However, use of marijuana, alcohol, or other mood-altering drugs also are known to interfere with treatment, Dr. Wilens said.

The problem is common among adults as well, but adolescents pose a greater challenge.

“Youths are more vulnerable to developing a substance use disorder because reward pathways develop before control pathways,” Dr. Wilens said. He cited data showing that about half of individuals who develop SUD, many of whom have other psychiatric diagnoses, do so by age 18 years, and 80% do so by age 26 years.

“Substance use disorder is a pediatric issue,” he emphasized.

The problem with legalization of marijuana is that adolescents are likely to conclude that what is safe for adults is safe for children. Citing a study that associated increased use of marijuana with reduced perception of harm (and the opposite), Dr. Wilens predicted that adolescents with comorbid SUD would resist treatment.

Because of those concerns, Massachusetts General Hospital, which is based in a state where recreational marijuana use is permitted, has issued a position statement. The statement endorses the study of marijuana for benefit and for harm but expresses specific concern about “the recreational use of marijuana at any age because of the potential downstream effects on children.”

Dr. Wilens expressed particular concern about parental use of marijuana in front of children because of the implication that it is safe and acceptable. For children at risk of comorbid substance use because of a mood disorder, he cautioned parents against even concealed use of marijuana because of the low likelihood that it will go unnoticed.

“Substance use disorders are associated with a more pernicious and longer course in adolescents than children,” said Dr. Wilens, paraphrasing one of the bullet points from the Massachusetts General position statement, which outlines the potential harms for children. Another of the bullet points maintains, “there are known structural and functional brain changes” that have been documented when marijuana use begins in childhood.

Citing a correlation between parental and adolescent marijuana use, Dr. Wilens said the legalization of marijuana appears destined to exacerbate the already considerable challenge of substance use in children. He noted that a very high proportion of adolescents with or without mood disorders experiment with marijuana at some point in high school, so there already is resistance to a characterization that it is harmful.

A realistic approach is therefore required in helping adolescents with comorbid substance use to curb this form of self-medication. It is essential to set priorities, he said, when treating adolescents with SUD and comorbid psychiatric disorders. “Don’t even think about treating substance use disorder until you treat the bipolar disease,” he said.

As the symptoms are relieved, the need for self-medication is likely to diminish, but Dr. Wilens cautioned against being too rigid when helping adolescents move away from marijuana and alcohol. He believes a zero tolerance approach can be counterproductive. Rather, he advocates a “harm reduction” approach in which adolescents agree to reasonable reductions, like avoiding marijuana during the week, while they eliminate dependence.

In an overview of pharmacotherapy to reduce cravings for drugs, he cited evidence, as well as personal experience, that over-the-counter N-acetylcysteine can be a useful tool. However, adolescents in particular should be warned about the pungent smell, which has been a barrier to adherence. He also suggested that psychotherapy, with or without pharmacotherapy, is helpful.

Treatment of comorbid SUD is a critical part of achieving control of accompanying psychiatric diseases, but this task might be complicated by legalized recreational marijuana, Dr. Wilens concluded. He encouraged clinicians to recognize that challenge.

Dr. Wilens reported financial relationships with Ironshore Pharmaceuticals, Janssen, KemPharm, and Otsuka Pharmaceutical.
 

BROOKLYN, N.Y. – The legalization of marijuana almost certainly will complicate the treatment of substance use disorder in adolescents, particularly when SUD occurs as a comorbidity of bipolar disorder or other psychiatric diseases, according to an expert review at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

The full effects of marijuana legalization on SUD have not yet been comprehensively studied in children or adults, but the consequences of easier access, diminished stigma, and potential for a diminished sense of harm are widely considered to be an important obstacle to successful therapy in children, said Timothy E. Wilens, MD, chief of the division of child and adolescent psychiatry at Massachusetts General Hospital, Boston.

Comorbid substance use in children with mood disorders or ADHD has long been understood as a form of self-medication. However, use of marijuana, alcohol, or other mood-altering drugs also are known to interfere with treatment, Dr. Wilens said.

The problem is common among adults as well, but adolescents pose a greater challenge.

“Youths are more vulnerable to developing a substance use disorder because reward pathways develop before control pathways,” Dr. Wilens said. He cited data showing that about half of individuals who develop SUD, many of whom have other psychiatric diagnoses, do so by age 18 years, and 80% do so by age 26 years.

“Substance use disorder is a pediatric issue,” he emphasized.

The problem with legalization of marijuana is that adolescents are likely to conclude that what is safe for adults is safe for children. Citing a study that associated increased use of marijuana with reduced perception of harm (and the opposite), Dr. Wilens predicted that adolescents with comorbid SUD would resist treatment.

Because of those concerns, Massachusetts General Hospital, which is based in a state where recreational marijuana use is permitted, has issued a position statement. The statement endorses the study of marijuana for benefit and for harm but expresses specific concern about “the recreational use of marijuana at any age because of the potential downstream effects on children.”

Dr. Wilens expressed particular concern about parental use of marijuana in front of children because of the implication that it is safe and acceptable. For children at risk of comorbid substance use because of a mood disorder, he cautioned parents against even concealed use of marijuana because of the low likelihood that it will go unnoticed.

“Substance use disorders are associated with a more pernicious and longer course in adolescents than children,” said Dr. Wilens, paraphrasing one of the bullet points from the Massachusetts General position statement, which outlines the potential harms for children. Another of the bullet points maintains, “there are known structural and functional brain changes” that have been documented when marijuana use begins in childhood.

Citing a correlation between parental and adolescent marijuana use, Dr. Wilens said the legalization of marijuana appears destined to exacerbate the already considerable challenge of substance use in children. He noted that a very high proportion of adolescents with or without mood disorders experiment with marijuana at some point in high school, so there already is resistance to a characterization that it is harmful.

A realistic approach is therefore required in helping adolescents with comorbid substance use to curb this form of self-medication. It is essential to set priorities, he said, when treating adolescents with SUD and comorbid psychiatric disorders. “Don’t even think about treating substance use disorder until you treat the bipolar disease,” he said.

As the symptoms are relieved, the need for self-medication is likely to diminish, but Dr. Wilens cautioned against being too rigid when helping adolescents move away from marijuana and alcohol. He believes a zero tolerance approach can be counterproductive. Rather, he advocates a “harm reduction” approach in which adolescents agree to reasonable reductions, like avoiding marijuana during the week, while they eliminate dependence.

In an overview of pharmacotherapy to reduce cravings for drugs, he cited evidence, as well as personal experience, that over-the-counter N-acetylcysteine can be a useful tool. However, adolescents in particular should be warned about the pungent smell, which has been a barrier to adherence. He also suggested that psychotherapy, with or without pharmacotherapy, is helpful.

Treatment of comorbid SUD is a critical part of achieving control of accompanying psychiatric diseases, but this task might be complicated by legalized recreational marijuana, Dr. Wilens concluded. He encouraged clinicians to recognize that challenge.

Dr. Wilens reported financial relationships with Ironshore Pharmaceuticals, Janssen, KemPharm, and Otsuka Pharmaceutical.
 

Mild aerobic exercise significantly shortened recovery time from sports-related concussion in adolescent athletes, compared with a stretching program in a randomized trial of 103 participants.

YanLev/ThinkStock

Sports-related concussion (SRC) remains a major public health problem with no effective treatment, wrote John J. Leddy, MD, of the State University of New York at Buffalo, and his colleagues.

Exercise tolerance after SRC has not been well studied. However, given the demonstrated benefits of aerobic exercise training on autonomic nervous system regulation, cerebral blood flow regulation, cardiovascular physiology, and brain neuroplasticity, the researchers hypothesized that exercise at a level that does not exacerbate symptoms might facilitate recovery in concussion patients.

In a study published in JAMA Pediatrics, the researchers randomized 103 adolescent athletes aged 13-18 years to a program of subsymptom aerobic exercise or a placebo stretching program. The participants were enrolled in the study within 10 days of an SRC, and were followed for 30 days or until recovery.

Athletes in the aerobic exercise group recovered in a median of 13 days, compared with 17 days for those in the stretching group (P = .009). Recovery was defined as “symptom resolution to normal,” based on normal physical and neurological examinations, “further confirmed by demonstration of the ability to exercise to exhaustion without exacerbation of symptoms” according to the Buffalo Concussion Treadmill Test, the researchers wrote.

No demographic differences or difference in previous concussions, time from injury until treatment, initial symptom severity score, initial exercise treadmill test, or physical exam were noted between the groups.

The average age of the participants was 15 years, 47% were female. The athletes performed the aerobic exercise or stretching programs approximately 20 minutes per day, and reported their daily symptoms and compliance via a website. The aerobic exercise consisted of walking or jogging on a treadmill or outdoors, or riding a stationary bike while wearing a heart rate monitor to maintain a target heart rate. The target heart rate was calculated as 80% of the heart rate at symptom exacerbation during the Buffalo Concussion Treadmill Test at each participant’s initial visit.

No adverse events related to the exercise intervention were reported, which supports the safety of subsymptom threshhold exercise, in the study population, Dr. Leddy and his associates noted.

The researchers also found lower rates of persistent symptoms at 1 month in the exercise group, compared with the stretching group (two participants vs. seven participants), but this difference was not statistically significant.

The study findings were limited by several factors, including the unblinded design and failure to address the mechanism of action for the effects of exercise. In addition, the results are not generalizable to younger children or other demographic groups, including those with concussions from causes other than sports and adults with heart conditions, the researchers noted.

However, “the results of this study should give clinicians confidence that moderate levels of physical activity, including prescribed subsymptom threshold aerobic exercise, after the first 48 hours following SRC can safely and significantly speed recovery,” Dr. Leddy and his associates concluded.

The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
 

[email protected]

SOURCE: Leddy JJ et al. JAMA Pediatr. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.4397.

Mild aerobic exercise significantly shortened recovery time from sports-related concussion in adolescent athletes, compared with a stretching program in a randomized trial of 103 participants.

YanLev/ThinkStock

Sports-related concussion (SRC) remains a major public health problem with no effective treatment, wrote John J. Leddy, MD, of the State University of New York at Buffalo, and his colleagues.

Exercise tolerance after SRC has not been well studied. However, given the demonstrated benefits of aerobic exercise training on autonomic nervous system regulation, cerebral blood flow regulation, cardiovascular physiology, and brain neuroplasticity, the researchers hypothesized that exercise at a level that does not exacerbate symptoms might facilitate recovery in concussion patients.

In a study published in JAMA Pediatrics, the researchers randomized 103 adolescent athletes aged 13-18 years to a program of subsymptom aerobic exercise or a placebo stretching program. The participants were enrolled in the study within 10 days of an SRC, and were followed for 30 days or until recovery.

Athletes in the aerobic exercise group recovered in a median of 13 days, compared with 17 days for those in the stretching group (P = .009). Recovery was defined as “symptom resolution to normal,” based on normal physical and neurological examinations, “further confirmed by demonstration of the ability to exercise to exhaustion without exacerbation of symptoms” according to the Buffalo Concussion Treadmill Test, the researchers wrote.

No demographic differences or difference in previous concussions, time from injury until treatment, initial symptom severity score, initial exercise treadmill test, or physical exam were noted between the groups.

The average age of the participants was 15 years, 47% were female. The athletes performed the aerobic exercise or stretching programs approximately 20 minutes per day, and reported their daily symptoms and compliance via a website. The aerobic exercise consisted of walking or jogging on a treadmill or outdoors, or riding a stationary bike while wearing a heart rate monitor to maintain a target heart rate. The target heart rate was calculated as 80% of the heart rate at symptom exacerbation during the Buffalo Concussion Treadmill Test at each participant’s initial visit.

No adverse events related to the exercise intervention were reported, which supports the safety of subsymptom threshhold exercise, in the study population, Dr. Leddy and his associates noted.

The researchers also found lower rates of persistent symptoms at 1 month in the exercise group, compared with the stretching group (two participants vs. seven participants), but this difference was not statistically significant.

The study findings were limited by several factors, including the unblinded design and failure to address the mechanism of action for the effects of exercise. In addition, the results are not generalizable to younger children or other demographic groups, including those with concussions from causes other than sports and adults with heart conditions, the researchers noted.

However, “the results of this study should give clinicians confidence that moderate levels of physical activity, including prescribed subsymptom threshold aerobic exercise, after the first 48 hours following SRC can safely and significantly speed recovery,” Dr. Leddy and his associates concluded.

The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
 

[email protected]

SOURCE: Leddy JJ et al. JAMA Pediatr. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.4397.

Mild aerobic exercise significantly shortened recovery time from sports-related concussion in adolescent athletes, compared with a stretching program in a randomized trial of 103 participants.

YanLev/ThinkStock

Sports-related concussion (SRC) remains a major public health problem with no effective treatment, wrote John J. Leddy, MD, of the State University of New York at Buffalo, and his colleagues.

Exercise tolerance after SRC has not been well studied. However, given the demonstrated benefits of aerobic exercise training on autonomic nervous system regulation, cerebral blood flow regulation, cardiovascular physiology, and brain neuroplasticity, the researchers hypothesized that exercise at a level that does not exacerbate symptoms might facilitate recovery in concussion patients.

In a study published in JAMA Pediatrics, the researchers randomized 103 adolescent athletes aged 13-18 years to a program of subsymptom aerobic exercise or a placebo stretching program. The participants were enrolled in the study within 10 days of an SRC, and were followed for 30 days or until recovery.

Athletes in the aerobic exercise group recovered in a median of 13 days, compared with 17 days for those in the stretching group (P = .009). Recovery was defined as “symptom resolution to normal,” based on normal physical and neurological examinations, “further confirmed by demonstration of the ability to exercise to exhaustion without exacerbation of symptoms” according to the Buffalo Concussion Treadmill Test, the researchers wrote.

No demographic differences or difference in previous concussions, time from injury until treatment, initial symptom severity score, initial exercise treadmill test, or physical exam were noted between the groups.

The average age of the participants was 15 years, 47% were female. The athletes performed the aerobic exercise or stretching programs approximately 20 minutes per day, and reported their daily symptoms and compliance via a website. The aerobic exercise consisted of walking or jogging on a treadmill or outdoors, or riding a stationary bike while wearing a heart rate monitor to maintain a target heart rate. The target heart rate was calculated as 80% of the heart rate at symptom exacerbation during the Buffalo Concussion Treadmill Test at each participant’s initial visit.

No adverse events related to the exercise intervention were reported, which supports the safety of subsymptom threshhold exercise, in the study population, Dr. Leddy and his associates noted.

The researchers also found lower rates of persistent symptoms at 1 month in the exercise group, compared with the stretching group (two participants vs. seven participants), but this difference was not statistically significant.

The study findings were limited by several factors, including the unblinded design and failure to address the mechanism of action for the effects of exercise. In addition, the results are not generalizable to younger children or other demographic groups, including those with concussions from causes other than sports and adults with heart conditions, the researchers noted.

However, “the results of this study should give clinicians confidence that moderate levels of physical activity, including prescribed subsymptom threshold aerobic exercise, after the first 48 hours following SRC can safely and significantly speed recovery,” Dr. Leddy and his associates concluded.

The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
 

[email protected]

SOURCE: Leddy JJ et al. JAMA Pediatr. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.4397.

At present, 300,000 US women undergo breast augmentation surgery each year,¹ making this the second most common aesthetic procedure in women (after liposuction),^2–4 and making it extremely likely that clinicians will encounter women who have breast implants. In addition, approximately 110,000 women undergo breast reconstructive surgery after mastectomy, of whom more than 88,000 (81%) receive implants (2016 data).⁵

This review discusses the evolution of breast implants, their complications, and key considerations with regard to aesthetic and reconstructive breast surgery, as the principles are similar.

EVOLUTION OF IMPLANTS

Reports of breast augmentation surgery, also known as augmentation mammoplasty, date back to 1895, when a fatty tumor (lipoma) was successfully transplanted from a patient’s back to a breast defect in a mastectomy patient.^2,3,6,7 In the 1930s, implantation of a glass ball into a patient’s breast marked the first implant-based breast augmentation.⁶ By 1954, attempts at breast augmentation using local dermal-fat flaps, adipose tissue, and even omentum were described.

Alloplastic materials gained popularity throughout the 1950s and 1960s and included polyurethane, polytetrafluoroethylene (Teflon), and other synthetics. Adverse reactions associated with alloplastic materials were plentiful: local tissue reactions, distortion of the breast mound, increased firmness, and discomfort all contributed to the eventual discontinuation of their use. The history of alloplastic breast augmentation also included epoxy resin, shellac, beeswax, paraffin, rubber, petroleum jelly, and liquefied silicone. Outcomes were not good, and many patients ultimately needed mastectomy.⁷

The first modern breast prosthesis was developed in 1961, and since then, implant composition and design have evolved significantly.⁸

From silicone to saline, and back again

The first silicone gel implants, introduced in the early 1960s,^8–19 had high complication rates—some centers reported an incidence of capsular contracture of up to 70%.^8,11 This is a foreign body reaction in which pathologic scar tissue encases the implant, causing it to distort, appear misshapen, harden, and even become painful.¹¹ Attempts to minimize this reaction led to later generations of silicone implants with polyurethane shells.¹²

Inflatable implants filled with sterile saline solution were originally developed in France in 1965. Unlike silicone implants, saline implants have undergone minimal changes since their inception, and grew in popularity during the 1970s in view of the high rates of capsular contracture with silicone implants.⁸ However, saline implants have their own problems, and as they became increasingly popular, deflation and the unnatural feel of saline sparked a renewed interest in silicone gel.

By the late 1980s, the thinner-shelled generation of silicone implants displayed its own frustrating complications including implant rupture, capsular contracture, infection, and possible systemic and disseminated granulomatous disease. From 1992 to 2006, the US Food and Drug Administration (FDA) placed a moratorium on silicone implants due to concerns about a possible link with autoimmune and connective tissue diseases and the possible carcinogenic nature of silicone.

While silicone implants were prohibited in the United States, development continued abroad, and eventually the moratorium was lifted after several meta-analyses failed to reveal any link regarding the aforementioned concerns.¹³

Today, silicone gel implants dominate the world market.¹⁴ In the United States, approximately 60% of implants contain silicone gel filler, and trends are similar in Europe.⁷

Table 1 summarizes the evolution of silicone breast implants over the last 50 years.^2,6,11,12Table 2 lists the advantages and disadvantages of silicone and saline breast implants.^2,6,8,15

CURRENT IMPLANT OPTIONS

Currently, 3 companies (Allergan, Mentor, Sientra) manufacture and distribute breast implants and implant-associated products such as tissue expanders and sizers in the US market.⁶

Another company, Motiva, makes an implant that is available in Europe, Asia, and Australia, and the device is currently undergoing a 10-year clinical trial in the United States that began recruiting patients in 16 centers in April 2018.¹⁶ Pending final approval, the Cleveland Clinic Department of Plastic Surgery may be among the centers involved in the clinical trial of the Motiva implant. Innovations in the Motiva implant include a high-performance shell that maintains consistent strength and includes a proprietary barrier layer, improved silicone gel filler, 3-D imprinted surface texturing, and an implant shape that adapts with vertical and horizontal movement. It also contains radio-frequency identification transponders that can transmit data about the implant wirelessly.^17–19

Developed in the 1980s, texturing of the implant surface disrupts capsule formation around the prosthesis. Additionally, texturing stabilizes an anatomically shaped (teardrop) implant within the breast pocket, reducing malrotation.^20,21

The first textured implants were covered with polyurethane foam, but they were ultimately withdrawn from the US market because of concern for in vivo degradation to carcinogenic compounds. The focus subsequently turned to texturing implant shells by mechanically creating pores of different sizes. Smooth implants, by contrast, are manufactured by repeatedly dipping the implant shell into liquid silicone.²

The capsular contraction rate has been shown to be lower with textured silicone than with smooth silicone (number needed to treat = 7–9), and evidence suggests a lower risk of needing a secondary procedure.²¹

Form-stable vs fluid-form

Silicone is a polymer. The physical properties of polymers vary greatly and depend on the length of the individual chains and the degree to which those chains are cross-linked. Liquid silicone contains short chains and sparse cross-linking, resulting in an oily compound well suited for lubrication. Silicone gel contains longer chains and more cross-linking and is therefore more viscous.

In “form-stable” implants, the silicone interior has sufficient chain length and cross-linking to retain the designed shape even at rest,² but they require slightly larger incisions.⁷ “Fluid-form” refers to an implant with silicone filler with shorter chain length, less cross-linking, and more fluidity.⁶

Shell

As with silicone fillers, the properties of silicone implant shells also depend on chain length and cross-linking within the polymer. Silicone elastomer shells (Table 1) contain extensively cross-linked chains that impart a flexible yet rubbery character. Silicone elastomers can also be found in facial implants and tissue expanders.²

Implant shape (round vs anatomic)

The shape of an implant is determined by the gel distribution inside of it. To understand gel distribution and implant shape, one must understand the gel-shell ratio. This ratio increases as cohesivity of the filler increases, and it represents increased bonding of the gel filler to the shell and a preserved implant shape at rest.

The gel-shell ratio varies among manufacturers, and a less-viscous filler may be more prone to rippling or loss of upper pole fullness in some patients. For this reason, careful analysis, patient and implant selection, and discussion of complications remain paramount.²

No anatomically shaped implant is manufactured with a smooth shell, but rather with a textured shell that resists malrotation.^6,15 However, in the United States, 95% of patients receive round implants.¹⁶

PATIENT ASSESSMENT

Before breast augmentation surgery, the surgeon assesses a number of factors—physical and psychosocial—and helps the patient choose a type and size of implant. The surgeon and patient also plan where the implants will be placed—ie, above or beneath the chest wall muscle—and where the incisions will be made. Every decision is made in close consultation with the patient, taking into account the patient’s desires and expectations, as well as what the patient’s anatomy allows. An integral component of this shared decision-making process is a discussion of the possible complications, and often photographs to better illustrate what to expect postoperatively. 

Psychosocial factors

One must consider the patient’s psychology, motivations for surgery, and emotional stability. Here, we look for underlying body dysmorphic disorder; excessive or unusual encouragement to undergo the procedure by a spouse, friends, or others; a history of other aesthetic procedures; unrealistic expectations; and other factors influencing the desire to undergo this surgery.

Choosing an implant

Implant selection must take into account the patient’s height, weight,⁷ and overall body morphology: taller patients and those with wider hips or shoulders usually require larger implants. A reliable method for determining the appropriate implant must include the current breast shape, dimensions, volume, skin elasticity, soft-tissue thickness, and overall body habitus. Ultimately, the most important considerations include breast base diameter, implant volume,²⁰ and soft-tissue envelope.

Preoperative sizing can involve placing sample implants within a brassiere so that the patient can preview possible outcomes. This method is particularly effective in minimizing dissatisfaction because it shares ownership of the decision-making process.¹⁵

A computerized implant selection program available in Europe suggests a “best-fit” implant based on a clinician’s measurements.⁷

Traditionally, plastic surgeons place breast implants either beneath the pectoralis major muscle (submuscular placement) or over the pectoralis⁸ but beneath the glandular breast parenchyma (subglandular placement) (Figure 2).⁷

Advantages of submuscular placement are a smoother transition of the upper breast pole from the chest wall and less rippling visible through the skin, due to the additional muscular coverage of the implant. Another advantage is that capsular contraction rates are lower with submuscular placement, likely due to possible contamination of implants by lactiferous ductal microbes when accessing the subglandular plane.^14,20 Disadvantages are pronounced discomfort after surgery and animation deformities with muscle contraction, particularly in young, highly active patients.

A popular modification of submuscular placement involves creating a surgical dissection plane between the subglandular tissue and the pectoralis major fascia. This “dual­­plane” approach allows the parenchyma to retract superiorly and reduce breast ptosis.⁷

Incisions

Table 3 highlights important considerations with regard to incision location.^15,20,21

ANTIBIOTICS

Many surgeons give a single prophylactic dose of antibiotic before surgery, a practice that some studies have shown to be effective in reducing the risk of infection.¹⁵ However, the benefit of routine postoperative use of antibiotics remains unsubstantiated¹⁵: postoperative antibiotic use does not appear to protect against infection, capsular contracture, or overall complications in primary or secondary breast augmentation surgery.²⁰

PERIOPERATIVE PERIOD

At our institution, breast augmentation surgery is an ambulatory procedure—the patient goes home the same day unless circumstances such as pain control warrant admission. This is, however, according to surgeon preference, and differs on a case-by-case basis. General anesthesia is the standard of care.¹⁵

POSTOPERATIVE PERIOD

In the immediate postoperative period, patients are instructed to wear a surgical bra for up to 6 weeks to allow stable scarring. Early mobilization is encouraged.^7,15 Depending on the patient’s situation, recovery, and healing, she may be out of work for about 1 week, sometimes more, sometimes less. 

Additional instructions are surgeon-specific. However, the patient is instructed to avoid bathing, swimming, immersion in water, and wearing underwire brassieres that could impair healing of an inferior incision; instead, patients are often instructed to wear a surgical bra provided on the day of surgery until cleared in the clinic.

Showering is allowed the next day or the second day after surgery, and of course there is no driving while on narcotics. Additionally, patients are counseled extensively regarding hematoma formation and the signs and symptoms of infection.

Patients are typically seen in clinic 1 week after surgery.

The cost of surgery may be $5,000 to $6,000 but can vary significantly from center to center depending on who the patient sees and where, and whether the patient presents for breast reconstruction after cancer or repair of congenital anomalies, or in certain cases of transgender surgery. The patient is typically responsible for the fee, but again this depends on the patient, indications, and particular insurance concerns.

IMPLANT LONGEVITY AND RUPTURE

In the United States, implant rupture rates range from 1.1% to 17.7% at 6 to 10 years after primary augmentation, 2.9% to 14.7% after revision augmentation, 1.5% to 35.4% after primary breast reconstruction, and 0% to 19.6% after revision reconstruction.¹¹

Unfortunately, the existence of multiple implant manufacturers, numerous implant generations, and poorly standardized screening protocols and reporting systems make the true rate of implant rupture difficult to assess without definitive imaging or implant retrieval.¹¹

Damage from surgical instrumentation during implantation is the most common cause of silicone breast implant rupture (50% to 64% of cases).²² Other causes include underfilling and fold flaw from capsular contracture.

Leakage of silicone gel filler may be confined to the periprosthetic capsule (intracapsular rupture) or extend beyond and into the breast parenchyma (extracapsular rupture). One study reported that only 10% of intracapsular ruptures progressed extracapsularly, while 84% of patients with extracapsular involvement remained stable for up to 2 years,²³ indicating that intracapsular rupture may not portend worsening disease.¹¹

Implant rupture occurs silently in most cases, with no clinically detectable signs or symptoms. In other cases, patients may present with alterations in breast shape and size, sudden asymmetry, firmness, pronounced capsular contracture, contour irregularity, or pain.

Aside from physical examination, comprehensive diagnostic testing includes imaging—ultrasonography, mammography, computed tomography, and magnetic resonance imaging (MRI). Of these, MRI is the method of choice, with sensitivity and specificity exceeding 90% for detecting implant rupture.¹¹ Classic findings on MRI include the “linguine” sign from a deflating implant shell, or the teardrop sign from implant sagging. Classic findings on ultrasonography include the “snowstorm” sign of extracapsular rupture and the “stepladder” sign of intracapsular rupture.

Mammography effectively detects free silicone in breast tissue with extracapsular rupture (25% of ruptures according to some studies)²³; however, it cannot detect rupture within the implant capsule. As an aside, submuscular implant placement may interfere less with screening mammography than subglandular implants do.^14,24

Current FDA recommendations to detect implant rupture encourage women with silicone breast implants to undergo screening 3 years after implantation and then every 2 years thereafter; no long-term monitoring is suggested for saline implants.¹⁵ Many plastic surgeons evaluate silicone breast implant patients every 1 to 2 years for contracture and rupture.⁸ Of note, capsular contracture impairs the effectiveness of ultrasonography and may require MRI confirmation.¹¹

If implant rupture is confirmed, the current recommendation is to remove the implant and the capsule. Another implant may be placed depending on the patient’s preference. Rigorous washout remains a key feature of any surgical intervention for ruptured breast implants; however, in the event of extracapsular rupture, resection of silicone granulomas may also be required.¹¹

Reoperation rates for primary breast augmentation surgery approach 20% and are even higher for secondary augmentation over a patient’s lifetime—the highest rate of all aesthetic procedures.^7,14

Capsular contracture is the most common complication of breast augmentation,²⁵ typically presenting within the first postoperative year,^26,27 and the risk increases over time.²⁸ It occurs with both silicone and saline breast implants.

In some studies, the incidence exceeded 4% in the first 2 years after surgery,²⁹ and nearly 50% by 10 years.³⁰ Other studies found rates of 0% to 20% over 13 years.²⁰

The etiology is not well understood and is presumed to be multifactorial, with proposed mechanisms and factors that include bacterial contamination, surface texturing, the implant pocket selected, the incision type, drain placement, antibiotic use, and smoking.²⁵

A meta-analysis from 17,000 implants found that the risk of capsular contracture was significantly higher when an implant was placed in a subglandular pocket than in a submuscular pocket,^22,26 and that although texturing decreased capsular contracture compared with smooth implants, the effect was modest when a textured or smooth implant was placed in a submuscular location.²⁸ With regard to incision location, studies have reported that the incidence of capsular contracture is highest with transaxillary and periareolar incisions, and lowest with inframammary incisions.^20,21

The leading theory is that contamination of the implant (primarily from the mammary ducts) results in biofilm formation. Subclinical hematoma surrounding the implant may also provide key bacterial nutrients.²⁰

Textured implants induce a greater inflammatory response in the capsular tissue, resulting in a thicker capsule; however, contracture rates remain lower with textured than with smooth implants.^14,31 Interestingly, lower rates of capsular contracture have been observed with later-generation, cohesive-gel, form-stable implants than with those of earlier generations.¹²

Although more research is needed, silicone implants appear to confer a higher risk of capsular contracture than saline implants.^14,20

Irrigating the breast pocket intraoperatively with triple antibiotic solution (bacitracin, cefazolin, and gentamicin) before placing the implant may decrease the capsular contracture rate.^15,20

Treatments for capsular contracture include pocket modifications such as capsulotomy (making releasing, relaxing incisions in the scar capsule encasing the implant), capsulectomy (removing portions of or the entire capsule), and replacing the implant in the other pocket (ie, if the original implant was subglandular, the replacement is placed in the submuscular pocket). Patients who have contractures that fail to respond to these treatments may ultimately benefit from implant removal and autologous reconstruction (autoaugmentation) rather than implant replacement.^32,33

ADDITIONAL COMPLICATIONS

Other complications include infection, malposition, rippling, seroma, hematoma, and sensory alterations.

Irrigation during the implantation procedure with a triple antibiotic solution consisting of bacitracin, gentamycin, and cephalexin in normal saline decreases infection and seroma rates.^15,20,34

Some surgeons also choose to irrigate the pocket with a betadine solution, or to cleanse the skin with betadine and place sterile towels and redrape before inserting the implant. Additionally, many prefer using a sterile device much like a pastry funnel called a Keller funnel to insert the implant into the breast pocket.³⁵

Infection is less common with cosmetic augmentations than with implant-based breast reconstruction, likely because of healthier, well-vascularized tissue in patients undergoing cosmetic surgery than in those undergoing mastectomy.¹⁴

Seroma is thought to be a consequence of texturing, and more so with macro- vs microtexturing. Though poorly understood, an association between texturing and double capsules has also been reported.^12,20

After primary breast augmentation, 10-year follow-up rates of capsular contracture, seroma, rippling, and malposition vary across the 3 major silicone implant manufacturers.¹² Hematoma and infection occur in less than 1% of primary augmentation patients.¹⁵

Malposition of the implant over time is less frequent with textured implants because of the higher coefficient of friction compared with smooth implants^.6,8,15

Visible skin rippling may be a consequence of texturing and also of thin body habitus, eg, in patients with a body mass index less than 18.5 kg/m². If the soft-tissue layer of the breast is thin, the natural rippling of smooth saline implant shells are more likely to show when placed in the subglandular pocket. Form-stable implants, by contrast, resist rippling.^12,15

Large implants and extensive lateral dissection can cause alterations in nipple sensation and sensory loss within lower breast pole skin. Axillary incisions may traumatize or damage the intercostobrachial nerve, resulting in upper inner arm sensory aberrations.

Ultimately, the 10-year incidence of secondary surgery ranges from 0% to 36% and the 10-year incidence of capsular contracture ranges from 11% to 19%.¹⁵ Additional cosmetic complaints after augmentation with implants include enlargement of the areola and engorgement of breast veins.¹⁴

BREAST CANCER AND DETECTION

Patients with or without implants do not seem to differ with regard to breast cancer stage upon detection, tumor burden, recurrence, or survival. However, more patients with implants may present with palpable masses, invasive tumors, axillary metastasis, and falsely negative mammograms.

Breast implants may actually facilitate cancer detection on physical examination by providing a more dense or stable surface upon which to palpate the breast tissue. Although they do not necessarily impair mastectomy or breast reconstruction, they may result in an increased rate of revision surgery after breast conservation therapy.^24,36 Mammography remains the standard of care for radiologic diagnosis but can be further supported by MRI and ultrasonography if necessary in patients with implants.

Although concerns persist, multiple studies have demonstrated the safety of fourth- and fifth-generation silicone breast implants with regard to autoimmune disease.⁷

In various clinical studies in mastectomy patients who underwent breast reconstruction with either silicone implants or autologous tissue, no difference was found with regard to the incidence of autoimmune diseases.² Additionally, in meta-analyses of data from more than 87,000 women, no association was found between connective tissue disease and silicone breast implants.^2,11 One study^11,23 noted no increase in autoantibodies in patients with undamaged silicone implants vs patients who experienced rupture.

Studies have also demonstrated that in children born to mothers with breast implants, the risk of rheumatic disease, esophageal disorders, congenital malformations, and death during the perinatal period is comparable with that in controls.³⁷ Another study, examining breastfeeding in women with silicone breast implants, showed no significant difference in silicon levels (used as a proxy for silicone) in breast milk compared with controls without implants; silicon levels were found to be significantly higher in cow’s milk and store-bought formulas.³⁸

BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a subtype of T-cell lymphoma that develops in tissue adjacent to breast implants. It typically presents as breast swelling 2 to 38 years (mean of 8 years) after implant insertion.^39,40 The swelling may be secondary to periprosthetic seroma formation or, more rarely, palpable disease in the axilla. Patients occasionally complain of pain and, rarely, constitutional symptoms.²⁰ BIA-ALCL is not a disease of the surrounding breast tissue, but rather of the fibrous periprosthetic capsule.²¹

Of note, there is no documented case involving smooth implants,^41–43 but it may be related to fifth-generation textured implants.⁶ At present, it is not possible to definitively state which implant is associated with this condition; hence, more data are needed, and this association is currently under study.

The absolute risk of BIA-ALCL was reported in a Dutch study³⁹ as 1 in 35,000 by age 50, 1 in 12,000 by age 70, and 1 in 7,000 by age 75, with a number needed to harm of 6,920. Overall lifetime risk was estimated at 1 in 30,000 for women with textured implants in a 2015 US study.⁴⁰ In comparison, breast cancer risk is about 1 in 8 women. There is no apparent predilection for patients who underwent cosmetic augmentation vs reconstruction, or who received silicone vs saline implants.

The diagnosis is confirmed by ultrasonographically guided fine-needle aspiration of seroma fluid and subsequent immunohistochemical testing for CD30-positive and ALK-negative T lymphocytes. Other than positron-emission tomography for staging after diagnosis confirmation, imaging is ineffective. Expert opinion does not recommend routine screening unless the aforementioned symptoms arise.

Treatment involves implant removal and total capsulectomy, with samples sent for pathology study with cytokeratin staining.¹² Of note, in all cases of BIA-ALCL in which the disease was limited to the circumscribed scar tissue of the breast capsule, complete surgical excision has proved curative, whereas incomplete capsulectomy portends a greater risk of recurrence and decreased survival.⁴⁴

In cases of advanced or recurrent ALCL, diagnosed late or inappropriately, the National Comprehensive Cancer Network recommends a multidisciplinary approach involving adjuvant chemotherapy and radiation.⁴⁴ Anecdotally, at our institution, we have recently treated several cases of advanced ALCL presenting with invasive chest wall masses with extirpative surgery and subsequent reconstruction with the assistance of our thoracic surgery colleagues, as well as the aforementioned multidisciplinary approach using adjuvant therapy.

The mechanism of this malignancy is currently under investigation, but the current theory implicates an exaggerated lymphoproliferative response to bacterial contamination of the capsule superimposed upon genetic factors in susceptible patients.^42,43

National societies advise plastic surgeons to discuss the risk of BIA-ALCL with all patients at the time of breast augmentation consultation and to report all confirmed cases to the PROFILE registry (Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology).⁴⁵

ARE PATIENTS HAPPIER AFTERWARD?

Studies have shown that after undergoing breast augmentation surgery, patients note improvement in body image, and satisfaction rates range from 85% to 95% with respect to self-confidence and body image.⁴⁶ An evaluation of patient responses on the validated BREAST-Q Augmentation Questionnaire showed the following satisfaction rates: breasts 83%, psychosocial well-being 88%, and sexual functioning 81%.¹⁵

Although epidemiologic studies have reported higher suicide rates in women with cosmetic breast implants, this likely stems from preoperative psychological factors and underscores the role of psychiatric referral in patients with a mental health history or in those whom the surgeon deems it necessary.⁴⁶

Several high-quality studies have demonstrated that quality of life and psychosocial functioning (including depression) markedly improve after breast augmentation surgery.⁴⁷ Among a cohort of Norwegian patients, breast implant surgery resulted in improved motivation to perform daily activities, as well as improved quality of life from both a psychosocial and aesthetic perspective.⁴⁸ Interestingly, a recent study reported that patients who underwent breast implant surgery alone reported greater satisfaction and psychosocial quality of life than patients who underwent combination breast augmentation and mastopexy (breast-lifting) surgery.⁴⁹

Additional data are needed to refine our understanding of the complex interplay between psychosocial factors before and after surgery in patients seeking and undergoing breast augmentation procedures.

At present, 300,000 US women undergo breast augmentation surgery each year,¹ making this the second most common aesthetic procedure in women (after liposuction),^2–4 and making it extremely likely that clinicians will encounter women who have breast implants. In addition, approximately 110,000 women undergo breast reconstructive surgery after mastectomy, of whom more than 88,000 (81%) receive implants (2016 data).⁵

This review discusses the evolution of breast implants, their complications, and key considerations with regard to aesthetic and reconstructive breast surgery, as the principles are similar.

EVOLUTION OF IMPLANTS

Reports of breast augmentation surgery, also known as augmentation mammoplasty, date back to 1895, when a fatty tumor (lipoma) was successfully transplanted from a patient’s back to a breast defect in a mastectomy patient.^2,3,6,7 In the 1930s, implantation of a glass ball into a patient’s breast marked the first implant-based breast augmentation.⁶ By 1954, attempts at breast augmentation using local dermal-fat flaps, adipose tissue, and even omentum were described.

Alloplastic materials gained popularity throughout the 1950s and 1960s and included polyurethane, polytetrafluoroethylene (Teflon), and other synthetics. Adverse reactions associated with alloplastic materials were plentiful: local tissue reactions, distortion of the breast mound, increased firmness, and discomfort all contributed to the eventual discontinuation of their use. The history of alloplastic breast augmentation also included epoxy resin, shellac, beeswax, paraffin, rubber, petroleum jelly, and liquefied silicone. Outcomes were not good, and many patients ultimately needed mastectomy.⁷

The first modern breast prosthesis was developed in 1961, and since then, implant composition and design have evolved significantly.⁸

From silicone to saline, and back again

The first silicone gel implants, introduced in the early 1960s,^8–19 had high complication rates—some centers reported an incidence of capsular contracture of up to 70%.^8,11 This is a foreign body reaction in which pathologic scar tissue encases the implant, causing it to distort, appear misshapen, harden, and even become painful.¹¹ Attempts to minimize this reaction led to later generations of silicone implants with polyurethane shells.¹²

Inflatable implants filled with sterile saline solution were originally developed in France in 1965. Unlike silicone implants, saline implants have undergone minimal changes since their inception, and grew in popularity during the 1970s in view of the high rates of capsular contracture with silicone implants.⁸ However, saline implants have their own problems, and as they became increasingly popular, deflation and the unnatural feel of saline sparked a renewed interest in silicone gel.

By the late 1980s, the thinner-shelled generation of silicone implants displayed its own frustrating complications including implant rupture, capsular contracture, infection, and possible systemic and disseminated granulomatous disease. From 1992 to 2006, the US Food and Drug Administration (FDA) placed a moratorium on silicone implants due to concerns about a possible link with autoimmune and connective tissue diseases and the possible carcinogenic nature of silicone.

While silicone implants were prohibited in the United States, development continued abroad, and eventually the moratorium was lifted after several meta-analyses failed to reveal any link regarding the aforementioned concerns.¹³

Today, silicone gel implants dominate the world market.¹⁴ In the United States, approximately 60% of implants contain silicone gel filler, and trends are similar in Europe.⁷

Table 1 summarizes the evolution of silicone breast implants over the last 50 years.^2,6,11,12Table 2 lists the advantages and disadvantages of silicone and saline breast implants.^2,6,8,15

CURRENT IMPLANT OPTIONS

Currently, 3 companies (Allergan, Mentor, Sientra) manufacture and distribute breast implants and implant-associated products such as tissue expanders and sizers in the US market.⁶

Another company, Motiva, makes an implant that is available in Europe, Asia, and Australia, and the device is currently undergoing a 10-year clinical trial in the United States that began recruiting patients in 16 centers in April 2018.¹⁶ Pending final approval, the Cleveland Clinic Department of Plastic Surgery may be among the centers involved in the clinical trial of the Motiva implant. Innovations in the Motiva implant include a high-performance shell that maintains consistent strength and includes a proprietary barrier layer, improved silicone gel filler, 3-D imprinted surface texturing, and an implant shape that adapts with vertical and horizontal movement. It also contains radio-frequency identification transponders that can transmit data about the implant wirelessly.^17–19

Developed in the 1980s, texturing of the implant surface disrupts capsule formation around the prosthesis. Additionally, texturing stabilizes an anatomically shaped (teardrop) implant within the breast pocket, reducing malrotation.^20,21

The first textured implants were covered with polyurethane foam, but they were ultimately withdrawn from the US market because of concern for in vivo degradation to carcinogenic compounds. The focus subsequently turned to texturing implant shells by mechanically creating pores of different sizes. Smooth implants, by contrast, are manufactured by repeatedly dipping the implant shell into liquid silicone.²

The capsular contraction rate has been shown to be lower with textured silicone than with smooth silicone (number needed to treat = 7–9), and evidence suggests a lower risk of needing a secondary procedure.²¹

Form-stable vs fluid-form

Silicone is a polymer. The physical properties of polymers vary greatly and depend on the length of the individual chains and the degree to which those chains are cross-linked. Liquid silicone contains short chains and sparse cross-linking, resulting in an oily compound well suited for lubrication. Silicone gel contains longer chains and more cross-linking and is therefore more viscous.

In “form-stable” implants, the silicone interior has sufficient chain length and cross-linking to retain the designed shape even at rest,² but they require slightly larger incisions.⁷ “Fluid-form” refers to an implant with silicone filler with shorter chain length, less cross-linking, and more fluidity.⁶

Shell

As with silicone fillers, the properties of silicone implant shells also depend on chain length and cross-linking within the polymer. Silicone elastomer shells (Table 1) contain extensively cross-linked chains that impart a flexible yet rubbery character. Silicone elastomers can also be found in facial implants and tissue expanders.²

Implant shape (round vs anatomic)

The shape of an implant is determined by the gel distribution inside of it. To understand gel distribution and implant shape, one must understand the gel-shell ratio. This ratio increases as cohesivity of the filler increases, and it represents increased bonding of the gel filler to the shell and a preserved implant shape at rest.

The gel-shell ratio varies among manufacturers, and a less-viscous filler may be more prone to rippling or loss of upper pole fullness in some patients. For this reason, careful analysis, patient and implant selection, and discussion of complications remain paramount.²

No anatomically shaped implant is manufactured with a smooth shell, but rather with a textured shell that resists malrotation.^6,15 However, in the United States, 95% of patients receive round implants.¹⁶

PATIENT ASSESSMENT

Before breast augmentation surgery, the surgeon assesses a number of factors—physical and psychosocial—and helps the patient choose a type and size of implant. The surgeon and patient also plan where the implants will be placed—ie, above or beneath the chest wall muscle—and where the incisions will be made. Every decision is made in close consultation with the patient, taking into account the patient’s desires and expectations, as well as what the patient’s anatomy allows. An integral component of this shared decision-making process is a discussion of the possible complications, and often photographs to better illustrate what to expect postoperatively. 

Psychosocial factors

One must consider the patient’s psychology, motivations for surgery, and emotional stability. Here, we look for underlying body dysmorphic disorder; excessive or unusual encouragement to undergo the procedure by a spouse, friends, or others; a history of other aesthetic procedures; unrealistic expectations; and other factors influencing the desire to undergo this surgery.

Choosing an implant

Implant selection must take into account the patient’s height, weight,⁷ and overall body morphology: taller patients and those with wider hips or shoulders usually require larger implants. A reliable method for determining the appropriate implant must include the current breast shape, dimensions, volume, skin elasticity, soft-tissue thickness, and overall body habitus. Ultimately, the most important considerations include breast base diameter, implant volume,²⁰ and soft-tissue envelope.

Preoperative sizing can involve placing sample implants within a brassiere so that the patient can preview possible outcomes. This method is particularly effective in minimizing dissatisfaction because it shares ownership of the decision-making process.¹⁵

A computerized implant selection program available in Europe suggests a “best-fit” implant based on a clinician’s measurements.⁷

Traditionally, plastic surgeons place breast implants either beneath the pectoralis major muscle (submuscular placement) or over the pectoralis⁸ but beneath the glandular breast parenchyma (subglandular placement) (Figure 2).⁷

Advantages of submuscular placement are a smoother transition of the upper breast pole from the chest wall and less rippling visible through the skin, due to the additional muscular coverage of the implant. Another advantage is that capsular contraction rates are lower with submuscular placement, likely due to possible contamination of implants by lactiferous ductal microbes when accessing the subglandular plane.^14,20 Disadvantages are pronounced discomfort after surgery and animation deformities with muscle contraction, particularly in young, highly active patients.

A popular modification of submuscular placement involves creating a surgical dissection plane between the subglandular tissue and the pectoralis major fascia. This “dual­­plane” approach allows the parenchyma to retract superiorly and reduce breast ptosis.⁷

Incisions

Table 3 highlights important considerations with regard to incision location.^15,20,21

ANTIBIOTICS

Many surgeons give a single prophylactic dose of antibiotic before surgery, a practice that some studies have shown to be effective in reducing the risk of infection.¹⁵ However, the benefit of routine postoperative use of antibiotics remains unsubstantiated¹⁵: postoperative antibiotic use does not appear to protect against infection, capsular contracture, or overall complications in primary or secondary breast augmentation surgery.²⁰

PERIOPERATIVE PERIOD

At our institution, breast augmentation surgery is an ambulatory procedure—the patient goes home the same day unless circumstances such as pain control warrant admission. This is, however, according to surgeon preference, and differs on a case-by-case basis. General anesthesia is the standard of care.¹⁵

POSTOPERATIVE PERIOD

In the immediate postoperative period, patients are instructed to wear a surgical bra for up to 6 weeks to allow stable scarring. Early mobilization is encouraged.^7,15 Depending on the patient’s situation, recovery, and healing, she may be out of work for about 1 week, sometimes more, sometimes less. 

Additional instructions are surgeon-specific. However, the patient is instructed to avoid bathing, swimming, immersion in water, and wearing underwire brassieres that could impair healing of an inferior incision; instead, patients are often instructed to wear a surgical bra provided on the day of surgery until cleared in the clinic.

Showering is allowed the next day or the second day after surgery, and of course there is no driving while on narcotics. Additionally, patients are counseled extensively regarding hematoma formation and the signs and symptoms of infection.

Patients are typically seen in clinic 1 week after surgery.

The cost of surgery may be $5,000 to $6,000 but can vary significantly from center to center depending on who the patient sees and where, and whether the patient presents for breast reconstruction after cancer or repair of congenital anomalies, or in certain cases of transgender surgery. The patient is typically responsible for the fee, but again this depends on the patient, indications, and particular insurance concerns.

IMPLANT LONGEVITY AND RUPTURE

In the United States, implant rupture rates range from 1.1% to 17.7% at 6 to 10 years after primary augmentation, 2.9% to 14.7% after revision augmentation, 1.5% to 35.4% after primary breast reconstruction, and 0% to 19.6% after revision reconstruction.¹¹

Unfortunately, the existence of multiple implant manufacturers, numerous implant generations, and poorly standardized screening protocols and reporting systems make the true rate of implant rupture difficult to assess without definitive imaging or implant retrieval.¹¹

Damage from surgical instrumentation during implantation is the most common cause of silicone breast implant rupture (50% to 64% of cases).²² Other causes include underfilling and fold flaw from capsular contracture.

Leakage of silicone gel filler may be confined to the periprosthetic capsule (intracapsular rupture) or extend beyond and into the breast parenchyma (extracapsular rupture). One study reported that only 10% of intracapsular ruptures progressed extracapsularly, while 84% of patients with extracapsular involvement remained stable for up to 2 years,²³ indicating that intracapsular rupture may not portend worsening disease.¹¹

Implant rupture occurs silently in most cases, with no clinically detectable signs or symptoms. In other cases, patients may present with alterations in breast shape and size, sudden asymmetry, firmness, pronounced capsular contracture, contour irregularity, or pain.

Aside from physical examination, comprehensive diagnostic testing includes imaging—ultrasonography, mammography, computed tomography, and magnetic resonance imaging (MRI). Of these, MRI is the method of choice, with sensitivity and specificity exceeding 90% for detecting implant rupture.¹¹ Classic findings on MRI include the “linguine” sign from a deflating implant shell, or the teardrop sign from implant sagging. Classic findings on ultrasonography include the “snowstorm” sign of extracapsular rupture and the “stepladder” sign of intracapsular rupture.

Mammography effectively detects free silicone in breast tissue with extracapsular rupture (25% of ruptures according to some studies)²³; however, it cannot detect rupture within the implant capsule. As an aside, submuscular implant placement may interfere less with screening mammography than subglandular implants do.^14,24

Current FDA recommendations to detect implant rupture encourage women with silicone breast implants to undergo screening 3 years after implantation and then every 2 years thereafter; no long-term monitoring is suggested for saline implants.¹⁵ Many plastic surgeons evaluate silicone breast implant patients every 1 to 2 years for contracture and rupture.⁸ Of note, capsular contracture impairs the effectiveness of ultrasonography and may require MRI confirmation.¹¹

If implant rupture is confirmed, the current recommendation is to remove the implant and the capsule. Another implant may be placed depending on the patient’s preference. Rigorous washout remains a key feature of any surgical intervention for ruptured breast implants; however, in the event of extracapsular rupture, resection of silicone granulomas may also be required.¹¹

Reoperation rates for primary breast augmentation surgery approach 20% and are even higher for secondary augmentation over a patient’s lifetime—the highest rate of all aesthetic procedures.^7,14

Capsular contracture is the most common complication of breast augmentation,²⁵ typically presenting within the first postoperative year,^26,27 and the risk increases over time.²⁸ It occurs with both silicone and saline breast implants.

In some studies, the incidence exceeded 4% in the first 2 years after surgery,²⁹ and nearly 50% by 10 years.³⁰ Other studies found rates of 0% to 20% over 13 years.²⁰

The etiology is not well understood and is presumed to be multifactorial, with proposed mechanisms and factors that include bacterial contamination, surface texturing, the implant pocket selected, the incision type, drain placement, antibiotic use, and smoking.²⁵

A meta-analysis from 17,000 implants found that the risk of capsular contracture was significantly higher when an implant was placed in a subglandular pocket than in a submuscular pocket,^22,26 and that although texturing decreased capsular contracture compared with smooth implants, the effect was modest when a textured or smooth implant was placed in a submuscular location.²⁸ With regard to incision location, studies have reported that the incidence of capsular contracture is highest with transaxillary and periareolar incisions, and lowest with inframammary incisions.^20,21

The leading theory is that contamination of the implant (primarily from the mammary ducts) results in biofilm formation. Subclinical hematoma surrounding the implant may also provide key bacterial nutrients.²⁰

Textured implants induce a greater inflammatory response in the capsular tissue, resulting in a thicker capsule; however, contracture rates remain lower with textured than with smooth implants.^14,31 Interestingly, lower rates of capsular contracture have been observed with later-generation, cohesive-gel, form-stable implants than with those of earlier generations.¹²

Although more research is needed, silicone implants appear to confer a higher risk of capsular contracture than saline implants.^14,20

Irrigating the breast pocket intraoperatively with triple antibiotic solution (bacitracin, cefazolin, and gentamicin) before placing the implant may decrease the capsular contracture rate.^15,20

Treatments for capsular contracture include pocket modifications such as capsulotomy (making releasing, relaxing incisions in the scar capsule encasing the implant), capsulectomy (removing portions of or the entire capsule), and replacing the implant in the other pocket (ie, if the original implant was subglandular, the replacement is placed in the submuscular pocket). Patients who have contractures that fail to respond to these treatments may ultimately benefit from implant removal and autologous reconstruction (autoaugmentation) rather than implant replacement.^32,33

ADDITIONAL COMPLICATIONS

Other complications include infection, malposition, rippling, seroma, hematoma, and sensory alterations.

Irrigation during the implantation procedure with a triple antibiotic solution consisting of bacitracin, gentamycin, and cephalexin in normal saline decreases infection and seroma rates.^15,20,34

Some surgeons also choose to irrigate the pocket with a betadine solution, or to cleanse the skin with betadine and place sterile towels and redrape before inserting the implant. Additionally, many prefer using a sterile device much like a pastry funnel called a Keller funnel to insert the implant into the breast pocket.³⁵

Infection is less common with cosmetic augmentations than with implant-based breast reconstruction, likely because of healthier, well-vascularized tissue in patients undergoing cosmetic surgery than in those undergoing mastectomy.¹⁴

Seroma is thought to be a consequence of texturing, and more so with macro- vs microtexturing. Though poorly understood, an association between texturing and double capsules has also been reported.^12,20

After primary breast augmentation, 10-year follow-up rates of capsular contracture, seroma, rippling, and malposition vary across the 3 major silicone implant manufacturers.¹² Hematoma and infection occur in less than 1% of primary augmentation patients.¹⁵

Malposition of the implant over time is less frequent with textured implants because of the higher coefficient of friction compared with smooth implants^.6,8,15

Visible skin rippling may be a consequence of texturing and also of thin body habitus, eg, in patients with a body mass index less than 18.5 kg/m². If the soft-tissue layer of the breast is thin, the natural rippling of smooth saline implant shells are more likely to show when placed in the subglandular pocket. Form-stable implants, by contrast, resist rippling.^12,15

Large implants and extensive lateral dissection can cause alterations in nipple sensation and sensory loss within lower breast pole skin. Axillary incisions may traumatize or damage the intercostobrachial nerve, resulting in upper inner arm sensory aberrations.

Ultimately, the 10-year incidence of secondary surgery ranges from 0% to 36% and the 10-year incidence of capsular contracture ranges from 11% to 19%.¹⁵ Additional cosmetic complaints after augmentation with implants include enlargement of the areola and engorgement of breast veins.¹⁴

BREAST CANCER AND DETECTION

Patients with or without implants do not seem to differ with regard to breast cancer stage upon detection, tumor burden, recurrence, or survival. However, more patients with implants may present with palpable masses, invasive tumors, axillary metastasis, and falsely negative mammograms.

Breast implants may actually facilitate cancer detection on physical examination by providing a more dense or stable surface upon which to palpate the breast tissue. Although they do not necessarily impair mastectomy or breast reconstruction, they may result in an increased rate of revision surgery after breast conservation therapy.^24,36 Mammography remains the standard of care for radiologic diagnosis but can be further supported by MRI and ultrasonography if necessary in patients with implants.

Although concerns persist, multiple studies have demonstrated the safety of fourth- and fifth-generation silicone breast implants with regard to autoimmune disease.⁷

In various clinical studies in mastectomy patients who underwent breast reconstruction with either silicone implants or autologous tissue, no difference was found with regard to the incidence of autoimmune diseases.² Additionally, in meta-analyses of data from more than 87,000 women, no association was found between connective tissue disease and silicone breast implants.^2,11 One study^11,23 noted no increase in autoantibodies in patients with undamaged silicone implants vs patients who experienced rupture.

Studies have also demonstrated that in children born to mothers with breast implants, the risk of rheumatic disease, esophageal disorders, congenital malformations, and death during the perinatal period is comparable with that in controls.³⁷ Another study, examining breastfeeding in women with silicone breast implants, showed no significant difference in silicon levels (used as a proxy for silicone) in breast milk compared with controls without implants; silicon levels were found to be significantly higher in cow’s milk and store-bought formulas.³⁸

BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a subtype of T-cell lymphoma that develops in tissue adjacent to breast implants. It typically presents as breast swelling 2 to 38 years (mean of 8 years) after implant insertion.^39,40 The swelling may be secondary to periprosthetic seroma formation or, more rarely, palpable disease in the axilla. Patients occasionally complain of pain and, rarely, constitutional symptoms.²⁰ BIA-ALCL is not a disease of the surrounding breast tissue, but rather of the fibrous periprosthetic capsule.²¹

Of note, there is no documented case involving smooth implants,^41–43 but it may be related to fifth-generation textured implants.⁶ At present, it is not possible to definitively state which implant is associated with this condition; hence, more data are needed, and this association is currently under study.

The absolute risk of BIA-ALCL was reported in a Dutch study³⁹ as 1 in 35,000 by age 50, 1 in 12,000 by age 70, and 1 in 7,000 by age 75, with a number needed to harm of 6,920. Overall lifetime risk was estimated at 1 in 30,000 for women with textured implants in a 2015 US study.⁴⁰ In comparison, breast cancer risk is about 1 in 8 women. There is no apparent predilection for patients who underwent cosmetic augmentation vs reconstruction, or who received silicone vs saline implants.

The diagnosis is confirmed by ultrasonographically guided fine-needle aspiration of seroma fluid and subsequent immunohistochemical testing for CD30-positive and ALK-negative T lymphocytes. Other than positron-emission tomography for staging after diagnosis confirmation, imaging is ineffective. Expert opinion does not recommend routine screening unless the aforementioned symptoms arise.

Treatment involves implant removal and total capsulectomy, with samples sent for pathology study with cytokeratin staining.¹² Of note, in all cases of BIA-ALCL in which the disease was limited to the circumscribed scar tissue of the breast capsule, complete surgical excision has proved curative, whereas incomplete capsulectomy portends a greater risk of recurrence and decreased survival.⁴⁴

In cases of advanced or recurrent ALCL, diagnosed late or inappropriately, the National Comprehensive Cancer Network recommends a multidisciplinary approach involving adjuvant chemotherapy and radiation.⁴⁴ Anecdotally, at our institution, we have recently treated several cases of advanced ALCL presenting with invasive chest wall masses with extirpative surgery and subsequent reconstruction with the assistance of our thoracic surgery colleagues, as well as the aforementioned multidisciplinary approach using adjuvant therapy.

The mechanism of this malignancy is currently under investigation, but the current theory implicates an exaggerated lymphoproliferative response to bacterial contamination of the capsule superimposed upon genetic factors in susceptible patients.^42,43

National societies advise plastic surgeons to discuss the risk of BIA-ALCL with all patients at the time of breast augmentation consultation and to report all confirmed cases to the PROFILE registry (Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology).⁴⁵

ARE PATIENTS HAPPIER AFTERWARD?

Studies have shown that after undergoing breast augmentation surgery, patients note improvement in body image, and satisfaction rates range from 85% to 95% with respect to self-confidence and body image.⁴⁶ An evaluation of patient responses on the validated BREAST-Q Augmentation Questionnaire showed the following satisfaction rates: breasts 83%, psychosocial well-being 88%, and sexual functioning 81%.¹⁵

Although epidemiologic studies have reported higher suicide rates in women with cosmetic breast implants, this likely stems from preoperative psychological factors and underscores the role of psychiatric referral in patients with a mental health history or in those whom the surgeon deems it necessary.⁴⁶

Several high-quality studies have demonstrated that quality of life and psychosocial functioning (including depression) markedly improve after breast augmentation surgery.⁴⁷ Among a cohort of Norwegian patients, breast implant surgery resulted in improved motivation to perform daily activities, as well as improved quality of life from both a psychosocial and aesthetic perspective.⁴⁸ Interestingly, a recent study reported that patients who underwent breast implant surgery alone reported greater satisfaction and psychosocial quality of life than patients who underwent combination breast augmentation and mastopexy (breast-lifting) surgery.⁴⁹

Additional data are needed to refine our understanding of the complex interplay between psychosocial factors before and after surgery in patients seeking and undergoing breast augmentation procedures.

At present, 300,000 US women undergo breast augmentation surgery each year,¹ making this the second most common aesthetic procedure in women (after liposuction),^2–4 and making it extremely likely that clinicians will encounter women who have breast implants. In addition, approximately 110,000 women undergo breast reconstructive surgery after mastectomy, of whom more than 88,000 (81%) receive implants (2016 data).⁵

This review discusses the evolution of breast implants, their complications, and key considerations with regard to aesthetic and reconstructive breast surgery, as the principles are similar.

EVOLUTION OF IMPLANTS

Reports of breast augmentation surgery, also known as augmentation mammoplasty, date back to 1895, when a fatty tumor (lipoma) was successfully transplanted from a patient’s back to a breast defect in a mastectomy patient.^2,3,6,7 In the 1930s, implantation of a glass ball into a patient’s breast marked the first implant-based breast augmentation.⁶ By 1954, attempts at breast augmentation using local dermal-fat flaps, adipose tissue, and even omentum were described.

Alloplastic materials gained popularity throughout the 1950s and 1960s and included polyurethane, polytetrafluoroethylene (Teflon), and other synthetics. Adverse reactions associated with alloplastic materials were plentiful: local tissue reactions, distortion of the breast mound, increased firmness, and discomfort all contributed to the eventual discontinuation of their use. The history of alloplastic breast augmentation also included epoxy resin, shellac, beeswax, paraffin, rubber, petroleum jelly, and liquefied silicone. Outcomes were not good, and many patients ultimately needed mastectomy.⁷

The first modern breast prosthesis was developed in 1961, and since then, implant composition and design have evolved significantly.⁸

From silicone to saline, and back again

The first silicone gel implants, introduced in the early 1960s,^8–19 had high complication rates—some centers reported an incidence of capsular contracture of up to 70%.^8,11 This is a foreign body reaction in which pathologic scar tissue encases the implant, causing it to distort, appear misshapen, harden, and even become painful.¹¹ Attempts to minimize this reaction led to later generations of silicone implants with polyurethane shells.¹²

Inflatable implants filled with sterile saline solution were originally developed in France in 1965. Unlike silicone implants, saline implants have undergone minimal changes since their inception, and grew in popularity during the 1970s in view of the high rates of capsular contracture with silicone implants.⁸ However, saline implants have their own problems, and as they became increasingly popular, deflation and the unnatural feel of saline sparked a renewed interest in silicone gel.

By the late 1980s, the thinner-shelled generation of silicone implants displayed its own frustrating complications including implant rupture, capsular contracture, infection, and possible systemic and disseminated granulomatous disease. From 1992 to 2006, the US Food and Drug Administration (FDA) placed a moratorium on silicone implants due to concerns about a possible link with autoimmune and connective tissue diseases and the possible carcinogenic nature of silicone.

While silicone implants were prohibited in the United States, development continued abroad, and eventually the moratorium was lifted after several meta-analyses failed to reveal any link regarding the aforementioned concerns.¹³

Today, silicone gel implants dominate the world market.¹⁴ In the United States, approximately 60% of implants contain silicone gel filler, and trends are similar in Europe.⁷

Table 1 summarizes the evolution of silicone breast implants over the last 50 years.^2,6,11,12Table 2 lists the advantages and disadvantages of silicone and saline breast implants.^2,6,8,15

CURRENT IMPLANT OPTIONS

Currently, 3 companies (Allergan, Mentor, Sientra) manufacture and distribute breast implants and implant-associated products such as tissue expanders and sizers in the US market.⁶

Another company, Motiva, makes an implant that is available in Europe, Asia, and Australia, and the device is currently undergoing a 10-year clinical trial in the United States that began recruiting patients in 16 centers in April 2018.¹⁶ Pending final approval, the Cleveland Clinic Department of Plastic Surgery may be among the centers involved in the clinical trial of the Motiva implant. Innovations in the Motiva implant include a high-performance shell that maintains consistent strength and includes a proprietary barrier layer, improved silicone gel filler, 3-D imprinted surface texturing, and an implant shape that adapts with vertical and horizontal movement. It also contains radio-frequency identification transponders that can transmit data about the implant wirelessly.^17–19

Developed in the 1980s, texturing of the implant surface disrupts capsule formation around the prosthesis. Additionally, texturing stabilizes an anatomically shaped (teardrop) implant within the breast pocket, reducing malrotation.^20,21

The first textured implants were covered with polyurethane foam, but they were ultimately withdrawn from the US market because of concern for in vivo degradation to carcinogenic compounds. The focus subsequently turned to texturing implant shells by mechanically creating pores of different sizes. Smooth implants, by contrast, are manufactured by repeatedly dipping the implant shell into liquid silicone.²

The capsular contraction rate has been shown to be lower with textured silicone than with smooth silicone (number needed to treat = 7–9), and evidence suggests a lower risk of needing a secondary procedure.²¹

Form-stable vs fluid-form

Silicone is a polymer. The physical properties of polymers vary greatly and depend on the length of the individual chains and the degree to which those chains are cross-linked. Liquid silicone contains short chains and sparse cross-linking, resulting in an oily compound well suited for lubrication. Silicone gel contains longer chains and more cross-linking and is therefore more viscous.

In “form-stable” implants, the silicone interior has sufficient chain length and cross-linking to retain the designed shape even at rest,² but they require slightly larger incisions.⁷ “Fluid-form” refers to an implant with silicone filler with shorter chain length, less cross-linking, and more fluidity.⁶

Shell

As with silicone fillers, the properties of silicone implant shells also depend on chain length and cross-linking within the polymer. Silicone elastomer shells (Table 1) contain extensively cross-linked chains that impart a flexible yet rubbery character. Silicone elastomers can also be found in facial implants and tissue expanders.²

Implant shape (round vs anatomic)

The shape of an implant is determined by the gel distribution inside of it. To understand gel distribution and implant shape, one must understand the gel-shell ratio. This ratio increases as cohesivity of the filler increases, and it represents increased bonding of the gel filler to the shell and a preserved implant shape at rest.

The gel-shell ratio varies among manufacturers, and a less-viscous filler may be more prone to rippling or loss of upper pole fullness in some patients. For this reason, careful analysis, patient and implant selection, and discussion of complications remain paramount.²

No anatomically shaped implant is manufactured with a smooth shell, but rather with a textured shell that resists malrotation.^6,15 However, in the United States, 95% of patients receive round implants.¹⁶

PATIENT ASSESSMENT

Before breast augmentation surgery, the surgeon assesses a number of factors—physical and psychosocial—and helps the patient choose a type and size of implant. The surgeon and patient also plan where the implants will be placed—ie, above or beneath the chest wall muscle—and where the incisions will be made. Every decision is made in close consultation with the patient, taking into account the patient’s desires and expectations, as well as what the patient’s anatomy allows. An integral component of this shared decision-making process is a discussion of the possible complications, and often photographs to better illustrate what to expect postoperatively. 

Psychosocial factors

One must consider the patient’s psychology, motivations for surgery, and emotional stability. Here, we look for underlying body dysmorphic disorder; excessive or unusual encouragement to undergo the procedure by a spouse, friends, or others; a history of other aesthetic procedures; unrealistic expectations; and other factors influencing the desire to undergo this surgery.

Choosing an implant

Implant selection must take into account the patient’s height, weight,⁷ and overall body morphology: taller patients and those with wider hips or shoulders usually require larger implants. A reliable method for determining the appropriate implant must include the current breast shape, dimensions, volume, skin elasticity, soft-tissue thickness, and overall body habitus. Ultimately, the most important considerations include breast base diameter, implant volume,²⁰ and soft-tissue envelope.

Preoperative sizing can involve placing sample implants within a brassiere so that the patient can preview possible outcomes. This method is particularly effective in minimizing dissatisfaction because it shares ownership of the decision-making process.¹⁵

A computerized implant selection program available in Europe suggests a “best-fit” implant based on a clinician’s measurements.⁷

Traditionally, plastic surgeons place breast implants either beneath the pectoralis major muscle (submuscular placement) or over the pectoralis⁸ but beneath the glandular breast parenchyma (subglandular placement) (Figure 2).⁷

Advantages of submuscular placement are a smoother transition of the upper breast pole from the chest wall and less rippling visible through the skin, due to the additional muscular coverage of the implant. Another advantage is that capsular contraction rates are lower with submuscular placement, likely due to possible contamination of implants by lactiferous ductal microbes when accessing the subglandular plane.^14,20 Disadvantages are pronounced discomfort after surgery and animation deformities with muscle contraction, particularly in young, highly active patients.

A popular modification of submuscular placement involves creating a surgical dissection plane between the subglandular tissue and the pectoralis major fascia. This “dual­­plane” approach allows the parenchyma to retract superiorly and reduce breast ptosis.⁷

Incisions

Table 3 highlights important considerations with regard to incision location.^15,20,21

ANTIBIOTICS

Many surgeons give a single prophylactic dose of antibiotic before surgery, a practice that some studies have shown to be effective in reducing the risk of infection.¹⁵ However, the benefit of routine postoperative use of antibiotics remains unsubstantiated¹⁵: postoperative antibiotic use does not appear to protect against infection, capsular contracture, or overall complications in primary or secondary breast augmentation surgery.²⁰

PERIOPERATIVE PERIOD

At our institution, breast augmentation surgery is an ambulatory procedure—the patient goes home the same day unless circumstances such as pain control warrant admission. This is, however, according to surgeon preference, and differs on a case-by-case basis. General anesthesia is the standard of care.¹⁵

POSTOPERATIVE PERIOD

In the immediate postoperative period, patients are instructed to wear a surgical bra for up to 6 weeks to allow stable scarring. Early mobilization is encouraged.^7,15 Depending on the patient’s situation, recovery, and healing, she may be out of work for about 1 week, sometimes more, sometimes less. 

Additional instructions are surgeon-specific. However, the patient is instructed to avoid bathing, swimming, immersion in water, and wearing underwire brassieres that could impair healing of an inferior incision; instead, patients are often instructed to wear a surgical bra provided on the day of surgery until cleared in the clinic.

Showering is allowed the next day or the second day after surgery, and of course there is no driving while on narcotics. Additionally, patients are counseled extensively regarding hematoma formation and the signs and symptoms of infection.

Patients are typically seen in clinic 1 week after surgery.

The cost of surgery may be $5,000 to $6,000 but can vary significantly from center to center depending on who the patient sees and where, and whether the patient presents for breast reconstruction after cancer or repair of congenital anomalies, or in certain cases of transgender surgery. The patient is typically responsible for the fee, but again this depends on the patient, indications, and particular insurance concerns.

IMPLANT LONGEVITY AND RUPTURE

In the United States, implant rupture rates range from 1.1% to 17.7% at 6 to 10 years after primary augmentation, 2.9% to 14.7% after revision augmentation, 1.5% to 35.4% after primary breast reconstruction, and 0% to 19.6% after revision reconstruction.¹¹

Unfortunately, the existence of multiple implant manufacturers, numerous implant generations, and poorly standardized screening protocols and reporting systems make the true rate of implant rupture difficult to assess without definitive imaging or implant retrieval.¹¹

Damage from surgical instrumentation during implantation is the most common cause of silicone breast implant rupture (50% to 64% of cases).²² Other causes include underfilling and fold flaw from capsular contracture.

Leakage of silicone gel filler may be confined to the periprosthetic capsule (intracapsular rupture) or extend beyond and into the breast parenchyma (extracapsular rupture). One study reported that only 10% of intracapsular ruptures progressed extracapsularly, while 84% of patients with extracapsular involvement remained stable for up to 2 years,²³ indicating that intracapsular rupture may not portend worsening disease.¹¹

Implant rupture occurs silently in most cases, with no clinically detectable signs or symptoms. In other cases, patients may present with alterations in breast shape and size, sudden asymmetry, firmness, pronounced capsular contracture, contour irregularity, or pain.

Aside from physical examination, comprehensive diagnostic testing includes imaging—ultrasonography, mammography, computed tomography, and magnetic resonance imaging (MRI). Of these, MRI is the method of choice, with sensitivity and specificity exceeding 90% for detecting implant rupture.¹¹ Classic findings on MRI include the “linguine” sign from a deflating implant shell, or the teardrop sign from implant sagging. Classic findings on ultrasonography include the “snowstorm” sign of extracapsular rupture and the “stepladder” sign of intracapsular rupture.

Mammography effectively detects free silicone in breast tissue with extracapsular rupture (25% of ruptures according to some studies)²³; however, it cannot detect rupture within the implant capsule. As an aside, submuscular implant placement may interfere less with screening mammography than subglandular implants do.^14,24

Current FDA recommendations to detect implant rupture encourage women with silicone breast implants to undergo screening 3 years after implantation and then every 2 years thereafter; no long-term monitoring is suggested for saline implants.¹⁵ Many plastic surgeons evaluate silicone breast implant patients every 1 to 2 years for contracture and rupture.⁸ Of note, capsular contracture impairs the effectiveness of ultrasonography and may require MRI confirmation.¹¹

If implant rupture is confirmed, the current recommendation is to remove the implant and the capsule. Another implant may be placed depending on the patient’s preference. Rigorous washout remains a key feature of any surgical intervention for ruptured breast implants; however, in the event of extracapsular rupture, resection of silicone granulomas may also be required.¹¹

Reoperation rates for primary breast augmentation surgery approach 20% and are even higher for secondary augmentation over a patient’s lifetime—the highest rate of all aesthetic procedures.^7,14

Capsular contracture is the most common complication of breast augmentation,²⁵ typically presenting within the first postoperative year,^26,27 and the risk increases over time.²⁸ It occurs with both silicone and saline breast implants.

In some studies, the incidence exceeded 4% in the first 2 years after surgery,²⁹ and nearly 50% by 10 years.³⁰ Other studies found rates of 0% to 20% over 13 years.²⁰

The etiology is not well understood and is presumed to be multifactorial, with proposed mechanisms and factors that include bacterial contamination, surface texturing, the implant pocket selected, the incision type, drain placement, antibiotic use, and smoking.²⁵

A meta-analysis from 17,000 implants found that the risk of capsular contracture was significantly higher when an implant was placed in a subglandular pocket than in a submuscular pocket,^22,26 and that although texturing decreased capsular contracture compared with smooth implants, the effect was modest when a textured or smooth implant was placed in a submuscular location.²⁸ With regard to incision location, studies have reported that the incidence of capsular contracture is highest with transaxillary and periareolar incisions, and lowest with inframammary incisions.^20,21

The leading theory is that contamination of the implant (primarily from the mammary ducts) results in biofilm formation. Subclinical hematoma surrounding the implant may also provide key bacterial nutrients.²⁰

Textured implants induce a greater inflammatory response in the capsular tissue, resulting in a thicker capsule; however, contracture rates remain lower with textured than with smooth implants.^14,31 Interestingly, lower rates of capsular contracture have been observed with later-generation, cohesive-gel, form-stable implants than with those of earlier generations.¹²

Although more research is needed, silicone implants appear to confer a higher risk of capsular contracture than saline implants.^14,20

Irrigating the breast pocket intraoperatively with triple antibiotic solution (bacitracin, cefazolin, and gentamicin) before placing the implant may decrease the capsular contracture rate.^15,20

Treatments for capsular contracture include pocket modifications such as capsulotomy (making releasing, relaxing incisions in the scar capsule encasing the implant), capsulectomy (removing portions of or the entire capsule), and replacing the implant in the other pocket (ie, if the original implant was subglandular, the replacement is placed in the submuscular pocket). Patients who have contractures that fail to respond to these treatments may ultimately benefit from implant removal and autologous reconstruction (autoaugmentation) rather than implant replacement.^32,33

ADDITIONAL COMPLICATIONS

Other complications include infection, malposition, rippling, seroma, hematoma, and sensory alterations.

Irrigation during the implantation procedure with a triple antibiotic solution consisting of bacitracin, gentamycin, and cephalexin in normal saline decreases infection and seroma rates.^15,20,34

Some surgeons also choose to irrigate the pocket with a betadine solution, or to cleanse the skin with betadine and place sterile towels and redrape before inserting the implant. Additionally, many prefer using a sterile device much like a pastry funnel called a Keller funnel to insert the implant into the breast pocket.³⁵

Infection is less common with cosmetic augmentations than with implant-based breast reconstruction, likely because of healthier, well-vascularized tissue in patients undergoing cosmetic surgery than in those undergoing mastectomy.¹⁴

Seroma is thought to be a consequence of texturing, and more so with macro- vs microtexturing. Though poorly understood, an association between texturing and double capsules has also been reported.^12,20

After primary breast augmentation, 10-year follow-up rates of capsular contracture, seroma, rippling, and malposition vary across the 3 major silicone implant manufacturers.¹² Hematoma and infection occur in less than 1% of primary augmentation patients.¹⁵

Malposition of the implant over time is less frequent with textured implants because of the higher coefficient of friction compared with smooth implants^.6,8,15

Visible skin rippling may be a consequence of texturing and also of thin body habitus, eg, in patients with a body mass index less than 18.5 kg/m². If the soft-tissue layer of the breast is thin, the natural rippling of smooth saline implant shells are more likely to show when placed in the subglandular pocket. Form-stable implants, by contrast, resist rippling.^12,15

Large implants and extensive lateral dissection can cause alterations in nipple sensation and sensory loss within lower breast pole skin. Axillary incisions may traumatize or damage the intercostobrachial nerve, resulting in upper inner arm sensory aberrations.

Ultimately, the 10-year incidence of secondary surgery ranges from 0% to 36% and the 10-year incidence of capsular contracture ranges from 11% to 19%.¹⁵ Additional cosmetic complaints after augmentation with implants include enlargement of the areola and engorgement of breast veins.¹⁴

BREAST CANCER AND DETECTION

Patients with or without implants do not seem to differ with regard to breast cancer stage upon detection, tumor burden, recurrence, or survival. However, more patients with implants may present with palpable masses, invasive tumors, axillary metastasis, and falsely negative mammograms.

Breast implants may actually facilitate cancer detection on physical examination by providing a more dense or stable surface upon which to palpate the breast tissue. Although they do not necessarily impair mastectomy or breast reconstruction, they may result in an increased rate of revision surgery after breast conservation therapy.^24,36 Mammography remains the standard of care for radiologic diagnosis but can be further supported by MRI and ultrasonography if necessary in patients with implants.

Although concerns persist, multiple studies have demonstrated the safety of fourth- and fifth-generation silicone breast implants with regard to autoimmune disease.⁷

In various clinical studies in mastectomy patients who underwent breast reconstruction with either silicone implants or autologous tissue, no difference was found with regard to the incidence of autoimmune diseases.² Additionally, in meta-analyses of data from more than 87,000 women, no association was found between connective tissue disease and silicone breast implants.^2,11 One study^11,23 noted no increase in autoantibodies in patients with undamaged silicone implants vs patients who experienced rupture.

Studies have also demonstrated that in children born to mothers with breast implants, the risk of rheumatic disease, esophageal disorders, congenital malformations, and death during the perinatal period is comparable with that in controls.³⁷ Another study, examining breastfeeding in women with silicone breast implants, showed no significant difference in silicon levels (used as a proxy for silicone) in breast milk compared with controls without implants; silicon levels were found to be significantly higher in cow’s milk and store-bought formulas.³⁸

BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a subtype of T-cell lymphoma that develops in tissue adjacent to breast implants. It typically presents as breast swelling 2 to 38 years (mean of 8 years) after implant insertion.^39,40 The swelling may be secondary to periprosthetic seroma formation or, more rarely, palpable disease in the axilla. Patients occasionally complain of pain and, rarely, constitutional symptoms.²⁰ BIA-ALCL is not a disease of the surrounding breast tissue, but rather of the fibrous periprosthetic capsule.²¹

Of note, there is no documented case involving smooth implants,^41–43 but it may be related to fifth-generation textured implants.⁶ At present, it is not possible to definitively state which implant is associated with this condition; hence, more data are needed, and this association is currently under study.

The absolute risk of BIA-ALCL was reported in a Dutch study³⁹ as 1 in 35,000 by age 50, 1 in 12,000 by age 70, and 1 in 7,000 by age 75, with a number needed to harm of 6,920. Overall lifetime risk was estimated at 1 in 30,000 for women with textured implants in a 2015 US study.⁴⁰ In comparison, breast cancer risk is about 1 in 8 women. There is no apparent predilection for patients who underwent cosmetic augmentation vs reconstruction, or who received silicone vs saline implants.

The diagnosis is confirmed by ultrasonographically guided fine-needle aspiration of seroma fluid and subsequent immunohistochemical testing for CD30-positive and ALK-negative T lymphocytes. Other than positron-emission tomography for staging after diagnosis confirmation, imaging is ineffective. Expert opinion does not recommend routine screening unless the aforementioned symptoms arise.

Treatment involves implant removal and total capsulectomy, with samples sent for pathology study with cytokeratin staining.¹² Of note, in all cases of BIA-ALCL in which the disease was limited to the circumscribed scar tissue of the breast capsule, complete surgical excision has proved curative, whereas incomplete capsulectomy portends a greater risk of recurrence and decreased survival.⁴⁴

In cases of advanced or recurrent ALCL, diagnosed late or inappropriately, the National Comprehensive Cancer Network recommends a multidisciplinary approach involving adjuvant chemotherapy and radiation.⁴⁴ Anecdotally, at our institution, we have recently treated several cases of advanced ALCL presenting with invasive chest wall masses with extirpative surgery and subsequent reconstruction with the assistance of our thoracic surgery colleagues, as well as the aforementioned multidisciplinary approach using adjuvant therapy.

The mechanism of this malignancy is currently under investigation, but the current theory implicates an exaggerated lymphoproliferative response to bacterial contamination of the capsule superimposed upon genetic factors in susceptible patients.^42,43

National societies advise plastic surgeons to discuss the risk of BIA-ALCL with all patients at the time of breast augmentation consultation and to report all confirmed cases to the PROFILE registry (Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology).⁴⁵

ARE PATIENTS HAPPIER AFTERWARD?

Studies have shown that after undergoing breast augmentation surgery, patients note improvement in body image, and satisfaction rates range from 85% to 95% with respect to self-confidence and body image.⁴⁶ An evaluation of patient responses on the validated BREAST-Q Augmentation Questionnaire showed the following satisfaction rates: breasts 83%, psychosocial well-being 88%, and sexual functioning 81%.¹⁵

Although epidemiologic studies have reported higher suicide rates in women with cosmetic breast implants, this likely stems from preoperative psychological factors and underscores the role of psychiatric referral in patients with a mental health history or in those whom the surgeon deems it necessary.⁴⁶

Several high-quality studies have demonstrated that quality of life and psychosocial functioning (including depression) markedly improve after breast augmentation surgery.⁴⁷ Among a cohort of Norwegian patients, breast implant surgery resulted in improved motivation to perform daily activities, as well as improved quality of life from both a psychosocial and aesthetic perspective.⁴⁸ Interestingly, a recent study reported that patients who underwent breast implant surgery alone reported greater satisfaction and psychosocial quality of life than patients who underwent combination breast augmentation and mastopexy (breast-lifting) surgery.⁴⁹

Additional data are needed to refine our understanding of the complex interplay between psychosocial factors before and after surgery in patients seeking and undergoing breast augmentation procedures.

BROOKLYN, N.Y. – Intervening effectively for children and adolescents at suicide risk involves watching for triggers such as personal loss, sleep disturbances, or interpersonal conflict, an expert said at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

It is important to distinguish the distal risks, which are factors known to increase suicidal ideation, and proximal risk factors, which predict attempts, according to Tina R. Goldstein, PhD, associate professor of psychiatry and psychology at the University of Pittsburgh. “We know that the optimal targets for preventing suicidal behavior are proximal,” Dr. Goldstein said. Treatment of distal risks, such as depression or substance use, is a foundation for risk management, but suicidal events are driven by acute crises that appear to require individualized intervention.

Dr. Goldstein said she had just “one sad slide” to summarize drug treatments aimed at controlling suicidal behavior. That slide included citations for studies associating neuroleptics and antidepressants with a reduction in aggressive or impulsive behavior in children. The only study associating a drug with a reduction in suicide attempts was performed with lithium in adults.

However, intensive cognitive and dialectical behavior interventions involving the family have been shown to reduce suicide attempts in randomized controlled trials, said Dr. Goldstein, who also is affiliated with the university’s Child and Adolescent Bipolar Spectrum Services Research Program. Those trials underscore the messages that personalizing therapy is essential, as are addressing specific triggers and helping patients develop defenses against suicidal thoughts.

Dr. Goldstein described a recently published, National Institutes of Health–funded study that focused on suicide reduction. The study was conducted in adolescents who were being discharged from a brief hospitalization for acute suicidal ideation or a suicide attempt (J Adolesc Health. 2018 Nov. 8. doi: 10.1016/j.jadohealth.2018.09.015). “We know that there is this really high-risk period after discharge from the hospital for which we could potentially do things better,” said Dr. Goldstein, whose center was involved in the study.

The tested intervention, called As Safe As Possible (ASAP), involved “front-loading some coping skills and giving [the patients] a good safety plan even before they are discharged,” Dr. Goldstein said. For risk management after discharge, the adolescents were provided with a smartphone app called BRITE that contained the safety plan as well as a summary of personalized coping skills, including reminders that the patients themselves had provided for reasons for living. The app was augmented as appropriate with favorite songs, photos of the patients’ pet, or other customized aids to provide support during the typical delay between the time of discharge and the next step in care.

In 6 months of follow-up, the rate of suicide attempts was 8.7% of those enrolled in the intensive outpatient program, compared with 27.3% (P = .08) for those who received treatment as usual. Dr. Goldstein called this trend promising, particularly in the context of other favorable results, including a significantly longer (P = .03) time to a suicide attempt in the ASAP group.

In patients at imminent risk of a suicide attempt, it is logical to assume that treatment must be personalized to the issues behind increased suicidal ideation. However, a study published by Dr. Goldstein and her associates several years ago suggested that evidence of deteriorating mental health can signal a need for intensification of suicide risk management (Arch Gen Psychiatry. 2012;69:1113-22). In one part of that study, risk factors for suicide were evaluated in the 8 weeks before a suicide attempt in 413 children with bipolar disorder. During that time, depression scores increased as did substance use, but, surprisingly, so did use of mental health services.

“The way we have come to think of these data is that the kids, their parents, and their providers were recognizing that things were getting worse and they needed more services,” Dr. Goldstein said. “The bad news is that the services we were giving them were not particularly effective.”

Those data underscore some of the challenges facing clinicians who treat pediatric patients with mental illness. “Our field has not yet developed ... gold standard treatments for preventing suicidal behavior in kids with mood disorder,” Dr. Goldstein said. However, she thinks that some progress has been made and that some of the personalized approaches are demonstrating efficacy – particularly in children and adolescents who exhibit signs of imminent risk.

BROOKLYN, N.Y. – Intervening effectively for children and adolescents at suicide risk involves watching for triggers such as personal loss, sleep disturbances, or interpersonal conflict, an expert said at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

It is important to distinguish the distal risks, which are factors known to increase suicidal ideation, and proximal risk factors, which predict attempts, according to Tina R. Goldstein, PhD, associate professor of psychiatry and psychology at the University of Pittsburgh. “We know that the optimal targets for preventing suicidal behavior are proximal,” Dr. Goldstein said. Treatment of distal risks, such as depression or substance use, is a foundation for risk management, but suicidal events are driven by acute crises that appear to require individualized intervention.

Dr. Goldstein said she had just “one sad slide” to summarize drug treatments aimed at controlling suicidal behavior. That slide included citations for studies associating neuroleptics and antidepressants with a reduction in aggressive or impulsive behavior in children. The only study associating a drug with a reduction in suicide attempts was performed with lithium in adults.

However, intensive cognitive and dialectical behavior interventions involving the family have been shown to reduce suicide attempts in randomized controlled trials, said Dr. Goldstein, who also is affiliated with the university’s Child and Adolescent Bipolar Spectrum Services Research Program. Those trials underscore the messages that personalizing therapy is essential, as are addressing specific triggers and helping patients develop defenses against suicidal thoughts.

Dr. Goldstein described a recently published, National Institutes of Health–funded study that focused on suicide reduction. The study was conducted in adolescents who were being discharged from a brief hospitalization for acute suicidal ideation or a suicide attempt (J Adolesc Health. 2018 Nov. 8. doi: 10.1016/j.jadohealth.2018.09.015). “We know that there is this really high-risk period after discharge from the hospital for which we could potentially do things better,” said Dr. Goldstein, whose center was involved in the study.

The tested intervention, called As Safe As Possible (ASAP), involved “front-loading some coping skills and giving [the patients] a good safety plan even before they are discharged,” Dr. Goldstein said. For risk management after discharge, the adolescents were provided with a smartphone app called BRITE that contained the safety plan as well as a summary of personalized coping skills, including reminders that the patients themselves had provided for reasons for living. The app was augmented as appropriate with favorite songs, photos of the patients’ pet, or other customized aids to provide support during the typical delay between the time of discharge and the next step in care.

In 6 months of follow-up, the rate of suicide attempts was 8.7% of those enrolled in the intensive outpatient program, compared with 27.3% (P = .08) for those who received treatment as usual. Dr. Goldstein called this trend promising, particularly in the context of other favorable results, including a significantly longer (P = .03) time to a suicide attempt in the ASAP group.

In patients at imminent risk of a suicide attempt, it is logical to assume that treatment must be personalized to the issues behind increased suicidal ideation. However, a study published by Dr. Goldstein and her associates several years ago suggested that evidence of deteriorating mental health can signal a need for intensification of suicide risk management (Arch Gen Psychiatry. 2012;69:1113-22). In one part of that study, risk factors for suicide were evaluated in the 8 weeks before a suicide attempt in 413 children with bipolar disorder. During that time, depression scores increased as did substance use, but, surprisingly, so did use of mental health services.

“The way we have come to think of these data is that the kids, their parents, and their providers were recognizing that things were getting worse and they needed more services,” Dr. Goldstein said. “The bad news is that the services we were giving them were not particularly effective.”

Those data underscore some of the challenges facing clinicians who treat pediatric patients with mental illness. “Our field has not yet developed ... gold standard treatments for preventing suicidal behavior in kids with mood disorder,” Dr. Goldstein said. However, she thinks that some progress has been made and that some of the personalized approaches are demonstrating efficacy – particularly in children and adolescents who exhibit signs of imminent risk.

BROOKLYN, N.Y. – Intervening effectively for children and adolescents at suicide risk involves watching for triggers such as personal loss, sleep disturbances, or interpersonal conflict, an expert said at a pediatric psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry.

It is important to distinguish the distal risks, which are factors known to increase suicidal ideation, and proximal risk factors, which predict attempts, according to Tina R. Goldstein, PhD, associate professor of psychiatry and psychology at the University of Pittsburgh. “We know that the optimal targets for preventing suicidal behavior are proximal,” Dr. Goldstein said. Treatment of distal risks, such as depression or substance use, is a foundation for risk management, but suicidal events are driven by acute crises that appear to require individualized intervention.

Dr. Goldstein said she had just “one sad slide” to summarize drug treatments aimed at controlling suicidal behavior. That slide included citations for studies associating neuroleptics and antidepressants with a reduction in aggressive or impulsive behavior in children. The only study associating a drug with a reduction in suicide attempts was performed with lithium in adults.

However, intensive cognitive and dialectical behavior interventions involving the family have been shown to reduce suicide attempts in randomized controlled trials, said Dr. Goldstein, who also is affiliated with the university’s Child and Adolescent Bipolar Spectrum Services Research Program. Those trials underscore the messages that personalizing therapy is essential, as are addressing specific triggers and helping patients develop defenses against suicidal thoughts.

Dr. Goldstein described a recently published, National Institutes of Health–funded study that focused on suicide reduction. The study was conducted in adolescents who were being discharged from a brief hospitalization for acute suicidal ideation or a suicide attempt (J Adolesc Health. 2018 Nov. 8. doi: 10.1016/j.jadohealth.2018.09.015). “We know that there is this really high-risk period after discharge from the hospital for which we could potentially do things better,” said Dr. Goldstein, whose center was involved in the study.

The tested intervention, called As Safe As Possible (ASAP), involved “front-loading some coping skills and giving [the patients] a good safety plan even before they are discharged,” Dr. Goldstein said. For risk management after discharge, the adolescents were provided with a smartphone app called BRITE that contained the safety plan as well as a summary of personalized coping skills, including reminders that the patients themselves had provided for reasons for living. The app was augmented as appropriate with favorite songs, photos of the patients’ pet, or other customized aids to provide support during the typical delay between the time of discharge and the next step in care.

In 6 months of follow-up, the rate of suicide attempts was 8.7% of those enrolled in the intensive outpatient program, compared with 27.3% (P = .08) for those who received treatment as usual. Dr. Goldstein called this trend promising, particularly in the context of other favorable results, including a significantly longer (P = .03) time to a suicide attempt in the ASAP group.

In patients at imminent risk of a suicide attempt, it is logical to assume that treatment must be personalized to the issues behind increased suicidal ideation. However, a study published by Dr. Goldstein and her associates several years ago suggested that evidence of deteriorating mental health can signal a need for intensification of suicide risk management (Arch Gen Psychiatry. 2012;69:1113-22). In one part of that study, risk factors for suicide were evaluated in the 8 weeks before a suicide attempt in 413 children with bipolar disorder. During that time, depression scores increased as did substance use, but, surprisingly, so did use of mental health services.

“The way we have come to think of these data is that the kids, their parents, and their providers were recognizing that things were getting worse and they needed more services,” Dr. Goldstein said. “The bad news is that the services we were giving them were not particularly effective.”

Those data underscore some of the challenges facing clinicians who treat pediatric patients with mental illness. “Our field has not yet developed ... gold standard treatments for preventing suicidal behavior in kids with mood disorder,” Dr. Goldstein said. However, she thinks that some progress has been made and that some of the personalized approaches are demonstrating efficacy – particularly in children and adolescents who exhibit signs of imminent risk.

The Food and Drug Administration has permitted marketing of the Aptima Mycoplasma genitalium assay, the first test for the diagnoses of sexually transmitted infections (STIs) caused by the M. genitalium bacterium, the agency reported in a press release.

Wikimedia Commons/FitzColinGerald/Creative Commons License

M. genitalium is associated with nongonococcal urethritis in men and cervicitis in women, causing 15%-30% of persistent or recurring urethritis cases and 10%-30% of cervicitis cases, according to the Centers for Disease Control and Prevention. It also can lead to pelvic inflammatory disease (PID) in women. The assay is a nucleic acid amplification test, which can detect the bacterium in urine, as well as urethral, penile meatal, endocervical, or vaginal swab samples.

In a clinical study of 11,774 samples, the Aptima assay correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. It also correctly identified the bacterium in female urine and endocervical samples 78% and 82% of the time, respectively. The test was even more accurate in identifying samples that did not have M. genitalium present, according to an FDA press release

“In the past, it has been hard to diagnose this organism. By being able to detect it more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” FDA Commissioner Scott Gottlieb, MD, said in the press release. “Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.”

Find the full press release on the FDA website.

The Food and Drug Administration has permitted marketing of the Aptima Mycoplasma genitalium assay, the first test for the diagnoses of sexually transmitted infections (STIs) caused by the M. genitalium bacterium, the agency reported in a press release.

Wikimedia Commons/FitzColinGerald/Creative Commons License

M. genitalium is associated with nongonococcal urethritis in men and cervicitis in women, causing 15%-30% of persistent or recurring urethritis cases and 10%-30% of cervicitis cases, according to the Centers for Disease Control and Prevention. It also can lead to pelvic inflammatory disease (PID) in women. The assay is a nucleic acid amplification test, which can detect the bacterium in urine, as well as urethral, penile meatal, endocervical, or vaginal swab samples.

In a clinical study of 11,774 samples, the Aptima assay correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. It also correctly identified the bacterium in female urine and endocervical samples 78% and 82% of the time, respectively. The test was even more accurate in identifying samples that did not have M. genitalium present, according to an FDA press release

“In the past, it has been hard to diagnose this organism. By being able to detect it more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” FDA Commissioner Scott Gottlieb, MD, said in the press release. “Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.”

Find the full press release on the FDA website.

The Food and Drug Administration has permitted marketing of the Aptima Mycoplasma genitalium assay, the first test for the diagnoses of sexually transmitted infections (STIs) caused by the M. genitalium bacterium, the agency reported in a press release.

Wikimedia Commons/FitzColinGerald/Creative Commons License

M. genitalium is associated with nongonococcal urethritis in men and cervicitis in women, causing 15%-30% of persistent or recurring urethritis cases and 10%-30% of cervicitis cases, according to the Centers for Disease Control and Prevention. It also can lead to pelvic inflammatory disease (PID) in women. The assay is a nucleic acid amplification test, which can detect the bacterium in urine, as well as urethral, penile meatal, endocervical, or vaginal swab samples.

In a clinical study of 11,774 samples, the Aptima assay correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. It also correctly identified the bacterium in female urine and endocervical samples 78% and 82% of the time, respectively. The test was even more accurate in identifying samples that did not have M. genitalium present, according to an FDA press release

“In the past, it has been hard to diagnose this organism. By being able to detect it more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” FDA Commissioner Scott Gottlieb, MD, said in the press release. “Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.”

Find the full press release on the FDA website.

The American Academy of Pediatrics is pushing for pediatricians to be more proactive in keeping youth from becoming addicted to nicotine through the use of electronic cigarettes. “E-cigarettes are the most common tobacco product used among youth,” Brian Jenssen, MD, policy chair of the AAP Section on Tobacco Control and Susan Walley, MD, chair of the section, wrote in recommendations for pediatricians and policy makers regarding the use of e-cigarettes and similar devices. These recommendations were published in0 Pediatrics.

mauro grigollo/Thinkstock

“To prevent children, adolescents, and young adults from transitioning from e-cigarettes to traditional cigarettes and to minimize the potential public health harm from e-cigarette use, there is a critical need for e-cigarette legislative action, and counterpromotion to help youth live tobacco-free lives,” the authors continued.

To that end, AAP is making a series of recommended actions by pediatricians. First, they are calling for pediatricians to screen for e-cigarette use and exposure and to provide prevention counseling in clinical practice.

Second, the organization is calling on pediatricians to provide counseling that areas where youth spend time – including homes, cars, schools, and other places – should have “comprehensive tobacco-free bans that include e-cigarettes as well as combustible tobacco products.”

Finally, pediatricians should never recommend e-cigarettes as a tobacco-dependence treatment product.

AAP in the guidance document also made a series of policy recommendations, including calling on the Food and Drug Administration to regulate e-cigarettes as they do traditional tobacco products; ban the sale of e-cigarettes to anyone under 21 years of age; ban all flavored e-cigarettes, including menthol; ban advertising of e-cigarettes that is accessible to youth; tax e-cigarettes similar to traditional cigarettes; and incorporate e-cigarettes into current tobacco-free laws and ordinances.

Dr. Jenssen and Dr. Walley also call for more research to inform public policy and understand health effects.

“Additional research is needed to understand the trajectory of addiction among youth and the progression to combustible tobacco products,” they wrote. “Studies are needed to determine if and how e-cigarettes may be effective for smoking cessation; these trials must be carefully designed and adequately powered. Finally, research is needed to evaluate effective countermessaging and public health interventions.”

[email protected]

SOURCE: Jenssen B et al. Pediatrics. doi: 10.1542/peds.2018-3652.

The American Academy of Pediatrics is pushing for pediatricians to be more proactive in keeping youth from becoming addicted to nicotine through the use of electronic cigarettes. “E-cigarettes are the most common tobacco product used among youth,” Brian Jenssen, MD, policy chair of the AAP Section on Tobacco Control and Susan Walley, MD, chair of the section, wrote in recommendations for pediatricians and policy makers regarding the use of e-cigarettes and similar devices. These recommendations were published in0 Pediatrics.

mauro grigollo/Thinkstock

“To prevent children, adolescents, and young adults from transitioning from e-cigarettes to traditional cigarettes and to minimize the potential public health harm from e-cigarette use, there is a critical need for e-cigarette legislative action, and counterpromotion to help youth live tobacco-free lives,” the authors continued.

To that end, AAP is making a series of recommended actions by pediatricians. First, they are calling for pediatricians to screen for e-cigarette use and exposure and to provide prevention counseling in clinical practice.

Second, the organization is calling on pediatricians to provide counseling that areas where youth spend time – including homes, cars, schools, and other places – should have “comprehensive tobacco-free bans that include e-cigarettes as well as combustible tobacco products.”

Finally, pediatricians should never recommend e-cigarettes as a tobacco-dependence treatment product.

AAP in the guidance document also made a series of policy recommendations, including calling on the Food and Drug Administration to regulate e-cigarettes as they do traditional tobacco products; ban the sale of e-cigarettes to anyone under 21 years of age; ban all flavored e-cigarettes, including menthol; ban advertising of e-cigarettes that is accessible to youth; tax e-cigarettes similar to traditional cigarettes; and incorporate e-cigarettes into current tobacco-free laws and ordinances.

Dr. Jenssen and Dr. Walley also call for more research to inform public policy and understand health effects.

“Additional research is needed to understand the trajectory of addiction among youth and the progression to combustible tobacco products,” they wrote. “Studies are needed to determine if and how e-cigarettes may be effective for smoking cessation; these trials must be carefully designed and adequately powered. Finally, research is needed to evaluate effective countermessaging and public health interventions.”

[email protected]

SOURCE: Jenssen B et al. Pediatrics. doi: 10.1542/peds.2018-3652.

The American Academy of Pediatrics is pushing for pediatricians to be more proactive in keeping youth from becoming addicted to nicotine through the use of electronic cigarettes. “E-cigarettes are the most common tobacco product used among youth,” Brian Jenssen, MD, policy chair of the AAP Section on Tobacco Control and Susan Walley, MD, chair of the section, wrote in recommendations for pediatricians and policy makers regarding the use of e-cigarettes and similar devices. These recommendations were published in0 Pediatrics.

mauro grigollo/Thinkstock

“To prevent children, adolescents, and young adults from transitioning from e-cigarettes to traditional cigarettes and to minimize the potential public health harm from e-cigarette use, there is a critical need for e-cigarette legislative action, and counterpromotion to help youth live tobacco-free lives,” the authors continued.

To that end, AAP is making a series of recommended actions by pediatricians. First, they are calling for pediatricians to screen for e-cigarette use and exposure and to provide prevention counseling in clinical practice.

Second, the organization is calling on pediatricians to provide counseling that areas where youth spend time – including homes, cars, schools, and other places – should have “comprehensive tobacco-free bans that include e-cigarettes as well as combustible tobacco products.”

Finally, pediatricians should never recommend e-cigarettes as a tobacco-dependence treatment product.

AAP in the guidance document also made a series of policy recommendations, including calling on the Food and Drug Administration to regulate e-cigarettes as they do traditional tobacco products; ban the sale of e-cigarettes to anyone under 21 years of age; ban all flavored e-cigarettes, including menthol; ban advertising of e-cigarettes that is accessible to youth; tax e-cigarettes similar to traditional cigarettes; and incorporate e-cigarettes into current tobacco-free laws and ordinances.

Dr. Jenssen and Dr. Walley also call for more research to inform public policy and understand health effects.

“Additional research is needed to understand the trajectory of addiction among youth and the progression to combustible tobacco products,” they wrote. “Studies are needed to determine if and how e-cigarettes may be effective for smoking cessation; these trials must be carefully designed and adequately powered. Finally, research is needed to evaluate effective countermessaging and public health interventions.”

[email protected]

SOURCE: Jenssen B et al. Pediatrics. doi: 10.1542/peds.2018-3652.

Most parents are unaware their teenager has been having suicidal thoughts or thinking about death, according to a study published in Pediatrics.

asiseeit/E+/Getty Images

Jason D. Jones, PhD, from the Children’s Hospital of Philadelphia, and his coauthors wrote that more than two-thirds of adolescents who experience suicidal thoughts do not get medical help, and this may be because their parents – the gatekeepers for mental health services – are unaware of what their teen is going through.

In this study, researchers recruited 5,137 adolescents aged 11-17 years and either a parent or step-parent, and interviewed both about the adolescent’s lifetime suicidal thoughts.

While 413 (8%) of the adolescents surveyed said they had had thoughts about killing themselves, 50% of those adolescents’ parents said their teen hadn’t experienced suicidal thoughts. Similarly, 786 (15%) of adolescents surveyed said they had had thoughts about death and dying, but three-quarters of their parents were unaware.

A significant number of parents – 8% – said their teenager had had suicidal thoughts, but in 48% of these cases, the teenager said they had not thought about killing themselves.

Researchers saw more agreement between parents and adolescents when the adolescents were older: The parents were less likely to be unaware that their older teen had had suicidal thoughts, and older adolescents were less likely to deny it.

“This indicates that younger adolescents may be more likely to go unnoticed and not receive services either because their parents are unaware of their suicidal thoughts or because they deny suicidal thoughts that their parents think they are having,” Dr. Jones and his associates wrote. They also suggested younger adolescents may have “interpretive difficulties” around questions of suicidal ideation.

“These age findings are particularly noteworthy in light of recent evidence that deaths by suicide have increased among younger adolescents,” they noted.

There also was an interaction between age and gender. For girls, parents were less likely to be aware of suicidal thoughts in their younger daughters but more likely to be aware of them in their older daughters. However the opposite was true for boys: Parental unawareness increased slightly in older boys.

Parents of Hispanic or Latino ethnicity were less likely to be aware that their offspring had had thoughts about death and dying.

Generally fathers were less likely than mothers to be aware of suicidal thoughts in their adolescents.

However, if adolescents had previously received psychiatric treatment, or there was a family history of suicide, parents were more likely to be aware of suicidal thoughts, and adolescents who had a history of psychiatric hospitalization were less likely to deny suicidal thoughts, the researchers reported.

The study was supported by grants from the National Institutes of Health, the Dowshen Program for Neuroscience, and the Lifespan Brain Institute of the Children’s Hospital of Philadelphia and University of Pennsylvania. The study was funded by NIH. One author declared a board position and stock options in Taliaz Health unrelated to the study subject; the other authors said they had no relevant financial disclosures.

SOURCE: Jones JD et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-1771.
 

Most parents are unaware their teenager has been having suicidal thoughts or thinking about death, according to a study published in Pediatrics.

asiseeit/E+/Getty Images

Jason D. Jones, PhD, from the Children’s Hospital of Philadelphia, and his coauthors wrote that more than two-thirds of adolescents who experience suicidal thoughts do not get medical help, and this may be because their parents – the gatekeepers for mental health services – are unaware of what their teen is going through.

In this study, researchers recruited 5,137 adolescents aged 11-17 years and either a parent or step-parent, and interviewed both about the adolescent’s lifetime suicidal thoughts.

While 413 (8%) of the adolescents surveyed said they had had thoughts about killing themselves, 50% of those adolescents’ parents said their teen hadn’t experienced suicidal thoughts. Similarly, 786 (15%) of adolescents surveyed said they had had thoughts about death and dying, but three-quarters of their parents were unaware.

A significant number of parents – 8% – said their teenager had had suicidal thoughts, but in 48% of these cases, the teenager said they had not thought about killing themselves.

Researchers saw more agreement between parents and adolescents when the adolescents were older: The parents were less likely to be unaware that their older teen had had suicidal thoughts, and older adolescents were less likely to deny it.

“This indicates that younger adolescents may be more likely to go unnoticed and not receive services either because their parents are unaware of their suicidal thoughts or because they deny suicidal thoughts that their parents think they are having,” Dr. Jones and his associates wrote. They also suggested younger adolescents may have “interpretive difficulties” around questions of suicidal ideation.

“These age findings are particularly noteworthy in light of recent evidence that deaths by suicide have increased among younger adolescents,” they noted.

There also was an interaction between age and gender. For girls, parents were less likely to be aware of suicidal thoughts in their younger daughters but more likely to be aware of them in their older daughters. However the opposite was true for boys: Parental unawareness increased slightly in older boys.

Parents of Hispanic or Latino ethnicity were less likely to be aware that their offspring had had thoughts about death and dying.

Generally fathers were less likely than mothers to be aware of suicidal thoughts in their adolescents.

However, if adolescents had previously received psychiatric treatment, or there was a family history of suicide, parents were more likely to be aware of suicidal thoughts, and adolescents who had a history of psychiatric hospitalization were less likely to deny suicidal thoughts, the researchers reported.

The study was supported by grants from the National Institutes of Health, the Dowshen Program for Neuroscience, and the Lifespan Brain Institute of the Children’s Hospital of Philadelphia and University of Pennsylvania. The study was funded by NIH. One author declared a board position and stock options in Taliaz Health unrelated to the study subject; the other authors said they had no relevant financial disclosures.

SOURCE: Jones JD et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-1771.
 

Most parents are unaware their teenager has been having suicidal thoughts or thinking about death, according to a study published in Pediatrics.

asiseeit/E+/Getty Images

Jason D. Jones, PhD, from the Children’s Hospital of Philadelphia, and his coauthors wrote that more than two-thirds of adolescents who experience suicidal thoughts do not get medical help, and this may be because their parents – the gatekeepers for mental health services – are unaware of what their teen is going through.

In this study, researchers recruited 5,137 adolescents aged 11-17 years and either a parent or step-parent, and interviewed both about the adolescent’s lifetime suicidal thoughts.

While 413 (8%) of the adolescents surveyed said they had had thoughts about killing themselves, 50% of those adolescents’ parents said their teen hadn’t experienced suicidal thoughts. Similarly, 786 (15%) of adolescents surveyed said they had had thoughts about death and dying, but three-quarters of their parents were unaware.

A significant number of parents – 8% – said their teenager had had suicidal thoughts, but in 48% of these cases, the teenager said they had not thought about killing themselves.

Researchers saw more agreement between parents and adolescents when the adolescents were older: The parents were less likely to be unaware that their older teen had had suicidal thoughts, and older adolescents were less likely to deny it.

“This indicates that younger adolescents may be more likely to go unnoticed and not receive services either because their parents are unaware of their suicidal thoughts or because they deny suicidal thoughts that their parents think they are having,” Dr. Jones and his associates wrote. They also suggested younger adolescents may have “interpretive difficulties” around questions of suicidal ideation.

“These age findings are particularly noteworthy in light of recent evidence that deaths by suicide have increased among younger adolescents,” they noted.

There also was an interaction between age and gender. For girls, parents were less likely to be aware of suicidal thoughts in their younger daughters but more likely to be aware of them in their older daughters. However the opposite was true for boys: Parental unawareness increased slightly in older boys.

Parents of Hispanic or Latino ethnicity were less likely to be aware that their offspring had had thoughts about death and dying.

Generally fathers were less likely than mothers to be aware of suicidal thoughts in their adolescents.

However, if adolescents had previously received psychiatric treatment, or there was a family history of suicide, parents were more likely to be aware of suicidal thoughts, and adolescents who had a history of psychiatric hospitalization were less likely to deny suicidal thoughts, the researchers reported.

The study was supported by grants from the National Institutes of Health, the Dowshen Program for Neuroscience, and the Lifespan Brain Institute of the Children’s Hospital of Philadelphia and University of Pennsylvania. The study was funded by NIH. One author declared a board position and stock options in Taliaz Health unrelated to the study subject; the other authors said they had no relevant financial disclosures.

SOURCE: Jones JD et al. Pediatrics. 2019 Jan 14. doi: 10.1542/peds.2018-1771.
 

Introduction of the quadrivalent human papillomavirus (HPV) vaccine was associated with significant declines in the incidence of vaccine-type virus both in vaccinated and unvaccinated young women, according to a study published in Pediatrics.

copyright itsmejust/Thinkstock

Four surveillance studies, conducted between 2006 and 2017, examined the rate of positive tests for vaccine-type HPV among 1,580 vaccinated and unvaccinated women aged 13-26 years. The majority of participants identified as African American or multiracial.

Overall, 97% of study participants received the quadrivalent vaccine, with vaccination rates increasing from 0% to 84% over the four waves of vaccination. Vaccine effectiveness – representing the relative risk of infection in vaccinated individuals, compared with unvaccinated risk before introduction of the vaccine – increased by 72% from wave 1 to wave 2, 91% from wave 1 to wave 3, and 80% from wave 1 to wave 4.

Among women who were vaccinated, rates of the quadrivalent vaccine–type HPV decreased by 81%, from 35% to 7%. But even among women who were unvaccinated, detection of the vaccine-targeted strains of HPV decreased by 40%, from 32% to 19%.

Chelse Spinner of the University of Cincinnati and her coauthors wrote that the decline in the quadrivalent vaccine–type HPV provided evidence of direct protection and high vaccine effectiveness in this real-world setting.

“This degree of effectiveness is remarkable given the fact that vaccination was defined as having received one or more doses (i.e., was not defined as having completed the vaccination series) and that women in this study were likely at a substantially higher risk for preexisting HPV infection than [were] those in the HPV vaccine clinical trials because of their reported sexual behaviors,” they wrote. “As noted in a recent review, evidence about herd protection will be a key component of cost-effectiveness analysis evaluating cervical cancer screening strategies.”

Twelve percent of women in the studies received the nine-valent HPV vaccine, and among these women, the rate of infection with the nine-valent vaccine-type HPV decreased from 47% in the first wave of vaccination to 14% in the last wave, representing a 71% decline.

The proportion of vaccinated women in the study who were infected with one or more of the five viral subtypes included in the nine-valent but not in the quadrivalent vaccine decreased significantly by 69%, from 23% to 7%.

However, these data also suggested a nonsignificant 58% increase among unvaccinated women in infections with one of the five subtypes covered by the nine-valent vaccine but not the quadrivalent vaccine.

Ms. Spinner and her associates noted this increase was unexpected and suggested the increase may be caused by the differences between vaccinated and unvaccinated women.

“For example, if women who are unvaccinated versus women who are vaccinated are more likely to practice riskier behaviors that would increase their risk of acquiring HPV, they would be more likely to acquire non–vaccine-type HPV,” they wrote.

Ms. Spinner graduated from the University of Cincinnati and now is a graduate student at the University of South Florida, Tampa. The study was funded by the National Institutes of Health. Darron R. Brown declared shares of Merck, but the other coauthors declared no other relevant financial disclosures.

SOURCE: Spinner C et al. Pediatrics. 2019, Jan 22. doi: 10.1542/peds.2018-1902.
 

Introduction of the quadrivalent human papillomavirus (HPV) vaccine was associated with significant declines in the incidence of vaccine-type virus both in vaccinated and unvaccinated young women, according to a study published in Pediatrics.

copyright itsmejust/Thinkstock

Four surveillance studies, conducted between 2006 and 2017, examined the rate of positive tests for vaccine-type HPV among 1,580 vaccinated and unvaccinated women aged 13-26 years. The majority of participants identified as African American or multiracial.

Overall, 97% of study participants received the quadrivalent vaccine, with vaccination rates increasing from 0% to 84% over the four waves of vaccination. Vaccine effectiveness – representing the relative risk of infection in vaccinated individuals, compared with unvaccinated risk before introduction of the vaccine – increased by 72% from wave 1 to wave 2, 91% from wave 1 to wave 3, and 80% from wave 1 to wave 4.

Among women who were vaccinated, rates of the quadrivalent vaccine–type HPV decreased by 81%, from 35% to 7%. But even among women who were unvaccinated, detection of the vaccine-targeted strains of HPV decreased by 40%, from 32% to 19%.

Chelse Spinner of the University of Cincinnati and her coauthors wrote that the decline in the quadrivalent vaccine–type HPV provided evidence of direct protection and high vaccine effectiveness in this real-world setting.

“This degree of effectiveness is remarkable given the fact that vaccination was defined as having received one or more doses (i.e., was not defined as having completed the vaccination series) and that women in this study were likely at a substantially higher risk for preexisting HPV infection than [were] those in the HPV vaccine clinical trials because of their reported sexual behaviors,” they wrote. “As noted in a recent review, evidence about herd protection will be a key component of cost-effectiveness analysis evaluating cervical cancer screening strategies.”

Twelve percent of women in the studies received the nine-valent HPV vaccine, and among these women, the rate of infection with the nine-valent vaccine-type HPV decreased from 47% in the first wave of vaccination to 14% in the last wave, representing a 71% decline.

The proportion of vaccinated women in the study who were infected with one or more of the five viral subtypes included in the nine-valent but not in the quadrivalent vaccine decreased significantly by 69%, from 23% to 7%.

However, these data also suggested a nonsignificant 58% increase among unvaccinated women in infections with one of the five subtypes covered by the nine-valent vaccine but not the quadrivalent vaccine.

Ms. Spinner and her associates noted this increase was unexpected and suggested the increase may be caused by the differences between vaccinated and unvaccinated women.

“For example, if women who are unvaccinated versus women who are vaccinated are more likely to practice riskier behaviors that would increase their risk of acquiring HPV, they would be more likely to acquire non–vaccine-type HPV,” they wrote.

Ms. Spinner graduated from the University of Cincinnati and now is a graduate student at the University of South Florida, Tampa. The study was funded by the National Institutes of Health. Darron R. Brown declared shares of Merck, but the other coauthors declared no other relevant financial disclosures.

SOURCE: Spinner C et al. Pediatrics. 2019, Jan 22. doi: 10.1542/peds.2018-1902.
 

Introduction of the quadrivalent human papillomavirus (HPV) vaccine was associated with significant declines in the incidence of vaccine-type virus both in vaccinated and unvaccinated young women, according to a study published in Pediatrics.

copyright itsmejust/Thinkstock

Four surveillance studies, conducted between 2006 and 2017, examined the rate of positive tests for vaccine-type HPV among 1,580 vaccinated and unvaccinated women aged 13-26 years. The majority of participants identified as African American or multiracial.

Overall, 97% of study participants received the quadrivalent vaccine, with vaccination rates increasing from 0% to 84% over the four waves of vaccination. Vaccine effectiveness – representing the relative risk of infection in vaccinated individuals, compared with unvaccinated risk before introduction of the vaccine – increased by 72% from wave 1 to wave 2, 91% from wave 1 to wave 3, and 80% from wave 1 to wave 4.

Among women who were vaccinated, rates of the quadrivalent vaccine–type HPV decreased by 81%, from 35% to 7%. But even among women who were unvaccinated, detection of the vaccine-targeted strains of HPV decreased by 40%, from 32% to 19%.

Chelse Spinner of the University of Cincinnati and her coauthors wrote that the decline in the quadrivalent vaccine–type HPV provided evidence of direct protection and high vaccine effectiveness in this real-world setting.

“This degree of effectiveness is remarkable given the fact that vaccination was defined as having received one or more doses (i.e., was not defined as having completed the vaccination series) and that women in this study were likely at a substantially higher risk for preexisting HPV infection than [were] those in the HPV vaccine clinical trials because of their reported sexual behaviors,” they wrote. “As noted in a recent review, evidence about herd protection will be a key component of cost-effectiveness analysis evaluating cervical cancer screening strategies.”

Twelve percent of women in the studies received the nine-valent HPV vaccine, and among these women, the rate of infection with the nine-valent vaccine-type HPV decreased from 47% in the first wave of vaccination to 14% in the last wave, representing a 71% decline.

The proportion of vaccinated women in the study who were infected with one or more of the five viral subtypes included in the nine-valent but not in the quadrivalent vaccine decreased significantly by 69%, from 23% to 7%.

However, these data also suggested a nonsignificant 58% increase among unvaccinated women in infections with one of the five subtypes covered by the nine-valent vaccine but not the quadrivalent vaccine.

Ms. Spinner and her associates noted this increase was unexpected and suggested the increase may be caused by the differences between vaccinated and unvaccinated women.

“For example, if women who are unvaccinated versus women who are vaccinated are more likely to practice riskier behaviors that would increase their risk of acquiring HPV, they would be more likely to acquire non–vaccine-type HPV,” they wrote.

Ms. Spinner graduated from the University of Cincinnati and now is a graduate student at the University of South Florida, Tampa. The study was funded by the National Institutes of Health. Darron R. Brown declared shares of Merck, but the other coauthors declared no other relevant financial disclosures.

SOURCE: Spinner C et al. Pediatrics. 2019, Jan 22. doi: 10.1542/peds.2018-1902.
 

Teenage boys with nonalcoholic fatty liver disease (NAFLD) who followed a diet low in free sugars demonstrated significantly improved hepatic steatosis after 8 weeks, compared with boys on a usual diet.

“Because of growing evidence implicating dietary sugars in NAFLD, well-controlled studies in children with NAFLD are needed to inform clinical practice and public policy,” wrote Jeffrey B. Schwimmer, MD, of the University of California, San Diego, La Jolla, and colleagues in JAMA.

The researchers randomized 40 boys aged 11-16 years with active NAFLD to a diet low in free sugars or their usual diet. The intervention diet involved personalized menu planning and provision of meals for the boys’ entire households that were designed to restrict free sugar intake to less than 3% of daily calories. Adherence to the diet was assessed by twice-weekly phone calls.

In the intervention group, hepatic steatosis decreased from an average of 25% at baseline to 17% after 8 weeks, compared with a change from 21% to 20% in the control group. The adjusted mean difference at 8 weeks was −6.23%, which was statistically significant (P less than .001).

The average age of the participants was 13 years, 95% were Hispanic. All 40 completed the study, and 18 of the 20 boys in the intervention group reported less than 3% of calories from free sugar during the study period. No adverse events were reported related to study participation.

The results were limited by several factors, including the small sample size and homogeneous population. In addition, neither hepatic steatosis or serum alanine aminotransferase (ALT) levels decreased enough to enter the normal range, the researchers noted. The findings, though preliminary, support the value of reducing free sugars, including glucose, fructose, and sucrose, to help manage NAFLD in adolescents, and “further research is required to assess long-term and clinical outcomes,” they said.

The study was supported by grants from multiple foundations and organizations, including the Nutrition Science Initiative, the University of California, San Diego, the National Institutes of Health, Children’s Healthcare of Atlanta and Emory University Pediatric Biostatistics Core, and the Georgia Clinical and Translational Science Alliance. Dr. Schwimmer reported receiving research support from Galmed and Intercept.

SOURCE: Schwimmer JB et al. JAMA. 2019;321(3):256-265.

Teenage boys with nonalcoholic fatty liver disease (NAFLD) who followed a diet low in free sugars demonstrated significantly improved hepatic steatosis after 8 weeks, compared with boys on a usual diet.

“Because of growing evidence implicating dietary sugars in NAFLD, well-controlled studies in children with NAFLD are needed to inform clinical practice and public policy,” wrote Jeffrey B. Schwimmer, MD, of the University of California, San Diego, La Jolla, and colleagues in JAMA.

The researchers randomized 40 boys aged 11-16 years with active NAFLD to a diet low in free sugars or their usual diet. The intervention diet involved personalized menu planning and provision of meals for the boys’ entire households that were designed to restrict free sugar intake to less than 3% of daily calories. Adherence to the diet was assessed by twice-weekly phone calls.

In the intervention group, hepatic steatosis decreased from an average of 25% at baseline to 17% after 8 weeks, compared with a change from 21% to 20% in the control group. The adjusted mean difference at 8 weeks was −6.23%, which was statistically significant (P less than .001).

The average age of the participants was 13 years, 95% were Hispanic. All 40 completed the study, and 18 of the 20 boys in the intervention group reported less than 3% of calories from free sugar during the study period. No adverse events were reported related to study participation.

The results were limited by several factors, including the small sample size and homogeneous population. In addition, neither hepatic steatosis or serum alanine aminotransferase (ALT) levels decreased enough to enter the normal range, the researchers noted. The findings, though preliminary, support the value of reducing free sugars, including glucose, fructose, and sucrose, to help manage NAFLD in adolescents, and “further research is required to assess long-term and clinical outcomes,” they said.

The study was supported by grants from multiple foundations and organizations, including the Nutrition Science Initiative, the University of California, San Diego, the National Institutes of Health, Children’s Healthcare of Atlanta and Emory University Pediatric Biostatistics Core, and the Georgia Clinical and Translational Science Alliance. Dr. Schwimmer reported receiving research support from Galmed and Intercept.

SOURCE: Schwimmer JB et al. JAMA. 2019;321(3):256-265.

Teenage boys with nonalcoholic fatty liver disease (NAFLD) who followed a diet low in free sugars demonstrated significantly improved hepatic steatosis after 8 weeks, compared with boys on a usual diet.

“Because of growing evidence implicating dietary sugars in NAFLD, well-controlled studies in children with NAFLD are needed to inform clinical practice and public policy,” wrote Jeffrey B. Schwimmer, MD, of the University of California, San Diego, La Jolla, and colleagues in JAMA.

The researchers randomized 40 boys aged 11-16 years with active NAFLD to a diet low in free sugars or their usual diet. The intervention diet involved personalized menu planning and provision of meals for the boys’ entire households that were designed to restrict free sugar intake to less than 3% of daily calories. Adherence to the diet was assessed by twice-weekly phone calls.

In the intervention group, hepatic steatosis decreased from an average of 25% at baseline to 17% after 8 weeks, compared with a change from 21% to 20% in the control group. The adjusted mean difference at 8 weeks was −6.23%, which was statistically significant (P less than .001).

The average age of the participants was 13 years, 95% were Hispanic. All 40 completed the study, and 18 of the 20 boys in the intervention group reported less than 3% of calories from free sugar during the study period. No adverse events were reported related to study participation.

The results were limited by several factors, including the small sample size and homogeneous population. In addition, neither hepatic steatosis or serum alanine aminotransferase (ALT) levels decreased enough to enter the normal range, the researchers noted. The findings, though preliminary, support the value of reducing free sugars, including glucose, fructose, and sucrose, to help manage NAFLD in adolescents, and “further research is required to assess long-term and clinical outcomes,” they said.

The study was supported by grants from multiple foundations and organizations, including the Nutrition Science Initiative, the University of California, San Diego, the National Institutes of Health, Children’s Healthcare of Atlanta and Emory University Pediatric Biostatistics Core, and the Georgia Clinical and Translational Science Alliance. Dr. Schwimmer reported receiving research support from Galmed and Intercept.

SOURCE: Schwimmer JB et al. JAMA. 2019;321(3):256-265.

Parents were much more confident about vaccinating their children against the human papillomavirus (HPV) when they were told about the diseases that the vaccine prevents rather than about safety, new research found.

Stuart Jenner/Thinkstock

In Pediatrics, researchers reported the outcomes of an online video-messaging study that attempted to address the most common parental questions and concerns about the HPV vaccine. They surveyed a national sample of 1,196 parents of children (aged 9-17 years) who watched four brief videos of a pediatrician talking about one of seven common concerns regarding HPV vaccination. The parents then were asked how each video affected them.

Parents who were exposed to messages about the diseases that the HPV vaccine prevented had the highest confidence in the HPV vaccine (46%). These messages included “HPV is a common virus that millions of people get every year. The HPV vaccine will protect your child from some cancers and genital warts” and “HPV infection can cause cancer in both men and women. The HPV vaccine will protect your child from many of these cancers.”

Similarly, parents exposed to messages about the need for HPV vaccination for both boys and girls also had the highest levels of confidence about HPV vaccination (44%).

Confidence was lower in parents exposed to messages about safety and side effects (30%)

“As such, reiterating vaccination benefits (including cancer prevention) when addressing concerns may also improve the impact of messages,” wrote Parth D. Shah, PhD, from the Fred Hutchinson Cancer Research Center, Seattle, and his coauthors.

Parents who received messages that expressed urgency about vaccination had lower confidence in the HPV vaccine.

“One reason may be that parents who are hesitant feel inappropriately rushed or that their concerns are not being treated with appropriate care,” the authors wrote.

However, messages that required a higher reading grade level and messages that were longer also seemed to inspire more confidence among parents. Parents who were exposed to messages about cancer prevention additionally were even more confident in HPV vaccine, Dr. Shah and his associates reported.

The study also found that 84% of parents wanted to talk to their children’s doctor about the diseases that the HPV vaccine prevented, while 68% wanted to talk about safety and side effects.

The study was funded by the Centers for Disease Control and Prevention and the National Cancer Institute. Dr. Shah was partially supported by an Agency for Healthcare Research and Quality grant. Another author declared being on paid advisory boards of research grants from Merck, Pfizer, and GlaxoSmithKline. No other conflicts of interest were declared.

SOURCE: Shah PD et al. Pediatrics. 2019 Feb. doi: 10.1542/peds.2018-1872.
 

Parents were much more confident about vaccinating their children against the human papillomavirus (HPV) when they were told about the diseases that the vaccine prevents rather than about safety, new research found.

Stuart Jenner/Thinkstock

In Pediatrics, researchers reported the outcomes of an online video-messaging study that attempted to address the most common parental questions and concerns about the HPV vaccine. They surveyed a national sample of 1,196 parents of children (aged 9-17 years) who watched four brief videos of a pediatrician talking about one of seven common concerns regarding HPV vaccination. The parents then were asked how each video affected them.

Parents who were exposed to messages about the diseases that the HPV vaccine prevented had the highest confidence in the HPV vaccine (46%). These messages included “HPV is a common virus that millions of people get every year. The HPV vaccine will protect your child from some cancers and genital warts” and “HPV infection can cause cancer in both men and women. The HPV vaccine will protect your child from many of these cancers.”

Similarly, parents exposed to messages about the need for HPV vaccination for both boys and girls also had the highest levels of confidence about HPV vaccination (44%).

Confidence was lower in parents exposed to messages about safety and side effects (30%)

“As such, reiterating vaccination benefits (including cancer prevention) when addressing concerns may also improve the impact of messages,” wrote Parth D. Shah, PhD, from the Fred Hutchinson Cancer Research Center, Seattle, and his coauthors.

Parents who received messages that expressed urgency about vaccination had lower confidence in the HPV vaccine.

“One reason may be that parents who are hesitant feel inappropriately rushed or that their concerns are not being treated with appropriate care,” the authors wrote.

However, messages that required a higher reading grade level and messages that were longer also seemed to inspire more confidence among parents. Parents who were exposed to messages about cancer prevention additionally were even more confident in HPV vaccine, Dr. Shah and his associates reported.

The study also found that 84% of parents wanted to talk to their children’s doctor about the diseases that the HPV vaccine prevented, while 68% wanted to talk about safety and side effects.

The study was funded by the Centers for Disease Control and Prevention and the National Cancer Institute. Dr. Shah was partially supported by an Agency for Healthcare Research and Quality grant. Another author declared being on paid advisory boards of research grants from Merck, Pfizer, and GlaxoSmithKline. No other conflicts of interest were declared.

SOURCE: Shah PD et al. Pediatrics. 2019 Feb. doi: 10.1542/peds.2018-1872.
 

Parents were much more confident about vaccinating their children against the human papillomavirus (HPV) when they were told about the diseases that the vaccine prevents rather than about safety, new research found.

Stuart Jenner/Thinkstock

In Pediatrics, researchers reported the outcomes of an online video-messaging study that attempted to address the most common parental questions and concerns about the HPV vaccine. They surveyed a national sample of 1,196 parents of children (aged 9-17 years) who watched four brief videos of a pediatrician talking about one of seven common concerns regarding HPV vaccination. The parents then were asked how each video affected them.

Parents who were exposed to messages about the diseases that the HPV vaccine prevented had the highest confidence in the HPV vaccine (46%). These messages included “HPV is a common virus that millions of people get every year. The HPV vaccine will protect your child from some cancers and genital warts” and “HPV infection can cause cancer in both men and women. The HPV vaccine will protect your child from many of these cancers.”

Similarly, parents exposed to messages about the need for HPV vaccination for both boys and girls also had the highest levels of confidence about HPV vaccination (44%).

Confidence was lower in parents exposed to messages about safety and side effects (30%)

“As such, reiterating vaccination benefits (including cancer prevention) when addressing concerns may also improve the impact of messages,” wrote Parth D. Shah, PhD, from the Fred Hutchinson Cancer Research Center, Seattle, and his coauthors.

Parents who received messages that expressed urgency about vaccination had lower confidence in the HPV vaccine.

“One reason may be that parents who are hesitant feel inappropriately rushed or that their concerns are not being treated with appropriate care,” the authors wrote.

However, messages that required a higher reading grade level and messages that were longer also seemed to inspire more confidence among parents. Parents who were exposed to messages about cancer prevention additionally were even more confident in HPV vaccine, Dr. Shah and his associates reported.

The study also found that 84% of parents wanted to talk to their children’s doctor about the diseases that the HPV vaccine prevented, while 68% wanted to talk about safety and side effects.

The study was funded by the Centers for Disease Control and Prevention and the National Cancer Institute. Dr. Shah was partially supported by an Agency for Healthcare Research and Quality grant. Another author declared being on paid advisory boards of research grants from Merck, Pfizer, and GlaxoSmithKline. No other conflicts of interest were declared.

SOURCE: Shah PD et al. Pediatrics. 2019 Feb. doi: 10.1542/peds.2018-1872.