Expert Commentary

Unless fetal lung maturity has been confirmed, elective cesarean delivery before 39 weeks’ gestation is associated with a higher rate of neonatal respiratory problems. In this observational study, performed at 19 US centers from 1999 to 2002, and funded by the National Institutes of Health, infants of women who underwent elective cesarean delivery at 37 or more weeks’ gestation were assessed for the primary outcome—a composite neonatal outcome that included the occurrence of any of the following:

• death
  
• respiratory distress syndrome
  
• transient tachypnea of the newborn
  
• hypoglycemia
  
• newborn sepsis
  
• confirmed seizures
  
• necrotizing enterocolitis
  
• hypoxic–ischemic encephalopathy
  
• cardiopulmonary resuscitation or ventilator support within 24 hours of birth
  
• umbilical cord–blood arterial pH
• 5-minute Apgar score of 3 or below
  
• admission to NICU
  
• hospitalization for 5 or more days.
  

Of 13,258 elective cesarean deliveries performed at term, 35.8% occurred before 39 completed weeks of gestation (6.3% at 37 weeks, 29.5% at 38 weeks) and 49.1% at 39 weeks. Women who delivered before 39 weeks were more likely to be married, white, and to have initiated prenatal care early.

Compared with infants delivered at 39 weeks, those born at 37 to 38 weeks’ gestation had a greater risk of the primary (composite) outcome. At 37 weeks, the adjusted odds ratio (OR) was 2.1 (95% confidence interval [CI], 1.7–2.5). At 38 weeks, the adjusted OR was 1.5 (1.3–1.7).

The authors estimated that, at 37 weeks’ gestation, postponing elective delivery until 39 weeks might prevent 48% of cases of the primary outcome; this percentage was estimated to be 27% at 38 weeks’ gestation.

Patient preference determines timing in some cases

Cesarean delivery accounts for almost one third of US births, and most women who have had such a delivery opt to repeat it in their next pregnancy. As an editorial accompanying this article points out, women in this study who delivered before 39 weeks were more likely to be private patients and had likely asked their own obstetrician to perform the delivery.¹ Obstetricians who wish to promote patient satisfaction are likely to honor such a request, recognizing that waiting until later would increase the likelihood of labor, which would exclude the possibility of an elective procedure.

Limitations of the study

Because this study lacked data about testing for fetal lung maturity, it is unclear whether the higher rate of adverse outcomes with elective cesarean delivery before 39 weeks could be explained by failure to assess for fetal lung maturity.

It also appears that the delay of delivery to 39 weeks or beyond may be associated with an increased risk of stillbirth. In other populations, this risk has been estimated to be roughly 0.5 of every 1,000 births for each advancing week of gestation.

Unless fetal lung maturity has been confirmed, elective cesarean delivery before 39 weeks’ gestation is associated with a higher rate of neonatal respiratory problems. In this observational study, performed at 19 US centers from 1999 to 2002, and funded by the National Institutes of Health, infants of women who underwent elective cesarean delivery at 37 or more weeks’ gestation were assessed for the primary outcome—a composite neonatal outcome that included the occurrence of any of the following:

• death
  
• respiratory distress syndrome
  
• transient tachypnea of the newborn
  
• hypoglycemia
  
• newborn sepsis
  
• confirmed seizures
  
• necrotizing enterocolitis
  
• hypoxic–ischemic encephalopathy
  
• cardiopulmonary resuscitation or ventilator support within 24 hours of birth
  
• umbilical cord–blood arterial pH
• 5-minute Apgar score of 3 or below
  
• admission to NICU
  
• hospitalization for 5 or more days.
  

Of 13,258 elective cesarean deliveries performed at term, 35.8% occurred before 39 completed weeks of gestation (6.3% at 37 weeks, 29.5% at 38 weeks) and 49.1% at 39 weeks. Women who delivered before 39 weeks were more likely to be married, white, and to have initiated prenatal care early.

Compared with infants delivered at 39 weeks, those born at 37 to 38 weeks’ gestation had a greater risk of the primary (composite) outcome. At 37 weeks, the adjusted odds ratio (OR) was 2.1 (95% confidence interval [CI], 1.7–2.5). At 38 weeks, the adjusted OR was 1.5 (1.3–1.7).

The authors estimated that, at 37 weeks’ gestation, postponing elective delivery until 39 weeks might prevent 48% of cases of the primary outcome; this percentage was estimated to be 27% at 38 weeks’ gestation.

Patient preference determines timing in some cases

Cesarean delivery accounts for almost one third of US births, and most women who have had such a delivery opt to repeat it in their next pregnancy. As an editorial accompanying this article points out, women in this study who delivered before 39 weeks were more likely to be private patients and had likely asked their own obstetrician to perform the delivery.¹ Obstetricians who wish to promote patient satisfaction are likely to honor such a request, recognizing that waiting until later would increase the likelihood of labor, which would exclude the possibility of an elective procedure.

Limitations of the study

Because this study lacked data about testing for fetal lung maturity, it is unclear whether the higher rate of adverse outcomes with elective cesarean delivery before 39 weeks could be explained by failure to assess for fetal lung maturity.

It also appears that the delay of delivery to 39 weeks or beyond may be associated with an increased risk of stillbirth. In other populations, this risk has been estimated to be roughly 0.5 of every 1,000 births for each advancing week of gestation.

Unless fetal lung maturity has been confirmed, elective cesarean delivery before 39 weeks’ gestation is associated with a higher rate of neonatal respiratory problems. In this observational study, performed at 19 US centers from 1999 to 2002, and funded by the National Institutes of Health, infants of women who underwent elective cesarean delivery at 37 or more weeks’ gestation were assessed for the primary outcome—a composite neonatal outcome that included the occurrence of any of the following:

• death
  
• respiratory distress syndrome
  
• transient tachypnea of the newborn
  
• hypoglycemia
  
• newborn sepsis
  
• confirmed seizures
  
• necrotizing enterocolitis
  
• hypoxic–ischemic encephalopathy
  
• cardiopulmonary resuscitation or ventilator support within 24 hours of birth
  
• umbilical cord–blood arterial pH
• 5-minute Apgar score of 3 or below
  
• admission to NICU
  
• hospitalization for 5 or more days.
  

Of 13,258 elective cesarean deliveries performed at term, 35.8% occurred before 39 completed weeks of gestation (6.3% at 37 weeks, 29.5% at 38 weeks) and 49.1% at 39 weeks. Women who delivered before 39 weeks were more likely to be married, white, and to have initiated prenatal care early.

Compared with infants delivered at 39 weeks, those born at 37 to 38 weeks’ gestation had a greater risk of the primary (composite) outcome. At 37 weeks, the adjusted odds ratio (OR) was 2.1 (95% confidence interval [CI], 1.7–2.5). At 38 weeks, the adjusted OR was 1.5 (1.3–1.7).

The authors estimated that, at 37 weeks’ gestation, postponing elective delivery until 39 weeks might prevent 48% of cases of the primary outcome; this percentage was estimated to be 27% at 38 weeks’ gestation.

Patient preference determines timing in some cases

Cesarean delivery accounts for almost one third of US births, and most women who have had such a delivery opt to repeat it in their next pregnancy. As an editorial accompanying this article points out, women in this study who delivered before 39 weeks were more likely to be private patients and had likely asked their own obstetrician to perform the delivery.¹ Obstetricians who wish to promote patient satisfaction are likely to honor such a request, recognizing that waiting until later would increase the likelihood of labor, which would exclude the possibility of an elective procedure.

Limitations of the study

Because this study lacked data about testing for fetal lung maturity, it is unclear whether the higher rate of adverse outcomes with elective cesarean delivery before 39 weeks could be explained by failure to assess for fetal lung maturity.

It also appears that the delay of delivery to 39 weeks or beyond may be associated with an increased risk of stillbirth. In other populations, this risk has been estimated to be roughly 0.5 of every 1,000 births for each advancing week of gestation.

Most obstetricians have been sued at some point in their career. The cost of these lawsuits can be measured in both financial and human terms—from the expense of mounting a defense to enormous stress and loss of physician productivity. Fear of litigation also leads to the practice of defensive medicine, driving up the cost of health care and further limiting our procedural options.

Suggestions for reform, such as modifying the tort system and reining in medical experts, have met with limited success. Neither an obstetric practice nor a hospital—let alone an individual obstetrician—can hope to effect these kinds of changes. The best solution for mitigating the cost of obstetric litigation is to make care safer. Safer obstetrics may lower obstetricians’ costs while reducing the financial and emotional toll that injury takes on our patients and their families.

A few caveats

The case series by Clark and colleagues is limited because it does not include a comparison group or address cases that were dropped, defended successfully, or filed despite good care. Nor do the authors fully explain how “substandard” care is defined or the evidence on which this finding is based.

In obstetric liability cases, decades may pass between the delivery of an infant and the delivery of a jury verdict, which limits the applicability of these findings to modern obstetric care.

As a case series, this study is hypothesis-generating. It offers four practice- or hospital-level solutions without proving that they work. The authors’ expert opinion should stimulate analytic research that utilizes a comparison group so that associations can be made.

Despite these weaknesses, the conclusions that:

• most cases were a result of substandard care
  
• documentation is often lacking or inadequate
  
• use of oxytocin should be standardized
  
• obstetric coverage should be 24/7
  
  

The blame game can be destructive

We live in a blame-based society, exemplified by the obstetric-litigation environment. The study by Clark and colleagues is a welcome step toward realigning our priorities and lowering costs by eliminating preventable errors.

Most obstetricians have been sued at some point in their career. The cost of these lawsuits can be measured in both financial and human terms—from the expense of mounting a defense to enormous stress and loss of physician productivity. Fear of litigation also leads to the practice of defensive medicine, driving up the cost of health care and further limiting our procedural options.

Suggestions for reform, such as modifying the tort system and reining in medical experts, have met with limited success. Neither an obstetric practice nor a hospital—let alone an individual obstetrician—can hope to effect these kinds of changes. The best solution for mitigating the cost of obstetric litigation is to make care safer. Safer obstetrics may lower obstetricians’ costs while reducing the financial and emotional toll that injury takes on our patients and their families.

A few caveats

The case series by Clark and colleagues is limited because it does not include a comparison group or address cases that were dropped, defended successfully, or filed despite good care. Nor do the authors fully explain how “substandard” care is defined or the evidence on which this finding is based.

In obstetric liability cases, decades may pass between the delivery of an infant and the delivery of a jury verdict, which limits the applicability of these findings to modern obstetric care.

As a case series, this study is hypothesis-generating. It offers four practice- or hospital-level solutions without proving that they work. The authors’ expert opinion should stimulate analytic research that utilizes a comparison group so that associations can be made.

Despite these weaknesses, the conclusions that:

• most cases were a result of substandard care
  
• documentation is often lacking or inadequate
  
• use of oxytocin should be standardized
  
• obstetric coverage should be 24/7
  
  

The blame game can be destructive

We live in a blame-based society, exemplified by the obstetric-litigation environment. The study by Clark and colleagues is a welcome step toward realigning our priorities and lowering costs by eliminating preventable errors.

Most obstetricians have been sued at some point in their career. The cost of these lawsuits can be measured in both financial and human terms—from the expense of mounting a defense to enormous stress and loss of physician productivity. Fear of litigation also leads to the practice of defensive medicine, driving up the cost of health care and further limiting our procedural options.

Suggestions for reform, such as modifying the tort system and reining in medical experts, have met with limited success. Neither an obstetric practice nor a hospital—let alone an individual obstetrician—can hope to effect these kinds of changes. The best solution for mitigating the cost of obstetric litigation is to make care safer. Safer obstetrics may lower obstetricians’ costs while reducing the financial and emotional toll that injury takes on our patients and their families.

A few caveats

The case series by Clark and colleagues is limited because it does not include a comparison group or address cases that were dropped, defended successfully, or filed despite good care. Nor do the authors fully explain how “substandard” care is defined or the evidence on which this finding is based.

In obstetric liability cases, decades may pass between the delivery of an infant and the delivery of a jury verdict, which limits the applicability of these findings to modern obstetric care.

As a case series, this study is hypothesis-generating. It offers four practice- or hospital-level solutions without proving that they work. The authors’ expert opinion should stimulate analytic research that utilizes a comparison group so that associations can be made.

Despite these weaknesses, the conclusions that:

• most cases were a result of substandard care
  
• documentation is often lacking or inadequate
  
• use of oxytocin should be standardized
  
• obstetric coverage should be 24/7
  
  

The blame game can be destructive

We live in a blame-based society, exemplified by the obstetric-litigation environment. The study by Clark and colleagues is a welcome step toward realigning our priorities and lowering costs by eliminating preventable errors.

In his editorial, Freeman acknowledges the complexity of the issue and allows that some cases of CP are clearly caused by substandard intrapartum care, but he leaves many essential questions unanswered.¹ Similarly, the meta-analysis itself offers multiple explanations of the possible causes of CP but relatively few conclusions that can be applied to any specific case of CP, when the cause in that case is unclear.

Authors focus on cord pH below 7.0

To be sure, an umbilical artery pH of less than 7.0 at birth is concerning, but even at this level of acidosis, results are conflicting. Combining data from multiple studies, the authors concluded that the incidence of significant neonatal neurologic morbidity and mortality was significant among nonanomalous infants who had such a pH level (23.1%). However, the remaining 76.9% of infants were neurologically normal at the time of hospital discharge.

Nor did Apgar scores predict asphyxial complications when cord pH was less than 7.0. However, the combination of an Apgar score of 3 or less and cord pH below 7.0 was a sensitive predictor of serious neonatal morbidity.

Questions abound—but not answers

It was thought that electronic fetal monitoring would eliminate intrapartum stillbirth and reduce the incidence of CP—but neither goal has been achieved. Moreover, the presence of meconium, long associated with nonreassuring fetal status, was found in one study to have no association with CP.²

As for the role of infection, inflammation, and intrapartum fever, Eastman and DeLeon suggested as early as 1955 that intrapartum fever was seven times more likely in mothers of children who were later diagnosed with CP than in mothers of normal children—and intrapartum fever, infection, and neonatal fever remain prime suspects in the CP mystery.³

How does the average clinical obstetrician interpret and use these results? How does our legal system use these results?

It depends. The overwhelming majority of nonanomalous term infants do well. For the few who develop CP, there often is an accepted reason for the diagnosis.

Graham and colleagues conclude that only 14.5% of CP cases are associated with intrapartum asphyxia. The dilemma? For that 14.5%—or even the remaining 85.5%—our ability to determine the true cause of CP in any given case is unreliable. Who or what test can conclusively eliminate intrapartum asphyxia as a medically probable cause?

The answers are disheartening.

In his editorial, Freeman acknowledges the complexity of the issue and allows that some cases of CP are clearly caused by substandard intrapartum care, but he leaves many essential questions unanswered.¹ Similarly, the meta-analysis itself offers multiple explanations of the possible causes of CP but relatively few conclusions that can be applied to any specific case of CP, when the cause in that case is unclear.

Authors focus on cord pH below 7.0

To be sure, an umbilical artery pH of less than 7.0 at birth is concerning, but even at this level of acidosis, results are conflicting. Combining data from multiple studies, the authors concluded that the incidence of significant neonatal neurologic morbidity and mortality was significant among nonanomalous infants who had such a pH level (23.1%). However, the remaining 76.9% of infants were neurologically normal at the time of hospital discharge.

Nor did Apgar scores predict asphyxial complications when cord pH was less than 7.0. However, the combination of an Apgar score of 3 or less and cord pH below 7.0 was a sensitive predictor of serious neonatal morbidity.

Questions abound—but not answers

It was thought that electronic fetal monitoring would eliminate intrapartum stillbirth and reduce the incidence of CP—but neither goal has been achieved. Moreover, the presence of meconium, long associated with nonreassuring fetal status, was found in one study to have no association with CP.²

As for the role of infection, inflammation, and intrapartum fever, Eastman and DeLeon suggested as early as 1955 that intrapartum fever was seven times more likely in mothers of children who were later diagnosed with CP than in mothers of normal children—and intrapartum fever, infection, and neonatal fever remain prime suspects in the CP mystery.³

How does the average clinical obstetrician interpret and use these results? How does our legal system use these results?

It depends. The overwhelming majority of nonanomalous term infants do well. For the few who develop CP, there often is an accepted reason for the diagnosis.

Graham and colleagues conclude that only 14.5% of CP cases are associated with intrapartum asphyxia. The dilemma? For that 14.5%—or even the remaining 85.5%—our ability to determine the true cause of CP in any given case is unreliable. Who or what test can conclusively eliminate intrapartum asphyxia as a medically probable cause?

The answers are disheartening.

In his editorial, Freeman acknowledges the complexity of the issue and allows that some cases of CP are clearly caused by substandard intrapartum care, but he leaves many essential questions unanswered.¹ Similarly, the meta-analysis itself offers multiple explanations of the possible causes of CP but relatively few conclusions that can be applied to any specific case of CP, when the cause in that case is unclear.

Authors focus on cord pH below 7.0

To be sure, an umbilical artery pH of less than 7.0 at birth is concerning, but even at this level of acidosis, results are conflicting. Combining data from multiple studies, the authors concluded that the incidence of significant neonatal neurologic morbidity and mortality was significant among nonanomalous infants who had such a pH level (23.1%). However, the remaining 76.9% of infants were neurologically normal at the time of hospital discharge.

Nor did Apgar scores predict asphyxial complications when cord pH was less than 7.0. However, the combination of an Apgar score of 3 or less and cord pH below 7.0 was a sensitive predictor of serious neonatal morbidity.

Questions abound—but not answers

It was thought that electronic fetal monitoring would eliminate intrapartum stillbirth and reduce the incidence of CP—but neither goal has been achieved. Moreover, the presence of meconium, long associated with nonreassuring fetal status, was found in one study to have no association with CP.²

As for the role of infection, inflammation, and intrapartum fever, Eastman and DeLeon suggested as early as 1955 that intrapartum fever was seven times more likely in mothers of children who were later diagnosed with CP than in mothers of normal children—and intrapartum fever, infection, and neonatal fever remain prime suspects in the CP mystery.³

How does the average clinical obstetrician interpret and use these results? How does our legal system use these results?

It depends. The overwhelming majority of nonanomalous term infants do well. For the few who develop CP, there often is an accepted reason for the diagnosis.

Graham and colleagues conclude that only 14.5% of CP cases are associated with intrapartum asphyxia. The dilemma? For that 14.5%—or even the remaining 85.5%—our ability to determine the true cause of CP in any given case is unreliable. Who or what test can conclusively eliminate intrapartum asphyxia as a medically probable cause?

The answers are disheartening.

The overall rate of ureteral injury at the time of hysterectomy and other gynecologic procedures for benign disease has been estimated at 8.8 injuries for every 1,000 procedures, with the highest rate (17.3/1,000) occurring during laparoscopic hysterectomy with bilateral salpingo-oophorectomy (BSO). The rate of bladder injury is estimated at 16.3 for every 1,000 gynecologic procedures and 29.2 for every 1,000 laparoscopic hysterectomies with BSO.¹

Cystoscopy is a low-risk procedure that may be beneficial in surgeries associated with a high rate (1% to 2%) of lower urinary tract injury.² Early detection of bladder or ureteral injury is preferable to avoid postoperative complications such as fistula formation, loss of renal function, and other complications requiring additional surgery and prolonged hospitalization. Early detection also reduces medicolegal risk.

Ibeanu and associates point out that many gynecologic surgeons do not perform cystoscopy routinely, because of either a lack of training or difficulty obtaining privileges to perform this urologic procedure. They also note that the benefits of cystoscopy clearly outweigh the risks.

Only 25.6% of injuries were detected by visual inspection

Roughly one in four injuries to the bladder and ureter were detected without the aid of cystoscopy; the rest were identified using cystoscopy.

Twenty-four cases of bladder injury (2.9%) and 15 cases of ureteral injury (1.8%) were identified at the time of rigid diagnostic cystoscopy after hysterectomy. The majority (544) of the hysterectomies were abdominal, followed by vaginal hysterectomy (227) and laparoscopically assisted vaginal hysterectomy (61) ( TABLE ).

Most ureteral injuries (80%) occurred at the level of the uterine artery. The ureter is difficult to visualize or palpate once it goes under the uterine artery and courses along the anterior vagina before entry into the urinary bladder.

Ureteral injury also was common at the level of the infundibulopelvic ligament. One patient developed vesicovaginal fistula postoperatively that was missed on initial cystoscopy.

TABLE

Injury rate, by hysterectomy procedure

Cystoscopy is imperfect, but effective, and its cost is justifiable

Cystoscopy should be performed routinely after any gynecologic procedure associated with a high risk of injury, such as difficult bladder or ureteral dissection. Findings that justify cystoscopy include de novo hematuria and air in the Foley bag during laparoscopy.

Although cystoscopy may not identify all injuries, its benefits likely outweigh any additional cost associated with the procedure when a high rate of injury is likely (greater than, say, 1.5%).³

This study was conducted over 8 years at three academic practices, so it may not be possible to generalize its findings broadly across practitioners.

The overall rate of ureteral injury at the time of hysterectomy and other gynecologic procedures for benign disease has been estimated at 8.8 injuries for every 1,000 procedures, with the highest rate (17.3/1,000) occurring during laparoscopic hysterectomy with bilateral salpingo-oophorectomy (BSO). The rate of bladder injury is estimated at 16.3 for every 1,000 gynecologic procedures and 29.2 for every 1,000 laparoscopic hysterectomies with BSO.¹

Cystoscopy is a low-risk procedure that may be beneficial in surgeries associated with a high rate (1% to 2%) of lower urinary tract injury.² Early detection of bladder or ureteral injury is preferable to avoid postoperative complications such as fistula formation, loss of renal function, and other complications requiring additional surgery and prolonged hospitalization. Early detection also reduces medicolegal risk.

Ibeanu and associates point out that many gynecologic surgeons do not perform cystoscopy routinely, because of either a lack of training or difficulty obtaining privileges to perform this urologic procedure. They also note that the benefits of cystoscopy clearly outweigh the risks.

Only 25.6% of injuries were detected by visual inspection

Roughly one in four injuries to the bladder and ureter were detected without the aid of cystoscopy; the rest were identified using cystoscopy.

Twenty-four cases of bladder injury (2.9%) and 15 cases of ureteral injury (1.8%) were identified at the time of rigid diagnostic cystoscopy after hysterectomy. The majority (544) of the hysterectomies were abdominal, followed by vaginal hysterectomy (227) and laparoscopically assisted vaginal hysterectomy (61) ( TABLE ).

Most ureteral injuries (80%) occurred at the level of the uterine artery. The ureter is difficult to visualize or palpate once it goes under the uterine artery and courses along the anterior vagina before entry into the urinary bladder.

Ureteral injury also was common at the level of the infundibulopelvic ligament. One patient developed vesicovaginal fistula postoperatively that was missed on initial cystoscopy.

TABLE

Injury rate, by hysterectomy procedure

Cystoscopy is imperfect, but effective, and its cost is justifiable

Cystoscopy should be performed routinely after any gynecologic procedure associated with a high risk of injury, such as difficult bladder or ureteral dissection. Findings that justify cystoscopy include de novo hematuria and air in the Foley bag during laparoscopy.

Although cystoscopy may not identify all injuries, its benefits likely outweigh any additional cost associated with the procedure when a high rate of injury is likely (greater than, say, 1.5%).³

This study was conducted over 8 years at three academic practices, so it may not be possible to generalize its findings broadly across practitioners.

The overall rate of ureteral injury at the time of hysterectomy and other gynecologic procedures for benign disease has been estimated at 8.8 injuries for every 1,000 procedures, with the highest rate (17.3/1,000) occurring during laparoscopic hysterectomy with bilateral salpingo-oophorectomy (BSO). The rate of bladder injury is estimated at 16.3 for every 1,000 gynecologic procedures and 29.2 for every 1,000 laparoscopic hysterectomies with BSO.¹

Cystoscopy is a low-risk procedure that may be beneficial in surgeries associated with a high rate (1% to 2%) of lower urinary tract injury.² Early detection of bladder or ureteral injury is preferable to avoid postoperative complications such as fistula formation, loss of renal function, and other complications requiring additional surgery and prolonged hospitalization. Early detection also reduces medicolegal risk.

Ibeanu and associates point out that many gynecologic surgeons do not perform cystoscopy routinely, because of either a lack of training or difficulty obtaining privileges to perform this urologic procedure. They also note that the benefits of cystoscopy clearly outweigh the risks.

Only 25.6% of injuries were detected by visual inspection

Roughly one in four injuries to the bladder and ureter were detected without the aid of cystoscopy; the rest were identified using cystoscopy.

Twenty-four cases of bladder injury (2.9%) and 15 cases of ureteral injury (1.8%) were identified at the time of rigid diagnostic cystoscopy after hysterectomy. The majority (544) of the hysterectomies were abdominal, followed by vaginal hysterectomy (227) and laparoscopically assisted vaginal hysterectomy (61) ( TABLE ).

Most ureteral injuries (80%) occurred at the level of the uterine artery. The ureter is difficult to visualize or palpate once it goes under the uterine artery and courses along the anterior vagina before entry into the urinary bladder.

Ureteral injury also was common at the level of the infundibulopelvic ligament. One patient developed vesicovaginal fistula postoperatively that was missed on initial cystoscopy.

TABLE

Injury rate, by hysterectomy procedure

Cystoscopy is imperfect, but effective, and its cost is justifiable

Cystoscopy should be performed routinely after any gynecologic procedure associated with a high risk of injury, such as difficult bladder or ureteral dissection. Findings that justify cystoscopy include de novo hematuria and air in the Foley bag during laparoscopy.

Although cystoscopy may not identify all injuries, its benefits likely outweigh any additional cost associated with the procedure when a high rate of injury is likely (greater than, say, 1.5%).³

This study was conducted over 8 years at three academic practices, so it may not be possible to generalize its findings broadly across practitioners.

From my vantage point, it appears that economic factors are playing an increasingly important role in how pelvic organ prolapse (POP) and urinary incontinence (UI) are managed—particularly, in regard to the use of surgical devices. As such, the topic of treating POP and UI deserves our attention to ensure that we make the best decisions for our patients.

Now, I’m a staunch supporter of innovation in treatment; certainly, there is room for improvement in current approaches—particularly in surgery—for treating POP and UI. At the same time, I strongly believe that innovation must be demonstrated to be an improvement before it is incorporated into practice. Although innovation is commonly taken on faith, we should know better than to equate “new” with “better” until evidence, gathered through clinical research, has demonstrated this conclusively. A look at the US Food and Drug Administration’s (FDA’s) process for clearing medical devices for clinical use reveals that such a standard often doesn’t apply—and this should matter to us.

The meaning of 510(k)

Most medical devices are evaluated through an FDA clearance mechanism known as the 510(k) process. This is wholly distinct from the agency’s drug approval process with which most of us are familiar. It’s beyond the scope of this commentary for me to go into detail about 510(k); if you are interested, see two recent commentaries^1,2 and visit http://www.fda.gov/cdrh/devadvice/314.html .

In a nutshell, the 510(k) process requires only that an applicant demonstrate that a new medical device has “substantial equivalence” to an already legally marketed device, known as the predicate, which may also have been cleared only through the 510(k) process. That means it’s possible to have generations of products cleared on the basis of one predicate device that was itself never studied adequately.

Indeed, this is the case with most medical devices that have been sold for the surgical treatment of POP and UI—from before the ProteGen Sling (Boston Scientific), through Tension-Free Vaginal Tape (TVT) (Gynecare), and continuing with the newest devices.

The story of the ProteGen Sling ( FIGURE ) offers a cautionary tale about what can go wrong when new devices are cleared by the FDA through 510(k), rather than evaluated through rigorous clinical trials, as drugs are. More recently, experience with the ObTape (Mentor Corporation) followed virtually the same trajectory of events; the product was pulled from the market in 2006 and is now the focus of lawsuits nationwide.

Fortunately, for our patients, experience with TVT (Gynecare) has been favorable. Although TVT was also cleared by the FDA through 510(k), clinical research performed after TVT was introduced has demonstrated its effectiveness and relative safety. Indeed, TVT has revolutionized the treatment of stress UI in women—and, even, our understanding of its etiology.

Several companies are capitalizing on the success of TVT by introducing competing products that are designed to be 1) similar enough to ride on the coattails of TVT yet 2) different enough to capture their own share of market—without evidence of safety or effectiveness required. Even Gynecare (part of Ethicon Women’s Health and Urology, a subsidiary of Johnson & Johnson) has introduced TVT SECUR to compete with its own TVT—again, without independent evidence of safety or effectiveness.

The current market in devices for stress UI is a moving target that makes it nearly impossible—even for research organizations, such as the federally funded Pelvic Floor Disorders Network, that are independent of industry—to develop and implement sound clinical trials of those devices. Why do I say “moving target”? First, there are no assurances that any device chosen for study will remain the same for the duration of a trial. Second, there is no way to foresee which products will be abandoned over the time required for a large clinical trial.

FIGURE The saga of the ProteGen Sling

Transparency over what might be considered “experimental”

Until the FDA changes its process—to one in which 1) medical devices are adequately assessed before they reach market and 2) postmarketing surveillance is required—it’s our duty to insist on evidence of safety and effectiveness before adopting the latest and greatest products that companies have to offer.

Of all the questions that a patient might ask before treatment, three of the most important, surely, are:

• “Will this help me?”
• “If it helps me, how long will it help?”
• “Whether or not this treatment helps me, what risks—in the short-term and over the long-term—does it present?”

Until we can provide our patients with answers that are supported by evidence, products that lack such evidence should be considered experimental, and patients should be counseled accordingly.

Some patients may accept what they’ve been advised are new and unproven treatments—in the way that some physicians are early adopters. Nevertheless, I am concerned that some clinicians do not appear to appreciate the true lack of evidence that accompanies most marketed devices for prolapse and incontinence. They may mistake the FDA 510(k) process of clearance for something similar to the agency’s extended and complex drug approval process. They may accept claims made in industry-produced white papers that are often largely promotional materials, and fail to look further into those claims.

Now, more than ever and above all else, we must stand between marketing and our patients’ safety. We are familiar with the toll that prolapse and incontinence, as chronic conditions, take on our patients; yet it’s that very chronic nature that should lead us to adopt patience and caution in accepting new treatments before they have been adequately studied.

If we cannot always rely on industry to provide clear information about the risks and benefits of new devices, neither can we routinely look to our professional organizations for unbiased information. Often, professional organizations accept cash contributions from industry, raising the question of conflict of interest that may undermine their actions when the priorities of industry do not align with the goal of safeguarding patients’ well-being.

In an unprecedented example of how a professional association can interfere with its own, expert-authored clinical practice guidelines, the American College of Obstetricians and Gynecologists (ACOG) more than a year ago rescinded one of its published guidelines on POP (Issue 79, February 2007³ ) and replaced it with a new guideline (Issue 85, September 2007⁴ ). The new guideline is nearly identical to the prior one—save for one sentence, in which “experimental” is deleted in a discussion of kits of trocar-based synthetic materials sold for the surgical treatment of pelvic organ prolapse (see the EXCERPT ).

The deletion is crucial because offering informed consent for surgery requires a patient to accept risks in balance with an expectation of benefit. A patient cannot be appropriately informed when no evidence of benefit exists and evidence of postoperative risk is extremely limited.

Now, I am not declaring that ACOG acted with bias because of a financial conflict of interest with industry in this instance; the fact that a financial conflict of interest exists for ACOG, however, cannot be disputed if one examines the College’s Annual Report, where contributors are listed. (For a comprehensive, if disillusioning, treatise on the many effects of financial conflict of interest within medicine, I recommend the book On The Take.⁵ )

Case: Radiofrequency therapy. Even when clinical experience demonstrates lack of effectiveness or an unacceptable rate of complications associated with certain techniques or devices, unequivocal evidence of such problems does not always appear in the literature. One example of this is how a technique was translated into a treatment for incontinence by way of its use in other fields.

Radiofrequency has, among other uses, been used to ablate nerves in intractable chronic pain and to address joint instability in orthopedic surgery. Radiofrequency energy was then, by extension, applied transvaginally to tissue (known as “endopelvic” fascia, of a distinctly different nature than parietal fascia involved in orthopedic procedures) surrounding the urethra. The goal was to coagulate “supporting” tissues and “correct” urethral hypermobility that purportedly causes stress incontinence.

Marketing of the SURx Transvaginal System (CooperSurgical, Inc.) began in 2002, followed by reports of success. One industry-sponsored study, for example, reported a 73% rate of either continence or improvement after 12 months.⁶

Despite such favorable early results, however, in 2006 CooperSurgical decided to abandon this system, citing “technique-dependent” results of the procedure. Since then, independent research has shown a very low initial success rate that declines rapidly—within weeks or months—of treatment.^7,8

A different radiofrequency technique continues to be marketed—the Renessa System™ (NovaSys Medical), which uses a urethral catheter-mounted system to deliver radiofrequency energy through the urethral mucosa to the submucosa and adjacent tissues. Once again, initial reports of industry-sponsored research showed promising results; one study of 110 patients reported 74% achieved continence or improvement after 1 year.⁹ In a follow-up report of 21 of the original 110 patients, “improvement” was reported in 74% after 3 years.¹⁰ Independent research has yet to be reported in the literature.

Of particular concern, no data exist on the long-term effect of denaturing collagen in the urethra and adjacent tissues in relation to UI, other aspects of bladder function, or sexual function. An apparent lack of immediate complications cannot be equated with safety; we need long-term studies to determine whether urethral function is affected adversely compared with that in untreated women and women treated with surgery.

Bring on innovation—in context!

For those who consider my argument anti-innovation, let me repeat: I believe strongly in innovation to improve care for our patients. Am I anti-industry? Only when there is an unbridled race to profit from marketing products without safeguards to ensure, first and foremost, the safety of our patients and, second, their long-term effectiveness. Knowingly or unknowingly, patients then become the guinea pigs on whom these products are tested—just not in the appropriate context of clinical research and informed consent for participation.

Instead (as happened in the US Public Health Service’s Tuskegee syphilis experiments), patients serve as research subjects without their consent when they receive untested products and undergo unproven treatments. And because clinicians are the conduit through which patients receive untested and unproven treatments, who is ultimately responsible for the outcome?

Industry brings innovation to clinical practice. But it is incumbent on clinicians to recognize, with unflinching honesty, the bottom line on which industry operates. Prolapse and incontinence are deeply distressing for our patients, but these chronic conditions are not life-threatening; virtually all women who suffer these conditions have been symptomatic for years before they come for care. I see no need, except to increase that bottom line, to rush products to market before they have been evaluated sufficiently to determine whether “new” is actually “better.”

For clinicians who style themselves as early adopters, remember: It’s not you, but your patient, who is “adopting” a foreign material and having it placed deep in the most intimate area of her body—a foreign material intended to stay for life (except for those unfortunate patients who must have it removed). Above all, we must do no harm—an elusive goal when some of us try to attract patients by being the first to use a product before evidence of its risk and utility have been established in practice.

Does this kind of talk encourage litigation?

Does a commentary like this one provide fodder for plaintiff attorneys who are seeking grounds for product liability lawsuits against manufacturers and malpractice claims against clinicians? Please! Spend a moment on the Web, and you will see that the lawyers are already busy—especially since the FDA’s October 2008 alert about complications with surgical mesh for prolapse and incontinence. [See “FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management, at www.obgmanagement.com.] It’s worth noting how these lawyers see themselves: They would likely tell you that they “provide an important service in protecting patients from unscrupulous manufacturers who profit from the vulnerability of people seeking treatment for distressing conditions.” As clinicians, are we absolutely sure that we can say the same of ourselves?

Is it wrong to harp on what happened in the past?

Why revisit events surrounding, for example, the ProteGen Sling? My reply is another question: Where is the evidence that such sequences of events are in the past? Among clinicians, who knows which is best in a collection of kits that changes from one month to the next, without their promoters skipping a beat in proclaiming theirs as the “best”? It isn’t shameful to admit that one doesn’t know which one is best; but it is a shame to act as if one does know, especially when the risk falls to another. The names change; the events are the same.

What is the solution to this problem?

Businesses succeed only when their products are purchased. If clinicians refused to be participants whenever the device industry introduces unproven treatments into the market, industry would be compelled to test their products beforehand. Patients would benefit—by being able to make truly informed choices, with adequate information about risk and benefit. Clinicians would benefit—by being able to provide the most effective treatment without sacrificing their integrity in the process. Ultimately, industry would benefit, by profiting appropriately from products that truly help our patients. Is that an impossible wish?

From my vantage point, it appears that economic factors are playing an increasingly important role in how pelvic organ prolapse (POP) and urinary incontinence (UI) are managed—particularly, in regard to the use of surgical devices. As such, the topic of treating POP and UI deserves our attention to ensure that we make the best decisions for our patients.

Now, I’m a staunch supporter of innovation in treatment; certainly, there is room for improvement in current approaches—particularly in surgery—for treating POP and UI. At the same time, I strongly believe that innovation must be demonstrated to be an improvement before it is incorporated into practice. Although innovation is commonly taken on faith, we should know better than to equate “new” with “better” until evidence, gathered through clinical research, has demonstrated this conclusively. A look at the US Food and Drug Administration’s (FDA’s) process for clearing medical devices for clinical use reveals that such a standard often doesn’t apply—and this should matter to us.

The meaning of 510(k)

Most medical devices are evaluated through an FDA clearance mechanism known as the 510(k) process. This is wholly distinct from the agency’s drug approval process with which most of us are familiar. It’s beyond the scope of this commentary for me to go into detail about 510(k); if you are interested, see two recent commentaries^1,2 and visit http://www.fda.gov/cdrh/devadvice/314.html .

In a nutshell, the 510(k) process requires only that an applicant demonstrate that a new medical device has “substantial equivalence” to an already legally marketed device, known as the predicate, which may also have been cleared only through the 510(k) process. That means it’s possible to have generations of products cleared on the basis of one predicate device that was itself never studied adequately.

Indeed, this is the case with most medical devices that have been sold for the surgical treatment of POP and UI—from before the ProteGen Sling (Boston Scientific), through Tension-Free Vaginal Tape (TVT) (Gynecare), and continuing with the newest devices.

The story of the ProteGen Sling ( FIGURE ) offers a cautionary tale about what can go wrong when new devices are cleared by the FDA through 510(k), rather than evaluated through rigorous clinical trials, as drugs are. More recently, experience with the ObTape (Mentor Corporation) followed virtually the same trajectory of events; the product was pulled from the market in 2006 and is now the focus of lawsuits nationwide.

Fortunately, for our patients, experience with TVT (Gynecare) has been favorable. Although TVT was also cleared by the FDA through 510(k), clinical research performed after TVT was introduced has demonstrated its effectiveness and relative safety. Indeed, TVT has revolutionized the treatment of stress UI in women—and, even, our understanding of its etiology.

Several companies are capitalizing on the success of TVT by introducing competing products that are designed to be 1) similar enough to ride on the coattails of TVT yet 2) different enough to capture their own share of market—without evidence of safety or effectiveness required. Even Gynecare (part of Ethicon Women’s Health and Urology, a subsidiary of Johnson & Johnson) has introduced TVT SECUR to compete with its own TVT—again, without independent evidence of safety or effectiveness.

The current market in devices for stress UI is a moving target that makes it nearly impossible—even for research organizations, such as the federally funded Pelvic Floor Disorders Network, that are independent of industry—to develop and implement sound clinical trials of those devices. Why do I say “moving target”? First, there are no assurances that any device chosen for study will remain the same for the duration of a trial. Second, there is no way to foresee which products will be abandoned over the time required for a large clinical trial.

FIGURE The saga of the ProteGen Sling

Transparency over what might be considered “experimental”

Until the FDA changes its process—to one in which 1) medical devices are adequately assessed before they reach market and 2) postmarketing surveillance is required—it’s our duty to insist on evidence of safety and effectiveness before adopting the latest and greatest products that companies have to offer.

Of all the questions that a patient might ask before treatment, three of the most important, surely, are:

• “Will this help me?”
• “If it helps me, how long will it help?”
• “Whether or not this treatment helps me, what risks—in the short-term and over the long-term—does it present?”

Until we can provide our patients with answers that are supported by evidence, products that lack such evidence should be considered experimental, and patients should be counseled accordingly.

Some patients may accept what they’ve been advised are new and unproven treatments—in the way that some physicians are early adopters. Nevertheless, I am concerned that some clinicians do not appear to appreciate the true lack of evidence that accompanies most marketed devices for prolapse and incontinence. They may mistake the FDA 510(k) process of clearance for something similar to the agency’s extended and complex drug approval process. They may accept claims made in industry-produced white papers that are often largely promotional materials, and fail to look further into those claims.

Now, more than ever and above all else, we must stand between marketing and our patients’ safety. We are familiar with the toll that prolapse and incontinence, as chronic conditions, take on our patients; yet it’s that very chronic nature that should lead us to adopt patience and caution in accepting new treatments before they have been adequately studied.

If we cannot always rely on industry to provide clear information about the risks and benefits of new devices, neither can we routinely look to our professional organizations for unbiased information. Often, professional organizations accept cash contributions from industry, raising the question of conflict of interest that may undermine their actions when the priorities of industry do not align with the goal of safeguarding patients’ well-being.

In an unprecedented example of how a professional association can interfere with its own, expert-authored clinical practice guidelines, the American College of Obstetricians and Gynecologists (ACOG) more than a year ago rescinded one of its published guidelines on POP (Issue 79, February 2007³ ) and replaced it with a new guideline (Issue 85, September 2007⁴ ). The new guideline is nearly identical to the prior one—save for one sentence, in which “experimental” is deleted in a discussion of kits of trocar-based synthetic materials sold for the surgical treatment of pelvic organ prolapse (see the EXCERPT ).

The deletion is crucial because offering informed consent for surgery requires a patient to accept risks in balance with an expectation of benefit. A patient cannot be appropriately informed when no evidence of benefit exists and evidence of postoperative risk is extremely limited.

Now, I am not declaring that ACOG acted with bias because of a financial conflict of interest with industry in this instance; the fact that a financial conflict of interest exists for ACOG, however, cannot be disputed if one examines the College’s Annual Report, where contributors are listed. (For a comprehensive, if disillusioning, treatise on the many effects of financial conflict of interest within medicine, I recommend the book On The Take.⁵ )

Case: Radiofrequency therapy. Even when clinical experience demonstrates lack of effectiveness or an unacceptable rate of complications associated with certain techniques or devices, unequivocal evidence of such problems does not always appear in the literature. One example of this is how a technique was translated into a treatment for incontinence by way of its use in other fields.

Radiofrequency has, among other uses, been used to ablate nerves in intractable chronic pain and to address joint instability in orthopedic surgery. Radiofrequency energy was then, by extension, applied transvaginally to tissue (known as “endopelvic” fascia, of a distinctly different nature than parietal fascia involved in orthopedic procedures) surrounding the urethra. The goal was to coagulate “supporting” tissues and “correct” urethral hypermobility that purportedly causes stress incontinence.

Marketing of the SURx Transvaginal System (CooperSurgical, Inc.) began in 2002, followed by reports of success. One industry-sponsored study, for example, reported a 73% rate of either continence or improvement after 12 months.⁶

Despite such favorable early results, however, in 2006 CooperSurgical decided to abandon this system, citing “technique-dependent” results of the procedure. Since then, independent research has shown a very low initial success rate that declines rapidly—within weeks or months—of treatment.^7,8

A different radiofrequency technique continues to be marketed—the Renessa System™ (NovaSys Medical), which uses a urethral catheter-mounted system to deliver radiofrequency energy through the urethral mucosa to the submucosa and adjacent tissues. Once again, initial reports of industry-sponsored research showed promising results; one study of 110 patients reported 74% achieved continence or improvement after 1 year.⁹ In a follow-up report of 21 of the original 110 patients, “improvement” was reported in 74% after 3 years.¹⁰ Independent research has yet to be reported in the literature.

Of particular concern, no data exist on the long-term effect of denaturing collagen in the urethra and adjacent tissues in relation to UI, other aspects of bladder function, or sexual function. An apparent lack of immediate complications cannot be equated with safety; we need long-term studies to determine whether urethral function is affected adversely compared with that in untreated women and women treated with surgery.

Bring on innovation—in context!

For those who consider my argument anti-innovation, let me repeat: I believe strongly in innovation to improve care for our patients. Am I anti-industry? Only when there is an unbridled race to profit from marketing products without safeguards to ensure, first and foremost, the safety of our patients and, second, their long-term effectiveness. Knowingly or unknowingly, patients then become the guinea pigs on whom these products are tested—just not in the appropriate context of clinical research and informed consent for participation.

Instead (as happened in the US Public Health Service’s Tuskegee syphilis experiments), patients serve as research subjects without their consent when they receive untested products and undergo unproven treatments. And because clinicians are the conduit through which patients receive untested and unproven treatments, who is ultimately responsible for the outcome?

Industry brings innovation to clinical practice. But it is incumbent on clinicians to recognize, with unflinching honesty, the bottom line on which industry operates. Prolapse and incontinence are deeply distressing for our patients, but these chronic conditions are not life-threatening; virtually all women who suffer these conditions have been symptomatic for years before they come for care. I see no need, except to increase that bottom line, to rush products to market before they have been evaluated sufficiently to determine whether “new” is actually “better.”

For clinicians who style themselves as early adopters, remember: It’s not you, but your patient, who is “adopting” a foreign material and having it placed deep in the most intimate area of her body—a foreign material intended to stay for life (except for those unfortunate patients who must have it removed). Above all, we must do no harm—an elusive goal when some of us try to attract patients by being the first to use a product before evidence of its risk and utility have been established in practice.

Does this kind of talk encourage litigation?

Does a commentary like this one provide fodder for plaintiff attorneys who are seeking grounds for product liability lawsuits against manufacturers and malpractice claims against clinicians? Please! Spend a moment on the Web, and you will see that the lawyers are already busy—especially since the FDA’s October 2008 alert about complications with surgical mesh for prolapse and incontinence. [See “FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management, at www.obgmanagement.com.] It’s worth noting how these lawyers see themselves: They would likely tell you that they “provide an important service in protecting patients from unscrupulous manufacturers who profit from the vulnerability of people seeking treatment for distressing conditions.” As clinicians, are we absolutely sure that we can say the same of ourselves?

Is it wrong to harp on what happened in the past?

Why revisit events surrounding, for example, the ProteGen Sling? My reply is another question: Where is the evidence that such sequences of events are in the past? Among clinicians, who knows which is best in a collection of kits that changes from one month to the next, without their promoters skipping a beat in proclaiming theirs as the “best”? It isn’t shameful to admit that one doesn’t know which one is best; but it is a shame to act as if one does know, especially when the risk falls to another. The names change; the events are the same.

What is the solution to this problem?

Businesses succeed only when their products are purchased. If clinicians refused to be participants whenever the device industry introduces unproven treatments into the market, industry would be compelled to test their products beforehand. Patients would benefit—by being able to make truly informed choices, with adequate information about risk and benefit. Clinicians would benefit—by being able to provide the most effective treatment without sacrificing their integrity in the process. Ultimately, industry would benefit, by profiting appropriately from products that truly help our patients. Is that an impossible wish?

From my vantage point, it appears that economic factors are playing an increasingly important role in how pelvic organ prolapse (POP) and urinary incontinence (UI) are managed—particularly, in regard to the use of surgical devices. As such, the topic of treating POP and UI deserves our attention to ensure that we make the best decisions for our patients.

Now, I’m a staunch supporter of innovation in treatment; certainly, there is room for improvement in current approaches—particularly in surgery—for treating POP and UI. At the same time, I strongly believe that innovation must be demonstrated to be an improvement before it is incorporated into practice. Although innovation is commonly taken on faith, we should know better than to equate “new” with “better” until evidence, gathered through clinical research, has demonstrated this conclusively. A look at the US Food and Drug Administration’s (FDA’s) process for clearing medical devices for clinical use reveals that such a standard often doesn’t apply—and this should matter to us.

The meaning of 510(k)

Most medical devices are evaluated through an FDA clearance mechanism known as the 510(k) process. This is wholly distinct from the agency’s drug approval process with which most of us are familiar. It’s beyond the scope of this commentary for me to go into detail about 510(k); if you are interested, see two recent commentaries^1,2 and visit http://www.fda.gov/cdrh/devadvice/314.html .

In a nutshell, the 510(k) process requires only that an applicant demonstrate that a new medical device has “substantial equivalence” to an already legally marketed device, known as the predicate, which may also have been cleared only through the 510(k) process. That means it’s possible to have generations of products cleared on the basis of one predicate device that was itself never studied adequately.

Indeed, this is the case with most medical devices that have been sold for the surgical treatment of POP and UI—from before the ProteGen Sling (Boston Scientific), through Tension-Free Vaginal Tape (TVT) (Gynecare), and continuing with the newest devices.

The story of the ProteGen Sling ( FIGURE ) offers a cautionary tale about what can go wrong when new devices are cleared by the FDA through 510(k), rather than evaluated through rigorous clinical trials, as drugs are. More recently, experience with the ObTape (Mentor Corporation) followed virtually the same trajectory of events; the product was pulled from the market in 2006 and is now the focus of lawsuits nationwide.

Fortunately, for our patients, experience with TVT (Gynecare) has been favorable. Although TVT was also cleared by the FDA through 510(k), clinical research performed after TVT was introduced has demonstrated its effectiveness and relative safety. Indeed, TVT has revolutionized the treatment of stress UI in women—and, even, our understanding of its etiology.

Several companies are capitalizing on the success of TVT by introducing competing products that are designed to be 1) similar enough to ride on the coattails of TVT yet 2) different enough to capture their own share of market—without evidence of safety or effectiveness required. Even Gynecare (part of Ethicon Women’s Health and Urology, a subsidiary of Johnson & Johnson) has introduced TVT SECUR to compete with its own TVT—again, without independent evidence of safety or effectiveness.

The current market in devices for stress UI is a moving target that makes it nearly impossible—even for research organizations, such as the federally funded Pelvic Floor Disorders Network, that are independent of industry—to develop and implement sound clinical trials of those devices. Why do I say “moving target”? First, there are no assurances that any device chosen for study will remain the same for the duration of a trial. Second, there is no way to foresee which products will be abandoned over the time required for a large clinical trial.

FIGURE The saga of the ProteGen Sling

Transparency over what might be considered “experimental”

Until the FDA changes its process—to one in which 1) medical devices are adequately assessed before they reach market and 2) postmarketing surveillance is required—it’s our duty to insist on evidence of safety and effectiveness before adopting the latest and greatest products that companies have to offer.

Of all the questions that a patient might ask before treatment, three of the most important, surely, are:

• “Will this help me?”
• “If it helps me, how long will it help?”
• “Whether or not this treatment helps me, what risks—in the short-term and over the long-term—does it present?”

Until we can provide our patients with answers that are supported by evidence, products that lack such evidence should be considered experimental, and patients should be counseled accordingly.

Some patients may accept what they’ve been advised are new and unproven treatments—in the way that some physicians are early adopters. Nevertheless, I am concerned that some clinicians do not appear to appreciate the true lack of evidence that accompanies most marketed devices for prolapse and incontinence. They may mistake the FDA 510(k) process of clearance for something similar to the agency’s extended and complex drug approval process. They may accept claims made in industry-produced white papers that are often largely promotional materials, and fail to look further into those claims.

Now, more than ever and above all else, we must stand between marketing and our patients’ safety. We are familiar with the toll that prolapse and incontinence, as chronic conditions, take on our patients; yet it’s that very chronic nature that should lead us to adopt patience and caution in accepting new treatments before they have been adequately studied.

If we cannot always rely on industry to provide clear information about the risks and benefits of new devices, neither can we routinely look to our professional organizations for unbiased information. Often, professional organizations accept cash contributions from industry, raising the question of conflict of interest that may undermine their actions when the priorities of industry do not align with the goal of safeguarding patients’ well-being.

In an unprecedented example of how a professional association can interfere with its own, expert-authored clinical practice guidelines, the American College of Obstetricians and Gynecologists (ACOG) more than a year ago rescinded one of its published guidelines on POP (Issue 79, February 2007³ ) and replaced it with a new guideline (Issue 85, September 2007⁴ ). The new guideline is nearly identical to the prior one—save for one sentence, in which “experimental” is deleted in a discussion of kits of trocar-based synthetic materials sold for the surgical treatment of pelvic organ prolapse (see the EXCERPT ).

The deletion is crucial because offering informed consent for surgery requires a patient to accept risks in balance with an expectation of benefit. A patient cannot be appropriately informed when no evidence of benefit exists and evidence of postoperative risk is extremely limited.

Now, I am not declaring that ACOG acted with bias because of a financial conflict of interest with industry in this instance; the fact that a financial conflict of interest exists for ACOG, however, cannot be disputed if one examines the College’s Annual Report, where contributors are listed. (For a comprehensive, if disillusioning, treatise on the many effects of financial conflict of interest within medicine, I recommend the book On The Take.⁵ )

Case: Radiofrequency therapy. Even when clinical experience demonstrates lack of effectiveness or an unacceptable rate of complications associated with certain techniques or devices, unequivocal evidence of such problems does not always appear in the literature. One example of this is how a technique was translated into a treatment for incontinence by way of its use in other fields.

Radiofrequency has, among other uses, been used to ablate nerves in intractable chronic pain and to address joint instability in orthopedic surgery. Radiofrequency energy was then, by extension, applied transvaginally to tissue (known as “endopelvic” fascia, of a distinctly different nature than parietal fascia involved in orthopedic procedures) surrounding the urethra. The goal was to coagulate “supporting” tissues and “correct” urethral hypermobility that purportedly causes stress incontinence.

Marketing of the SURx Transvaginal System (CooperSurgical, Inc.) began in 2002, followed by reports of success. One industry-sponsored study, for example, reported a 73% rate of either continence or improvement after 12 months.⁶

Despite such favorable early results, however, in 2006 CooperSurgical decided to abandon this system, citing “technique-dependent” results of the procedure. Since then, independent research has shown a very low initial success rate that declines rapidly—within weeks or months—of treatment.^7,8

A different radiofrequency technique continues to be marketed—the Renessa System™ (NovaSys Medical), which uses a urethral catheter-mounted system to deliver radiofrequency energy through the urethral mucosa to the submucosa and adjacent tissues. Once again, initial reports of industry-sponsored research showed promising results; one study of 110 patients reported 74% achieved continence or improvement after 1 year.⁹ In a follow-up report of 21 of the original 110 patients, “improvement” was reported in 74% after 3 years.¹⁰ Independent research has yet to be reported in the literature.

Of particular concern, no data exist on the long-term effect of denaturing collagen in the urethra and adjacent tissues in relation to UI, other aspects of bladder function, or sexual function. An apparent lack of immediate complications cannot be equated with safety; we need long-term studies to determine whether urethral function is affected adversely compared with that in untreated women and women treated with surgery.

Bring on innovation—in context!

For those who consider my argument anti-innovation, let me repeat: I believe strongly in innovation to improve care for our patients. Am I anti-industry? Only when there is an unbridled race to profit from marketing products without safeguards to ensure, first and foremost, the safety of our patients and, second, their long-term effectiveness. Knowingly or unknowingly, patients then become the guinea pigs on whom these products are tested—just not in the appropriate context of clinical research and informed consent for participation.

Instead (as happened in the US Public Health Service’s Tuskegee syphilis experiments), patients serve as research subjects without their consent when they receive untested products and undergo unproven treatments. And because clinicians are the conduit through which patients receive untested and unproven treatments, who is ultimately responsible for the outcome?

Industry brings innovation to clinical practice. But it is incumbent on clinicians to recognize, with unflinching honesty, the bottom line on which industry operates. Prolapse and incontinence are deeply distressing for our patients, but these chronic conditions are not life-threatening; virtually all women who suffer these conditions have been symptomatic for years before they come for care. I see no need, except to increase that bottom line, to rush products to market before they have been evaluated sufficiently to determine whether “new” is actually “better.”

For clinicians who style themselves as early adopters, remember: It’s not you, but your patient, who is “adopting” a foreign material and having it placed deep in the most intimate area of her body—a foreign material intended to stay for life (except for those unfortunate patients who must have it removed). Above all, we must do no harm—an elusive goal when some of us try to attract patients by being the first to use a product before evidence of its risk and utility have been established in practice.

Does this kind of talk encourage litigation?

Does a commentary like this one provide fodder for plaintiff attorneys who are seeking grounds for product liability lawsuits against manufacturers and malpractice claims against clinicians? Please! Spend a moment on the Web, and you will see that the lawyers are already busy—especially since the FDA’s October 2008 alert about complications with surgical mesh for prolapse and incontinence. [See “FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management, at www.obgmanagement.com.] It’s worth noting how these lawyers see themselves: They would likely tell you that they “provide an important service in protecting patients from unscrupulous manufacturers who profit from the vulnerability of people seeking treatment for distressing conditions.” As clinicians, are we absolutely sure that we can say the same of ourselves?

Is it wrong to harp on what happened in the past?

Why revisit events surrounding, for example, the ProteGen Sling? My reply is another question: Where is the evidence that such sequences of events are in the past? Among clinicians, who knows which is best in a collection of kits that changes from one month to the next, without their promoters skipping a beat in proclaiming theirs as the “best”? It isn’t shameful to admit that one doesn’t know which one is best; but it is a shame to act as if one does know, especially when the risk falls to another. The names change; the events are the same.

What is the solution to this problem?

Businesses succeed only when their products are purchased. If clinicians refused to be participants whenever the device industry introduces unproven treatments into the market, industry would be compelled to test their products beforehand. Patients would benefit—by being able to make truly informed choices, with adequate information about risk and benefit. Clinicians would benefit—by being able to provide the most effective treatment without sacrificing their integrity in the process. Ultimately, industry would benefit, by profiting appropriately from products that truly help our patients. Is that an impossible wish?

From my vantage point, it appears that economic factors are playing an increasingly important role in how pelvic organ prolapse (POP) and urinary incontinence (UI) are managed—particularly, in regard to the use of surgical devices. As such, the topic of treating POP and UI deserves our attention to ensure that we make the best decisions for our patients.

Now, I’m a staunch supporter of innovation in treatment; certainly, there is room for improvement in current approaches—particularly in surgery—for treating POP and UI. At the same time, I strongly believe that innovation must be demonstrated to be an improvement before it is incorporated into practice. Although innovation is commonly taken on faith, we should know better than to equate “new” with “better” until evidence, gathered through clinical research, has demonstrated this conclusively. A look at the US Food and Drug Administration’s (FDA’s) process for clearing medical devices for clinical use reveals that such a standard often doesn’t apply—and this should matter to us.

The meaning of 510(k)

Most medical devices are evaluated through an FDA clearance mechanism known as the 510(k) process. This is wholly distinct from the agency’s drug approval process with which most of us are familiar. It’s beyond the scope of this commentary for me to go into detail about 510(k); if you are interested, see two recent commentaries^{“FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management.] It’s worth noting how these lawyers see themselves: They would likely tell you that they “provide an important service in protecting patients from unscrupulous manufacturers who profit from the vulnerability of people seeking treatment for distressing conditions.” As clinicians, are we absolutely sure that we can say the same of ourselves?}

Is it wrong to harp on what happened in the past?

Why revisit events surrounding, for example, the ProteGen Sling? My reply is another question: Where is the evidence that such sequences of events are in the past? Among clinicians, who knows which is best in a collection of kits that changes from one month to the next, without their promoters skipping a beat in proclaiming theirs as the “best”? It isn’t shameful to admit that one doesn’t know which one is best; but it is a shame to act as if one does know, especially when the risk falls to another. The names change; the events are the same.

What is the solution to this problem?

Businesses succeed only when their products are purchased. If clinicians refused to be participants whenever the device industry introduces unproven treatments into the market, industry would be compelled to test their products beforehand. Patients would benefit—by being able to make truly informed choices, with adequate information about risk and benefit. Clinicians would benefit—by being able to provide the most effective treatment without sacrificing their integrity in the process. Ultimately, industry would benefit, by profiting appropriately from products that truly help our patients. Is that an impossible wish?

From my vantage point, it appears that economic factors are playing an increasingly important role in how pelvic organ prolapse (POP) and urinary incontinence (UI) are managed—particularly, in regard to the use of surgical devices. As such, the topic of treating POP and UI deserves our attention to ensure that we make the best decisions for our patients.

Now, I’m a staunch supporter of innovation in treatment; certainly, there is room for improvement in current approaches—particularly in surgery—for treating POP and UI. At the same time, I strongly believe that innovation must be demonstrated to be an improvement before it is incorporated into practice. Although innovation is commonly taken on faith, we should know better than to equate “new” with “better” until evidence, gathered through clinical research, has demonstrated this conclusively. A look at the US Food and Drug Administration’s (FDA’s) process for clearing medical devices for clinical use reveals that such a standard often doesn’t apply—and this should matter to us.

The meaning of 510(k)

Most medical devices are evaluated through an FDA clearance mechanism known as the 510(k) process. This is wholly distinct from the agency’s drug approval process with which most of us are familiar. It’s beyond the scope of this commentary for me to go into detail about 510(k); if you are interested, see two recent commentaries^{“FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management.] It’s worth noting how these lawyers see themselves: They would likely tell you that they “provide an important service in protecting patients from unscrupulous manufacturers who profit from the vulnerability of people seeking treatment for distressing conditions.” As clinicians, are we absolutely sure that we can say the same of ourselves?}

Is it wrong to harp on what happened in the past?

Why revisit events surrounding, for example, the ProteGen Sling? My reply is another question: Where is the evidence that such sequences of events are in the past? Among clinicians, who knows which is best in a collection of kits that changes from one month to the next, without their promoters skipping a beat in proclaiming theirs as the “best”? It isn’t shameful to admit that one doesn’t know which one is best; but it is a shame to act as if one does know, especially when the risk falls to another. The names change; the events are the same.

What is the solution to this problem?

Businesses succeed only when their products are purchased. If clinicians refused to be participants whenever the device industry introduces unproven treatments into the market, industry would be compelled to test their products beforehand. Patients would benefit—by being able to make truly informed choices, with adequate information about risk and benefit. Clinicians would benefit—by being able to provide the most effective treatment without sacrificing their integrity in the process. Ultimately, industry would benefit, by profiting appropriately from products that truly help our patients. Is that an impossible wish?

From my vantage point, it appears that economic factors are playing an increasingly important role in how pelvic organ prolapse (POP) and urinary incontinence (UI) are managed—particularly, in regard to the use of surgical devices. As such, the topic of treating POP and UI deserves our attention to ensure that we make the best decisions for our patients.

Now, I’m a staunch supporter of innovation in treatment; certainly, there is room for improvement in current approaches—particularly in surgery—for treating POP and UI. At the same time, I strongly believe that innovation must be demonstrated to be an improvement before it is incorporated into practice. Although innovation is commonly taken on faith, we should know better than to equate “new” with “better” until evidence, gathered through clinical research, has demonstrated this conclusively. A look at the US Food and Drug Administration’s (FDA’s) process for clearing medical devices for clinical use reveals that such a standard often doesn’t apply—and this should matter to us.

The meaning of 510(k)

Most medical devices are evaluated through an FDA clearance mechanism known as the 510(k) process. This is wholly distinct from the agency’s drug approval process with which most of us are familiar. It’s beyond the scope of this commentary for me to go into detail about 510(k); if you are interested, see two recent commentaries^{“FDA alert: Transvaginal placement of surgical mesh carries serious risks,” in the December 2008 issue of OBG Management.] It’s worth noting how these lawyers see themselves: They would likely tell you that they “provide an important service in protecting patients from unscrupulous manufacturers who profit from the vulnerability of people seeking treatment for distressing conditions.” As clinicians, are we absolutely sure that we can say the same of ourselves?}

Is it wrong to harp on what happened in the past?

Why revisit events surrounding, for example, the ProteGen Sling? My reply is another question: Where is the evidence that such sequences of events are in the past? Among clinicians, who knows which is best in a collection of kits that changes from one month to the next, without their promoters skipping a beat in proclaiming theirs as the “best”? It isn’t shameful to admit that one doesn’t know which one is best; but it is a shame to act as if one does know, especially when the risk falls to another. The names change; the events are the same.

What is the solution to this problem?

Businesses succeed only when their products are purchased. If clinicians refused to be participants whenever the device industry introduces unproven treatments into the market, industry would be compelled to test their products beforehand. Patients would benefit—by being able to make truly informed choices, with adequate information about risk and benefit. Clinicians would benefit—by being able to provide the most effective treatment without sacrificing their integrity in the process. Ultimately, industry would benefit, by profiting appropriately from products that truly help our patients. Is that an impossible wish?

The cervix is most susceptible at the transformation zone, but the remainder of the squamous epithelium of the lower genital tract may be at risk in susceptible persons.

What is the residual risk?
Who should we watch?

If the cervix is removed during hysterectomy after CIN 2+ is diagnosed, what is the residual risk to the patient? How should she be managed?

These are key questions, despite the fact that hysterectomy is not as commonly performed to treat high-grade CIN as it is for other indications, such as abnormal bleeding, pain, endometriosis, and fibroids. Hysterectomy for these other conditions without a concomitant history of neoplasia obviates the need for cervical cancer screening via cytology or HPV testing, or both. When CIN is the reason for the hysterectomy, however, or the patient has a history of CIN 2+, there is some residual risk, with the most common sequela being VAIN and, if the VAIN remains undiscovered, vaginal carcinoma. But how do we identify the patient at high risk for VAIN so that we can provide extra resources (screening or colposcopy services)?

Older women merit closer attention

One strength of this study is the fact that it statistically identifiled “older women” as a high-risk subset more likely to develop VAIN 2+. In the study, the mean age of women who were likely to develop VAIN 2+ was 61 years, compared with 46.9 years for women likely to remain free of disease.

The median interval between hysterectomy and diagnosis of VAIN 2+ was 35 months (range, 5–103 months). This information allows us to anticipate an optimal window in which to focus extra screening.

Retrospective design is a weakness

The retrospective design of this review of pathology data from multiple practices in multiple records is a limitation. The exclusion of patients who had coexisting VAIN or a history of VAIN is laudable, but bias is possible. The quality of the documentation of examination of the remainder of the lower genital tract in patients who had abnormal cervical screening during colposcopy (which led to the diagnosis of CIN) is subject to extreme variability, compared with a prospective design that would have defined the elements of vaginal and vulvar colposcopic examination.

In other words, I am concerned that these are truly incident—rather than persistent—lesions following hysterectomy.

How would HPV testing come into play?

This study and the other published studies that address the subject of hysterectomy in the treatment of CIN 2+ did not use HPV testing. If they had, it likely would have provided more information about the true risk of recurrence and helped determine the best screening interval.

The American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines from 2006 do not address this particular scenario, but American College of Obstetricians and Gynecologists (ACOG) guidelines do recommend annual Papanicolaou testing following hysterectomy for CIN until three consecutive tests are negative.¹

How reliable are screening methods when the vagina is the target tissue?

Cytologic sampling, HPV test sampling, and colposcopy of the “at-risk” transformation zone or endocervical canal are easier to accomplish than are examination and testing of the entire vaginal vault. The latter are more prone to error and lack evidence-based data to substantiate our practice.

Nevertheless, excellent practice recommendations regarding vaginal colposcopy can be found at the ASCCP Web site at www.asccp.org/edu/practice/vagina.shtml.

The cervix is most susceptible at the transformation zone, but the remainder of the squamous epithelium of the lower genital tract may be at risk in susceptible persons.

What is the residual risk?
Who should we watch?

If the cervix is removed during hysterectomy after CIN 2+ is diagnosed, what is the residual risk to the patient? How should she be managed?

These are key questions, despite the fact that hysterectomy is not as commonly performed to treat high-grade CIN as it is for other indications, such as abnormal bleeding, pain, endometriosis, and fibroids. Hysterectomy for these other conditions without a concomitant history of neoplasia obviates the need for cervical cancer screening via cytology or HPV testing, or both. When CIN is the reason for the hysterectomy, however, or the patient has a history of CIN 2+, there is some residual risk, with the most common sequela being VAIN and, if the VAIN remains undiscovered, vaginal carcinoma. But how do we identify the patient at high risk for VAIN so that we can provide extra resources (screening or colposcopy services)?

Older women merit closer attention

One strength of this study is the fact that it statistically identifiled “older women” as a high-risk subset more likely to develop VAIN 2+. In the study, the mean age of women who were likely to develop VAIN 2+ was 61 years, compared with 46.9 years for women likely to remain free of disease.

The median interval between hysterectomy and diagnosis of VAIN 2+ was 35 months (range, 5–103 months). This information allows us to anticipate an optimal window in which to focus extra screening.

Retrospective design is a weakness

The retrospective design of this review of pathology data from multiple practices in multiple records is a limitation. The exclusion of patients who had coexisting VAIN or a history of VAIN is laudable, but bias is possible. The quality of the documentation of examination of the remainder of the lower genital tract in patients who had abnormal cervical screening during colposcopy (which led to the diagnosis of CIN) is subject to extreme variability, compared with a prospective design that would have defined the elements of vaginal and vulvar colposcopic examination.

In other words, I am concerned that these are truly incident—rather than persistent—lesions following hysterectomy.

How would HPV testing come into play?

This study and the other published studies that address the subject of hysterectomy in the treatment of CIN 2+ did not use HPV testing. If they had, it likely would have provided more information about the true risk of recurrence and helped determine the best screening interval.

The American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines from 2006 do not address this particular scenario, but American College of Obstetricians and Gynecologists (ACOG) guidelines do recommend annual Papanicolaou testing following hysterectomy for CIN until three consecutive tests are negative.¹

How reliable are screening methods when the vagina is the target tissue?

Cytologic sampling, HPV test sampling, and colposcopy of the “at-risk” transformation zone or endocervical canal are easier to accomplish than are examination and testing of the entire vaginal vault. The latter are more prone to error and lack evidence-based data to substantiate our practice.

Nevertheless, excellent practice recommendations regarding vaginal colposcopy can be found at the ASCCP Web site at www.asccp.org/edu/practice/vagina.shtml.

The cervix is most susceptible at the transformation zone, but the remainder of the squamous epithelium of the lower genital tract may be at risk in susceptible persons.

What is the residual risk?
Who should we watch?

If the cervix is removed during hysterectomy after CIN 2+ is diagnosed, what is the residual risk to the patient? How should she be managed?

These are key questions, despite the fact that hysterectomy is not as commonly performed to treat high-grade CIN as it is for other indications, such as abnormal bleeding, pain, endometriosis, and fibroids. Hysterectomy for these other conditions without a concomitant history of neoplasia obviates the need for cervical cancer screening via cytology or HPV testing, or both. When CIN is the reason for the hysterectomy, however, or the patient has a history of CIN 2+, there is some residual risk, with the most common sequela being VAIN and, if the VAIN remains undiscovered, vaginal carcinoma. But how do we identify the patient at high risk for VAIN so that we can provide extra resources (screening or colposcopy services)?

Older women merit closer attention

One strength of this study is the fact that it statistically identifiled “older women” as a high-risk subset more likely to develop VAIN 2+. In the study, the mean age of women who were likely to develop VAIN 2+ was 61 years, compared with 46.9 years for women likely to remain free of disease.

The median interval between hysterectomy and diagnosis of VAIN 2+ was 35 months (range, 5–103 months). This information allows us to anticipate an optimal window in which to focus extra screening.

Retrospective design is a weakness

The retrospective design of this review of pathology data from multiple practices in multiple records is a limitation. The exclusion of patients who had coexisting VAIN or a history of VAIN is laudable, but bias is possible. The quality of the documentation of examination of the remainder of the lower genital tract in patients who had abnormal cervical screening during colposcopy (which led to the diagnosis of CIN) is subject to extreme variability, compared with a prospective design that would have defined the elements of vaginal and vulvar colposcopic examination.

In other words, I am concerned that these are truly incident—rather than persistent—lesions following hysterectomy.

How would HPV testing come into play?

This study and the other published studies that address the subject of hysterectomy in the treatment of CIN 2+ did not use HPV testing. If they had, it likely would have provided more information about the true risk of recurrence and helped determine the best screening interval.

The American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines from 2006 do not address this particular scenario, but American College of Obstetricians and Gynecologists (ACOG) guidelines do recommend annual Papanicolaou testing following hysterectomy for CIN until three consecutive tests are negative.¹

How reliable are screening methods when the vagina is the target tissue?

Cytologic sampling, HPV test sampling, and colposcopy of the “at-risk” transformation zone or endocervical canal are easier to accomplish than are examination and testing of the entire vaginal vault. The latter are more prone to error and lack evidence-based data to substantiate our practice.

Nevertheless, excellent practice recommendations regarding vaginal colposcopy can be found at the ASCCP Web site at www.asccp.org/edu/practice/vagina.shtml.

The vulva is especially susceptible to colonization by MRSA owing to its proximity to the rectum and to trauma caused by shaving, waxing, sexual contact, and use of personal hygiene products.

Moreover, obese and disabled women may have difficulty cleaning the vulva adequately; poor hygiene is also associated with MRSA colonization.

MRSA wasn’t the only pathogen identified

Gram-negative organisms, such as Proteus mirabilis and Escherichia coli, and gram-positive organisms, such as Enterococcus and group B Streptococcus also were isolated from patients in this study.

Although most of the vulvar abscesses in this study were colonized with MRSA, that fact was not apparent until specimens were cultured. No presenting signs or symptoms distinguished patients who had MRSA from those who did not.

Nor were women with MRSA more likely to require hospitalization or experience complications from treatment. Rather, hospitalization was more likely in women who had such comorbidities as:

• diabetes
  
• hypertension
  
• an initial serum glucose level above 200 mg/dL
  
• a larger abscess (mean, 5.2 cm in diameter)
  
• an elevated white blood cell count (≥12×10³/µL).
  

Management of MRSA-colonized vulvar abscess primarily involved incision and drainage. Most inpatients also received intravenous vancomycin or clindamycin. Among outpatients, trimethoprim-sulfamethoxazole, an antibiotic regimen known to be eff ective against MRSA, was given in selected cases.

Limitations of this study

This study was conducted in a large county hospital in San Antonio that served primarily low-income Hispanic patients. Findings may therefore apply only to this population or geographic region.

Several variables were either not presented or inadequately discussed in the published study. For example, 26 of the subjects were pregnant. Should they have been included in the overall analysis? Does pregnancy alter the immune system—thereby becoming a risk factor for MRSA-colonized vulvar abscess? Was antibiotic selection different for pregnant patients than it was for nonpregnant patients?

The article also fails to provide much information on the prevalence of sexually transmitted infections (STI) in this population. Only 41% of the 133 women who had their abscess cultured were screened for STI. If these patients were infected with HIV (AIDS-defined), Chlamydia trachomatis, gonorrhea, genital herpes, or other STI pathogen, how would this have changed the data and outcomes?

Last, it is unclear whether the 10 cases of recurrent vulvar abscess identified in this study came from the inpatient or outpatient group.

The vulva is especially susceptible to colonization by MRSA owing to its proximity to the rectum and to trauma caused by shaving, waxing, sexual contact, and use of personal hygiene products.

Moreover, obese and disabled women may have difficulty cleaning the vulva adequately; poor hygiene is also associated with MRSA colonization.

MRSA wasn’t the only pathogen identified

Gram-negative organisms, such as Proteus mirabilis and Escherichia coli, and gram-positive organisms, such as Enterococcus and group B Streptococcus also were isolated from patients in this study.

Although most of the vulvar abscesses in this study were colonized with MRSA, that fact was not apparent until specimens were cultured. No presenting signs or symptoms distinguished patients who had MRSA from those who did not.

Nor were women with MRSA more likely to require hospitalization or experience complications from treatment. Rather, hospitalization was more likely in women who had such comorbidities as:

• diabetes
  
• hypertension
  
• an initial serum glucose level above 200 mg/dL
  
• a larger abscess (mean, 5.2 cm in diameter)
  
• an elevated white blood cell count (≥12×10³/µL).
  

Management of MRSA-colonized vulvar abscess primarily involved incision and drainage. Most inpatients also received intravenous vancomycin or clindamycin. Among outpatients, trimethoprim-sulfamethoxazole, an antibiotic regimen known to be eff ective against MRSA, was given in selected cases.

Limitations of this study

This study was conducted in a large county hospital in San Antonio that served primarily low-income Hispanic patients. Findings may therefore apply only to this population or geographic region.

Several variables were either not presented or inadequately discussed in the published study. For example, 26 of the subjects were pregnant. Should they have been included in the overall analysis? Does pregnancy alter the immune system—thereby becoming a risk factor for MRSA-colonized vulvar abscess? Was antibiotic selection different for pregnant patients than it was for nonpregnant patients?

The article also fails to provide much information on the prevalence of sexually transmitted infections (STI) in this population. Only 41% of the 133 women who had their abscess cultured were screened for STI. If these patients were infected with HIV (AIDS-defined), Chlamydia trachomatis, gonorrhea, genital herpes, or other STI pathogen, how would this have changed the data and outcomes?

Last, it is unclear whether the 10 cases of recurrent vulvar abscess identified in this study came from the inpatient or outpatient group.

The vulva is especially susceptible to colonization by MRSA owing to its proximity to the rectum and to trauma caused by shaving, waxing, sexual contact, and use of personal hygiene products.

Moreover, obese and disabled women may have difficulty cleaning the vulva adequately; poor hygiene is also associated with MRSA colonization.

MRSA wasn’t the only pathogen identified

Gram-negative organisms, such as Proteus mirabilis and Escherichia coli, and gram-positive organisms, such as Enterococcus and group B Streptococcus also were isolated from patients in this study.

Although most of the vulvar abscesses in this study were colonized with MRSA, that fact was not apparent until specimens were cultured. No presenting signs or symptoms distinguished patients who had MRSA from those who did not.

Nor were women with MRSA more likely to require hospitalization or experience complications from treatment. Rather, hospitalization was more likely in women who had such comorbidities as:

• diabetes
  
• hypertension
  
• an initial serum glucose level above 200 mg/dL
  
• a larger abscess (mean, 5.2 cm in diameter)
  
• an elevated white blood cell count (≥12×10³/µL).
  

Management of MRSA-colonized vulvar abscess primarily involved incision and drainage. Most inpatients also received intravenous vancomycin or clindamycin. Among outpatients, trimethoprim-sulfamethoxazole, an antibiotic regimen known to be eff ective against MRSA, was given in selected cases.

Limitations of this study

This study was conducted in a large county hospital in San Antonio that served primarily low-income Hispanic patients. Findings may therefore apply only to this population or geographic region.

Several variables were either not presented or inadequately discussed in the published study. For example, 26 of the subjects were pregnant. Should they have been included in the overall analysis? Does pregnancy alter the immune system—thereby becoming a risk factor for MRSA-colonized vulvar abscess? Was antibiotic selection different for pregnant patients than it was for nonpregnant patients?

The article also fails to provide much information on the prevalence of sexually transmitted infections (STI) in this population. Only 41% of the 133 women who had their abscess cultured were screened for STI. If these patients were infected with HIV (AIDS-defined), Chlamydia trachomatis, gonorrhea, genital herpes, or other STI pathogen, how would this have changed the data and outcomes?

Last, it is unclear whether the 10 cases of recurrent vulvar abscess identified in this study came from the inpatient or outpatient group.

In the survey described by this study, which had a response rate of 63% (n=31,581), female heads of household 18 years of age and older were asked to evaluate their sexual function using the female short-form Changes in Sexual Functioning Questionnaire and the Female Sexual Distress Scale. The prevalence of any sexual problem was 44.2%, with the most common problems being:

• low desire (38.7%)
  
• low arousal (26.1%)
  
• orgasmic dysfunction (20.5%).
  

Dyspareunia was not assessed in this survey because a physical examination is required.

How the findings broke down by age

The prevalence of sexual problems increased with age:

• Among women 18 to 44 years old, 27.2% reported a problem with desire, arousal, orgasm, or a combination of the three.
  
• Among women 45 to 64 years old, the prevalence was 44.6%.
  
• Among women 65 years and older, the prevalence of one or more of these problems was 80.1%.
  

• highest (14.8%) among respondents 45 to 64 years old
  
• lowest (8.9%) among women 65 years or older
  
• intermediate (10.8%) in women 18 to 44 years old.
  

Medical problems associated with a higher prevalence of distressing problems of desire were depression, thyroid dysfunction, anxiety, and urinary incontinence.

Strengths and weaknesses of the study

The large sample size, wide age range, and use of verified instruments to measure sexual problems and related distress were all strengths of this study.

However, to increase response rates to “sensitive” questions, the authors used a research panel that was not randomly chosen. As a result, respondents may have been more health-conscious and self-aware than otherwise would have been the case; they also may have had more time to answer mailed questionnaires.

The fact that sexual problems and distress were self-reported without clinical evaluation also may have biased the findings slightly. Because the study was cross-sectional, cause and effect could not be established.

In the survey described by this study, which had a response rate of 63% (n=31,581), female heads of household 18 years of age and older were asked to evaluate their sexual function using the female short-form Changes in Sexual Functioning Questionnaire and the Female Sexual Distress Scale. The prevalence of any sexual problem was 44.2%, with the most common problems being:

• low desire (38.7%)
  
• low arousal (26.1%)
  
• orgasmic dysfunction (20.5%).
  

Dyspareunia was not assessed in this survey because a physical examination is required.

How the findings broke down by age

The prevalence of sexual problems increased with age:

• Among women 18 to 44 years old, 27.2% reported a problem with desire, arousal, orgasm, or a combination of the three.
  
• Among women 45 to 64 years old, the prevalence was 44.6%.
  
• Among women 65 years and older, the prevalence of one or more of these problems was 80.1%.
  

• highest (14.8%) among respondents 45 to 64 years old
  
• lowest (8.9%) among women 65 years or older
  
• intermediate (10.8%) in women 18 to 44 years old.
  

Medical problems associated with a higher prevalence of distressing problems of desire were depression, thyroid dysfunction, anxiety, and urinary incontinence.

Strengths and weaknesses of the study

The large sample size, wide age range, and use of verified instruments to measure sexual problems and related distress were all strengths of this study.

However, to increase response rates to “sensitive” questions, the authors used a research panel that was not randomly chosen. As a result, respondents may have been more health-conscious and self-aware than otherwise would have been the case; they also may have had more time to answer mailed questionnaires.

The fact that sexual problems and distress were self-reported without clinical evaluation also may have biased the findings slightly. Because the study was cross-sectional, cause and effect could not be established.

In the survey described by this study, which had a response rate of 63% (n=31,581), female heads of household 18 years of age and older were asked to evaluate their sexual function using the female short-form Changes in Sexual Functioning Questionnaire and the Female Sexual Distress Scale. The prevalence of any sexual problem was 44.2%, with the most common problems being:

• low desire (38.7%)
  
• low arousal (26.1%)
  
• orgasmic dysfunction (20.5%).
  

Dyspareunia was not assessed in this survey because a physical examination is required.

How the findings broke down by age

The prevalence of sexual problems increased with age:

• Among women 18 to 44 years old, 27.2% reported a problem with desire, arousal, orgasm, or a combination of the three.
  
• Among women 45 to 64 years old, the prevalence was 44.6%.
  
• Among women 65 years and older, the prevalence of one or more of these problems was 80.1%.
  

• highest (14.8%) among respondents 45 to 64 years old
  
• lowest (8.9%) among women 65 years or older
  
• intermediate (10.8%) in women 18 to 44 years old.
  

Medical problems associated with a higher prevalence of distressing problems of desire were depression, thyroid dysfunction, anxiety, and urinary incontinence.

Strengths and weaknesses of the study

The large sample size, wide age range, and use of verified instruments to measure sexual problems and related distress were all strengths of this study.

However, to increase response rates to “sensitive” questions, the authors used a research panel that was not randomly chosen. As a result, respondents may have been more health-conscious and self-aware than otherwise would have been the case; they also may have had more time to answer mailed questionnaires.

The fact that sexual problems and distress were self-reported without clinical evaluation also may have biased the findings slightly. Because the study was cross-sectional, cause and effect could not be established.