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One in five women undergoes urogynecologic surgery

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High number is not surprising

Dr. David M. Jaspan comments: Direct to consumer advertising has enabled more women to feel comfortable discussing incontinence with their health care providers, which is great. Industry had inundated general ob.gyn. offices with the opportunity to attend short courses to learn "mesh procedures," which may not have been great. Therefore, I am not surprised that the numbers of women with private insurance undergoing urogynecologic surgery are so high.

These advanced procedures should be undertaken by those surgeons with sufficient training and experience to properly counsel women about the risk and benefit of a native tissue repair, compared with a graft placement. In addition, surgeons should have a volume of experience and training that qualifies them to provide this detailed counseling and should perform an appropriate preoperative evaluation to determine the absolute need for a procedure. More procedures may have brought more risk to women.

I applaud the American College of Obstetricians and Gynecologists for the 2011 ACOG Committee Opinion #513, which says, "Surgeons performing complex pelvic floor reconstructive surgery should have adequate experience and training in native tissue repairs as well as repairs using mesh augmentation specific to each device, should have a thorough understanding of pelvic anatomy, and should be able to counsel patients regarding the risk/benefit ratio on the use of mesh compared with native tissue repairs" (Obstet. Gynecol. 2011;118:1459-64).

In its 2011 Safety Communication, the Food and Drug Administration said that transvaginal placement of surgical mesh for POP is of "continuing serious concern." In the document, the FDA restated its 2008 recommendation that health care providers "inform patients about the potential for serious complications and the effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh; and provide a copy of the patient labeling from the surgical mesh manufacturer if available."

The FDA also made several new recommendations for health care providers in its report:

  • Surgeons should recognize that, in most cases, POP can be treated successfully without mesh, thus avoiding the risk of mesh-related complications.
  • Surgeons should choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and nonsurgical alternatives.
  • Removal of mesh may involve multiple surgical procedures and significantly impair the patient's quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.

Patient counseling needs to include discussion of alternative native tissue repair and the fact that synthetic mesh is permanent, according to ACOG. Other issues to discuss include that vaginal bleeding, pain, and dyspareunia may be related to vaginal mesh; Patients reporting such symptoms should undergo a thorough vaginal exam, including an exam under anesthesia if necessary.

Dr. David M. Jaspan is chairman of ob.gyn. for the Einstein Health Care Network in Philadelphia. He was asked to comment on Dr. Wu's study. Dr. Jaspan said that he had no financial disclosures.

Remember to ask about pelvic floor issues

Dr. Meadow Maze Good comments: This is a well done and important study that highlights the magnitude of pelvic floor disorders in women. Previous studies indicate that women delay or do not seek care for pelvic floor disorders and incorrectly think that these problems are a normal result of aging.

These data presented at the American Urogynecologic Society meeting by Dr. Wu and her colleagues reinforce the need for increased public awareness and education regarding pelvic floor disorders as well as available treatment options, including nonsurgical and surgical options. Additionally, this study points out that the physicians treating women of all ages including the primary care provider (family practice physicians and obstetrician/gynecologists) should query women about possible pelvic floor symptoms, including incontinence, prolapse, and sexual function.

It is especially important for the ob.gyn. to ask their patient about these symptoms if there is planning underway for a hysterectomy for other causes. This is an exciting time for the newly board-certifiable field of female pelvic medicine and reconstructive surgery. As the aging population of women with prolapse and incontinence increases, fellowship programs are graduating physicians knowledgeable in this specific field who are dedicated to taking care of women with these treatable conditions.

Meadow Maze Good, D.O., is a fellow in female pelvic medicine and reconstructive surgery at the University of Texas Southwestern Medical Center, Dallas. Dr. Good, who is also the chair of the Junior Fellow Congress Advisory Council of the American Congress of Obstetricians and Gynecologists, was asked to comment on Dr. Wu's study. She said she had no relevant financial disclosures.


 

AT THE AUGS ANNUAL MEETING

LAS VEGAS – Among women with private health insurance in this country, the lifetime risk of surgery for either stress urinary incontinence or pelvic organ prolapse stands at 20.2%, results from a large analysis demonstrated.

"This means that one out of every five women in the United States will undergo a urogynecologic procedure by the age of 80," Dr. Jennifer M. Wu said at the annual meeting of the American Urogynecologic Society. "This high rate highlights the public health burden of pelvic floor disorders, exposes the need for improved prevention strategies, and underscores the importance of effective long-term surgical interventions."

A commonly referenced statistic is that the lifetime risk of surgery for either stress urinary incontinence (SUI) or pelvic organ prolapse (POP) is 11%, but this was based on a study of 395 patients who underwent surgery in 1995 in the Northwest (Obstet. Gynecol. 1997;89:501-6).

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Since 1995, several factors may have increased this risk. These include "the integration of midurethral slings and vaginal mesh prolapse procedures, regional differences in surgery rates, and the greater number of elderly women," explained Dr. Wu of the department of obstetrics and gynecology and the Center for Women’s Health Research at the University of North Carolina at Chapel Hill. "Thus, the objective of our study was to estimate the cumulative risk of SUI or POP surgery over a woman’s lifetime until the age of 80."

The researchers used the Market Scan Commercial Claims and Encounters database with the Medicare Supplemental, which contains de-identified inpatient and outpatient claims data from about 100 employer-based insurance plans in the United States. They included women aged 18 years and older and identified any SUI or POP surgery performed between 2007 and 2011 based on CPT codes. This resulted in a study population of 51.8 million women. Of these, 311,070 underwent surgery for either SUI or POP.

To estimate age-specific incidence rates for each age between 18 and 80 years, Dr. Wu and her associates multiplied age-specific prevalence rates by the proportion of cases that were incident. To estimate the proportion of all procedures that were repeat surgeries, they evaluated women who had a SUI or POP surgery in 2011 and "looked back" 5 years to identify prior surgeries. Finally, they used Monte Carlo simulations to determine the cumulative lifetime risk of either incontinence or prolapse surgery with 95% confidence intervals.

Dr. Wu reported that the cumulative lifetime risk of either SUI or POP surgery was 20.2% (95% CI, 19.2%-21.1%). The cumulative lifetime risk of SUI was 14.5% (95% CI, 13.4%-15.5%), and the risk of POP surgery was 13.7% (95% CI, 12.6%-14.8%). The cumulative lifetime risk for SUI or POP surgery increased with age in a stepwise fashion, from 11.4% by age 60 years to 15.9% by age 70 and 20.2% by age 80, she noted.

To place the risk of any primary surgery for SUI or POP in perspective, Dr. Wu drew a comparison with the lifetime risk estimates for colon cancer (4.8%), lung cancer (6.3%), breast cancer (14.8%), and any type of cancer (41.3%). "Granted, incontinence and prolapse are not life-threatening conditions, but this 20% risk highlights how common surgeries are for pelvic floor disorders, despite the fact that they’re widely underrecognized," she noted.

She acknowledged certain limitations of the study, including the fact that she and her associates were unable to review actual medical records to confirm the rate of prior surgeries. "In addition, we assumed a closed cohort and no competing risks such that all women live until the age of 80," she said. "Also, these results reflect women with private insurance and may not be generalizable to those who are uninsured or underinsured."

Dr. Wu disclosed that she is a consultant for Procter & Gamble.

dbrunk@frontlinemedcom.com

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