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Is pelvic organ prolapse surgery with mesh safe?

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More than 3 million women in the US suffer from pelvic organ prolapse, which is characterized by the bulging of pelvic organs into—and even beyond—the vagina. In addition, the number of women suffering from this condition is expected to increase by 46% by the year 2050. A procedure known as abdominal sacrocolpopexy using synthetic mesh has been reported to have high success rates and many gynecologists consider it to be better than native tissue repair for some women. In addition, in recent years, many gynecologists have been performing a minimally invasive transvaginal prolapse repair using synthetic mesh and biologic grafts; the goal is to replicate the surgical outcomes obtained with the more invasive sacrocolpopexy procedure. Studies evaluating transvaginal prolapse repair using synthetic mesh have reported an improvement in short-term objective outcomes, compared to the abdominal procedure; however, implant-related complications have prompted the Food and Drug Administration (FDA) to release several public notifications that question the safety and effectiveness of transvaginal mesh for treatment of pelvic organ prolapse.

A study that evaluated adverse events associated with pelvic organ prolapse surgeries that use implants was conducted by researchers in the departments of obstetrics and gynecology at Kaiser Permanente, Downey, San Diego, and Roseville, California, and Honolulu, Hawaii, as well as the Division of Epidemiology, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland. They published their findings in the December 2013 edition of the journal Obstetrics and Gynecology.

The researchers evaluated biologic grafts and permanent mesh used for pelvic organ prolapse surgery in regard to complications and success rates. In addition, they evaluated complications that occurred during and immediately following the surgery. The reviewed the hospital records of women who were treated at Kaiser Permanente Southern California, Northern California, and Hawaii. The study reviewed women who underwent pelvic organ prolapse surgeries with biologic grafts and permanent mesh between September 2008 and May 2010. The records were reviewed for postoperative adverse events.

During the 21-month period, the investigators reviewed the medical records of 1,282 women (average age: 62 years) who had delivered an average of three children, and had an average body mass index (BMI) of 28. The women underwent prolapse surgery with 1,484 implants; the average follow-up was 358 days. Vaginal exposures (graft material breaking through the vaginal wall) occurred more often with permanent mesh (53/847; 6%) than biologic grafts (10/637; 1.6%). Resolution of vaginal exposure was obtained after the first treatment in 24 of 63 (38%) women; however 39 of 63 (62%) required multiple treatments. In 20 of 63 (32%) exposures, surgical excision was performed. They also found that permanent mesh exposures were more likely to require surgical excision (20/53; 38%) than biologic graft exposures (zero of 10).

The study authors concluded that vaginal exposure occurred more frequently with permanent mesh than biologic graft; furthermore, it may require multiple treatments, and occasionally require surgical excision.

Take home message:
If you suffer from pelvic organ prolapse, locate a gynecologic surgeon who has expertise with the procedure. It is also appropriate to ask how many procedures he or she has performed and the complication rate. Information can also be obtained on a physician via an Internet search. In general, results of surgery are better if performed by a surgeon who is well trained in the procedure and has performed at least 50 (the more the better).

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