FDA Reveals Use of Pelvic Mesh Devices May Be More Risky than Beneficial
Bladder mesh products commonly implanted in women to help ease urinary incontinence, and treat pelvic organ prolapse (POP) or similar pelvic disorders may be potentially more damaging than beneficial, according to a 2011 Safety Communication issued by the United States Food and Drug Administration. |Vaginal mesh products frequently utilized in surgeries to alleviate urinary incontinence and pelvic organ organ prolapse (POP) or similar pelvic problems may yield more risks than benefits to women, according to a 2011 Safety Communication released by the United States Food and Drug Administration. Women who received a bladder mesh inserted transvaginally for POP repair may be left susceptible to debilitating pain, bleeding, and infection, as opposed to patients who went through more conservative treatments, the agency added.
Over 500,000 number of women undergo a POP repair surgery every year, however, not all operating procedures involve the use of mesh devices, according to national statistics reports. About 75,000 women had prolapse surgery with mesh inserted through the vagina two years ago, and more than 200,000 women had the procedure for incontinence.
While the Safety Communication issued in July 2011 only goes for mesh devices used as treatment to POP, a reviewing panel of the FDA is also looking at the evaluate the safety and effectiveness of these medical devices when used for stress urinary incontinence (SUI) repair. It has been reported by performing surgeons that surgical procedures for SUI involve less use of mesh, possibly contributing to lesser reports of side effects, compared to bladder mesh implants used for POP repair.
Between 2005 through 2007, the number of adverse event reports related to vaginal or bladder mesh devices for POP and SUI repair, as has been received by the FDA, has reportedly reached over 1,000. More than 2,000 adverse event reports has also been received by the FDA since 2008, all related to complications at some point after surgery, with more than 1,000 reports related to transvaginal placement of mesh implants for POP, and nearly 1,400 reports connected to SUI repair.
Despite the high incidence of injury, the withdrawal of these products from the market may still be out of the question, according to some medical device scientists, explaining that these devices may still be of benefit to certain patients. The Obstetrics & Gynecology Devices Advisory Committee by the FDA, however, expressed support to the reclassification of surgical mesh devices from moderate-risk devices (Class II) to high-risk devices (Class III). In a two-day meeting, the 15-member panel of experts also appeared to be in favor of recommending a tougher call toward the pre-market testing of vaginal or bladder mesh products. Patients who are suffering from an ongoing pain and injury allegedly related to mesh devices seek out for these products to be prohibited in all but the most compromising cases.
Sources:
- foxnews.com/health/2011/07/14/fda-pelvic-mesh-for-women-riskier-than-thought/
- webmd.com/urinary-incontinence-oab/news/20110713/fda-surgical-mesh-for-pelvic-prolapse-risky-unnecessary
- fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
- medscape.com/viewarticle/749468
