FDA Warns That Transvaginal Mesh Use May Increase Risk of Injury
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The U.S. Food & Drug Administration (FDA) is warning healthcare providers and patients that using transvaginal mesh to repair pelvic organ prolapse (POP) may increase the risk of injury. The latest warning follows a string of others – which is likely making transvaginal mesh manufacturers such as C.R. Bard, Gynecare, Tyco Covidien, Mentor OB, Ethicon, AMS and Boston Scientific take notice.
FDA Says Other Mesh Surgical Options May Be Safer
The FDA warning dated July 13th, 2011 states that evidence gathered by the administration does not show that using transvaginal mesh products to repair POP are any safer than the numerous other procedures available. The FDA reviewed scientific literature published between 1996 and 2010 which compared mesh surgeries to non-mesh surgeries and found that patients who had undergone transvaginal mesh POP repair were exposed to greater risks than those treated with stitches alone. It's an issue which concerns thousands of women who undergo POP repairs every year.
100,000 POP Repairs Performed In 2010
Although it may seem staggering, the FDA reports that there were at least 100,000 POP repairs performed in 2010 – about 75 percent of those involving transvaginal procedures. Unfortunately, a greater and greater number of those procedures are resulting in injuries. The FDA says that it received over 1,500 adverse event reports (AER) from 2008 to 2010 – a number nearly five times greater than reports received in the three years prior.
While those AERs range in severity, the FDA says that the most frequently reported surgical mesh side effects from POP repair surgeries include:
- mesh becoming exposed or protruding out of the vaginal tissue (erosion)
- organ perforation
- pain during sexual intercourse
- urinary problems
Some of the FDA's reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh altogether. The FDA is recommending that patients considering transvaginal mesh surgery:
- ask their doctors about all possible POP treatments including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh
- continue with routine check-ups and follow-up care after surgery and notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex)
The FDA is also recommending that patients who have already had POP surgery, but don’t know if the surgeon used mesh, should find out whether mesh was used during their next scheduled doctor visit.
Surgical Mesh Lawsuits Continue; FDA Calling In Outside Experts
Surgical mesh lawsuits against transvaginal mesh manufacturers alleging that companies failed to conduct enough clinical trials and failed to warn consumers about the known dangers of surgical mesh products continue – with thousands pending in courts throughout the nation. The issue has become so heated that the FDA is calling in an outside panel of experts in obstetrics and gynecology to discuss the safety and effectiveness of surgical mesh. The panel will meet in September of 2011 to discuss the risks involved in transvaginal POP repair and decide if further clinical studies may be needed.