FDA Proposes to Reclassify Mesh for Transvaginal Surgery
FDA has identified risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse
TUESDAY, April 29, 2014 (HealthDay News) -- Surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) may get stricter oversight in the future due to safety concerns, the U.S. Food and Drug Administration announced Tuesday.
The FDA has issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse. If finalized, the orders would reclassify surgical mesh for transvaginal POP from its "moderate" to "high" risk category. The agency will also require manufacturers to submit pre-market approval applications to the FDA, so it can better evaluate a device's safety and effectiveness beforehand.
The new rules apply to surgical placement of the mesh devices in transvaginal repair of pelvic organ prolapse. The proposals, which will be open for comment for 90 days, do not apply to other uses of surgical mesh, the FDA said.
"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, said in an agency news release. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."