MASSDEVICE ON CALL — An FDA advisory panel will meet today to discuss the possibility of putting transvaginal mesh products into a higher risk category, effectively pulling existing devices off the market until further testing can prove safety and efficacy.
The latest report from the watchdog agency’s Obstetrics & Gynecology Devices Panel recommended revoking 510(k) clearance for the devices, which are used to treat pelvic organ prolapse, over rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.
The recommendations followed last month’s warnings, which in turn updated 2008 reports that addressed concerns about adverse events associated with the transvaginal placement of the mesh.
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.
"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications."
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