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FDA Moves To Require Premarket Approval For Vaginal Mesh

Law360, New York (April 29, 2014, 12:56 PM EDT) -- The U.S. Food and Drug Administration on Tuesday issued two proposed orders that would reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a high-risk device and would require manufacturers to apply for premarket approval with the agency.

The two orders would address the health risks associated with the mesh, which is used to treat women whose internal structures become so weak or broken that their organs drop from their normal position and bulge into the vagina. Currently, the surgical mesh is classified as a moderate-risk device, according to the agency.

"The FDA has identified clear risks associated with...

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