FDA orders surgical mesh for pelvic procedure off the market

The Food and Drug Administration today ordered manufacturers to immediately stop selling and distributing surgical mesh products for transvaginal repair of pelvic organ prolapse in the U.S. Women planning to have the procedure should discuss other treatment options with their doctors, and women who have had it should continue their routine follow-up care and notify their provider if they have complications or symptoms, FDA said. The agency reclassified the mesh devices as high risk in 2016, and required the two manufacturers — Boston Scientific and Coloplast — to submit premarket approval applications. “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair [pelvic organ prolapse],” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”