The FDA is considering reclassifying surgical mesh used in common procedures as a high-risk device. Plastic mesh used to treat pelvic organ prolapse in gynecologic surgery has not received much public attention, but a number of women who have undergone the surgery have experienced serious complications.
FDA’s Obstetrics and Gynecology Devices panel recommended the reclassification after reviewing the records of those complications. Women considering such surgery for prolapse or stress incontinence should ask about the kind of mesh being used. Having a high-risk classification on mesh would make future approvals of mesh more rigorous and require evidence that the mesh is safe and effective. It may also spur the development of safer devices for such surgeries.
