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FDA May Reclassify Surgical Mesh–Is It High Risk Now?

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.


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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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