FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women
TUESDAY, April 16, 2019 -- The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products.
"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," Jeffrey Shuren, M.D., director of the FDA Center for Devices and Radiological Health, said in a statement. "That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."
Simply put, the remaining makers of the mesh devices -- Boston Scientific and Coloplast -- failed to prove the long-term safety or benefit of their devices, the FDA said in a news release. The companies will have 10 days to submit plans to withdraw these products from the market.
The FDA has issued repeated warnings about the risks associated with using transvaginal mesh for pelvic organ prolapse repair. Women who have had the procedure should continue with routine checkups. No additional measures are needed if they are satisfied with their surgery and do not have complications or symptoms. Those who do have complications or symptoms -- such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex -- should see their health care provider, the agency added. They should also inform their health care provider if they have surgical mesh, especially if they are scheduled for another surgery or medical procedure.
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Posted: April 2019