FDA orders pelvic mesh removed from market

The Food and Drug Administration on Tuesday ordered manufacturers of surgical mesh used for certain pelvic procedures to immediately halt sales of the products.

The agency said the companies, Boston Scientific and Coloplast, had not demonstrated “a reasonable assurance” of safety and effectiveness for the devices. The companies will have 10 days to submit their plans to the FDA for withdrawing the items from the market.

The mesh is used for the transvaginal repair of a condition called pelvic organ prolapse, which occurs when the muscles and tissues supporting the uterus, bladder or rectum become weak or loose. That can allow the organs to drop or press into the vagina.

The FDA move is the latest in steps the agency has taken in recent years as rising safety concerns — and reports of adverse events — have emerged involving the devices.

In 2016, the FDA reclassified the products as high-risk devices and required manufacturers to obtain approval to continue to market them.

“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, director of the agency’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.”

Thousands of women have sued manufacturers of the mesh, saying they have been injured by the products.

Boston Scientific said it was “deeply disappointed” by the agency’s decision, adding that “patient safety is always our highest priority.” The company said the FDA action will “severely limit” options for women seeking treatment for pelvic organ prolapse.

The FDA said surgeons began using surgical mesh to repair abdominal hernias beginning in the 1950s. In 2002, the first mesh device for transvaginal repair of pelvic organ prolapse was cleared by the agency.

About 1 in 8 women have surgery to repair the condition, the agency said, and a subset of the procedures use the mesh. The FDA added that the proportion of women undergoing the mesh procedures decreased after the agency began issuing warnings.

The FDA said the women who have had transvaginal mesh used for their condition don’t need to take any action if they are satisfied with their surgeries and don’t have any symptoms. But they should notify their physicians if they have any issues, the agency said.