FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

FDA Shuts Down Sales of Surgical Mesh Products

April 18, 2019
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The FDA ordered two manufacturers of surgical mesh products for transvaginal repair of pelvic organ prolapse (POP) to cease selling the devices immediately.

The agency cited concerns over surgical mesh’s safety and effectiveness, noting that evidence has not been produced in premarket applications to show mesh works better than meshless surgery.

Two manufacturers selling three surgical mesh products—Boston Scientific and Coloplast—did not conduct a sufficient assessment of their devices’ long-term safety, nor did they show a satisfactory long-term benefit for their products compared to transvaginal surgical tissue repair without the use of mesh, the agency said.

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