FDA Orders Surgical Mesh To Treat POP Be Removed From Market

FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16). The companies, FDA says, have not demonstrated a reasonable assurance of safety and effectiveness for the mesh, and they now have 10 days to submit plans for how they will withdraw their products from the market. The announcement comes five months after FDA device center chief Jeff Shuren said...