Manufacturers Ordered to Stop Selling Class III Transvaginal Mesh Devices for POP Repair
April 17, 2019
WASHINGTON, D.C. — The Food and Drug Administration has ordered all manufacturers of class III transvaginal mesh devices intended to repair pelvic organ prolapse to stop selling and distributing the devices immediately, according to the agency’s website.
In the April 16 announcement, the FDA explained that the device makers, Boston Scientific and Coloplast, have not shown that the mesh products are safe and effective, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016.
The FDA gave the companies 10 days to submit their plans to withdraw …