FDA orders pelvic mesh makers to stop sales

The FDA has ordered two manufacturers to stop selling a type of surgical mesh used to repair pelvic conditions in women, after thousands of lawsuits claiming the device caused complications including bleeding and infection. The device is used in place of stitches for surgeries that repair pelvic organ prolapse, in which the bladder or reproductive organs fall out of place and cause other problems. In 2016, the FDA classified these devices as “high-risk,” but said yesterday that the two remaining manufacturers — Boston Scientific and Denmark-based Coloplast — didn’t prove that the mesh could be used safely on a long-term basis. The companies have 10 days to submit their plans to withdraw the devices from the market.