The Food and Drug Administration is tightening regulations for surgical mesh products used to repair a condition known as pelvic organ prolapse, following years of scrutiny by the U.S. regulator and many lawsuits by women who allege they have suffered harm from such products.
The products will be reclassified as high-risk rather than moderate-risk medical devices when used in procedures that go through the vagina to repair organ prolapse. The FDA will require all manufacturers to submit data to support the effectiveness and safety of such devices before they are allowed on the market.
