Endo International has agreed to pay $830 million to resolve legal claims in transvaginal mesh litigation against its subsidiary American Medical Systems without admitting liability or fault. Approximately 22,000 lawsuits have been filed by women who allege they have suffered injuries from the mesh devices such as painful sex, bleeding, and other complications. Reuters reports that the agreement is still subject to several conditions, including confirmation of medical records from plaintiffs.
According to an FDA News Release, on April 29, 2014, the US Food and Drug Administration issued two proposed orders to address the health risk associated with surgical mesh used for transvaginal repair of pelvic organ prolapse. If finalized, surgical mesh would be reclassified from a moderate-risk device to a high-risk device and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.