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J&J-Led Vaginal Mesh Group Says FDA Should Require More Studies

Johnson & Johnson and rival makers of transvaginal meshes told Food and Drug Administration advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks.

Manufacturers including J&J and Endo Pharmaceuticals Holdings Inc. proposed that new versions of the devices require clinical trials before they can be sold and existing implants be tracked for safety. That stopped short of a recommendation from FDA staff last month that the mesh be reclassified as high risk and face even more regulatory controls.