The U.S. Food and Drug Administration (FDA) continues to tighten its stance on surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). On April 29th the FDA issued two proposed orders that, if approved, could put a stop to the manufacturing of faulty, untested mesh implants such as Johnson & Johnson’s TVT-O pelvic mesh sling. If the new regulations pass, surgical mesh, as well as urogynecologic surgical mesh instrumentation (used during implantation) would be reclassified from a moderate-risk device (Class II) to a high-risk device (Class III) and would require the submission of a premarket approval application (PMA) to evaluate the risks and efficacy of the products. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health.
THE 510(K) APPROVAL PROCESS