An FDA advisory committee recommended Feb. 12 that US FDA take up to three years to assess the benefits and risks of pelvic mesh, and that product labels call for experienced surgeons only for implantations, if any new mesh products for transvaginal repair of pelvic organ prolapse (POP) are approved. Meanwhile, public-health groups said ongoing PMA applications for current mesh products should be rejected, given the large number of reoperations and adverse events associated with the use of mesh.
US FDA’s Obstetrics and Gynecology Devices Advisory Committee cautioned the agency to very carefully consider risks and benefits prior to agency approval of any new pelvic mesh products at its Feb. 12 meeting on mesh for transvaginal repair of pelvic organ prolapse (POP).
The advisory committee met in Gaithersburg, Md., during the daylong session, which included one-and-a-half hours of public testimony from women implanted with mesh who described experiencing extraordinary pain, bleeding and...