US FDA Advisory Committee Recommends 3-Year Benefit-Risk Reviews For Pelvic Mesh
Executive Summary
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.