Study Says FDA Waited Too Long To Ban Pelvic Mesh For POP Repairs
Almost 20% of POP repair mesh patients with follow-ups face complications
Roughly 18.5% of patients who received reinterventions to fix mesh implants for pelvic organ prolapse (POP) repair experienced complications they will likely endure for the rest of their lives, and they also face a 2.5% higher rate of further surgeries than non-mesh patients, says a recent 54,194-woman study detailed in Obstetrics & Gynecology. The study authors lay out a case that the US FDA should have forced removal of mesh from the market sooner.
You may also be interested in...
FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan
Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.
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.
Existing manufacturers of transvaginal surgical mesh for pelvic organ prolapse procedures, including Boston Scientific Corp., ACell Inc., Coloplast AS, and American Medical Systems Holdings Inc., will have to file for PMAs in 30 months to keep their mesh products on the markets, says FDA in a Jan. 4 final order.