PMA Mandate Set For Pelvic Organ Prolapse Transvaginal Mesh
This article was originally published in The Gray Sheet
FDA issued final orders up-classifying surgical mesh for transvaginal repair of pelvic organ prolapse from class II to class III and calling for PMA standards, including clinical trial, animal studies, and materials testing data from new and existing manufacturers.
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.
Endo International plans to shutter its Astora Women's Health business unit – formerly part of American Medical Systems – this month due to ongoing legal concerns tied to the company’s vaginal mesh products. What’s unclear is what this means for the company’s investigational fecal incontinence treatment, which received unanimous support from an FDA advisory panel just days before the shutdown was announced.