FDA to Determine Future of Transvaginal Mesh

After warning about the dangers and risks of using Transvaginal Mesh in 2008, and then making that warning stronger in July of 2011, the FDA plans to meet next week to determine the future of all vaginal mesh products and whether they should be classified as high risk.  The FDA will convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee on September 8-9, 2011.  The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh.  There are many consumer groups across the country asking that manufacturers recall all vaginal mesh products.

FDA staff has concluded that the mesh products may expose patients to greater risk than other more traditional repairs.  They also indicated that they had not seen conclusive evidence of improved outcomes with the mesh.  The primary manufacturers of this mesh are Johnson and Johnson, Bard, Mentor, American Medical Systems and Boston Scientific.  It has been reported that during last year alone, three hundred thousand women had surgery to repair pelvic organ prolapse.

Many people will be watching next week to see what the FDA does with these devices.