Things have been heating up for manufacturers of controversial synthetic surgical mesh used for pelvic organ prolapse (POP) repair in women. The U.S. Food and Drug Administration (FDA) is now proposing the medical device should undergo a premarket review process which involves a much more stringent review including clinical studies looking for safety and efficacy prior to approval.
Presently, the medical devices are considered Class II and of moderate risk. Clinical studies are not required while the devices are approved only for marketing under the 510 (k) process where manufacturers claim it is “substantially equivalent” to a product already on the market bypassing safety and efficacy assurances.
According to an FDA Executive Summary report released Wednesday, August 31, on the FDA website, the agency said, “Because of the outstanding safety and effectiveness concerns for mesh products indicated for vaginal POP repair and an inability to adequately address these concerns via the 510(k) pathway, the FDA believes that 510(k) premarket notification is no longer an appropriate premarket pathway for devices indicated for vaginal POP repair. Therefore the FDA believes that reclassification of these devices to Class III and evaluation via the PMA process is warranted.”
Side effects of surgical mesh include immobility and pain, infection, mesh erosion and a return of pelvic organ prolapse where a woman’s organs fall because of weak muscles and connective tissue. Repeated surgeries are often needed to try and remove the mesh, which is extremely difficult.
The FDA reports it received 1,503 reports of adverse side effects associated with synthetic plastic surgical mesh for pelvic organ repair, which is five times the number from 2005 to 2007.
Synthetic mesh, which is also used to treat incontinence, would not have to be reclassified from Class II to Class III, or most high risk, even though it is the same mesh.
An expert FDA panel will gather September 8 and 9 to consider reclassifying the medical device. According to the FDA, about 75,000 pelvic surgeries were performed with synthetic mesh last year.
The agency cleared 85 surgical mesh products to treat pelvic organ prolapse from 1992 to 2010, according to Bloomberg.
