Non-absorbable synthetic surgical meshes used to repair pelvic organ prolapse (POP) offer no significant benefits and expose female patients to serious complications and harm, claims the consumer advocacy group Public Citizen.
It has petitioned the U.S. Food and Drug Administration to recall and ban the marketing of all non-absorbable mesh products designed and labeled for transvaginal repair of POP.
The group has also called for future versions of these meshes to be labeled as Class III medical devices, which must undergo stringent testing in humans before gaining approval for widespread clinical use.
The requests follow a safety statement released by the FDA in July that said mesh complications during transvaginal POP repair are "not rare." It also said it is "not clear" that performing the procedure with mesh is any more effective than traditional surgery without mesh, and that mesh use may expose patients to greater risk.
From 2008 to 2010, the FDA reportedly received more than 1,500 reports of complications associated with surgical meshes used during POP procedures, including vaginal mesh erosion, infection, pain and incontinence. In some cases, says Public Citizen, complications included vaginal scarring and mesh erosion, which led to patient discomfort and pain and a significant decrease in patient quality of life.
L. Lewis Wall, MD, a professor of obstetrics and gynecology and a bioethicist at Washington University in St. Louis, Mo., and Daniel S. Elliott, MD, a urologic surgeon specializing in female urology at the Mayo Clinic in Rochester, Minn., are co-petitioners.
"There is substantial evidence that such mesh is neither safer nor more effective than traditional native tissue repair operations for these conditions," notes Dr. Wall.
Dr. Elliot says he has stopped using transvaginal mesh kits for POP repair. "Patients have suffered needlessly," he explains. "The standard POP repair without mesh, in properly trained hands, is easy, fast and effective, avoiding the unique complications associated with non-absorbable mesh kits."
Daniel Cook
