The findings of a new transvaginal mesh safety study published May 15 in the Journal of the American Medical Association (JAMA) support previous studies and U.S. Food and Drug Administration (FDA) warnings that mesh devices used to correct pelvic organ prolapse (POP) pose a higher risk of injury than conventional surgical repairs.
The study’s authors also say that the medical community knows little about the special safety risks and long-term effectiveness of the devices, even though more than 225,000 women are implanted with them every year in the United States. The statement underscores the claim of many plaintiffs and other critics of the devices, who allege the mesh products weren’t adequately tested before they entered the market.
The study, chaired by Ingrid Nygaard, MD, of University of Utah Health Care, looked at outcomes in patients up to 7 years after abdominal sacrocolpopexy, a form of surgery using a polypropylene mesh sling to shore up the pelvic organs and hold them in place.
The study’s researchers found that the rate of mesh erosion was 10.5 percent after 7 years. The study’s authors concluded that “abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion.”
Erosion is a key safety concern in using transvaginal mesh kits to repair POP and stress urinary continence (SUI). In July 2011, the FDA warned “that serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and calculated the risk of complications to be about 10 percent.
Complications associated with transvaginal mesh erosion include infection; bowel, bladder, and blood vessel perforations; intense pain; inability to engage in sexual intercourse; narrowing and scarring of the vaginal wall; and heightened risk for future surgeries.
One of the most troubling problems for women experiencing painful mesh complications is the difficulty, and in some cases the inability, of surgeons to remove the defective mesh from the body. The mesh is designed to become incorporated with the body’s natural tissue, a process that occurs in a short period of time. Many women seeking to have the mesh removed must undergo multiple surgeries.
The FDA strengthened its original 2008 warning after finding a fivefold increase in the number of deaths, injuries, and malfunctions linked to transvaginal mesh devices. FDA regulators then ordered 33 manufacturers of the mesh products to conduct three years of safety and efficacy trials – testing that wasn’t conducted before the FDA granted them approval through its 510k fast-track process.