FDA cites risks of implant used to strengthen vaginal tissue
After an increase in reported complications, the Food and Drug Administration on Wednesday released an advisory saying a surgical mesh implanted to strengthen vaginal tissue can become weakened, especially after childbirth.
In its report, which updates an earlier advisory, the FDA says a review of industry literature and patient reports has shown little evidence that the device improves pelvic organ prolapse, in which a woman’s uterus, bladder or rectum can slip out of place.
The mesh can be implanted vaginally or abdominally. The review found that vaginal implantation exposes patients to a number of serious risks.
The FDA will hold a meeting of outside experts in September to solicit recommendations on how to proceed. The options could include calling for clinical trials and reclassifying the implants to require formal approval applications, said Dr. William Maisel, chief scientist at the agency’s medical devices office.
Manufacturers estimate that 100,000 women were treated for pelvic organ prolapse with surgical mesh last year, with 75,000 of those implanted vaginally.
The agency first cautioned doctors of the risks associated with the mesh in 2008, citing more than 1,000 reports of complications between 2005 and 2007. The FDA recommended that doctors receive specialized training and warned patients of pain and urinary problems, complications that were serious but rare.
Since then, complaints of serious problems associated with prolapse repair have jumped fivefold, and include erosion, when the skin breaks and the device protrudes, and contraction of the mesh that leads to vaginal shrinkage. The agency no longer believes these problems are rare.
The FDA decided it was not necessary to remove the products from the market, Maisel said. “However, we do think it’s important that patients and healthcare providers have the information we have about the adverse events.”
Patient advocates say the agency didn’t go far enough.
“The troublesome issue is how is that going to affect what actually happens to patients as long as this product is still on the market and widely available,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families.