The FDA formally rejected a 2011 citizen petition calling for the ban of all nonabsorbable surgical mesh products for transvaginal repair of pelvic organ prolapse in a letter to Dr. Michael Carome, then deputy director of Public Citizen's Health Research Group, that was released this week, according to Mass Device. The agency expressed sympathy and agreement with the petitioner's concerns, but did not agree with the proposed remedy.
The agency said it worries that the products pose safety risks to women and that it is taking steps to counter those concerns, but said it does not believe a ban and total recall is warranted, saying, "There is not sufficient evidence at this time to support a finding that there is a reasonable probability that all nonabsorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP would cause serious, adverse health consequences or death."
The letter reminds Carmone that the FDA issued a proposed reclassification order in the Federal Register on May 1 that would upgrade the products to Class III, meaning they would require a PMA for commercialization. It also pointed to safety communications and increased post-market scrutiny as steps it has taken in light of worries about side effects like vaginal scarring and shrinkage, as well as pelvic pain.
In addition, the agency pointed to the potential benefits: "Based on our assessment of the published literature, input from clinical organizations, and the Panel's recommendations, we believe there are potential benefits from surgical mesh used for transvaginal repair of POP."
The response comes as calls for banning another device mount. Relatives of women who died after their uterine cancer was upstaged following power morcellation called on the FDA to ban power morcellators during a recent hearing. The agency indicated it is considering their request, which has been echoed by some medical professionals as well.
Manufacturers of the transvaginal mesh, such as Johnson & Johnson ($JNJ), have faced a number of lawsuits over the product. Scotland's regional health boards have suspended use of the product due to an investigation into their safety, Mass Device points out.
- read FDA's response to the petition (PDF)
- here's the Mass Device take