After years of concern about the safety of vaginal mesh and several warnings that stopped short of an outright ban, the FDA has put a stop to its sale, which is often used to shore up weakened pelvic muscles that can lead to prolapse.
The New York Times reported on the move, which affects the two companies still selling the product in America, despite mounting legal challenges. (You have probably seen TV ads soliciting plaintiffs for lawsuits involving transvaginal mesh.) The call was made out of concerns about complications and longterm safety:
Litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.
For years, women and legal advocates have tried to persuade the F.D.A. that the pelvic mesh implant causes harm. As the number of serious complications increased significantly, the F.D.A. reclassified this type of pelvic mesh as high risk in 2016 and told manufacturers to submit more evidence that the devices were safe and would benefit patients with the condition.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse,” said the FDA’s Dr. Jeffrey Shuren, adding that, “We couldn’t assure women that these devices were safe and effective long term.” That said, the FDA said that women who’ve already had the surgery done and haven’t had any problems don’t need to do anything, besides continuing to check in with their doctor.
The decision doesn’t extend to mesh used to treat stress incontinence, another distressingly common condition that really ought to have a better treatment at this point. Wild that women’s bodies are just a great big mystery!