Transvaginal mesh litigation ranks as one of the largest mass tort cases in U.S. history. Trial lawyers have taken mesh manufacturers to task after 100,000 women suffered injuries from having these defective mesh products surgically implanted to repair pelvic organ prolapse. Last week, a long-overdue move by the FDA put an end to all future surgeries using the products.
The FDA ordered the two remaining manufacturers of transvaginal surgical mesh to stop selling and distributing their products. The move comes after Boston Scientific and Coloplast failed to provide evidence of long-term safety that’s required for class III products, which the FDA considers “high risk.”
After reclassifying transvaginal surgical mesh as class III, Boston Scientific and Coloplast were required to submit premarket approval applications for their products and receive approval from the FDA to continue marketing their devices in the U.S. However, their assessments fell short.
“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 POP,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a press release on April 16. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
The FDA cleared the first mesh device for transvaginal repair of pelvic organ prolapse in 2002, but the agency initially listed it as a class II or “moderate-risk” device. In 2016, the products were reclassified as class III after the FDA began seeing a major increase in problems related to their use for transvaginal repair. Amid the FDA’s warnings of the risks since then, the percentage of women electing to do these surgeries has decreased.
The FDA urges women who have had transvaginal mesh placed for the surgical repair of pelvic organ prolapse to continue with their routine check-ups and care. Patients should notify their health care professionals if they have complications or symptoms, which include persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex. For more information, visit the FDA’s advisory page.
A West Point graduate where he served as captain and military aviator, John Bair continues his commitment to our country through his efforts within the settlement planning industry. He has represented families of victims lost in the Flight 3407 crash, offered pro bono services to the families of 9/11 victims and drafted the first consumer protection bill for plaintiffs (H.R. 3699).