Transvaginal mesh implants used to treat pelvic organ prolapse have been reclassified by the U.S. Food and Drug Administration as high-risk medical devices. Previously, they were considered a moderate-risk procedure and received approval for market through the FDA’s outdated 501(k) process.
The move comes in response to tens of thousands of women reporting injuries related to their TVM implants, including erosion, scarring and other severe problems. Simmons Hanly Conroy represents thousands of the injured women in federal courts across the country. An estimated 70,000 to 100,000 TVM lawsuits are pending nationwide in five multidistrict litigations.
Simmons Hanly Conroy Shareholder Jayne Conroy told Law360 in an interview, “It’s significant that the FDA made this decision because it’s what plaintiffs have been arguing all along — that these devices are risky and it’s why companies need to have significant research behind them before they market them.”
This most recent reclassification removes mesh devices used to treat pelvic organ prolapse from the 501(k) process and instead requires manufacturers to submit data to support the effectively and safety of the medical devices before they are permitted to sell them.
Manufacturers who currently sell TVM products have 30 months to comply with the new data requirements.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, in a statement. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
In 2008, the FDA issued safety warnings about the dangerous medical device. Then, in 2012, the agency ordered TVM makers to conduct post-market surveillance regarding the safety of the devices.