How is a medical device on the market for 2 years without the FDA being aware of it?
According to a report from Bloomberg News, Johnson & Johnson’s Gynecare Prolift transvaginal mesh device product was brought to market in 2005, but the U.S. Food & Drug Administration (FDA) was not even aware that the device was being sold until 2007.
According to the report, Johnson & Johnson’s Ethicon unit introduced the Gynecare Prolift transvaginal mesh product, under the assumption that FDA approval was not needed.
The company, the world’s second-biggest health-care products maker, said it could market the original Prolift product without approval because it was so similar to an approved device, the Gynecare Gynemesh.
Upon learning of the Gynecare Prolift’s existence, the FDA informed Johnson & Johnson that it did not agree with the company’s assertion that clearance wasn’t needed for the device. It required Johnson & Johnson to file a 510(k) application for Gynecare Prolift. The FDA’s 510(k) approval protocols allow a “fast-track” clearance, without a requirement for human testing.
“That information would have been important for most surgeons,” Sokol said. “Most surgeons probably would have not used a completely new product if there was no oversight.”
Johnson & Johnson now faces more than 550 lawsuits filed by women who allege they sustained serious, life-changing injuries following surgery with the Gynecare Prolift vaginal mesh product to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The revelation that the device was sold without FDA approval could make those cases far more costly for the company to resolve, Bloomberg said.