Johnson & Johnson’s Gynecare Prolift transvaginal mesh device was apparently on the U.S. market for two years before the company applied for regulatory approval of the product. According to a report from Bloomberg News, the Gynecare Prolift product was brought to market by Johnson & Johnson in 2005, but the U.S. Food & Drug Administration (FDA) was not even aware that the device was being sold until 2007.
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.
According to the report, Johnson & Johnson’s Ethicon unit introduced the Gynecare Prolift transvaginal mesh product in 2005, under the assumption that, because it was so similar to another product already on the market, FDA approval was not needed. The FDA only learned of the Gynecare Prolift product when Johnson & Johnson filed a 510(k) application for its Prolift+M transvaginal mesh device in 2007. The FDA’s 510(k) approval protocols allow a “fast-track” clearance, without a requirement for human testing, for medical devices shown to be substantially similar to a product already on the market. In the Prolift+M application, Johnson & Johnson cited the Gynecare Prolift as its predicate, Bloomberg said.
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. Both it and Prolift+M were cleared by the agency in 2008, according to Bloomberg.
Andrew Sokol, an associate professor of obstetrics/ gynecology and urology at the Georgetown University School of Medicine, expressed shock when he learned that Gynecare Prolift had been brought to market without the FDA’s knowledge or clearance.
“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.”
According to Bloomberg, a review of an FDA database of reported malfunctions, deaths or serious injuries shows that the agency got 123 complaints about Gynecare Prolift from 2005 to May 15, 2008, when the device was cleared by the agency.
This past July, the FDA said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products like Gynecare Prolift from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. Injuries attributed to the use of transvaginal mesh devices include inflammation and infection, pain from mesh shrinkage, and pain and bleeding due to extrusion of mesh through the vaginal wall. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
Transvaginal mesh devices were mostly approved through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that the products were similar in design to a previously-approved device. However, the FDA is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair, and has asked the makers of such devices to conduct safety studies of the products.