Gynecare Prolift Transvaginal Mesh Brought to Market Without FDA ApprovalMar 22, 2012 | Parker Waichman LLP
Hundreds of women who have filed lawsuits alleging severe injuries from Johnson & Johnson’s Gynecare Prolift transvaginal mesh product have some powerful evidence on their side. According to a report published by Bloomberg News, Johnson & Johnson's Ethicon unit brought the Gynecare Prolift to market in 2005, and sold it for two years without ever having the transvaginal mesh device approved by the U.S. Food & Drug Administration (FDA).
Apparently, Johnson & Johnson believed it did not have to bother with FDA approval of Gynecare Prolift because it was so similar to another product it was already selling. So the FDA wasn't even aware that Gynecare Prolift was being marketed until 2007, when Johnson & Johnson applied for approval of its Prolift+M tansvaginal mesh device.
It was only because the company sought FDA approval for Prolift+M under the agency's 510(k) program that the FDA learned of the existence of Gynecare Prolift. The 510(k) process doesn't require human testing if a device is substantially equivalent to a product already on the market. To prove its eligibility for a 510(k) clearance, Johnson & Johnson cited Gynecare Prolift as the predicate for Prolift+M.
Once it learned that Gynecare Prolift was being marketed, the FDA required the Johnson & Johnson file a 510(k) application for that device. Both Gynecare Prolift and Prolift+M were approved for sale by the FDA in 2008.
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). Many of those plaintiffs underwent multiple surgeries to remove the device and repair Gynecare Prolift injuries. However, for some victims, full recovery is not possible.
According to Bloomberg, the FDA's adverse event reporting database received 123 complaints about Gynecare Prolift from 2005 to May 15, 2008, when the device was finally cleared by the agency. According to the FDA, injuries from malfunctioning transvaginal mesh can include inflammation and infection, pain from mesh shrinkage, and pain and bleeding due to extrusion of mesh through the vaginal wall.