Gynecare Prolift Sales Continued After FDA Warned Johnson & Johnson to Stop Marketing the Transvaginal Mesh DeviceJun 27, 2012 | Parker Waichman LLP
More disturbing information has come to light regarding the way Johnson & Johnson brought its Gynecare Prolift transvaginal mesh device to market. According to a new report from Bloomberg News, Johnson & Johnson and its Ethicon unit received a letter in August 2007 from federal regulator stating that Gynecare Prolift could not be sold because it had not received regulatory clearance. But Johnson & Johnson apparently continued to sell the device without the U.S. Food & Drug Administration’s (FDA) go-ahead for nine months.
According to Bloomberg, Johnson & Johnson faces 1,400 lawsuits by women who claim Gynecare ProLift caused organ perforation, pain, scarring and nerve damage. Their cases could get a boost following revelations about the product's regulatory history.
As we've reported previously, 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 cleared by the 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 clearance of its Prolift+M tansvaginal mesh device under the FDA's 510(k) program and cited Prolift as its predicate.
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 cleared for sale by the FDA in 2008.
Now Bloomberg is reported that the FDA warned Johnson & Johnson in a letter dated August 24, 2007 that it could "not market this device until you have provided adequate information" on 16 potential deficiencies and received agency approval. Selling Gynecare Prolift without FDA clearance would be a violation of the Federal Food, Drug and Cosmetic Act, the letter said. The FDA also cited the "potential high risk for organ perforation" when surgeons insert the mesh vaginally to support weakened pelvic tissue."
But Gynecare Prolift was never pulled from the market while Johnson & Johnson awaited FDA approval for the product. When it was cleared for sale in May 2008, the FDA did not levy any sanctions on the company for continuing to sell the device.
Earlier this month, Johnson & Johnson revealed in court papers that it would stop marketing Gynecare Prolift and three other transvaginal mesh lawsuits by 2013. The company has maintained that the decision was not made because of safety concern surrounding the products.