Health care giant Johnson & Johnson (NYSE:JNJ) found itself again in the hot seat as new reports claim the company sold a transvaginal mesh product in the U.S. for 3 years before obtaining appropriate FDA clearance.
J&J launched its Gynecare Prolift mesh in the U.S. in March 2005 without seeking the FDA’s approval, considering the product similar enough to an approved device that it could forgo the application process, Bloomberg reported.
"FDA disagreed with this assertion," agency spokeswoman Morgan Liscinsky told Bloomberg, adding that the FDA learned of the Prolift device when J&J applied for clearance on a related product in 2007.
The news doesn’t bode well for J&J, which is already mired in a clutch of patient lawsuits claiming that the company’s transvaginal mesh products did more harm than good.
"They were initially able to put the Prolift on the market without even telling the FDA," Adam Slater, an attorney suing J&J on behalf of more than 100 women, told Bloomberg. "Even though Johnson & Johnson supposedly lives by a credo to put the patient 1st, this is an example of fast-tracking a product to market quickly rather than going to the FDA 1st."
The clamor began with a report from the FDA’s Obstetrics & Gynecology Devices Panel in September 2011 which recommended bumping transvaginal mesh products, which are used to treat pelvic organ prolapse, into a higher risk category given rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.
Consumer advocacy groups demanded an industry-wide recall of all transvaginal mesh devices until more testing can demonstrate safety and efficacy, but industry lobby AdvaMed and companies making transvaginal mesh products asked the FDA to leave the regulatory status for the products alone.
As public pressure mounted over the potential harm caused by transvaginal mesh implants the FDA in January ordered device makers, including Johnson & Johnson and C.R. Bard (NYSE:BCR), to take another look at complication rates associated with their devices.
J&J did not immediately return requests for comment.