
Health care giant Johnson & Johnson (NYSE:JNJ) insists it followed appropriate regulatory guidance with its Gynecare Prolift transvaginal mesh product in the U.S. during the 3 years before obtaining FDA clearance.
"Throughout this process, our actions were responsible, appropriate, and consistent with FDA regulations," spokesman Matthew Johnson told MassDevice in an email.
J&J’s Ethicon division brought the original Prolift device to market in March 2005, based on the safety and effectiveness of an existing device, the Gynemesh PS, which won FDA clearance in 2002, Johnson told us.
"FDA disagreed with this assertion," agency spokeswoman Morgan Liscinsky told Bloomberg in a report released yesterday, adding that the FDA learned of the Prolift device when J&J applied for clearance on a related product in 2007.
"During FDA’s review of Ethicon’s 510(k) submission for Prolift + M in 2007, FDA requested, and Ethicon provided, documentation of Ethicon’s assessment of Prolift as a change to Gynemesh PS that did not require a new 510(k) under FDA’s ‘Guidance on When to Submit a 510(k) for a Change to an Existing Device,’" Johnson told us.
Upon review of that documentation, J&J added Prolift to the 510(k) application for Prolift +M and the products were cleared together in 2008, he said.
"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."
Misgivings about the company’s path to the market may harm the company’s case as it moves forward with a clutch of patient lawsuits claiming that the company’s transvaginal mesh products did more harm than good.
"Ethicon remains committed to vigorously defending all product liability lawsuits concerning the use of our pelvic mesh products," Johnson told us. "Numerous clinical studies suggest that when combined with proper surgical technique, surgical mesh can improve patient outcomes, and Ethicon’s devices are among the most studied devices on the market for this condition."