NEW YORK — Johnson & Johnson, the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after US regulators told the company to stop marketing the device, according to court records.
The Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh to support weakened pelvic tissue.
The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who said the mesh caused organ perforation, pain, scarring, and nerve damage. Lawyers for the women said the device’s approval history could increase J&J’s cost to resolve the litigation. “If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it,” Adam Slater, an attorney suing on behalf of 150 women, said in a phone interview.