According to court records, Johnson & Johnson (J&J) continued to sell a vaginal mesh implant after U.S. Food and Drug Administration (FDA) regulators told the company to stop marketing the device.
In a letter on August 24, 2007, the FDA told J&J to stop Gynecare Prolift sales while the agency assessed whether the device was “substantially equivalent” to similar products on the market.
Specifically, the FDA was concerned about a “potential high risk for organ perforation” and stated that J&J could no longer market its Gynecare Prolift until the company provided the agency with information on 16 specific issues concerning the device. “If you market this device without conforming to these requirements,” the letter said, “you will be in violation of the Federal Food, Drug and Cosmetic Act.”
Bloomberg News reports that the FDA letter was part of a group of documents filed with a state court in Atlantic City, New Jersey, where vaginal mesh implant lawsuits are pending. There are lawsuits pending in federal court in Charleston, Virginia as well.
Johnson & Johnson didn’t file a new application for the Prolift in 2005 because it had decided that it was substantially similar to the Gynemesh, a J&J device that had already been approved by the FDA. The FDA wasn’t even aware the Prolift was on the market until 2007.
The FDA finally did approve the device in May of 2008 – nine months after the letter was sent to J&J. Attorneys for the plaintiffs contend that the medical device giant continued marketing the device, even after it had received the letter telling it to halt.
Johnson and Johnson, for its part, contends the letter has been taken out of context and that it followed all of the FDA’s directives concerning the vaginal mesh device.
The Florida transvaginal mesh injury lawyers at Farah & Farah are dedicated to helping those injured by defective transvaginal mesh implants. If you have been injured due to a mesh implant and have questions concerning your legal options, call us at (800) 533-3555.