In what a company spokesman describes as a “global discontinuation,” Johnson & Johnson’s Ethicon unit said in June it had asked FDA for permission to stop selling four controversial vaginal mesh implants in the United States within 120 days. FDA has received more than 1500 adverse event reports about the devices and they are the subject of several hundred lawsuits against the company and others manufacturing similar devices.
In a letter to the judges handling litigation in New Jersey state court and West Virginia federal court, the company said FDA has not yet replied to its request. It said the 120 days it requested would permit Ethicon to notify its customers and provide sufficient time for them to select alternative treatment options for their patients.
The company said it would also discontinue or revise, as appropriate, all marketing materials during that period. It promised to continue to report adverse events and provide medical communications for the four products, consistent with applicable regulations, but asked CDRH’s Office of Surveillance and Biometrics to place the existing 522 orders requiring additional studies for the products on hold.
Last summer, FDA said there had been a fivefold increase in deaths, injuries, or malfunctions tied to vaginal mesh for prolapsed organs. In September 2011 an advisory panel recommended that the devices be reclassified as “high risk.” And the agency in January said that manufacturers must study organ damage and complications related to the products.
Earlier this year, Bloomberg News reported that J&J had sold some of the products for several years without FDA approval. The company said it followed appropriate FDA guidance for the 510(k) process in which devices are cleared based on their relationship to earlier devices.
J&J said it plans to stop sales of the products in all global markets over the next three to nine months on a region-by-region basis. The devices include its Gynecare TVT Secur system, Gynecare Prosima Pelvic Floor Repair System, Gnecare Prolift Pelvic Floor Repair System, and Gynecare Prolift+M Pelvic Floor Repair System.
“This is not a recall; it’s a global discontinuation,” company spokesman Matthew Johnson told Reuters. The letter said the company “has no present intention to commercialize these products in the future.” Johnson said J&J was ending sales of the products largely due to negative overall publicity about vaginal mesh devices and not because of lawsuits against it. He said the company will continue to sell a related product called Gynecare Gynemesh PS for pelvic organ prolapse, as well as other vaginal devices, including for incontinence.