Johnson & Johnson’s subsidiary Ethicon said in court filings yesterday that it plans to stop selling four vaginal mesh products. Ethicon and other transvaginal mesh manufacturers are currently facing hundreds of lawsuits consolidated in U.S. District Court in Charleston, West Virginia under Judge Joseph R. Goodwin
Ethicon requested approval from the FDA to stop selling Prolift Prolift + M, TVT Secur, and Prosima systems, and intends to pull the devices from the worldwide market. Ethicon asked the FDA to give it 120 days to pull the products from the market and “notify its customers and providce those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.” The compay said that it “will discontinue or revise as appropriate, all marketing materials during this time.”
The company requests that it continue to market Gynecare Gynemesh but with a label change restricting its use.
Bloomberg reports that an Ethicon spokesperson said in an e-mail that the company “came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regularty environments in which we operate, and the availability of other treatment options for women.” He also said, “We continue to have confidence in the safety and efficacy of these products.”