Johnson & Johnson/Ethicon ($JNJ) will stop selling four vaginal mesh implants in the face of hundreds of lawsuits challenging the products' safety.
As Bloomberg and The New York Times report, the company informed a West Virginia U.S. District Court judge about the news in the face of a lawsuit from over 600 women who say the devices harmed them (he's handling the legal cases). The Prolift, Prolift+M, TVT Secur and Prosima surgical meshes are the affected products, though the company said it is seeking FDA permission to keep selling its Gynecare Gynemesh with a new label that restricts how it can be used.
J&J has already been under fire for how it sells the implants. Back in March, the FDA ruled that the conglomerate had sold the Gynecare Prolift vaginal implant for three years even though it lacked the right regulatory approval, according to the story. And vaginal implants as a product class are drawing increased scrutiny as it is. In January, in the face of increased safety concerns, the FDA ordered companies that make vaginal implants--this also includes C.R. Bard ($BCR), Covidien ($COV), Boston Scientific ($BSX) and others--to launch three years of studies to gather more data on how safe and effective the meshes really are.
FDA officials are also considering reclassifying the meshes as Class III, a more serious designation than the 510(k) process the products typically run through.
A J&J/Ethicon spokesperson told Bloomberg that it isn't recalling meshes that are already sold, and that the decision is not based on safety concerns, nor is it a formal FDA recall. Rather, the spokesperson said, the move is based on factors including changing market conditions, the complex regulatory environment "and the availability of other treatment options for women."
But this time, J&J is truly in the hot seat. An Ethicon spokesperson is quoted as saying in the Bloomberg piece that it would stop selling the vaginal mesh products globally. What's more, the company has formally asked the FDA for four months to end the sales in an orderly fashion so it can give hospitals and surgeons time to pick "alternative treatment options." So far, according to the story, the FDA hasn't responded to the request to stop selling the mesh products. Johnson & Johnson/Ethicon hopes to end sales region-by-region, completing the process by the first quarter of 2013