By Alex Nussbaum and Jef Feeley
Johnson & Johnson’s Ethicon unit told a federal judge in West Virginia it intends to stop selling four vaginal mesh implants after being sued by more than 600 women who say the products caused internal injuries.
Johnson & Johnson said it has requested approval from the Food and Drug Administration to stop “commercializing” the devices, in a letter filed yesterday with U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, who is overseeing the litigation. An Ethicon spokesman said in an e- mail that the unit would halt sales of the devices worldwide.
The FDA in March said New Brunswick, New Jersey-based J&J had sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval. That followed the agency’s order in January that J&J and 30 other makers of vaginal mesh implants study organ damage and other health complications blamed on the products, which are used to treat incontinence and shore up weakened pelvic muscles.
Ethicon has asked the FDA for 120 days to end sales so it can “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” the J&J subsidiary said in its letter. “Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time.”
The FDA hadn’t responded to the request, according to the letter. The move covers the Prolift, Prolift+ M, TVT Secur and Prosima systems. Ethicon said it’s asked the agency to let it continue selling a fifth product, the Gyencare Gynemesh, with a change to the labeling that restricts its use.
Hundreds of Lawsuits
Hundreds of women say the meshes have eroded and shrank over time, causing pain and injuries, after the devices were threaded into place through vaginal incisions. Patients have filed suits against J&J, C.R. Bard Inc. (BCR) of Murray Hill, New Jersey; and Endo Pharmaceuticals Holdings Inc. (ENDP) of Chadds Ford, Pennsylvania, along with other manufacturers.
“We are happy to see that Ethicon finally decided to do the right thing and stop selling these products,” Bryan Aylstock, a Pensacola, Florida-based lawyer for mesh patients who are suing J&J, said in a telephone interview.
Ethicon is discontinuing sales of the products worldwide, Matthew Johnson, a company spokesman, said in an e-mail. It’s not recalling meshes already sold or implanted and its decision isn’t based on any safety concerns, he said.
“We 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 regulatory environments in which we operate, and the availability of other treatment options for women,” Johnson said.
Safety and Efficacy
“We continue to have confidence in the safety and efficacy of these products,” he said.
Sales will be ended on a region-by-region basis, with the entire process to be completed by the first quarter of 2013, Johnson said. The Gynemesh will remain on the market only for abdominal implantations, he said.
An FDA spokeswoman, Erica Jefferson, said in an e-mail that she couldn’t comment on Johnson & Johnson (JNJ)’s plan regarding the vaginal mesh implants.
An agency report last year found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for organs that slump, or “prolapse,” because of weakened support. Two months later, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.
Ethicon introduced one such mesh, the Gynecare Prolift, in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened muscles. The FDA said it learned of the Prolift only in 2007, when J&J sought approval for a related product.
The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to the already approved Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in March. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.
The FDA cleared the Prolift in May 2008.