According to Johnson & Johnson (JNJ)’s Ethicon unit, the company has announced in a letter this week that it intends to stop selling four vaginal mesh implants. The letter was sent to the court overseeing the Vaginal Mesh lawsuits.
Johnson & Johnson said it has requested approval from the Food and Drug Administration to stop “commercializing” the devices
FDA Warnings
According to the FDA, J&J had sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval.
The regulatory agency issued an 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 female stress urinary incontinence and pelvic organ prolapse.
The affected products includes the Prolift, Prolift+ M, TVT Secur and Prosima surgical meshes. Ethicon said it’s asked the agency to let it continue selling a fifth product, the Gynecare Gynemesh, with a change to the labeling that restricts its use.
Thousands of Lawsuits expected
According to the hundreds of lawsuits filed, the meshes are pushed into place through incisions in the vagina, and have eroded and shrank over time, causing pain and injuries. Experts believe that since trans vaginal mesh surgery is commonly used procedure for stress incontinence and pelvic prolapse , the number of lawsuits is only expected to increase with time.
Patients have filed suits against J&J, C.R. Bard Inc. and Endo Health Solutions Inc., along with other manufacturers.
FDA Reports
The FDA report last year found a fivefold increase in deaths, injuries or malfunctions related to vaginal mesh for pelvic organ prolapse. Later, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.
Ethicon introduced its Gynecare Prolift mesh 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 said it could market the Prolift without approval because it was so similar to the already approved Gynecare Gynemesh. The FDA cleared the Prolift in May 2008.
The case is In Re Ethicon Inc. Pelvic Repair System Product Liability Litigation, MDL No. 2327, U.S. District Court for the Southern District of West Virginia (Charleston).