Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation now underway in federal court in West Virginia.
According to a report from Bloomberg News, Ethicon stated in the letter that it was seeking U.S. Food & Drug Administration (FDA) approval to stop commercializing the Gynecare Prolift, Prolift+ M, TVT Secur and Prosima transvaginal mesh systems. The letter stated that Ethicon will “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients. The company also said it would “discontinue or revise, as appropriate, all marketing materials during this time,” Bloomberg said.
According to the report, Ethicon also said it will ask the FDA to allow it to continue selling its Gynecare Gynemesh product, but is seeking to change its label to restrict its use. The FDA has yet to respond to the company’s requests.
An Ethicon spokesperson told Bloomberg that the company is not recalling any transvaginal mesh products already sold or implanted. The spokesperson also said its decision isn’t based on any safety concerns.
Transvaginal Mesh Lawsuits
Ethicon and Johnson & Johnson have been named in roughly 600 lawsuits currently pending in the multidistrict litigation in U.S. District Court, Southern District of West Virginia before U.S. District Judge Joseph R. Goodwin. The lawsuits allege the companies’ transvaginal mesh devices caused serious and painful injuries when they were implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Judge Goodwin is also overseeing multidistrict litigation involving similar lawsuits that name transvaginal mesh products sold by American Medical Systems, Boston Scientific and C.R. Bard. The first bellwether trial in the West Virginia litigation, involving lawsuits against C.R. Bard, is scheduled to start on February 5, 2012. Bellwether trials will help determine how much responsibility the mesh manufacturers bear for plaintiffs’ injuries, and how much any damages are worth.
Transvaginal Mesh Injuries
More than 75,000 women a year have transvaginal mesh devices implanted to treat SUI and POP. Last July, the FDA said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products made by Johnson & Johnson and other companies from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
Injuries attributed to the use of transvaginal mesh devices include
- Inflammation and infection
- Pain from mesh shrinkage
- Extrusion of mesh through the vaginal wall
- Pain during intercourse and urination
In January, the FDA asked transvaginal mesh manufacturers to conduct post-market safety studies of their products. The agency is considering moving transvaginal mesh for POP repair to a higher risk medical device category.
Gynecare Prolift Controversy
As we previously reported, Ethicon sold the Gynecare Prolift device for two years before it sought FDA approval for the device. While the product was brought to market in 2005, the FDA said it learned of the Prolift device only in 2007, when J&J sought approval for a related product. The agency Ethicon at that time that it was required to submit a 510(k) application for the device. The company did so, and the FDA approved Gynecare Prolift in 2008.