Johnson & Johnson said it would stop selling vaginal mesh implants after a raft of lawsuits about the devices causing complications such as infections and bleeding.
The diversified healthcare agency and numerous other device makers have been sued in recent years by patients who allege organ damage and other injuries from the implants, many of which are used to support weakened vaginal muscles.
There are over a thousand lawsuits pending against Ethicon Inc, the J & J unit that makes the devices.
J & J spokesman Matthew Johnson said on Tuesday that the company has asked the U.S. Food and Drug Administration for permission to stop selling four of its mesh products within the next four months, after giving hospitals and surgeons time to select other options. It plans to stop selling the products worldwide within the next three to nine months.
The FDA has said the company sold one type of vaginal implant, the Gynecare Prolift Pelvic Floor Repair System, for three years without getting official permission.
Surgical mesh is commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP). The condition happens when tissue that holds the pelvic organs in place becomes weak or stretched and bulges into the vagina. There are different types of such prolapse, including vaginal prolapse, usually after menopause, childbirth or a hysterectomy.
The mesh is also used to help patients with a severe overactive bladder known as stress urinary incontinence.
About 75,000 women received mesh repairs for pelvic organ prolapse in 2010 and about 200,000 received transvaginal repairs for stress urinary incontinence, according to the FDA.
NO FDA CLEARANCE
Most devices now get FDA approval under a special process known as 510(k) that allows companies to sell the mesh if they can prove it is similar to products already on the market.
The FDA said J&J never applied for this approval before starting to sell its Prolift mesh in 2005 and only got FDA permission in 2008. According to documents seen by Reuters, the FDA also said the label for the device should have included a warning to patients that the mesh’s safety and effectiveness had not been proven in randomized, controlled clinical trials.
J&J said it believed it could sell the device without formal FDA clearance because it was so similar to another approved device, the Gynemesh PS.
The company formally applied for FDA 510(k) approval in 2007, and said it always acted “responsibly, appropriately, and consistent with FDA regulations.”
FDA spokeswoman Sarah Clark-Lynn said the agency disagreed with J&J’s initial decision to market Prolift without FDA clearance. But regulators decided to take no action since the company “promptly complied” in seeking approval, once the FDA realized in 2007 that the product was already being sold.
Four years after finally receiving formal approval, J&J said it plans to no longer make the Prolift mesh, or three other Gynecare products: the Prosima Pelvic Floor Repair System, the Prolift+M, Gynemesh M and Gynecare TVT Secur System.
The company announced the decision in a letter sent on Monday to a federal judge in West Virginia and a state judge in New Jersey who are overseeing lawsuits about the mesh.
J&J said its decision to stop making the implants was based on “concerns and questions” raised about the devices and their commercial viability, and was not related to the lawsuits or to the implants’ safety or efficacy.
“This is not a recall; it’s a global discontinuation,” Ethicon spokesman Johnson said.
J&J said it will continue to sell a related product called Gynecare Gynemesh PS for pelvic organ prolapse, as well as other vaginal devices, including for incontinence.
NO SAFETY TRIALS
The company said the decision means it should not have to comply with requirements for additional safety studies of the mesh - although it will continue to report to the FDA any complaints, or adverse events, from the devices.
The FDA in January sent letters to 35 manufacturers of surgical mesh implants, including J&J, ordering new safety studies.