Johnson & Johnson has requested that the U.S. Food and Drug Administration allow the company 120 days to take four types of vaginal mesh implants off the market, despite widespread complaints that the devices are causing severe injuries for women who receive them.
Johnson & Johnson said in a statement that the action is not technically a recall.
Vaginal mesh implants are used to treat urinary incontinence and pelvic organ prolapse, which occurs when muscles are weakened – usually through childbirth – and no longer able to support internal organs. Thousands of patients have complained that the devices have shrunk or eroded since implantation, causing debilitating pain and injuries including organ perforation.
In a number of lawsuits, patients allege that the company continued to market the devices despite being aware of the injuries they were causing, and the fact that safer treatments are available.
A representative of Johnson & Johnson’s Ethicon division informed a federal judge that the company intends to take the devices off the market, but has requested that the FDA give the company 120 days to “cease commercialization” during which it will “discontinue or revise, as appropriate, all marketing materials.”
The letter states: “Ethicon will continue to report adverse events and provide medical communications for these products, consistent with applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold. Ethicon is awaiting written confirmation of that plan.” The Ethicon letter can be viewed here.
In January, the FDA ordered Johnson & Johnson and 30 other makers of vaginal mesh implants to study organ damage and other health complications blamed on the devices.
If you have a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.