Johnson & Johnson has agreed to stop selling four types of vaginal mesh implants in response to mesh lawsuits from more than 600 women who claim the devices injured them.
According to Bloomberg, the company informed a federal judge in West Virginia that it intends to stop “commercializing” the implants. Bloomberg quotes a spokesman for Johnson & Johnson’s Ethicon unit as saying that sales of the devices will be halted worldwide.
Vaginal mesh implants are used to treat urinary incontinence and “pelvic organ prolapse,” which occurs when weakened muscles are unable to hold up internal organs. Alternative safe, effective treatments are available for both conditions, neither of which is debilitating or life-threatening.
The U.S. Food and Drug Administration originally approved vaginal mesh implants under a regulatory loophole that requires the agency to OK medical devices based on their alleged similarity to products already on the market. But the device that served as the basis of the approval had already been recalled from the market because of safety concerns.
Thousands of patients who received the devices have since complained that they eroded and shrank over time, causing debilitating pain and injuries including organ perforation.
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. And in March, the FDA declared that Johnson & Johnson sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval.
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,” according to the Bloomberg report.
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.
See the Bloomberg report here: