More than 800 women who allegedly developed permanent pain and discomfort following treatment with transvaginal mesh have filed suit against the UK’s National Health Services (NHS) and numerous device manufacturers, claiming they were never apprised of the risks allegedly associated with the implants. According to the International Business Times, the NHS could be on the hook for millions in damages if the litigation is successful.
Transvaginal mesh is used to treat women suffering from stress urinary incontinence and pelvic organ prolapse. However, plaintiffs in the U.K. claim that the devices caused many women to develop life-changing complications, leaving them unable to walk, work or have sex. Data from the NHS Hospital Episodes Statistics indicates that some 92,000 women in the U.K. were implanted with transvaginal mesh between 2007 and 2015. Roughly one out of 11 experienced painful complications following treatment.
“I wouldn’t at all be surprised if there are mesh-injured women that have taken their own lives and didn’t know what the problem was,” plaintiff Claire Cooper told the International Business Times. “I want the procedure banned, I want the material banned.”
Cooper began experiencing pain about three years after she was implanted with pelvic mesh. She and her husband have not been intimate for over four years and she has experienced suicidal thoughts.
Johnson & Johnson and other medical device manufacturers are also named defendants in tens of thousands of transvaginal mesh lawsuits currently pending in courts throughout the U.S. Just last month, a Pennsylvania jury ordered Johnson & Johnson and its Ethicon, Inc. subsidiary to pay $20 million to a woman who suffered painful complications following implantation of Gynecare TVT-Secure Mesh.
According to Bloomberg News, Johnson & Johnson and Ethicon have lost five pelvic mesh trials since 2014, with jury awards totaling more than $35 million. Some trials have concluded in the company’s favor, and others have settled.
The U.S. Food & Drug Administration (FDA) issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in complications and injuries related to the use of transvaginal mesh implants. In 2012, the agency ordered the manufacturers of these devices to conduct post-market surveillance studies to help the FDA better assess the safety and effectiveness of transvaginal mesh for pelvic prolapse repair.
Just last year, the agency finalized rules that reclassified mesh used for transvaginal prolapse repair as high risk (Class III) medical devices. The new FDA regulations also preclude device manufacturers from seeking 510(k) clearance these implants, which had previously allowed such products to come to market without first undergoing human clinical trials.
In 2012, Ethicon announced it would stop selling four transvaginal mesh devices, including Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+M. However, the company maintained that the decision was driven by commercial factors, rather than safety concerns.