More than 800 Australian women participating in a transvaginal mesh class action lawsuit have accused Johnson & Johnson of attempting to block a French report that warned against the use of Ethicon Inc.’s Prolift implants.
According to The Guardian, as many as 8,000 women in Australia have received Ethicon’s vaginal mesh products to treat pelvic organ prolapse and stress urinary incontinence. Plaintiffs involved in the class action complaint, which is currently at trial in Sydney, claim that Johnson & Johnson and its Ethicon subsidiary failed to warn patients that the devices could cause permanent and life-changing complications, including mesh erosion into the vagina, scarring and adhesions, infection, and organ damage. Many of the women say they continue to suffer from debilitating pain, despite having undergone multiple surgeries to remove the mesh from their bodies.
Ethicon’s Prolift mesh was approved for the Australian market in 2005. No randomize controlled trials were conducted to test its safety and effectiveness, and plaintiffs assert that what testing was done was scant and too short term. They further charge that adequate studies would have found that Prolift posed an unacceptable risk to women.
Last Wednesday, much of the trial focused on a 2007 report from French health authorities, in which they warned that Prolift mesh should only be used for clinical research pending the completion of a randomized controlled study. Meeting minutes cited by plaintiffs suggest that Johnson & Johnson and Ethicon were concerned that the French report “could have a major impact on our business if made public”.
“So there is no randomized clinical trial, the [French] commission wants one and essentially until it gets one, Prolift, which has already been on the market in Australia for two years, is considered only suitable for clinical research,” the plaintiffs’ transvaginal mesh lawyer told the court.
Hundreds of thousands of women in this country have also been implanted with transvaginal mesh devices manufactured by Ethicon and other companies. The U.S. Food & Drug Administration (FDA) issued warnings in 2008 and 2011 after it had received thousands of injury reports involving the devices. In 2011, the agency also reversed its previous position regarding the frequency of adverse events related to transvaginal mesh prolapse repair, stating it no longer considered such complications to be rare. The FDA also expressed doubt that such procedures offered any additional benefits compared to traditional non-mesh surgery.
In 2012, Ethicon announced it would stop selling four pelvic mesh devices, including Prolift. At the time, the company attributed the decision to slowing sales. However, the FDA had previously ordered Ethicon and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.
Johnson & Johnson and Ethicon are named defendants in more than 50,000 pelvic mesh lawsuits currently pending in U.S. courts. Numerous cases have gone to trial in recent years, with juries delivering verdicts for both plaintiffs and the defense. The company has also agreed to settle some claims.
Other transvaginal mesh manufacturers involved in the U.S. litigation include American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic.