Thousands of women filed lawsuits against vaginal mesh implant manufacturers, claiming they suffered serious health problems from the implants. Within the last couple of years, it has come to light that one mesh maker, Johnson & Johnson, sold vaginal mesh devices before receiving federal regulatory approval to do so.
J&J’s Ethicon unit began selling the Gynecare Prolift mesh implant in 2005, marketing it as an “innovative and effective surgical option” for women suffering from weakened pelvis muscles, Bloomberg reported last year. It wasn’t until 2007 when the company sought product approval from the FDA, which the FDA gave in May 2008.
J&J argued it was okay to sell the Gynecare Prolift mesh device because it was similar to already approved devices including the Gynecare Gynemesh, the article stated.
“FDA disagreed with this assertion,” said Morgan Liscinsky, an FDA spokeswoman. The federal agency decided J&J began distributing the Prolift mesh “without appropriate clearance, ” she said.
However, the J&J mesh implant was ultimately cleared based on data the company provided that showed “substantial equivalence in safety and effectiveness to predicate devices,” according to Bloomberg.
Typically, when companies that market devices without first receiving federal approval will receive warning letters from the FDA, or the agency will seize the illegal devices and impose fines and other penalties on the company.
“FDA typically would not take these actions against companies that relied in good faith – albeit mistakenly – on agency guidance,” she said. “But absent this reliance, or in response to repeated mistakes, these actions might follow.”
An FDA database shows between 2005 and 2008, the FDA received 123 complaints about complications women experienced from Prolift. These came in before the FDA cleared the mesh implant for use.
Women sue J&J
J&J now faces more than 550 lawsuits from women who say the company’s mesh implants injured them, Bloomberg reported.
“They were initially able to put the Prolift on the market without even telling the FDA,” said attorney Adam Slater, who is representing more than 100 women in a lawsuit against J&J, according to the source. “Even though Johnson & Johnson supposedly lives by a credo to put the patient first, this is an example of fast-tracking a product to market quickly rather than going to the FDA first.”
Matthew Johnson, a spokesperson for J&J, told Bloomberg the company introduced Prolift to the market after “applying the relevant FDA guidance and based on the safety and effectiveness.” He also said that J&J Ethicon’s devices are “among the most studied devices on the market” for weakened pelvic muscles.
Others say they are very concerned that J&J was selling Prolift without FDA approval for that specific product.
“That information would have been important for most surgeons,” Andrew Sokol, an associate professor of obstetrics, gynecology and urology at the Georgetown University School of Medicine, told Bloomberg. “Most surgeons probably would have not used a completely new product if there was no oversight.”
Some J&J lawsuits are progressing in federal court in West Virginia. Some companies are discussing the possibilities of offering settlements to women who filed lawsuits against them due to transvaginal mesh lawsuits. These companies include C.R. Bars, Endo Health Solutions, Boston Scientific Corp, Coloplast and Cook Medical. They are looking to settle about 30,000 lawsuits around the United States. However, Ethicon is not among those companies.
Among the complications women have experienced include mesh erosion, organ perforation, pain, discomfort and bleeding. In some cases, attempts at one or more surgeries to correct these issues were not successful.
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Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.