As early as October 20, 2008 the FDA issued a Public Health Notification, warning health care practitioners about the serious complications associated with vaginal mesh products often used to treat conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These medical devices, commonly referred to as pelvic mesh, vaginal mesh, bladder slings, and bladder hammocks are predominantly made of polypropylene mesh and are permanently implanted. At the time, the FDA warned that “although rare, these complications can have serious consequences.”
On July 13, 2011, based on a growing number of complaints suffered by victims of vaginal mesh and an updated analysis of adverse events reported to the FDA and complications described in scientific literature, the FDA issued a strongly worded report and warnings regarding these medical devices. Specifically, the FDA stated: (i) Complications related to transvaginal mesh surgery are NOT rare; (ii) There is no evidence that transvaginal mesh repair is more effective than traditional non mesh repair; and (iii) Transvaginal mesh surgery exposes patients to greater risk than traditional non mesh repair.
On September 7, 2011, the Wall Street Journal, Bloomberg News, and ABC News each reported that because of safety concerns over transvaginal mesh devices an FDA panel is recommending that these devices should not be approved for surgical repair of pelvic organ prolapse (POP) through the less-rigorous FDA approval process. Partner, Adam Slater, is quoted in each article:
“Clinical trials should have been done,” said Adam Slater, a plaintiffs’ attorney who is involved in nearly 300 mesh cases. “Instead, they used real patients as guinea pigs.”
“The whole concept of the 510(k) process should be scrapped,” says Adam Slater, the New Jersey attorney representing Gross and other women who are suing Johnson & Johnson.
“The 510(k) process utterly failed to protect the thousands of women who were implanted,” Slater wrote to the advisors. “Now the FDA has the opportunity to at least protect women on a going-forward basis.”
As reported in Bloomberg News, on March 16, 2012 the FDA confirmed the vaginally placed pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc., since March 2005, was initially marketed without any clearance or approval from the FDA. Partner, Adam Slater, is quoted in the article:
“They were initially able to put the Prolift on the market without even telling the FDA,”… “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.”
On June 5, 2012, the Wall Street Journal reported that Johnson & Johnson would halt the sales of a number of its pelvic floor products, including the Gynecare Prolift, Gynecare Prolift +M, Gynecare TVT Secur, and Gynecare Prosima. In addition, the company changed the indications for use of its Gynecare Gynemesh product for insertion through the abdomen only. Partner, Adam Slater, is quoted in this article as well:
“This is the first domino to fall,” said Adam Slater, the co-lead plaintiffs attorney involved with hundreds of mesh cases. “I think the other manufacturers will follow.”
Mazie Slater Katz and Freeman has been at the forefront of this litigation from its inception, having filed the first ever vaginal mesh case in New Jersey, ever before the initial FDA Public Health Notification was issued and now having won the largest, ever jury verdict in the country involving these mesh products. Unlike many other law firms claiming an expertise in this field, who are “collecting” cases, we are actually filing lawsuits and aggressively litigating these cases for our clients, having already obtained and reviewed millions of pages of internal documents from the product manufacturers, among other things.
If you or a loved one has suffered complications as a result of a transvaginal mesh or bladder sling implant, please contact a Vaginal Mesh and Bladder Sling Lawyer today.