In Early 2014, the U.S. Food and Drug Administration sent a warning letter to American Medical Systems (AMS) following a growing number of lawsuits against the company due to faulty transvaginal mesh devices (TVM), and a statement from parent company Endo International PLC announced that AMS will move forward with the 522 postmarket surveillance study for the Elevate product.
The FDA ordered that all TVM manufacturers conduct studies to more distinctly clarify the risks and benefits of these devices.
Since October 2008 when the public was first made aware of the serious complications of TVM, the FDA has been reviewing how safe transvaginal mesh products are as a treatment option for pelvic organ prolapse (POP) and stress urinary incontinence. In July 2011, the organization alerted the public about the device issues after it received thousands of injury reports relating the the products, and in 2012, the FDA ordered manufactures of vaginal mesh devices to conduct postmarket surveillance studies, like the one currently being conducted by American Medical Systems, to find additional information regarding safety hazards and effectiveness of these devices. Most recently, the FDA announced in April 2014 that it was proposing to reclassify TVM products as high-risk medical devices.
According to court documents, AMS is a defendant in more than 18,000 currently pending transvaginal mesh lawsuits in a federal multidistrict litigation in U.S. District Court, Southern District of West Virginia. The women who filed these cases claim that TVM devices cause serious, sometimes life-threatening complications, including organ damage, chronic pain, erosion and scarring, which often leads to the need for surgical removal of the mesh. They also state that the devices have a defective design and are sold without proper risk warnings.
If you’ve needed mesh removal surgery after serious complications with the product and want to file a transvaginal mesh lawsuit, it’s best to contact a lawyer. Attorneys who specialize in transvaginal mesh mass tort cases can give you your best chance at winning and receiving damages.
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.