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Thousands of transvaginal mesh cases have been consolidated into six multidistrict litigation (MDL) trials. Over the past few months, American Medical Systems (AMS) reached a settlement before the series of bellweather trial begins, while the remaining cases appear to be moving forward into early 2015.
According to Lawyers and Settlements, AMS reached a settlement for its 17,000-plus claims in May and has since set up a fund. The decision, coincidence or not, came nearly a month after the FDA sent the company a warning regarding its risk management and quality control practices.
Following this decision, AMS further announced a study on two of its products. The FDA previously recommended all transvaginal mesh manufacturers conduct post-market surveillance research, and in response, AMS is enrolling 500 subjects for each product and comparing them with a “native tissue repair control group.” Research is predicted to take up to five years.
However, while AMS appears to bow out before others move forward, the remaining cases concern the following:
• 17,638 Ethicon Gynecare
• 7,783 Bard Avaulta
• 1,325 Coloplast
• 184 Cook Medical
• 28 Neomedic Pelvic devices
Judge Joseph R, Goodwin in the Southern District of West Virginia is presiding over the remaining cases. Boston Scientific, the first out of the group, begins in October 2014. Prior to that, a series of bellweather trials will help assist with and determine settlement agreements.
Transvaginal mesh had been prescribed to treat pelvic organ prolapse and stress urinary incontinence. Although claims concerning these products date back years, the issue came to light early in 2013. Women given these products experienced mesh erosion, scarring, pain, and infection, and an estimated 10 percent have required revision surgery. In certain instances, multiple revision surgeries have been required. Plaintiffs in MDL cases, as a result, have sought compensation for medical expenses, future treatments, time off from work, decreased earnings, and pain and suffering.
