AMS Launches First of Two Transvaginal Mesh Safety Studies Ordered by FDA
American Medical Systems Inc. has launched a safety review of two transvaginal mesh products now blamed for chronic pain, pain during sexual intercourse and other side effects in thousands of U.S. lawsuits, MarketWatch.com reports.
According to a recent article, the Endo International plc subsidiary announced on June 9th that the first patient had been enrolled in its Embrace ™ study, which will involve the AMS Elevate Anterior and Atypical Prolapse Repair System. This follows an order from the U.S. Food and Drug Administration (FDA) that all transvaginal mesh manufacturers conduct post-market surveillance studies to test products currently on the market for risks vs. benefits of the surgery. Leading the Embrace research will be the Co-Chief of Urogynecology and Pelvic Reconstructive Surgery at the Stanford University School of Medicine, who will compare both devices with a native tissue repair control group.
“Pelvic organ prolapse is often complex,” he said. “Multiple treatment options are needed to address the exact nature and complexity of the prolapse and there are particular circumstances when the placement of transvaginal mesh may be beneficial and appropriate.”
The first patient enrolled in the study was by a doctor from the Center for Specialized Women’s Health, at the Division of Garden State Urology in New Jersey, and the first patient procedure was performed by Dr. Richard Bercik of Yale Gynecological Oncology in New Haven, Connecticut.
AMS Vaginal Mesh Studies to Reach Completion at Five Years
According to MarketWatch.com, the Embrace Study is one of the largest studies ever led by American Medical Systems, and is the largest involving its Elevate Anterior and Apical Prolapse Repair System.
494 patients are expected to enroll in the research at 40 locations throughout the U.S., the article indicates. AMS is also planning to conduct similar research involving its Elevate Posterior and Apical Prolapse Repair System. This will be referred to as the Harmony ™ study, and will also involve 494 patients at 40 U.S. locations. AMS said each of the transvaginal mesh studies will involve a two-year enrollment period and continue thereafter for three years. Both are expected to reach completion after 5 years, making them substantially longer than other trials involving the devices.
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If you received a transvaginal mesh implant from American Medical Systems or another manufacturer, call our Firm today to receive a free evaluation of your potential lawsuit. Call us now at (877) 779-1414.