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FDA Orders Transvaginal Mesh Manufacturers to Conduct Risk Evaluation Studies

Once touted as a revolutionary breakthrough in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP), transvaginal mesh has become the subject of a critical debate. Industry representatives and healthcare officials have exchanged opposing theories on the safety and efficacy of such products for several years. However, the catalyst for concern remains the significant influx of adverse events that have transpired after patients receive transvaginal mesh treatment. Subsequently, the U.S. Food and Drug Administration (FDA) has attempted to further understand the safety and efficacy of these products by requesting the makers of implantable surgical mesh to study their corresponding risks.

Surgical mesh products were originally designed to assist in the treatment of abdominal hernia repairs. However, surgical mesh experienced a revolutionary breakthrough that witnessed the products transition to vaginal applications. Vaginal mesh is intended to assist in the treatment of compromised vaginal tissue that has sustained a traumatic injury from a number of complications such as SUI, POP and childbirth.

Unfortunately, women who have received transvaginal mesh treatment may increase their risk of experiencing severe pain and suffering in the form of infection and swelling. Transvaginal mesh failure may be responsible for the reoccurrence of the injuries it was intended to treat. Reports of complications such as these were responsible for the initial FDA warning issued in 2008.

Due to the severity and frequency of transvaginal mesh complications, the FDA conducted an extensive investigation to determine the safety and efficacy of the products. Subsequently, the FDA initiated a search of the Manufacturer and User Device Experience (MAUDE) database for medical device reports of adverse events associated with all surgical procedures involving transvaginal mesh products received between 2005 and 2010. Data revealed approximately 3,979 incidents of injury, death, and malfunctioning transvaginal mesh devices. Of those reported incidents, 2,874 were reported in the last three years, and included 1,503 cases related to POP repairs.

In response to the influx of adverse events, the FDA sent out 35 letters this week requesting manufacturers of transvaginal mesh products to participate in a comprehensive risk evaluation study. The letters requested three-year studies of several hundred women, in which researchers will examine side effects, as well as their overall quality of life. By providing sufficient clinical data, these studies should provide the FDA with the ability to determine the frequency and severity of complications.

Though the studies have yet to begin, it is reasonable to assume that their results will have overwhelming ramifications on the future of transvaginal mesh regulations.

Do I Have a Transvaginal Mesh Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in transvaginal mesh lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by transvaginal mesh, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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