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Recall

History

Transvaginal mesh devices were introduced in the 1990s and were marketed as a low-risk method to repair pelvic organ prolapse and to treat urinary incontinence. Medical studies have shown that the vaginal mesh has a much higher rate of serious complications than previously claimed by the mesh manufacturers. Once patients learned this news women began to suffer serious, in some cases life-changing complications, that are believed to be linked to the mesh implants. Many of these patients were required to have risky and painful revision surgeries that required long recoveries and significant expense. Many of those that suffered the side effects and complications of the mesh devices sought compensto persue justice through the legal system.

Despite the thousands of lawsuits and complaints from those that have purportedly suffered from transvaginal mesh products, The U.S. Food and Drug Administration (FDA) has yet to issue any large scale recall of the the products. There are however, several mesh manufacturers that have recalled products on their own accord and have stopped marketing and selling other mesh devices once the safety of these devices came into question. These voluntary recalls were the result of a wave of allegations and adverse side effects from the products. The victims felt that due to design defects, lack of proper risk warnings and little testing caused them to suffer life-altering, possibly permanent damage.

Even though the FDA has not issued a massive transvaginal mesh recall, they have raised concerns about the safety of the products. In 2008, the FDA issued a Public Health Notification that addressed serious complications linked to surgical mesh. The in 2011, that FDA notification was updated to reflect the FDA's position that potentially dangerous complications stemming from mesh implantation were not rare and that the heath benefits may not outweigh the risk.


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