While the Food and Drug Administration (FDA) determine whether to place a stronger emphasis on their safety warning about transvaginal mesh, a number of medical device litigations continue to spark concern. After receiving more than 1,500 complaints in just two years, the FDA is currently looking more closely into the serious side effects of transvaginal mesh, questioning whether the products should be pulled from the shelves.
In September 2011, a South Dakota woman filed a lawsuit against Johnson & Johnson over their vaginal mesh product, Gynecare Prolift. What was suppose to be a simple and easy procedure resulted into twelve failed surgeries and long term severe side effects. According to ABC News, after having her surgery in 2006, the patient has continuously suffered from “urinary complications, constant pain and swelling as her body continues to reject the mesh. She says she can’t sit for more than 20 minutes, she can’t have sex with her husband, and she can’t be active for more than a few minutes at a time. ‘It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain.” the woman told ABCNews.com. “I wouldn’t wish this on anyone.'”
At the time of the implantation, transvaginal mesh had not yet undergone the FDA’s standard testing for medical devices, instead the product was approved by the 510(k), a plan that “allows devices to go to market taking a short cut through the regulatory procedures as long as they are proved to be “substantially equivalent” to something already on the market”(ABC News). Johnson & Johnson had compared the Gynecare Prolift to one of their similar products, Gynemesh, which has been on the market since 2002. The patient is in the process of suing Johnson & Johnson for compensatory and punitive damages, she is also hoping to raise the awareness to women across the U.S. about the dangers of transvaginal mesh. (read full story)
The FDA is continuing to research the safety and side effects of transvaginal mesh through tests and studies in hopes to determine if the product needs to be taken off the market. If you or someone you know have undergone a transvaginal mesh placement and have had serious complications, don’t hesitate to contact your Dallas Fort Worth transvaginal mesh lawyer to discuss your legal options. At Borchardt Law Firm we have seen and dealt with many medical device litigations, and we feel the work we do will continue to protect future generations of Texans. Feel free to give us a call.
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