Published September 11, 2012 on Carey & Danis
A manufacturer of transvaginal mesh products has recently been ordered in a vaginal mesh federal lawsuit to fully supply the safety information it imparted to the U.S. Food and Drug Administration (FDA) for the purpose of gathering whether the medical device manufacturer withheld any integral pieces of data regarding negative impacts on health from use of its transvaginal mesh product.
A superior court judge in New Jersey made the request of the transvaginal mesh manufacturer, Ethicon Inc., that it release documents on the subject of its clinical trial data and safety observations of its Gynecare transvaginal mesh products. In a report by Bloomberg news, it is understood that the FDA in 2007 mandated that, as adequate safety information was never recorded in regards to Ethicon’s Gynecare transvaginal mesh products, the medical device manufacturer remove such products from the market.
According to the Bloomberg report, Ethicon continued to sell its Gynecare transvaginal mesh products to patients in spite of the FDA mandate. Apparently, the total dismissal of such an FDA mandate is considered a violation of the Federal Food, Drug, and Cosmetic Act. Ethicon reported that, without receiving official FDA approval, they could market and sell the Gynecare transvaginal mesh products because they had received prior FDA approval on a similar transvaginal mesh product. The release of the Gynecare transvaginal mesh line has been referred to as a fast tracking process, one that eliminates the important safety checks via the FDA.
In a multidistrict litigation (MDL), presided over by Judge Joseph R. Goodwin in the U.S. District Court for the Southern Court of Virginia, it has been reported by a Drugwatch journalist that two Arkansas residents have filed a transvaginal mesh lawsuit against medical device manufacturer Boston Scientific Center. The Arkansas couple’s lawsuit makes the claim that Boston Scientific Center developed a transvaginal mesh product made out of materials that cause painful internal tissue inflammation.
Boston Scientific Center’s transvaginal mesh product under question is made out of a monofilament polypropylene that, according to the plaintiff, was known by the manufacturer to cause tissue damage. However, despite such knowledge, the medical device manufacturer made the decision to dismiss such important safety information in order to place the transvaginal mesh product on the market. In the plaintiff’s words, she has suffered enormously from receiving an implantation of Boston Scientific Center’s transvaginal mesh.
Transvaginal mesh is a medical device used as a reinforcing structure, and is especially useful in cases where a patient’s vaginal wall tissues can no longer support surrounding organs. In theory, the surgical implantation of transvaginal mesh should alter a patient’s life for the better, but such is often not the case due to medical device manufacturers releasing products onto the market that are understood to cause severe harm when surgically implanted.