A Wyoming woman claims her Johnson & Johnson transvaginal mesh surgical device was defective and has been suffering from persistent severe pain and forced to deal with rising medical costs as a result.
The woman is the latest of thousands to make this claim in the U.S. and has decided to file a lawsuit against the makers of the device, claiming they failed to warn of the potential dangers of its transvaginal mesh and that it failed to properly test this product for safety before releasing it onto the market. She is being represented by the national law firm of Parker Waichman LLP, which represents numerous victims of transvaginal mesh injuries.
The lawsuit has been filed as part of a federal Multidistrict Litigation in U.S. District Court for the Southern District of West Virginia where it joins a growing number of similar claims from women who’ve sought a solution to painful conditions like Pelvic Organ Prolapse and Stress Urinary Incontinence. The Wyoming woman claims she was suffering from both conditions and was implanted with J&J’s Gynecare Gynemesh PS device in September 2005, soon after they were released onto the market but prior to much knowledge that they had been rushed to surgeons without much, or any, pre-market testing.
Transvaginal mesh devices, as a class of devices, were largely passed through the Food and Drug Administration’s 510(k) “fast-track” approval system, which grants approval of new medical devices that are similar in design to previously-approved devices. It requires very little pre-market safety testing but it’s a process that has put tens of thousands of people at risk of serious injuries and a lifetime of pain and suffering all in the interest of profits for the manufacturer.
The Wyoming woman’s lawsuit claims the defective transvaginal mesh device she received has led to “significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of her bodily organ system,” according to a firm press release announcing the lawsuit. Additionally, she claims that Johnson & Johnson continued marketing the device she received after learning that it had been linked to numerous instances of vaginal erosion, infection, extrusion, perforation, chronic pain, and/or abscess.
These injuries can practically cripple a woman who once thought the transvaginal mesh device would allow her to regain some semblance of a normal life. Women who experience complications with transvaginal mesh have a difficult time with normal mobility and even sedentary activity can cause pain and discomfort, with women complaining they are unable to sit or lay in one position for a long period of time or can not walk without pain.
Faced with thousands of reports of complications caused by transvaginal mesh devices, late last year the FDA ordered 33 makers of transvaginal mesh devices to conduct full post-market safety studies of their own devices, an action that could determine the fate of transvaginal mesh in the future. Since that order was given, J&J has become just one of several companies that has promised to stop marketing certain transvaginal mesh products, but not the ones that forced the Wyoming woman to file her lawsuit.