She has filed a lawsuit that’s been added to a growing Multidistrict Litigation against several makers of transvaginal mesh devices face allegations they failed to warn the public about the dangers of transvaginal mesh devices and that they were not properly tested prior to reaching the market.
The woman is being represented by the national law firm of Parker Waichman LLP and the lawsuit was filed in U.S. District Court for the Southern District of West Virginia. It names Ethicon, Inc., Ethicon Women’s Health and Urology, Gynecare, and Johnson & Johnson as Defendants. She claims two transvaginal mesh devices – the Gynecare Prolift + M Pelvic Floor Repair System, and the Gynecare TVT Obturator System – for causing painful and costly injuries after being implanted with them for the treatment of developing Pelvic Organ Prolapse and Stress Urinary Incontinence in July 2009. The complaint states the New York woman suffered “significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, and loss of bodily organ system,” as a direct result of these defects.
The firm represents numerous women who’ve all fallen victim to the defects of transvaginal mesh devices. Each complaint shares similar complaints, that these and other transvaginal mesh devices were not properly tested before being used in surgery. They’ve been alleged to cause myriad injuries that are likely to cause life-altering injuries that require numerous revision surgeries to repair, with no promise that each surgery will completely remedy the injuries incurred after the first surgery.
Transvaginal mesh devices were approved through the Food and Drug Administration’s 510(k) “fast-track” approval system which requires little or no comprehensive pre-market safety testing based on the theory they are similar in design to other surgical products. While mesh devices have been used in surgery before, they were never used in this application and the results of this haphazard approach have been disastrous for thousands of women. These transvaginal mesh devices are prone to erode through skin and the vaginal wall. They have also been known to cause extrusion, perforation, and abscess. They can also break apart, making surgery to remove the defective device even more dangerous, painful, and costly. Pain, inflammation, and the risk of infection present themselves to women who suffer from the dangerous effects of these devices.
Late last year, the Food and Drug Administration acknowledged the apparent failures of transvaginal mesh devices and said errors from these surgeries were “not rare” and in doing so, ordered 33 manufacturers to conduct thorough post-market safety testing which could determine the fate of the class of devices. Since then, Johnson & Johnson has stopped sales of four of its products: Prolift, Prolift + M, TVT Secur and Prosima systems.