National law firm, Parker Waichman LLP, just filed a lawsuit against device maker, Ethicon, over its TVT Transvaginal Mesh in response to a New York woman’s allegations that the transvaginal mesh caused her severe injuries. Johnson & Johnson is the parent company of Ethicon.
According to the lawsuit, the transvaginal mesh implant poses an unreasonable and dangerous risk to women. The lawsuit was filed on December 27, 2012 in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case 2:12-cv-09722). It is one of the many cases filed in the transvaginal mesh multidistrict litigation (MDL) as part of the In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation (MDL No.2327). Ethicon, Inc., Ethicon, LLC, and Johnson & Johnson have been named as defendants.
Transvaginal mesh implants are medical devices approved to treat pelvic organ prolapse (POP), a condition in which weakened pelvic muscles cause organs to slide out of place. The device is also approved to treat stress urinary incontinence (SUI) and is meant to strengthen pelvic walls; however, according to the lawsuit, the device poses more risks than benefits.
According to this complaint, the woman was implanted with the Ethicon TVT transvaginal mesh in November 2008, soon suffering from a number of injuries, allegedly due to the Ethicon TVT transvaginal mesh. The lawsuit also alleges that the mesh poses a dangerous and unreasonable risk to women because, among other things, the material used for the mesh is not inert and reacts with the tissues of the body and that Ethicon and Johnson & Johnson were aware of the risks but chose to sell the devices without warning the plaintiff or the public.
Meanwhile, the U.S. Food and Drug Administration (FDA) has warned that complications associated with transvaginal mesh implants are “not rare.” The agency also stated that no clear evidence exists that transvaginal mesh is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers, including Johnson & Johnson, to conduct post market studies evaluating the dangers of transvaginal mesh. Also, according to an agency Safety Communication issued last summer, the most common reported adverse events related to transvaginal mesh include:
- Mesh erosion through the vagina (exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyapareunia)
- Organ perforation
- Urinary problems
In June, Ethicon announced that they would no longer sell four types of transvaginal mesh, including the Prolift + M™ , TVT Secur, Prolift, and Prosima.
Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety. The devices were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, the process has drawn increasing criticism.
As we’ve explained, thousands of women were recipients of transvaginal mesh devices, which have come under increased scrutiny since many recipients of these devices began experiencing complications related to their defects, including severe pain, erosion of the devices through the skin or tissue, serious infections, and the need for constant revision surgeries to either correct or remove the devices. Transvaginal mesh allegedly has a risk of erosion, in which it travels through the body’s tissues. In some cases, the device can become embedded in inappropriate areas and multiple surgeries are required to remove it. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed.