A patient has filed a TVT lawsuit saying that a transvaginal mesh made by Ethicon Inc. and Johnson & Johnson causes severe complications. This lawsuit joins a multidistrict litigation arguing that numerous transvaginal mesh products made by the companies are defective and dangerous in their design.

Plaintiff Diana G. and her husband Robert G. are California residents who say that Diana was implanted with the TVT vaginal mesh product on May 4, 2001 and Dec. 18, 2002 in Walnut Creek, Calif. The couple says Diana was implanted with the product to help with issues like vaginal or uterine prolapse.

Diana says that the design of the product was defective in such a way that it caused her physical injury, and was difficult or dangerous to remove because of its defects.

Diana aims to hold Ethicon and Johnson & Johnson accountable for her physical injury, saying that they knew or should have known that the device was dangerous, but sold it anyway. Robert aims to hold the companies accountable for loss of consortium, saying that the product’s defect and the injury it caused his wife negatively impacted their relationship. The couple seeks compensatory and other damages from the companies.

According to the couple’s TVT lawsuit, the TVT device does not allow it to help reinforce a patient’s body to repair vaginal or uterine prolapse, as it is intended. Allegedly, the device has a propensity to “contract, retract, and/or shrink in the body,” thereby not providing the intended support. The TVT lawsuit argues that the device is not porous enough, so does not adhere properly to the pelvic floor and vaginal region, thereby preventing it from functioning as intended.

Additionally, the device can allegedly degrade or fragment in a patient’s body, possibly causing infection, permanent scarring, chronic inflammation, and pain. Diana says that the device can also cause a permanent shortening of the vagina. She also says that these defects often require corrective or revision surgery to address the complications, but the revision surgery is often not possible, and often does not completely solve the problems created by the device’s defects.

Diana says that in addition to posing many health risks because of its design, the TVT mesh is “no more effective than feasible than available alternatives,” and “exposes patients to greater risk than feasible available alternatives. Patients in the transvaginal mesh multi-district litigation say the same of a range of transvaginal mesh products mad by Ethicon and Johnson & Johnson, including the Prolift, Prolift + M, Gynemesh/Gynemesh PS, Prosima, TVT-Obturator, TVT-SECUR, TVT-Exact, and TVT-Abbrevo mesh products.

The TVT lawsuit asserts that Johnson & Johnson and Ethicon failed to adequately test their transvaginal mesh devices for efficacy and safety before releasing them into the market. Additionally, the TVT lawsuit claims that the companies provided incomplete, insufficient, and misleading training and information about the vaginal mesh products to physicians, in order to increase the number of physicians who would recommend the products to patients and use them in treatment.

The TVT Lawsuit is Case No. 2:18-cv-01295, in the U.S. District Court for the Southern District of West Virginia, Charleston Division.