Overview: Ethicon and parent company Johnson & Johnson are being sued by another transvaginal mesh user. The new lawsuit, filed by the national law firm of Parker Waichman LLP, is filed on behalf of a women implanted with the Prolift + M and the Gynecare TVT Secur. The suit accuses the companies of knowing the risks associated with the device and failing to warn consumers about them.
- Parker Waichman has filed a lawsuit on behalf of a woman who alleges that the Gynecare TVT Secur and the Prolift + M caused serious injuries
- The lawsuit was filed into the MDL, taking place in the U.S. District Court for the Southern District of West Virginia, Charleston Division
- Transvaginal mesh implants are used to treat stress urinary incontinence and pelvic organ prolapse, but their safety has been questioned due to reports that the mesh can erode and become embedded
Product: Gynecare Prolift + M™ and Gynecare TVT Secur™
Manufacturer: Ethicon/Johnson & Johnson
Side Effects & Complications
- Mesh erosion
- Pain during sexual intercourse (dyspareunia)
- Perforation or puncture of the bladder, bowels, intestines, and blood vessels near the vaginal wall
- Recurring Pelvic Organ Prolapse (POP)
- Vaginal bleeding
- Urinary problems
- Chronic vaginal drainage, discharge, or infection
- Vaginal scarring and shortening
Lawsuit Claims Transvaginal Mesh is Defective
Parker Waichman LLP filed the suit last Friday in the U.S. District Court for the Southern District of West Virginia, Charleston Division. According to a press release by the firm, in 2009 the Plaintiff was implanted with the Gynecare Prolift +M and the TVT Secur, two meshes that Ethicon will no longer be selling. The lawsuit alleges that the material used in the mesh is not inert, meaning that it can interact with tissues in the body. As a result, the transvaginal mesh may move, or erode, through the tissues of the vagina and may even become embedded in other areas.
Transvaginal Mesh Safety Concerns
Transvaginal mesh implants are approved to treat stress urinary incontinence and pelvic organ prolapse by strengthening the walls of the pelvis. According to allegations, however, these devices present a dangerous risk and are unsuited for use in the female body. Some controversy has also erupted over the fact that transvaginal mesh implants were approved without clinical testing. This is because they were approved through 510(k) which does not mandate safety tests if manufacturers can argue that it is similar enough to a product that has been approved in the past.