Johnson & Johnson Ethicon Gynecare Vaginal Mesh Recall
Attorneys for Ethicon, a subsidiary of Johnson & Johnson, have sent letters to the judges overseeing vaginal mesh lawsuits in federal and state court , notifying them that the company intends to stop selling the following products:
- Gynecare TVT Secur
- Gynecare Prosima Pelvic Floor System
- Gynecare Prolift Pelvic Floor System
- Gynecare Prolift+M Pelvic Floor System
- Gynecare Gynemesh PS (would only be sold for use during abdominal sacrocolpopexy procedure)
These products and a number of other vaginal mesh and blader sling products made by a different companies, which are used for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI), have been associated with a number of painful and debilitating complication, such as erosion of the mesh through the vagina, infection, pelvic pain, hardening or shrinkage of the mesh, pain during sexual intercourse and urinary problems.
The action by Johnson & Johnson and their Ethicon unit will essentially constitute a recall for Gynecare vaginal mesh products. However, the manufacturer has requested that the FDA allow 120 days to “cease commercialization” so that they may provide hospitals and surgeons with sufficient time to select alternative treatment options, revise marketing materials and notify customers.
Ethicon has also requested that the FDA place a hold on recent orders that they conduct studies to evaluate the growing concerns surrounding these products. The FDA required all manufacturers of transvaginal mesh products to conduct these tests after thousands of women experienced complications after procedures to repair POP and SUI. The FDA ordered the additional testing to give the agency a better idea about whether the risk of problems with vaginal mesh products outweigh the benefits.
The lawyers at Saiontz & Kirk, P.A. currently represent women throughout the United States who are pursuing an Ethicon Gynecare vaginal mesh lawsuit after experiencing problems. Allegations raised in complaints indicate that the manufacturer should have issued this vaginal mesh recall years ago, but instead continued to sell the products without adequate warnings or having conducted sufficient studies to establish that the transvaginal mesh products are safe and effective.
In addition to claims involving Ethicon/Gynecare mesh, our law firm is also investigating potential Bard Avaulta mesh lawsuits, AMS vaginal mesh lawsuits, Boston Scientific mesh lawsuits and claims for individuals who are not sure what type of transvaginal mesh was used.