On Friday, June 1st, Johnson & Johnson’s Ethicon Unit announced that it intends to stop selling four vaginal mesh implants. The company’s announcement came in a letter filed with a federal judge in West Virginia overseeing multi-district litigation involving more than 600 women who claim to have sustained internal injuries from the implants. An Ethicon spokesman said in an e-mail that the unit would halt sales of the devices worldwide.
Ethicon markets five different vaginal mesh products, and sales of four models – Prolift, Prolift+ M, TVT Secur and Prosima – will be ended on a region-by-region basis by the first quarter of 2013. The fifth product – Gynemesh – will remain on the market for abdominal implantations only, with revised labeling to indicate its restricted use. Other manufacturers include C.R. Bard, Endo Pharmaceuticals, Boston Scientific, and W.L. Gore & Associates.
Women seeking relief from urinary incontinence and weakened pelvic muscles were naturally drawn to the benefits that manufacturers promised surgical mesh implants could offer. As a result of mesh erosion and shrinkage, however, hundreds of women have died or been injured by the allegedly defective products. The rapid increase in death and organ damage – 500% over one period of time – prompted an advisory panel to urge the FDA to reclassify vaginal mesh devices as “high-risk” products requiring human testing. (For additional background, click here to read our prior post).
This recall is the first movement by a pelvic mesh manufacturer to cease production and withdraw a group of pelvic mesh products from the market in an apparent response to both FDA scrutiny and increasing pressure from mounting litigation. There are now over 600 vaginal mesh cases on file in state and federal courts throughout America.
This news highlights the fact that the pressure hundreds of lawsuits filed by women across the country has forced the first multi-national corporation to acknowledge the problem and stop hurting more women. Ultimately, the actions of woman who come forward and file suit will continue to have a very significant effect on the other manufactures of vaginal mesh, and help prevent thousands of additional women from being injured.
Instances of vaginal mesh failure continue to occur in the over 75,000 woman who have received the procedure. If you’ve been injured as a result of a defective vaginal mesh implant, please contact us as soon as possible to discuss your case and learn how the law can work for you.