Ethicon Deceptive Marketing Tactics: Prolene

On February 28, 2023, Johnson and Johnson Inc. and Joel T. Metze, M.D. have been hit with a lawsuit from a woman who was injured by the defective TVT-O sling in the Court of Common Pleas in Montgomery County, Ohio. (Case 2023 CV 01040 Docket ID: 329116912). The lawsuit was filed by Ms. TB who was injured by the TVT-O, a polypropylene transobturator sling, used for the surgical management of stress prinary incontinence. The TVT-O, a full-length transobturator sling that is manufactured by Ethicon Inc, a wholly owned subsidiary of Johnson & Johnson, Inc, and the first TVT-O was implanted on December 14, 2021 and then another TVT-O implanted on March 1, 2022 at a hospital in Ohio after the first TVT-O failed.

Dr. Metze is accused of failing to warn Ms. TB of the significant risk of harm that Ms. TB suffered from the implantation of a TVT-O that would be substantially reduced or eliminated by using safer alternative options for the surgical management of stress urinary incontinence. Dr. Greg Vigna, MD, JD, national pharmaceutical injury attorney states, “No reasonable woman, including Ms. TB, would consent to this defective device if they had been provided a legally required informed consent. There is plenty of blame to go around.”

The claim against Ethicon is for failure to warn and a design defect and is based largely on the findings of fact in the recently upheld California $302,000,000 verdict against Johnson & Johnson for violations of California’s Unfair Competition and False Advertising Law for its pelvic mesh products, the basis of which led to a $116.9 million dollar settlement that included 43 States, including Ohio and the District of Columbia. The claim against Ethicon is for a defective design as the, heavyweight/small pore mesh of the TVT-O goes through the obturator space into the groin. The dangers of the TVT-O are recognized elsewhere including England where the National Institute for Health and Care Excellence (NICE) “guideline does not recommend offering the transobturator approach except in exceptional circumstance.”

“No reasonable woman, including Ms. TB, would consent to this defective device if they had been provided a legally required informed consent. There is plenty of blame to go around.” – Greg Vigna, M.D, J.D

Dr. Vigna adds, “The sling was rushed to market in 2004 and has been injuring women for way too long. There are no exceptional circumstance that would warrant a transobturator sling as stress urinary incontinence is not life threatening.” Safer alternative designs to the defective TVT-O include non-mesh repair, a retropubic sling, retropubic sling made with PVDF, a retropubic sling with lighterweight/larger pore mesh, a retropubic mini-sling made with PVDF or polypropylene, and a transobturator sling made with PVDF.

Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic injuries and the neurological injuries caused by mid-urethral slings including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and complex regional pain syndrome.  Ben Martin is a national pharmaceutical injury attorney in Dallas, Texas, licensed in Pennsylvania.  The lawyers represent women in courts across the country. To learn more on the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia click here.