New Jersey Ethicon Transvaginal Mesh Lawsuits Exceed 400

More than 400 lawsuits are pending in New Jersey state court against Ethicon, a division of Johnson & Johnson, for injuries allegedly caused by several of the company’s <"">transvaginal mesh products. The products cited in the lawsuits include Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, and Gynecare TVT sling.

When the Ethicon transvaginal mesh lawsuits were consolidated as a mass tort last September before Judge Carol E. Higbee in Atlantic County, only 60 had been filed. However, information from the court indicates that a total of 402 are now pending. The lawsuits allege Johnson & Johnson knew the Ethicon transvaginal mesh products were unreasonably dangerous, but continued to manufacture and sell them. Charges include manufacturing a defective product, negligence, failure to warn, strict liability, and fraud.

Transvaginal mesh products, which are used in surgical procedures to repair pelvic organ prolapse (POP) and stress urinary incontinence, are marketed by several companies, including American Medical Systems (AMS), C.R. Bard and Mentor. Over the past several years, AMS, C.R. Bard and Mentor have all been named in lawsuits filed by women who claim to have been injured as a result of transvaginal mesh complications.

Earlier this month, the U.S. Food & Drug Administration (FDA) warned that complications associated with transvaginal mesh products used in POP repair are not rare. According to the agency, it has received more than 2,800 complaints about transvaginal mesh complications since it last issued a warning in 2008, and of those, more than 1,500 were associated with POP repair. In three of those cases, women died. The agency also it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and may actually expose patients to greater risk of complications.

The FDA also received more than 1,300 additional reports of complications when the mesh was used in SUI surgery during the same time period, but that did not represent as sharp of an increase as what was seen in POP repair. The FDA is still studying that issue, and will make recommendations about the use of transvaginal mesh in SUI surgery at a later date.

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