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More than 30,000 consolidated lawsuits concerning transvaginal mesh implants are headed toward a national trial in Charleston, West Virginia, by February. However, with less than two months to go, it was recently revealed Johnson & Johnson’s Ethicon division lost crucial documents for the case.
Reported by Bloomberg, officials admitted to destroying or deleted documents related to the implants. Although executives had ordered employees to preserve the files, Ethicon’s team did away with roughly a decade’s worth of patient information about the implants. Johnson & Johnson further claims employees weren’t aware preservation was necessary.
In response, lawyers representing the plaintiffs involved in the national class action lawsuit have stated Johnson & Johnson should be blocked from attempting to throw out any of the lawsuits because of a lack of information.
Throughout 2013, other manufacturers of transvaginal mesh products settled on state and national levels with plaintiffs. Endo Health Solutions settled for $54.5 million with multiple plaintiffs, and talk of other amounts have included C.R. Bard, Boston Scientific, and Coloplast. While Johnson & Johnson hadn’t been involved in talks back in September, the company did settle on a state level for $11 million.
Since that point, Johnson & Johnson pulled some of its transvaginal mesh implants.
Patients suffering from pelvic organ prolapse or stress urinary incontinence received transvaginal mesh implants – a product approved by the FDA in the late 1990s. Recipients, even years after surgery, experienced organ perforation, recurrent prolapse, neuromuscular issues, scarring, or emotional distress, as the mesh contracted or shrank. Removal often involves multiple revision surgeries.
Regarding the product, the FDA released two warnings: one in 2008 and again in 2011. Although the products have not been recalled, they’re now considered Class III devices – indicative of pre-market approval. Manufacturers must also perform stricter testing and, as of 2012, conduct a three-year study on transvaginal mesh’s effectiveness.