Johnson & Johnson (J&J) and its subsidiary Ethicon have agreed to a $117m multistate settlement over allegations of deceptively marketed transvaginal surgical mesh products.
A total of 41 states, as well as the District of Columbia, settled.
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Transvaginal mesh is made of synthetic material and is surgically implanted through the vagina to support the pelvic organs of patients with pelvic organ prolapse or urinary incontinence.
An investigation carried out by the states found that J&J and Ethicon misrepresented the safety and effectiveness of the surgical mesh devices.
Furthermore, the companies have allegedly failed to adequately disclose risks related to these products, such as chronic pain and inflammation and vaginal scarring.
According to the lawsuits, the companies were aware of the potential risks but did not sufficiently warn consumers or surgeons.
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By GlobalDataOhio state attorney general Dave Yost said: “Patients can’t make the best decision for their health unless they and their health care providers know all the pros and cons of a product.
“These companies didn’t paint a clear picture of the device’s medical risks, preventing patients from making well-informed decisions.”
Ohio will secure $6.3m as part of the $116.9m settlement.
In addition to payments, the settlement covers injunctive relief, the complete disclosure of the surgical mesh’s risks and precise information on promotional material, as well as ‘information for use’ package inserts regarding the product.
Reuters said that the settlement does not include lawsuits filed by California, West Virginia, Kentucky and Mississippi states. These lawsuits are still pending.
In April, a Philadelphia court ruled Ethicon to pay $120m in damages over allegations that the company’s mesh implant led to incontinence and chronic pain in a Pennsylvania woman.
