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S.C. to get $4M in medical device settlement

South Carolina is getting $4,097,718 in a multi-state settlement requiring Johnson & Johnson and its subsidiary, Ethicon, Inc., to pay for deceptive marketing of transvaginal mesh devices.

State Attorney General Alan Wilson announced the state’s share of a nearly $116.9 million settlement involving 41 states in a news release Thursday. Women who were injured by the product will receive payment for past and future medical costs through separate lawsuits brought by victims.

A multistate investigation found the companies had violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to disclose risks associated with their use.

Transvaginal mesh is a synthetic material that is surgically implanted to support the pelvic organs of women who suffer from pelvic organ prolapse or urinary incontinence. Evidence uncovered in the multistate investigation revealed the companies were aware of the possibility for serious medical complications but did not sufficiently warn consumers or the surgeons who implanted the devices.  

The settlement also includes injunctive relief, which requires full disclosure of the device’s risk and accurate information on promotional material and the product’s informational package inserts. Companies also are prevented from referring to the mesh as “FDA approved” and must train medical professionals on the risks involved with using the surgical mesh and disclose risks associated with its use.

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