Johnson & Johnson has agreed to pay $117 million in a settlement agreement for allegedly hiding the risks of its transvaginal mesh surgical product putting women at risk, officials announced Thursday.
New York Attorney General Letitia James and 41 other state AGs resolved the case with J & J and their subsidiary Ethicon, Inc. for allegedly not telling doctors and patients the slew of risks that come with having the synthetic surgical mesh product implanted vaginally in cases of prolapse or incontinence.
An investigation uncovered that the companies “continued to misrepresent risk and complications it knew to be inherent in the devices as caused by physician error,” a Manhattan Supreme Court lawsuit filed Thursday alleges.
The companies must now disclose the risks — some of which can be “irreversible” — including, chronic pain, inflammation, incontinence, painful sex and scarring, the court papers say.
They are also barred from saying the mesh is FDA approved as the oversight body — which first approved the product in 2002 — this year told manufacturers to stop selling “due to safety concerns,” the court documents say.
“While Johnson & Johnson and its subsidiary were putting income before the health of people in need of care, women were put in danger,” James said in a statement. “My office will never waver in its efforts to hold companies accountable for risking the health of its consumers.”
A rep with J&J said the settlement “involves no admission of liability or misconduct on the part of Ethicon, which remains focused on meeting the significant surgical care needs of health care providers and patients.”