Nevada will receive $1.8 million of a $117 million Following an investigation, Nevada Attorney General Aaron Ford announced a multistate settlement with Johnson & Johnson and it’s subsidiary Ethicon Inc. for their deceptive marketing of transvaginal mesh devices.
Transvaginal mesh is a synthetic material surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse. A multistate investigation found the companies failed to sufficiently disclose risks associated with its product’s use including chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations and vaginal scarring.
The investigation found the companies were aware of the possibility for serious medical complications and violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices to consumers or surgeons who implanted the devices.
“When companies’ actions risk the safety of Nevadans, my office works to hold them accountable,” Nevada Attorney General Aaron Ford said in a statement. “Medical device companies should fully disclose the safety, effectiveness and risks associated with their products so Nevadans can make informed decisions about their medical care.”
According to Ford’s office, Johnson & Johnson and its subsidiary Ethicon Inc. has agreed to pay $116.9 million to the 41 participating states as well as the District of Columbia.
The terms of the settlement also provide injunctive relief, which requires full disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts.
Additionally, the companies must refrain from referring to the mesh as “FDA approved” when that is not the case.