INDIANAPOLIS — Attorney General Curtis Hill today announced a settlement involving 41 states and the District of Columbia requiring Johnson & Johnson and its subsidiary Ethicon Inc. to pay nearly $116.9 million for their deceptive marketing of transvaginal surgical mesh devices.
A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use. Indiana will receive more than $4.4 million under the settlement, according to a news release from the Indiana Attorney General’s Office.
“My office will continue to hold accountable companies that cause harm to consumers through improper practices,” said Hill. “Women in Indiana and across the country have suffered as a result of the actions of Johnson & Johnson and Ethicon Inc.”
Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse.
Evidence shows the companies were aware of the possibility of serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.
Besides the monetary penalties, the settlement also provides injunctive relief, requiring full disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts.
Among the specific requirements, the companies must:
• Refrain from referring to the mesh as “FDA approved” when that is not the case.
• Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone.
• Ensure that product training provided to medical professionals covers the risks associated with the mesh.
• Omit claims that surgical mesh stretches after implantation, that it remains soft after implantation, that foreign body reactions are transient and that foreign body reactions “may” occur (when in fact they will occur).
• Disclose that mesh risks include: fistula formation, inflammation, as well as mesh extrusion, exposure and erosion into the vagina and other organs.
• Disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following transvaginal implantation and vaginal scarring.
• Disclose that risks include that revision surgeries may be necessary to treat complications, that revision surgeries may not resolve complications and that revision surgeries are also associated with a risk of adverse reactions.