2 medical companies will pay nearly $116.9 million for deceptive marketing of transvaginal surgical mesh devices.
Attorney General Alan Wilson said Johnson & Johnson and its subsidiary …
This item is available in full to subscribers.
Please log in to continueNeed an account?
|
2 medical companies will pay nearly $116.9 million for deceptive marketing of transvaginal surgical mesh devices.
Attorney General Alan Wilson said Johnson & Johnson and its subsidiary Ethicon agreed to the multistate settlement along with 40 states and the District of Columbia.
Investigators found the companies violated consumer protection laws by:
• Misrepresenting the safety and effectiveness of the devices.
• Failing to sufficiently disclose risks of their use.
South Carolina will receive $4,097,718.60 under the settlement.
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.
The companies must:
• Refrain from referring to the mesh as “FDA approved.”
• Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone.
• Ensure product training for medical professionals covers the risks.
• Omit claims that surgical mesh stretches and remains soft after implantation, that foreign body reactions are transient and that foreign body reactions “will” occur.
• Disclose the 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.
Other items that may interest you
Comments
No comments on this item Please log in to comment by clicking here