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$116.9M settlement for deceptive mesh marketing
Photo courtesy of www.dukehealth.org
Surgical mesh
Posted
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
Keywords
Lexington County,
South Carolina,
attorney general alan wilson,
settlement
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