$116.9M settlement for deceptive mesh marketing

Posted 10/21/19

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 …

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$116.9M settlement for deceptive mesh marketing

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
Lexington County, South Carolina, attorney general alan wilson, settlement

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