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Medical device manufacturer Boston Scientific Corporation held accountable for deceiving consumers

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A multistate settlement with Boston Scientific Corporation to resolve allegations of deceptive marketing of its surgical mesh products for women requires the company to pay $188.6 million to resolve allegations that it deceptively marketed transvaginal surgical mesh devices to patients.

Virginia will receive $3,734,173 as its share of the settlement.

“Deceptive or false marketing of any kind of product will not be tolerated in Virginia, but especially when those products are medical devices that could negatively impact a patient’s health,” Virginia Attorney General Mark Herring said. “As attorney general, my top priority is always to protect Virginians and I want to make sure that both doctors and patients can always feel confident that they are making the best, most informed decisions about their health.”

Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions in women such as stress urinary incontinence and pelvic organ prolapse. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors.

Although use of surgical mesh involves the risk of serious complications and is not proven to be any more effective than traditional tissue repair, millions of women were implanted with the devices and thousands of women are alleged to have suffered serious complications resulting from these devices.

Herring and his colleagues allege that Boston Scientific Corporation misrepresented the safety of these products by failing to disclose the full range of potential serious and irreversible complications caused by mesh, including chronic pain, voiding dysfunction, and new onset of incontinence.

The settlement provides comprehensive injunctive relief.

Details

Under the terms of the settlement, Boston Scientific Corporation is required to:

Marketing reforms

  • For marketing materials intended for consumers, describe complications in understandable terms.
  • For certain marketing materials, disclose significant complications, including the inherent risks of mesh.
  • Refrain from representing that any inherent risks of mesh are risks common to any pelvic floor or other surgery not involving mesh.
  • Refrain from representing that inherent mesh complications can be eliminated with surgical experience or technique.
  • Refrain from representing that surgical mesh does not cause a foreign body reaction.
  • Refrain from representing that surgical mesh remains soft, supple, or pliable after mesh is implanted inside the body.
  • Refrain from representing that surgical mesh does not potentiate infection or does not increase the likelihood of infection.
  • Refrain from representing that surgical mesh repair is superior to native tissue repair unless such representations are supported by valid scientific evidence;

Training reforms

  • Inform healthcare providers of significant complications when providing training regarding procedures for insertion and implantation.
  • Maintain policies requiring that its independent contractors, agents, and employees who sell, market, or promote mesh are adequately trained to report patient complaints and adverse events to the company.

Clinical trial reforms

  • When submitting a clinical study or clinical data regarding mesh for publication, disclose the company’s role as a sponsor and any author’s potential conflict of interest.
  • Refrain from citing any clinical study, clinical data, preclinical data, research, or article regarding mesh for which the company has not complied with the disclosure requirements in the injunction.
  • Include a sponsorship disclosure provision requiring consultants to contractually agree to disclose in any public presentation or submission for publication any sponsorships by Boston related to the contracted-for activity.
  • Register all Boston-sponsored clinical studies regarding mesh with ClinicalTrials.gov.

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