NH joins $188.6 million multi-state settlement with surgical mesh maker Boston Scientific Corp.

CONCORD, NH — On Tuesday, Deputy Attorney General Jane E. Young announced a multistate settlement with Boston Scientific Corporation (Boston) to resolve allegations of deceptive marketing of its women’s surgical mesh products. The settlement requires Boston to pay $188.6 million to 47 states and the District of Columbia to resolve allegations that it deceptively marketed transvaginal surgical mesh devices to patients. New Hampshire’s share of the settlement is $1,368,328.

Surgical mesh is a synthetic fabric that is implanted into the pelvic floor through the vagina to treat common health problems in women, such as stress urinary incontinence and pelvic organ prolapse. These are common conditions that women face due to weakened pelvic floor muscles caused by childbirth, age, or other factors. Although the use of surgical mesh involves the risk of serious complications and has not been shown to be more effective than traditional tissue repair, millions of women have been implanted with the devices and thousands of women have reportedly suffered serious complications resulting from these devices.

The complaint alleges that Boston misrepresented the safety of these products by failing to disclose the full range of serious and irreversible potential complications caused by the mesh, including chronic pain, dysfunctional urination and the onset of new incontinence. .

The settlement provides for a full injunction. Under the terms of the settlement, Boston is required to undergo comprehensive marketing, training and clinical trial reforms.

Marketing reforms:

• For consumer marketing materials, describe the complications in understandable terms;
• For some marketing materials, disclose material complications, including risks inherent in networking;
• Refrain from claiming that the inherent risks of mesh are risks common to all pelvic floor surgery or any other non-mesh surgery;
• Refrain from claiming that the complications inherent in mesh can be eliminated through experience or surgical technique;
• Refrain from claiming that the surgical mesh does not cause a foreign body reaction;
• Refrain from claiming that the surgical mesh remains soft, flexible or malleable after the mesh has been implanted inside the body;
• Refrain from claiming that surgical mesh does not potentiate infection or increase the likelihood of infection;
• Refrain from making claims that surgical mesh repair is superior to native tissue repair unless these representations are supported by valid scientific evidence;

Training reforms:

• Inform health care providers of significant complications during training regarding insertion and implantation procedures;
• Maintain policies requiring that its independent contractors, agents, and employees who sell, market, or promote Meshes are properly trained in reporting patient complaints and adverse events to the Company;

Clinical trial reforms:

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

The Consumer Protection and Antitrust Bureau is funded entirely by the Consumer Protection Escrow Account and settlement funds received in state-initiated New Hampshire consumer protection lawsuits. The Bureau’s work includes consumer protection and antitrust enforcement, namely the investigation and prosecution of consumer fraud and unfair or deceptive marketing practices, as well as the ongoing education and awareness of consumers of the New Hampshire.

RSA 7:6-f, requires that “All funds received by the Attorney General on behalf of the State or its citizens as a result of a civil judgment or settlement of any claim, suit, petition or other action under RSA 358-A or the consumer protection laws must be filed in a consumer protection escrow account.The consumer protection escrow account shall at no time exceed $5 million, any amount greater than $5 million being deposited in the general fund.”