Boston Scientific to Pay $189 Million in Vaginal Mesh Lawsuit
Boston Scientific will pay $189 million to settle a multi-state lawsuit over the marketing of its surgical mesh devices. The settlement was announced Tuesday and investors responded accordingly. The stock fell nearly 3%.
The settlement funds will be divided up among 47 states and Washington, D.C. that were all part of the lawsuit against the company. Part of the settlement includes an agreement from the company to “describe more accurately to consumers the safety and risks” of using surgical mesh, Reuters reported.
Boston Scientific had been making surgical mesh particularly for use in the pelvis since the early 2000s. The mesh, often called pelvic mesh or transvaginal mesh, is surgically implanted in women as a treatment for two different conditions, pelvic organ prolapse, when organs shift from their normal position, and stress urinary incontinence.
However, the mesh implants manufactured by Boston Scientific, as well as other companies, became problematic. Lawsuits were filed by women who received the implants. Complaints ranged from intense pain, excessive bleeding, as well as loss of sexual function. State governments also filed lawsuits against the companies. In the case of Boston Scientific, the attorneys general from the states accused the company of “potential serious risks of using the devices, including chronic pain, urinary dysfunction and a new onset of incontinence,” Reuters said.
Boston Scientific’s settlement was not an admission of misconduct or liability. In a brief statement cited by Reuters, the company said the financial agreement was in its shareholder’s best interest.
Washington State Attorney General Bob Ferguson, who led the multistate lawsuit against the company, accused Boston Scientific of deceptive practices by failing to “include serious risks in the instructions and marketing materials for surgical mesh devices.”
In the lawsuit filed by Ferguson’s office, he alleged the company failed to adequately disclose serious and life-altering risks of its transvaginal mesh devices, such as rigid scarring and mesh shrinkage, chronic pain, a heightened risk of infections, and voiding dysfunction, among other complications.
“Boston Scientific knew that some of the most serious risks it failed to include — chronic pain, infections and more — were associated with the use of its mesh devices. It also knew that the impact of these reactions would exponentially increase due to the difficulty of removing the mesh once implanted,” Ferguson’s office said in a statement.
“While Boston Scientific was putting income before the health of people in need of care, women were put in danger,” New York Attorney General Letitia James said in a statement cited by Reuters.
In 2019, the U.S. Food and Drug Administration ordered a stop to the sale of all surgical mesh products intended for transvaginal repair and pelvic organ prolapse. At the time of the order, the regulatory agency determined Boston Scientific and Denmark-based Coloplast A/S failed to demonstrate a reasonable assurance of safety and effectiveness for these devices.
In a statement issued at the time, the FDA said the companies “failed to provide an adequate assessment of the long-term safety of these devices and failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh (native tissue repair).”
Boston Scientific isn’t the only company that manufactured the surgical mesh units for this type of procedure. Johnson & Johnson and its Ethicon business unit paid out $117 million in a multistate settlement in 2019. Becton Dickinson reached a $60 million settlement last year, Reuters said.