Boston Scientific Corp. owes Vermont $1.1 million after failing to properly inform women about serious and sometimes permanent risks associated with its surgical mesh product.
On Tuesday, Attorney General TJ Donovan announced Vermont’s involvement in the multi-state settlement against BSC, which will pay $188.6 million to a total of 47 states and Washington D.C.
Surgical mesh, a synthetic woven fabric used to treat a variety of common conditions — such as stress urinary incontinence and pelvic organ prolapse — has caused serious complications in women, including infection, fistula formation, sexual dysfunction, bruising, bleeding and new incontinence.
Donovan argued in a complaint that the company violated Vermont’s Consumer Protection Act by “engaging in unfair and deceptive acts and practices, including deceiving consumers by misrepresenting the safety and efficacy of its Surgical Mesh devices and failing to disclose risks and complications associated with their use.”
“Boston Scientific’s misrepresentations denied women the ability to make informed decisions about whether to permanently implant surgical mesh into their bodies,” he said in a statement.
The mesh is implanted surgically through the vagina, and some of the complications caused by the procedure can be irreversible, according to a stipulated judgment, which has been submitted for court approval. The company must now clearly state that “complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications.”
Traditional tissue repair is as effective as surgical mesh, the attorney general notes, but despite that, the mesh has been implanted into millions of women across the country, and thousands have reported serious complications.
It’s unclear how many women in the state have suffered after using the product, but Donovan notes that “Vermont consumers have suffered substantial injury by reason of the health effects and risks associated with the use of Defendant’s Surgical Mesh, as well as the associated financial costs.”
“Vermont had a very small share of the Boston Scientific surgical mesh market,” said Charity Clark, Donovan’s chief of staff. “The settlement is a good result for Vermont.”
Vermont has been involved in several multi-state settlements against manufacturers of surgical mesh. In 2019, the state received $1.37 million from Johnson & Johnson and its subsidiary, Ethicon Inc., for failing to accurately represent the risks of transvaginal mesh products. In September, the state won another $600,000 in a settlement against C.R. Bard, Inc. and its parent company Becton, Dickinson and Co. for the same reasons.
The terms of the settlement require the company to describe potential complications in understandable terms, disclose significant complications and refrain from equating the risks of mesh to other pelvic surgeries that do not involve mesh.
BSC must also “refrain from representing that surgical repair is superior to native tissue repair” without scientific evidence, inform healthcare providers about complications during training, and register all clinical studies related to mesh with clinicaltrials.gov.
In April of 2019, the Food and Drug Administration ordered BSC and Danish company Coloplast, the two remaining manufacturers of surgical mesh, to stop selling the products to treat pelvic organ prolapse, a condition in which weakened muscles in the pelvic area cause organs to shift from their natural positions.
While BSC stopped selling surgical mesh for treatment of pelvic organ prolapse, the company has continued selling the product to treat stress urinary incontinence, according to Donovan’s complaint.
