Boston Scientific Corp has agreed to a $188.6 million settlement to resolve claims that it falsely marketed the safety of its surgical mesh products for women.
Several state attorneys general announced the settlement on Tuesday. The $188.6 million will be split between 47 states and the District of Columbia.
The mesh products at the heart of the false marketing accusations are designed to be implanted in women to treat common health conditions such as urinary incontinence and other conditions that can result from a weakening of the pelvic region due to childbirth, age and other factors.
According to the attorneys general, Boston Scientific failed to disclose the full range of irreversible complications, such as chronic pain and voiding dysfunction, that can result from implanting mesh. The company’s mesh products have been implanted in millions of women.
"Boston Scientific's deception caused women to suffer in deeply personal ways," Washington state Attorney General Bob Ferguson said in a press release. "I hope this money will provide some measure of relief to the thousands of Washington women who live with the undisclosed side effects of these devices every day."
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In addition to the payment to the states and DC, Boston Scientific agreed to be subject to a number of marketing reforms. The company agreed to disclose the complications of implanting mesh in understandable terms in its marketing materials and refraining from representing the inherent risks of mesh as common to other types of treatment for the same conditions.
Boston Scientific will also be required to inform healthcare providers of the risk of significant complications resulting from their products’ use and disclose any potential conflicts of interest from sponsoring data or clinical studies regarding mesh that it publishes.
