By Robert Weisman GLOBE STAFF APRIL 01, 2016
Federal regulators said Friday that they are examining allegations Boston Scientific Corp. used counterfeit raw material in vaginal mesh implants that treat urinary incontinence and other pelvic organ problems in women.
The Food and Drug Administration disclosed the probe as it issued a safety alert about the products. The agency didn’t recommend women remove the implants.
“Available data do not suggest any decreased benefit associated with the device,” the FDA said. However, the alert said, “the FDA believes that health care professionals and their patients should be aware of this investigation.”
FDA officials also said Boston Scientific will conduct new tests on the safety and effectiveness of the product — technically called urogynecologic surgical mesh — over the next few months, and the agency will review the results.
In a statement, Marlborough-based Boston Scientific said it “does not use ‘counterfeit’ or ‘adulterated’ materials” in its medical devices.
“We have the highest confidence in the safety of our mesh devices,” the statement said. “We have shared our test data with the FDA, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions.”
Boston Scientific and other companies that market vaginal mesh implants have been the targets of thousands of lawsuits over the past decades by women who have used the products to fix a common gynecologic condition called pelvic organ prolapse. Many have reported painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding.
In its safety alert, the FDA said it “is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products.”
Mostyn Law, a Houston law firm, in January filed a suit in US court in West Virginia accusing Boston Scientific of selling defective vaginal mesh implants made from materials smuggled from China, and putting the health of thousands of women at risk. The suit, which seeks class-action status, asks for unspecified damages for as many as 55,000 women a year who received the mesh product since 2012.
Boston Scientific denied the charges and said it would vigorously fight the suit. The company, which already faces about 30,000 lawsuits for its vaginal mesh products, paid $119 million last year to settle about 3,000 of these cases.
Mostyn Law petitioned the FDA on Thursday seeking a recall of Boston Scientific’s mesh products. But an FDA spokeswoman said Friday that the agency had not received the petition and declined to comment on it.
Amber Mostyn, an attorney at Mostyn Law, faulted the FDA for not recalling the product, saying “it is absurd to rely on testing by the company.”