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After facing thousands of vaginal mesh lawsuits brought by women who suffered devastating injuries after receiving pelvic support products sold by Boston Scientific, the company now faces an investigation by federal regulators who are examining whether counterfeit raw materials were used in the surgical mesh.
The FDA issued a safety alert on April 1, indicating that it is aware of allegations that the medical device manufacturer used counterfeit resin in urogynecologic surgical mesh products. The agency now has Boston Scientific conducting additional testing to see if those materials are as safe and effective as other materials it used in transvaginal mesh and bladder sling products.
The agency indicates that it is not aware of any evidence that the allegedly counterfeit material contributed to complications associated with vaginal mesh, and states that it is not unusual for a company to change the source of a raw material without notifying the agency. However, the allegations raised enough concern that the agency called on the company to conduct additional testing.
That testing will involve chemical characterization and toxicological risk assessments of the raw material, as well as the final mesh’s chemical characterization and biocompatibility. The testing will not be finished for several months.
The concerns were raised as part of the ongoing Boston Scientific mesh litigation, where more than 20,000 women nationwide have indicated that they suffered painful and debilitating injuries when the pelvic support product migrated through the vagina, caused internal injuries and infections.
The FDA investigations was launched following allegations raised in a lawsuit filed by Teresa Stevens, who alleged that Boston Scientific and its subsidiaries conspired to import counterfeit resin from China for use in its Advantage mesh. A petition filed with the FDA calls for a ban and Boston Scientific mesh recall.
On April 1, in response to the allegations, Boston Scientific issued a press release denying the use of counterfeit resin. The company said it has used Marlex HGX-030-01, a polypropylene resin.
“In 2011, we located a new supplier of Marlex resin,” the company said in its press release. “Upon doing so, we put samples of the resin through a rigorous battery of tests to demonstrate equivalency. In addition, we conducted extensive mechanical tests to ensure that our mesh products manufactured with the newly sourced material met product specifications.”
While the additional testing is ongoing, the FDA indicates that health care professionals and patients should be aware of the investigation and the agency’s plan to review the additional data so they can make the most informed health care decision possible.
The agency is not recommending women with the Boston Scientific Advantage mesh that may contain the alleged counterfeit material have the devices removed, indicating that the risks of explant surgery outweigh any risks currently known to be caused by the material itself.