- Agency not aware of any harm from alleged counterfeit
- Company is conducting additional tests on safety of product
Allegations that Boston Scientific Corp.’s surgical mesh, used in gynecological operations, may contain counterfeit raw material are being examined by U.S. regulators.
The company is performing tests on the raw materials in question to determine if they will have any impact on the safety and effectiveness of the finished product, the U.S. Food and Drug Administration said in a statement on its website. The agency said it’s not aware of any harm that may stem from the allegedly counterfeit material.
Boston Scientific rejected allegations that it used any counterfeit or adulterated raw materials. In a statement in response to a petition to the FDA filed by a Texas-based law firm on March 31, the company said it has a robust quality control program and stands by the medical devices.
“We have the highest confidence in the safety of our mesh devices,” the company said in the statement. “We have shared or test data with the Food and Drug Administration, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions.”
The additional tests, including chemical characterization, toxicological risk and biocompatibility studies, will take several months to complete, the FDA said. While the agency may be able to determine the product’s safety once the results are in, health-care professionals and women should be made aware of the investigation until they are available, the agency said.
The FDA isn’t recommending removing surgical mesh that has already been implanted, saying the risks of removal may outweigh any theoretical danger women currently face.