A Texas law firm last week urged federal officials to recall surgical mesh products amid allegations that they were made from counterfeit and defective material smuggled from China. Boston Scientific Corp., however, denied the accusations and said that its materials went through “a rigorous battery of tests.”
In its petition to the U.S. Food and Drug Administration, Mostyn Law alleged that Boston Scientific bought more than 34,000 pounds of synthetic resin from a suspected counterfeiter in China in 2011 and 2012. The firm said that after Boston Scientific’s U.S. manufacturer suspended sales of Marlex resin for surgical mesh, it used mesh products made from counterfeit material after running out of its FDA-approved supply. Tests showed “significant differences between the Chinese resin and certified Marlex,” including the presence of selenium in the former that can degrade both the plastic and surrounding tissue.
Mostyn, which cited internal company emails in its petition, filed on behalf of Teresa Stevens, a West Virginia woman who allegedly suffered health problems due to a Boston Scientific implant and the lead plaintiff in a federal class-action suit against the company. The racketeering lawsuit filed in January is on hold, the firm said, after the judge decided to give the FDA — the agency with authority over medical device recalls — additional time to act.
“The FDA needs to do its job and ban this outright. We’ve clearly documented the health risks,” said attorney Amber Mostyn in a release. “Acknowledging there is a problem is not enough. It’s a like a firefighter watching a building burn while warning us not to play with matches.”
Boston Scientific officials responded that changing suppliers of resin and other raw materials is common in the medical device industry, and that the company’s new source conformed to strict quality standards after its 2011 switch.
The company added that its test data was shared with the FDA and that it offered to conduct further tests over the next several months. “We have the highest confidence in the safety of our mesh devices,” the company said in a statement.
