Boston Scientific has found itself caught in a tangled web as accusations fly over the sourcing of the resin in its vaginal mesh, which lawyers now say "should be banned outright" by the FDA.

The Houston-based Mostyn Law recently petitioned the FDA to recall Boston Scientific’s surgical mesh products, allegedly made of defective, counterfeit material from China. It revealed excerpts from Boston Scientific emails to illustrate the lengths the company went to regarding the material, and has made racketeering charges.

“The FDA needs to do its job and ban this outright," attorney Amber Mostyn said in a statement. “Acknowledging there is a problem is not enough. It’s like a firefighter watching a building burn while warning us not to play with matches.”
“They knew they could not verify the authenticity of this plastic resin that they found in a warehouse in China from a known counterfeiter,” Mostyn continued. “They bought it anyway and have been implanting it potentially into tens of thousands of women.”

About 55,000 women receive Boston Scientific’s pelvic mesh annually. The company has $120 million in yearly revenues from the material.

"Boston Scientific does not use 'counterfeit' or 'adulterated' materials in our medical devices. The company rejects the allegations in the petition to the Food and Drug Administration filed by a Texas-based law firm on March 31, 2016," the company responded in a statement.

“At Boston Scientific, patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products,” spokesman Tom Keppeler told the Boston Globe. “We don’t believe the case has merit and intend to vigorously defend these claims.”

The FDA, for its part, took a measured approach to the allegations, stating that it, "is aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material," it announced in a statement on the controversy. The agency noted that "it is not uncommon for a firm, based on its own appropriate evaluation of potential suppliers and raw material, to change the source of a raw material after the device has been cleared by the FDA, and such a change often does not require FDA premarket review."

The agency is now having Boston Scientific conduct additional tests on the material, which it noted include, "chemical characterization and toxicological risk assessment of the raw material alleged to be counterfeit, as well as chemical characterization and biocompatibility of the final finished urogynecologic surgical mesh."

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