FDA Probes Allegations Of 'counterfeit' Boston Scientific Surgical Mesh

April 07, 2016

By: Sabiya khan

medsearch

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.

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."