Questions for the FDA
- How can a company be allowed to make surgical mesh from a product that the manufacturer says should never be used in the human body?
- How can company be allowed to make surgical mesh from a “Chinese-sourced” version of a product that the U.S. manufacturer says should never been used in the human body?
- Are you going to continue to allow Boston Scientific to put the health and safety of women at risk by implanting surgical mesh made from a known dangerous product into their uteruses?
- When will you make a decision on the petition to remove BSC’s surgical mesh from the market?
- Why rely on testing conducted by BSC to determine whether the counterfeit resin is tainted?
- Shouldn’t that be conducted by independent testing company?
- What are you doing to investigate the counterfeit allegations?
- Does Boston Scientific have FDA approval to use any resin other than the brand Marlex?