Questions for the FDA

Questions for the FDA 

  1. 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?
  1. 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?
  1. 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?
  1. When will you make a decision on the petition to remove BSC’s surgical mesh from the market?
  1. Why rely on testing conducted by BSC to determine whether the counterfeit resin is tainted?
  1. Shouldn’t that be conducted by independent testing company?
  1. What are you doing to investigate the counterfeit allegations?
  1. Does Boston Scientific have FDA approval to use any resin other than the brand Marlex?