FDA Warns Of Possible Counterfeit Materials In Boston Scientific Mesh
This article was originally published in The Gray Sheet
Executive Summary
The company changed suppliers of a plastic resin called Marlex in 2011, and FDA is investigating allegations that resin from the new supplier wasn’t properly tested for safety. The FDA safety alert closely follows a citizen petition requesting that mesh made with the resin be recalled on the same grounds. However, Boston Scientific says the resin was tested and proven to be safe.