Sham Prolene not sterile
This article was originally published in The Gray Sheet
Executive Summary
Initial tests of counterfeit polypropylene mesh find bacillus cereus, licheniformis, amyloliquefacien and subtilis, but no "significant increase" in infections related to use of the device, FDA says in Dec. 19 alert. The agency will continue to test the fraudulent material and investigate whether the fake Prolene is still being sold. In October, J&J/Ethicon announced the product had hit at least 22 states (1"The Gray Sheet" Nov. 10, 2003, p. 11)...