FDA Alerts Industry to Counterfeit MeshFDA Alerts Industry to Counterfeit Mesh

Originally Published MDDI February 2004

NEWSTRENDS

FDA has issued a public health notification asking healthcare professionals to beware of counterfeit polypropylene mesh used in the repair of hernias and other fascial deficiencies.

In October 2003, Ethicon Inc. (Somerville, NJ), a Johnson & Johnson (J&J) company, issued an alert that its polypropylene mesh product, Prolene, had been counterfeited. 

The FDA report, released December 19, 2003, states that some samples of the counterfeit material are not sterile, though the agency is unaware of a significant increase in infections related to it. In particular, the presence of Bacillus cereus, Bacillus licheniformis, Bacillus amyloliquefaciens, and Bacillus subtillis has been detected in counterfeit material. It has also been found that the counterfeit product has a molecular structure similar to the legitimate product. As of the report date, FDA had not determined whether the counterfeit mesh was still being marketed. 

The agency advised healthcare professionals to carefully examine all polypropylene mesh products, to not use any suspected of being counterfeit, and to contact their distributors if they do have such a suspicion. The FDA report also advised that if a healthcare professional suspects a counterfeit product was implanted in a patient, that patient should be monitored as any other would be. Any reportable adverse events related to the counterfeit product should be sent directly to the agency.

The counterfeit mesh is labeled with lot numbers RBE609 (expiration date January 2007) and RJJ130 (expiration date July 2007). It may have a packaging seal that does not open smoothly, an additional small seal on top corner edges of the package, a fabric end that is jagged or not cleanly cut, and an Ethicon logo with a thicker-than-usual typeface. 

This incident and others have prompted a change in J&J's distribution policy. In December 2003, the firm announced it would sell devices, diagnostics, drugs, and biologics only to U.S. wholesalers that buy its products only from J&J. Those who buy J&J products from other sources will no longer be allowed to do business with J&J as of March 2004. The policy aims to eliminate the “secondary market” for healthcare products, one that has been linked to past counterfeiting incidents. J&J is believed to be the first firm to institute such a policy on a companywide basis.

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