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FDA Issues Alert on Counterfeit Polypropylene Mesh Used in Hernia Repair

The Food and Drug Administration (FDA) today alerted healthcare professionals to a counterfeit polypropylene mesh product labeled as PROLENE polypropylene mesh. The product is a non-absorbable mesh used in hernia repair and other surgery. The authentic PROLENE mesh is manufactured by Ethicon, Inc. Ethicon issued an alert to healthcare professionals about the counterfeit product on October 28.

Preliminary testing of the counterfeit PROLENE by FDA indicates that some samples are not sterile, although at this time FDA is not aware of a significant increase in the number of infections related to use of the counterfeit product. Additional preliminary testing indicates that the counterfeit product has a molecular structure similar to other polypropylene mesh products currently on the market. FDA is continuing to test the material.

FDA is continuing to investigate whether the counterfeit product is still being marketed. In the meantime, FDA recommends that healthcare professionals carefully examine all polypropylene mesh products and not use any suspected of being counterfeit. If they believe the counterfeit product may have been implanted in patients, they should continue to monitor the patients as they would any patient with a polypropylene mesh implant. Although FDA has not had reports of excess infections with the counterfeit product, the agency continues to be concerned about sterility.

The counterfeit mesh is labeled with lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07). It can be further identified by one of the following:

• A packaging seal that does not tear open smoothly;
• An additional small seal on top corner edges of the package;
• A fabric end that is jagged or not cleanly cut on the 3” side; and
• An Ethicon logo in a thicker than usual typeface.

In a Public Health Notification issued today, FDA encouraged the medical community to report adverse events related to the counterfeit mesh to the FDA through procedures established by their medical facility or through MedWatch, the FDA’s voluntary reporting program.

The “Public Health Notification on Counterfeit Polypropylene Mesh” is available at http://www.fda.gov/cdrh/safety/121903.html.

Ethicon also manufactures PROLENE sutures, which are not the subject of this alert.

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