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U.S. Department of Health and Human Services

Safety

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Prolene Mesh Dear Healthcare Professional Letter Nov 2003

The following is the text of a letter from Ethicon, Inc. Contact the company for a copy of any referenced enclosures.


Updated November 3, 2003

Dear Healthcare Professional:

ETHICON, INC. recently became aware of the existence of counterfeit mesh product labeled as PROLENE* polypropylene mesh product code PMII, bearing lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07).  This is a PROLENE flat mesh product (3" x 6").  As ETHICON did not manufacture this product, we cannot confirm the mechanical properties, biocompatibility or sterility of this material.  We want health care professionals to be aware of this situation so you can appropriately consider potential health risks to patients. 

PROLENE mesh is a nonabsorbable mesh used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.  

Physicians, nurses and all other healthcare professionals should carefully examine all PROLENE flat mesh product (3" x 6") before use.  The counterfeit product deviates from authentic PROLENE mesh in that the counterfeit product may exhibit the following:

  • Have a packaging seal that does not tear open smoothly.  Also, on top corner edges of the package, there is an additional small seal.

  • Have a fabric end that is jagged, not a clean cut on the 3" side

  • ETHICON logo appears in a thicker typeface

Please convey this information to your staff and any others who use PROLENE flat mesh in the operating room, so that they will be able to identify the characteristics of  suspect counterfeit product.

If you receive any product that you suspect is counterfeit, do not use the product.  Quarantine product to ensure it will not be used. 

Counterfeit product would have entered the supply chain at the distributor level. Therefore, if you suspect that you may be in possession of counterfeit product labeled as PROLENE Mesh, you should contact your distributor to discuss refund/replacement of the product.

If you have medical questions regarding suspected counterfeit product, please contact the ETHICON customer service center at 1-877-ETHICON.

 

ETHICON is working with the FDA to investigate this matter and prevent the further distribution of counterfeit product. As of October 24, ETHICON is aware of the distribution of counterfeit product in the U.S. only.

 

Full product information and updates on this situation will be available at www.ETHICON.com.

 

 

Joel Lippman, M.D.
Worldwide Vice President

Chief Medical Officer
Medical Affairs - ETHICON

 *Trademark of ETHICON, Inc.