Counterfeit surgical mesh reaches the U.S. market: how to spot the sham version

OB/GYN News, Dec 15, 2003 by Elizabeth Mechcatie

A counterfeit version of Prolene nonabsorbable surgical mesh has been found on the market, according to Ethicon Inc., the manufacturer of the authentic product.

In a "Dear Healthcare Professional" letter posted on the Food and Drug Administration's Medwatch Web site, Ethicon described features that can help distinguish the authentic mesh from the counterfeit version. The sham product has been found only in the United States.

Prolene is a nonabsorbable polypropylene mesh product used in the repair of hernias and other fascial deficiencies when reinforcing or bridging material is needed to obtain the desired surgical result.

The counterfeit product is labeled as Prolene polypropylene mesh and has a product code of PMII, with lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07). it is a flat mesh product, measuring 3 inches by 6 inches.

The Ethicon logo is in a bolder typeface on the outside package of the sham product, which may also have a packaging seal that "does not tear open smoothly" and may have an additional small seal on the corner edges, according to the letter.

The counterfeit product has clear tape where the box is opened and may also have an orange dot on the outside package, features that are not found on the authentic product.

The edge of the fabric on the 3-inch side is jagged and not cut cleanly on the counterfeit version, but is smooth on the authentic version. The counterfeit mesh is described as having "a tighter weave that is asymmetrical"; the authentic product has "a more open, linear weave."

The company can be reached by calling 877-ETHICON.

The Ethicon letter and photos comparing different features of the authentic and counterfeit products are available at www.fda.gov/medwatch/SAFETY/2003/prolene.htm.>

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