New York 12/1/2010 1:39:15 AM
News / Health & Wellness

Counterfeit Surgical Mesh Update Released by FDA

The FDA has received more information on the counterfeiting of the Marlex mesh, also known as the Bard flat polypropylene surgical mesh. The FDA first warned of the counterfeit surgical mesh products early in 2010. The counterfeit surgical meshes were not manufactured by C.R. Bard, but carried the Bard/Davol label. These products were distributed between Oct. 21, 2008 and Oct. 27, 2009. 

FDA testing has discovered that the counterfeit meshes are not sterile, even though they are labeled as such. The implantation of unsterilized meshes can increase a patient’s risk of infection. FDA testing has also revealed that the counterfeit mesh has a different weave pattern and structure than the original. Furthermore, the counterfeit may not have well-finished edges which could permit the mesh to unravel.

The counterfeit surgical meshes were sold by RAM Medical Inc. to the following companies: Amerimed Corporation; Medline Industries; Henry Schein Inc.; Marathon Medical Corporation; MMS – A Medical Supply Company; and Q-Med Corporation. These distributors then sold the counterfeit products to hospitals. RAM Medical has issued a recall of the counterfeit meshes. 

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