The U.S. Food and Drug Administration is warning surgical facilities that counterfeit polypropylene surgical mesh products have been distributed under the Bard Davol brand.
The agency and the Murray Hill, N.J.-based manufacturer have at present identified 4 counterfeit products and 14 counterfeit lot numbers. Facilities that find any of the following products, sizes or lot numbers in their inventory are urged not to use them, says the FDA, as they have not been manufactured by Bard.
Bard Flat Mesh 2"x 4" (Catalog #0112650): Lot numbers 43APD007 and 48HVS036.
Bard Flat Mesh 10"x 14" (Catalog #0112660): Lot numbers HURL0336 and HUSD0629.
Bard Flat Mesh 3"x 6" (Catalog #0112680): Lot numbers 43HPD027, 43HPD032, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011 and 43IPD038.
Bard Flat Mesh 6" x 6" (Catalog #0112720): Lot number 43FQD327.
Facilities that discover any of these products are asked to contact Bard Davol at (800) 556-6275 and the FDA Office of Criminal Investigations at (800) 551-3989 or http://www.fda.gov/oci.
The FDA hasn't yet determined whether the fake mesh has the same properties as the genuine implants and advises providers to monitor their patients for adverse events related to the mesh. The agency hasn't yet announced suspects or arrests in the incident, and is presently assessing the method, scope and impact of the counterfeiting.
Kent Steinriede
