The FDA is warning that health care professionals may have been sold a counterfeit surgical mesh under the C.R. Bard brand name, which could put patients in danger.
The counterfeit surgical mesh warning, issued on March 11, alerts health care providers and consumers that someone is distributing fake polypropylene mesh products. The FDA is uncertain whether these copycats are safe to use on patients, as they have not been evaluated or approved by the agency. The FDA warns that it does not know if the patches are durable or even sterile.
The counterfeit surgical products have been falsely sold under the C.R. Bard/Davol brand name in a variety of sizes. The FDA has confirmed that the meshes are not manufactured by C.R. Bard, but did not release any information on who might be producing or selling the fake medical devices or whether anyone had been injured by a counterfeit mesh.
Health care providers should be on the lookout for Bard Flat Mesh 2” x 4” sheets with lot numbers 48HVS036 and 43APD007; 10” x 14” sheets with lot numbers HUSD0629 and HURL0336; 3” x 6” sheets with lot numbers 43HPD027, 43HPD032, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011 and 43IPD038; 6” x 6” sheets with lot number 43FQD327.
Surgical mesh is used by surgeons to shore up weakened soft tissue in the body to prevent hernias or rupturing. The meshes being counterfeited are sold as flat sheets of polypropylene.
Davol, a subsidiary of C.R. Bard, Inc. currently faces a number of legal problems over some of their real surgical mesh products. More than 1,000 Kugel Hernia Mesh lawsuits have been filed against the companies by individuals who say they suffered injuries due to defective meshes. At least three separate Kugel hernia patch recalls were issued by Bard and Davol between December 2005 and January 2007 for different types of hernia mesh, which have been associated with problems like intestinal pain, bowel perforation, intestinal fistula and additional surgery to remove the mesh. All of the lawsuits involve allegations that plaintiffs suffered severe injuries and potentially life-threatening complications from hernia surgery repairs caused by defective mesh manufactured by C.R. Bard, Inc. and Davol.
Any health care providers who believe they have received counterfeit surgical meshes should not use the products and should contact the FDA’s Office of Criminal Investigation at http://www.fda.gov/OCI.