Counterfeit Surgical Mesh Found
FDA has issued a warning to healthcare providers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. To date, investigations have identified four product sizes as counterfeit flat sheet polypropylene surgical mesh:
0112650 – Bard Flat Mesh 2 x 4 in.
0112660 – Bard Flat Mesh 10 x 14 in.
0112680 – Bard Flat Mesh 3 x 6 in.
0112720 – Bard Flat Mesh 6 x 6 in.
Healthcare pracitioners are advised to examine all manufacturers’ polypropylene surgical mesh products and packaging for lot numbers and anything unusual that might indicate counterfeit mesh and to not use any counterfeit Bard surgical mesh from the lots listed. They should also contact the particular manufacturer if they notice anything unusual or suspicious with any other brand of surgical mesh product or packaging.
FDA reports that it is working to determine who may be responsible and how the counterfeiting and distribution occurred. FDA's assessment of the counterfeit mesh and its potential risk to health is ongoing.
Surgical mesh has been counterfeited before. In 2003 Ethicon reported that its Prolene polypropylene mesh had been counterfeited. FDA’s testing of the counterfeit polypropylene mesh had indicated that some samples were not sterile.
Health care professionals who believe they have received counterfeit or suspect product are asked to contact FDA’s Office of Criminal Investigations at 800-551-3989 or by visiting the Web site at http://www.fda.gov/OCI1.