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.
Lot 43APD007
Lot 48HVS036
0112660 – Bard Flat Mesh 10 x 14 in.
Lot HURL0336
Lot HUSD0629
0112680 – Bard Flat Mesh 3 x 6 in.
Lot 43HPD027
Lot 43HPD032
Lot HUSG0540
Lot 43HDP027
Lot HUSE0532
Lot 43LPD507
Lot HUSF0763
Lot 43IOD011
Lot 43IPD038
0112720 – Bard Flat Mesh 6 x 6 in.
Lot 43FQD327

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.


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