FDA warns on fake surgical mesh

March 12, 2010 by MassDevice staff

The Food & Drug Administration issues a warning to healthcare providers about counterfeit surgical mesh products that ape C.R. Bard's Davol brand.

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The Food & Drug Administration is warning healthcare providers to be on the lookout for fake surgical mesh products that ape C.R. Bard's (NYSE:BCR) Davol Inc. brand, saying hospitals and surgical centers — not to mention patients with surgical mesh implants — should be especially vigilant.

The federal watchdog agency said four sizes of the counterfeit flat sheet polypropylene surgical mesh have been pegged by the FDA and Bard so far:

  • 0112650 – Bard Flat Mesh 2” x 4”: Lots 43APD007 and 48HVS036;
  • 0112660 – Bard Flat Mesh 10” x 14”: Lots HURL0336 and HUSD0629;
  • 0112680 – Bard Flat Mesh 3” x 6”: Lots 43HPD027, 43HPD032, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011 and 43IPD038;
  • 0112720 – Bard Flat Mesh 6” x 6”: Lot 43FQD327.

The FDA is recommending that healthcare professionals refrain from using any of the fake lots and take a close look at their surgical mesh inventories to weed out any of the identified fakes and report other suspicious-looking products. Any truly ersatz or suspected counterfeit mesh products should be reported to Bard by calling (800) 556-6275 and to the FDA’s Office of Criminal Investigations by calling (800) 551-3989 or visiting http://www.fda.gov/OCI.

The agency said it is still investigating the fake mesh to determine the extent of the risk to public health and to pin down the culprits. It's unclear whether the counterfeits meet the authentic product’s specifications for strength, sterility or clinical performance.

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