FDA Warns of Counterfeit C.R. Bard/Davol Surgical Mesh

U.S. Food and Drug Administration has warned healthcare providers and patients about counterfeit surgical mesh being distributed in the United States under the C.R. Bard/Davol brand name, according to an FDA news release.

The warning is of particular significance to healthcare professionals, patients with surgical mesh implants, hospitals and surgical centers, operating room medical professionals and staff and purchasing and risk managers, according to the release.

FDA and Bard determined through its investigations that the following products (including sizes and lots) of flat sheet polypropylene surgical mesh are counterfeit and not manufactured by Bard. They are:

• 0112650 – Bard Flat Mesh 2" x 4"
  • Lot 43APD007
  • Lot 48HVS036
• 0112660 – Bard Flat Mesh 10" x 14"
  • Lot HURL0336
  • Lot HUSD0629
• 0112680 – Bard Flat Mesh 3" x 6"
  • 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"
  • Lot 43FQD327

The FDA recommends that healthcare professionals not use any of the surgical mesh from the lots listed and examine all manufacturers' polypropylene surgical mesh for anything that may be unusual or indicate a counterfeit, according to the release. The FDA also suggests that professionals contact Bard (1-800-556-6275) or other manufacturer if anything unusual or suspicious is observed.

If a patient is suspected or known to have been implanted with counterfeit mesh, the FDA recommends that healthcare professionals continue to monitor them for adverse events as they would any other patient with an authentic mesh implant, according to the release.

Further information on counterfeit mesh is available on the FDA's Web site.

Read the FDA's report about counterfeit surgical mesh.