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Counterfeit Polypropylene Surgical Mesh: Initial Communication

Tue, 06/08/2010 - 11:36am
U.S. Food & Drug Administration

Counterfeit flat sheets of polypropylene surgical mesh, used in the repair of hernias and chest wall defects, are being marketed in the United States, labeled with the C. R. Bard/Davol brand name. These products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturersâ?? polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. The product codes, sizes and lot numbers of the counterfeit product identified, to date, are noted in the linked Initial Communication, and recommendations/actions for healthcare professionals, healthcare facilities, and patients are provided.

Healthcare professionals and patients are encouraged to report adverse events, product problems, or suspected counterfeit product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Online: www.fda.gov/MedWatch/report.htm
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178

[03/11/2010 - Initial Communication - FDA]

    

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