FDA Warns On Counterfeit Surgical Mesh

The U.S. Food and Drug Administration (FDA) just issued a warning targeted to surgical services managers, and risk managers regarding counterfeit flat sheets of polypropylene surgical mesh, which are used in the repair of hernias and chest wall defects. The <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">counterfeit surgical mesh products are being marketed in the United States and are labeled with the C. R. Bard/Davol brand name.

According the FDA, these products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers’ 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 on the FDA’s Web site at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm203886.htm. Recommendations and actions for healthcare professionals, healthcare facilities, and patients are also 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 at: www.fda.gov/MedWatch/report.htm; by toll-free telephone at: 1-800-332-1088; by fax at: 1-800-FDA-0178; and by mail at: (return the postage-paid FDA form 3500, which may be downloaded from the MedWatch Download Forms page at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm) to the address on the pre-addressed form.

According the FDA, these products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers’ 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 on the FDA’s Web site at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm203886.htm. Recommendations and actions for healthcare professionals, healthcare facilities, and patients are also 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 at: www.fda.gov/MedWatch/report.htm; by toll-free telephone at: 1-800-332-1088; by fax at: 1-800-FDA-0178; and by mail at: (return the postage-paid FDA form 3500, which may be downloaded from the MedWatch Download Forms page at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm) to the address on the pre-addressed form.

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