Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Initial Communication
MedSun: Newsletter #47, April 2010
FDA Medical Device Safety
Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes 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 Initial Communication linked under Additional Information below. Recommendations and actions for healthcare professionals, healthcare facilities, and patients are also provided.
Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Initial Communication. FDA Medical Device Safety. March 11, 2010.