FDA Warns About Counterfeit Surgical Mesh

Counterfeit versions of a polypropylene surgical mesh, which are fraudulently labelled as originating from medical device company C R Bard have surfaced in the US market, according to the Food and Drug Administration.

The flat sheets of mesh mimic products sold by Bard for use in the repair of hernias and chest wall defects under the Bard or Davol brand names, but are not Bard-manufactured products, said the agency in a statement released on March 11.

There is no evidence to date whether anyone has been harmed by the use of the fakes, according to the FDA, but the copies could lack the originator products’ qualities with regard to strength, sterility and clinical performance.

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, it added.

Source – securingpharma.com, March 2010

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