MB: FDA is warning healthcare professionals and medical facilities about counterfeit versions of polypropylene surgical mesh. These products are labeled with the C.R. Bard/Davol brand name, but they were not manufactured by Bard.
AR: FDA is investigating this situation. We're testing samples of the counterfeit mesh to see whether it meets the authentic product specifications, including strength, sterility and performance. We're also working to find out who may be responsible for the counterfeiting and how the distribution occurred.
MB: Here are FDA's recommendations for healthcare professionals and facilities: First, if you have surgical mesh labeled as C.R. Bard, check your stock against the sizes and lot numbers of the counterfeit products. You'll find that information on our website. If your mesh matches any of the counterfeit sizes and lots, don't use it. Examine polypropylene mesh products from all manufacturers for anything unusual that might indicate the product could be counterfeit. If you think your mesh may be counterfeit, contact the manufacturer listed on the label. Also contact the FDA's Office of Criminal Investigations at 1-800-551-3989. If you suspect that a counterfeit mesh was implanted in a patient, monitor the patient as you would with any polypropylene mesh implant. And finally, report any adverse events to FDA's MedWatch program.

标题
Counterfeit Surgical Mesh (FDA)

视频介绍
FDA Patient Safety News - May, 2010 - Show #98
FDA is warning healthcare professionals and medical facilities about counterfeit versions of polypropylene surgical mesh.