Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) is warning health care professionals, hospital personnel and patients that counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States and labeled with the C.R. Bard/Davol brand name. Four products have been identified to date as not being Bard-manufactured products. These products are used to reinforce soft tissue where weakness exists in the repair of hernias and chest wall defects.

The recalled products include specific lots of Bard Flat Mesh 2” x 4”, Bard Flat Mesh 10” x 14”, Bard Flat Mesh 3” x 6”, and Bard Flat Mesh 6” x 6”. Health care professionals are urged not to use any surgical mesh labeled C.R. Bard from the recalled list. Before using any manufacturer’s polypropylene surgical mesh products they also should examine it for anything that may look counterfeit. Although counterfeiting of surgical mesh has occurred in the past, the FDA is not aware of other counterfeit mesh products being distributed at this time.

If there is a risk that a patient has been implanted with the counterfeit product, health care professionals are urged to monitor the patient for adverse events as would be done with any patient with an authentic polypropylene surgical mesh implant. Any adverse events with this or any other product should be reported to the FDA MedWatch Adverse Events Reporting program at www.FDA.gov/MedWatch.

Any health care establishment that believes it has received counterfeit or suspect products should contact the FDA’s Office of Criminal Investigations at 800-551-3989 or by visiting the Office of Criminal Investigations Web site. Patients with concerns should contact their surgeons with any questions.

This entry was posted on Tuesday, March 16th, 2010 at 2:15 pm and is filed under News, product liability, recalled products. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.