The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.
The warning is of particular significance to health care professionals and their patients with surgical mesh implants as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers.
Investigations by the FDA and Bard show that the following products, sizes and lots of counterfeit flat sheet polypropylene surgical mesh are not manufactured by Bard. To date, four product sizes have been identified:
The FDA is recommending that health care professionals:
Do not use any counterfeit Bard surgical mesh from the lots listed
Carefully examine all manufacturers' polypropylene surgical mesh products and packaging for lot numbers and anything unusual that might indicate counterfeit mesh
Contact Bard at 800-556-6275 if they think they have one of the counterfeit products
Contact the particular manufacturer if they notice anything unusual or suspicious with any other brand of surgical mesh product or packaging.
The FDA also recommends that health care professionals continue to monitor patients for adverse events as they would any patient with an authentic polypropylene surgical mesh implant, if they suspect or know that counterfeit mesh has been implanted.
Patients should contact their surgeon if they experience problems that they think may be related to surgical mesh.
The FDA continues to gather information and data on the counterfeit mesh to better understand its potential public health impact. The agency also is working to determine who may be responsible and how the counterfeiting and distribution occurred.