FDA Issues Warning on Counterfeit Surgical Mesh
The Food and Drug Administration is warning 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 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:
- 0112650 – Bard Flat Mesh 2"x 4"- Lot 43APD007 and Lot 48HVS036
- 0112660 – Bard Flat Mesh 10"x 14" - Lot HURL0336 and Lot HUSD0629
- 0112680 – Bard Flat Mesh 3"x 6" - Lot 43HPD027, Lot 43HPD032, Lot HUSG0540, Lot 43HDP027, Lot HUSE0532, Lot 43LPD507, Lot HUSF0763, Lot 43IOD011, and Lot 43IPD038
- 0112720 – Bard Flat Mesh 6" x 6" - Lot 43FQD327
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.
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.
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.
At this time, FDA does not know if the counterfeit surgical mesh meets the authentic product's specifications, including its strength, sterility, or clinical performance. Assessment of the counterfeit mesh and its potential risk to health is ongoing.
Health care professionals who believe they have received counterfeit or suspect product are asked to contact FDA's Office of Criminal Investigations at 800-551-3989 or by visiting the Web site at www.fda.gov/OCI1.