FDA Updates Warning To Providers On Counterfeit Surgical Mesh
Published: June 11th, 2010
Washington, DC. June 10 -- The Health Forum issued the following news release: The Food and Drug Administration today alerted hospitals and others not to use certain surgical mesh products that have been identified as counterfeit and are not sterile, although labeled as so. The counterfeit mesh, which has been recalled, may increase the risk of infection if implanted in a patient and may not meet other specifications of the authentic product, the FDA said. The mesh is labeled with the C.R. Bard/Davol brand name, but was not made by Bard. RAM Medical sold the counterfeit products to six distributors, who distributed them to hospitals or possibly other distributors. For more information, see the FDA notice (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm203886.htm).
(2010 Targeted News Service)
FDA’s notice includes the following information:
FDA is updating its Initial Communication on counterfeit polypropylene surgical mesh, which was issued on March 11, 2010.
Various sizes of counterfeit flat sheets of polypropylene surgical mesh have been marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes, specifically identified below, are not Bard-manufactured products. Surgical meshes of this kind are used to reinforce soft tissue where weakness exists, such as in the repair of hernias and chest wall defects.
Here is what FDA has found in its laboratory analysis of the counterfeit mesh samples to date: The counterfeit samples are not sterile although labeled as sterile, which may mean increased risk for infection if implanted in a patient.
They have a weave pattern and structure that is different from the authentic mesh. For example, the counterfeit mesh weave openings are larger than the authentic mesh.
The counterfeit mesh does not have properly finished selvage edges as compared to the authentic mesh, which may allow the counterfeit mesh to unravel. The counterfeit mesh edges appear to be cut using heat, as the edge is fused or melted together.
The packaging of the counterfeit samples is different from that of the authentic mesh.
The expiration dates shown on the labeling of some of the counterfeit product samples do not match. The counterfeit mesh may not meet the authentic product's specifications, including strength and clinical performance.
FDA is continuing to test samples of the counterfeit mesh and will update this communication if additional information becomes available. FDA is also
investigating to determine who is responsible for the counterfeiting and how the counterfeiting and distribution occurred.
Summary of Problem and Scope:
FDA's and Bard's investigations found the counterfeit product is labeled with the following product codes, sizes and lots of Bard Flat Mesh (commonly known as Marlex mesh). Investigations found most of the counterfeit product is labeled with genuine Bard lot numbers. To date, four product sizes have been identified:
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Product Codes and Sizes
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Lot Numbers
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0112650 – Bard Flat Mesh 2" x 4"
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Lot 48HVS036
Lot 43APD007 |
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0112660 – Bard Flat Mesh 10" x 14"
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Lot HUSD0629
Lot HURL0336 |
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0112680 – Bard Flat Mesh 3" x 6"
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Lot 43HPD027
Lot 43HPD032 Lot 43HPD034 Lot HUSG0540 Lot 43HDP027 Lot HUSE0532 Lot 43LPD507 Lot HUSF0763 Lot 43IOD011 Lot 43IPD038 |
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0112720 – Bard Flat Mesh 6" x 6"
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Lot 43FQD327
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These counterfeit products were distributed from October 21, 2008 to October 27, 2009.
Although counterfeiting of surgical mesh has occurred in the past, we are not aware of any other counterfeit mesh products being distributed at this time.
Voluntary Recall:
RAM Medical, Inc., a medical product distributor located in Wayne, New Jersey, initiated a voluntary recall of one lot of the counterfeit surgical mesh on March 5, 2010. RAM Medical expanded the recall on March 15, 2010 to include all of the above lots.
RAM Medical sold the counterfeit products to the distributors below, who then distributed them to hospitals or possibly other distributors:
Amerimed Corporation
Henry Schein Inc.
Marathon Medical Corporation
Medline Industries
MMS - A Medical Supply Company
Q-Med Corporation
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