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news.US FDA has issued warning to health care providers and consumers in regard to counterfeit surgical mesh being distributed in the US under the C R Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.
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The warning is also of particular significance to patients with surgical mesh implants, and also 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. Till date, four product sizes have been identified: 0112650 – Bard Flat Mesh 2”x 4”; Lot 43APD007 Lot 48HVS036 ; 0112660 – Bard Flat Mesh 10”x 14”; Lot HURL0336 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; Lot 43IPD038 0112720 – Bard Flat Mesh 6” x 6”; and Lot 43FQD327.
FDA has recommended healthcare professionals not to use any counterfeit Bard surgical mesh from the lots listed, carefully examine all manufacturers’ polypropylene surgical mesh products and packaging for lot numbers.
The agency also recommended 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.
As of now, the FDA does not know if the counterfeit surgical mesh meets the authentic product’s specifications, including its strength, sterility, or clinical performance. The FDA assessment of the counterfeit mesh and its potential risk to health is ongoing.