Warning by FDA on Counterfeit Surgical Mesh

  • Date: March 15, 2010
  • Source: admin
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A good surgical mesh product helps to reinforce soft tissues at the place of weakness, but a fake surgical mesh can augment health complications for the patients. Being known to the fact, FDA has issued a warning against using counterfeit polypropylene mesh products that are being marketed under the C. R. Bard/Davol brand name in the U.S.
This warning to avoid using fake surgical mesh goes mainly for the doctors along with their patients with surgical mesh implants, and also to hospitals and surgical centers, medical professionals and staff of the operating rooms, and purchasing and risk managers.
Till now, the FDA has identified thirteen lots of Bard Flat Mesh that were not actually made by the company. The counterfeit products come in following four sizes.
0112650 – Bard Flat Mesh 2”x 4”                                    
Lot 48HVS036
Lot 43APD007   
0112660 – Bard Flat Mesh 10”x14”     
Lot HUSD0629
                                                                                              Lot HURL0336
0112680 – Bard Flat Mesh 3”x 6”
Lot 43HPD027
                                                                                              Lot 43HPD032
                                                                                             Lot HUSG0540
                                                                                              Lot 43HDP027
                                                                                             Lot HUSE0532   
                                                                                              Lot 43LPD507
                                                                                          Lot HUSF0763
0112720 – Bard Flat Mesh 6” x 6”                  
Lot 43FQD327
FDA Recommendations
The FDA’s recommendations to the health care professionals are:
  • Stop using any of the fake Bard surgical mesh listed above
  •  Careful examination of all manufacturers’ polypropylene surgical mesh products and packaging for lot numbers will help them avoid using fake mesh
  • In case, someone buys a fake surgical mesh, contact Bard at 800-556-6275
  • In case of noticing anything unusual or suspicious with any other brand of surgical mesh product or packaging, contact the particular manufacturer
  • Extra attention in terms of regular monitoring of the patients with unauthentic surgical mesh has to be done from the physician’s end
  • Patients who are experiencing problem related to surgical mesh, contact their surgeon
FDA…Still Digging
The FDA is still digging more into discovering the info about who and how the this fake surgical mesh has come into being and what would be its potential health risks.
However, for further support and information or for filing a voluntary report, contact FDA’s Safety Information and Adverse Event Reporting Program.


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