Monday, March 15, 2010

FDA: Beware of Fake Surgical Mesh

The FDA cautioned healthcare professionals and consumers about counterfeit surgical mesh products marketed as a known brand of the soft tissue support product.

The fake mesh is marketed under the C. R. Bard/Davol name, with a number of fake lot numbers on the label.

The FDA has not received any adverse event reports from doctors or patients who have used the counterfeit, but the agency cautioned healthcare professionals that the strength, sterility, and clinical performance of the fake have not been evaluated and may be suspect, the agency said in a statement.

The FDA said it's trying to find out who's running the counterfeiting operation.

The real C. R. Bard/Davol and the FDA identified products with these lot numbers as fakes:

* Bard Flat Mesh 2" x 4" Lot 48HVS036 and 43APD007
* Bard Flat Mesh 10" x 14" Lot HUSD0629 and HURL0336
* Bard Flat Mesh 3" x 6" Lot 43HPD027, 43HPD032, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSEF0763, 43IOD011, and 43IPD038
* Bard Flat Mesh 6" x 6" Lot 43FQD327

Source here.