Medical Product Liability Claims

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Counterfeit Surgical Mesh

The Bell Legal Group in Georgetown, South Carolina is currently investigating the health risks associated with the FDA Class I recall of counterfeit polypropylene surgical mesh. Surgical mesh is used by surgeons to reinforce soft tissue in the human body where weakness exists, such as in the repair of hernias and chest wall defects. Surgical mesh is also used in connection with the implantation of laparoscopic gastric bands.

The FDA has determined that various sizes of counterfeit surgical mesh distributed throughout the United States that has been labeled with the C.R. Bard/Davol brand name is counterfeit. The counterfeit surgical mesh does not appear to meet the authentic C.R. Bard/Davol product specifications, including specifications for strength and clinical performance.

The FDA has noted that the counterfeit surgical mesh:

  • is NOT sterile
  • has a weave pattern and structure that is different from the authentic mesh
  • does not has properly finished edges that may allow the counterfeit mesh to unravel

These deficiencies can lead to a number of serious health complications including severe infection and the requirement of additional surgical procedures. Class I recalls are the most serious serous type of recall, and involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

The FDA has further released a list of Lot Numbers of C.R. Bard/Davol mesh that may be counterfeit, and a list of distributors that may have provided counterfeit mesh to surgeons and hospitals for implementation into the human body. Much of the counterfeit surgical mesh was distributed to hospitals between October 21, 2008 and October 27, 2009, though the dates of the surgical procedures in which patients were implanted with counterfeit surgical mesh may extend well beyond these dates.

Some patients who have been implanted with counterfeit surgical mesh have been notified by their physician. If you have received notice from you physician that you have been implanted with counterfeit surgical mesh, or believe that you may have been implanted with counterfeit surgical mesh during a surgical procedure or hospital stay, please contact the Bell Legal Group to discuss your rights.