FDA Announcement: Davol XenMatrix Surgical Grafts recalled nationwide after failing to meet safe toxicity levels. Injuries from endotoxins can include bacterial meningitis, meningococcal disease, and sepsis. C.R. Bard and Davol currently face thousands of lawsuits over their Kugel mesh hernia patch products.
What’s the problem?
On January 11, 2011, Davol, Inc., the maker of the recalled Composix Kugel hernia repair patch, announced that it is now recalling its XenMatrix hernia and abdominal surgical graft due to a failure to meet the FDA’s standards for endotoxins. Endotoxins are gram-negative bacteria which can cause bacterial meningitis and meningococcal disease, which causes sepsis. Symptoms of these infections include:
- high fever
- stiff neck
- sensitivity to light
- easy bruising
These symptoms can develop over several hours, or they may take 1 to 2 days. As the diseases progress, seizures can also accompany infections in certain patients. People who have had close or prolonged contact with a patient with any of these conditions can also be at an increased risk.
Additional Products Being Recalled
In addition to the XenMatrix, C.R. Bard and Davol currently face approximately 3,000 lawsuits over their Kugel hernia patch products, which allegedly contain design defects that caused plaintiffs to suffer severe internal injuries. A Kugel mesh hernia recall has been issued for several different models of the patch.