Since the Davol, Inc.
Compsix® Kugel® Mesh Hernia Patchwas approved by the FDA in 1996, it has plagued the medical community with
numerous voluntary recalls in 2005, 2006 and again in 2007, resulting
in product liability cases. But Davol has continued to experience such
recalls with the newly released product XenMatrix® Surgical Graft.
Manufactured during June 2010 through October 2010, the XenMatrix Surgical
Graft was recalled by the Food and Drug Administration (FDA), in March
2011. Like the previous introduction of the Kugel Mesh hernia patch, the
XenMatrix Surgical Graft is a medical device that is used to repair the
abdominal wall and hernias.
"Testing cannot confirm that all units of the XenMatrix Surgical Graft
are within FDA requirements," the administration said. "Several
lots have been found to have elevated Endotoxin levels."
Pyrogens, the endotoxin levels the FDA warns consumers about, are located
in bacteria, posing serious risks when present in high amounts. In addition
to the health hazards associated with high endotoxin levels, the graft
could possibly present consumers with fatal results.
Classified by the FDA as a Class I recall, the XenMatrix Surgical Graft
is listed in one of the most serious classifications due to high chances
of causing serious injury and even death. Although the FDA issued a recall
in March 2011, Davol Inc. also sent consumers a recall issue earlier this
year, prior to FDA consumer notification.