Federal regulators say that contamination levels in some XenMatrix Surgical Grafts could lead to serious and potentially fatal injuries if used on a patient.
The FDA has classified a XenMatrix Surgical Graft recall issued in January as a Class 1 medical device recall, meaning that the agency believes there is a reasonable probability of death or serious injury for any patient implanted with a contaminated grafts.
The XenMatrix recall was first announced in a letter to customers sent on January 6 by Davol, a subsidiary of C.R. Bard, after samples of the hernia and abdominal surgical graft were found to contain endotoxins that exceed the FDA’s acceptable levels. However, the company indicates that there have been no consumer complaints regarding problems with the XenMatrix.
Davol acquired the XenMatrix in September 2009 from Brennan Medical. It is a collagen matrix patch used to treat hernias in the abdominal wall when the connective tissue has ruptured.
Endotoxins are usually gram-negative bacteria which can cause toxicity in the human body. Examples include bacterial meningitis, and meningococcal disease; which causes sepsis.
The endotoxins have been detected in several lots. The affected XenMatrix Surgical Grafts have lot numbers beginning with the following four letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ. The grafts were distributed between July 1, 2010 and October 31, 2010.
The XenMatrix is not the only surgical product that C.R. Bard and Davol have had problems with in recent years. The companies currently face about 3,000 lawsuits over their Kugel hernia patch products, which allegedly contain design defectives that caused plaintiffs to suffer severe internal injuries. A Kugel hernia mesh recall has been issued for several different models of the patch.
C.R. Bard also faces a growing number of Bard Avaulta lawsuits, involving their vaginal surgical mesh that is used to treat pelvic organ prolapse in women. Complaints allege that the Bard Avaulta system was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement. In October, the federal Bard Avaulta litigation was consolidated for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia as part of a multidistrict litigation (MDL).