Davol, a subsidiary of C.R. Bard, has announced that it is issuing a recall for XenMatrix, a hernia and abdominal surgical graft, due to a failure to meet the FDA’s standards for endotoxins.
The XenMatrix recall was announced on Tuesday in a filing with the U.S. Security and Exchange Commission. There has been no official announcement from the FDA or a press release.
C.R. Bard officials have said that the recall came after the company realized that it could not get the XenMatrix surgical graft to meet the FDA’s acceptable levels of endotoxins, according to a report by the Wall Street Journal. However, the company indicates that there have been no consumer complaints regarding 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 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 lawsuits over their Bard Avaulta surgical mesh, which is used to treat pelvic organ prolapse in women. Complaints allege that the vaginal mesh 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).