A type of collagen graft used in hernia and abdominal wall repair surgeries has been recalled by its manufacturer, Davol, Inc., reports the FDA. As of January 11, 2011, XenMatrix surgical grafts are subject to a class I recall, the FDA explains, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
When tested, some of the XenMatrix grafts were found to contain higher than permissible levels of endotoxins, according to the recall notice. The Merck Manual Online Medical Library notes that endotoxins are toxic substances found on the outer membranes of certain types of bacteria. When these outer membranes are disturbed, says the Manual, the endotoxins are released into the surrounding area and contribute to the symptoms of a bacterial infection, such as inflammation and, in severe cases, even septic shock.
According to the FDA’s recall notice, the endotoxins found on the grafts are pyrogens, meaning they can cause fever if they are introduced into the bloodstream. Since the grafts are inserted during surgery, introduction to the bloodstream is essentially inevitable. There are yet to be any consumer complaints, reports the FDA, so the recall is being used as a preventative measure.
The recall applies to XenMatrix surgical grafts manufactured between June 1 and October 31, 2010, and sold beginning on July 1, says the FDA. The recall notice applies to grafts with lot numbers beginning with the following four-letter combinations: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC,
HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ.
This product is not sold directly to patients, but any doctors, hospitals, or other health care agencies or professionals who purchased the recalled units are urged to contact the Davol customer service line at 1-800-556-6275 for instructions on returning the grafts, says the FDA. Davol, a subsidiary of C.R. Bard, Inc., is based out of Rhode Island in the FDA’s New England district. Any problems with the grafts can also be reported to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program.
Merck Manuals Online Medical Library. (September, 2008). “Introduction: Bacterial infections.” Retrieved March 8, 2011 from MerckSource.
U.S. Food and Drug Administration. (March 7, 2011). “Davol Inc., Xenmatrix surgical graft.” Retrieved March 8, 2011 from the FDA.