FDA Recall of Human Tissue Will Not Cause a ‘Crisis,’ Orthopedic Surgeons Say

Following the FDA's recall Wednesday of most human tissue distributed by Georgia-based CryoLife Inc., orthopedic surgeons are "reassur[ing]" patients that the recall will not lead to a "long-term crisis ... because alternative sources are available," the Wall Street Journal reports (Carrns/Elstein, Wall Street Journal, 8/16). Surgeons also said that the risk of infection from cadaver tissue is "small" (Blakeslee, New York Times, 8/16). On Wednesday, the FDA ordered CryoLife to recall all human tissue, with the exception of heart valves, distributed since Oct. 3 and to "destroy or stop distributing almost all tissue from its inventory." An FDA investigation in the spring found that CryoLife, which distributes ligaments, tendons, bones and other tissues, could not "ensure that its tissue was free of contaminants" and that the company's systems to detect bacteria and other contaminants "were deficient and not reliable" (California Healthline, 8/15). Dr. Gary Friedlaender, chair of the orthopedics and rehabilitation department at the Yale University School of Medicine and a spokesperson on tissue bank safety for the American Academy of Orthopedic Surgeons, said, "There is no need to panic. There's no crisis in supply or confidence in these procedures," adding, "There are many excellent tissue banks that follow extremely good tissue practices" (New York Times, 8/16).

The recall did not include human heart valves processed by the company, but FDA officials have said they are investigating whether the valves pose a similar risk, the Journal reports (Wall Street Journal, 8/16). Cynthia Herrington, a University of Minnesota pediatric heart surgeon, said that a heart valve recall "would be severe" because there is a shortage of such valves, especially for children and infants. Because of the "short supply" of valves, Herrington said pediatric heart surgeons "would like to see better evidence that there is a (safety) issue" (Marcotty, Minneapolis Star Tribune, 8/16). The agency said it would take "further regulatory action if appropriate" (Wall Street Journal, 8/16).

CryoLife officials said that the company has hired an outside consultant to "advise about technical issues" and is working on "validations" of its process for the FDA. The company is appealing the recall and is "seeking immediate relief" on the recall of non-valve cardiac and vascular tissue used in procedures for children with congenital heart conditions, the Journal reports (Wall Street Journal, 8/16).

ABCNews' "World News Tonight" yesterday reported on the tissue recall. The segment included comments from Friedlaender and FDA Senior Associate Commissioner Dr. Murray Lumpkin (Judd, "World News Tonight," ABCNews, 8/15). A video clip of the segment is available online. NPR's "All Things Considered" yesterday interviewed CDC epidemiologist Dr. Daniel Jernigan about how the agency's researchers tracked the bacteria from infected knee-transplant patients to tissue from CryoLife (Ydstie, "All Things Considered," NPR, 8/15). The full segment is available online. Note: You will need RealPlayer to access the segments.