FDA stops sales from major tissue bank, citing germ risk

WASHINGTON - The government has ordered a Georgia tissue bank to stop selling its cadaver tissue because its products have been linked to a death and serious infections. <br> <br> Federal officials say Kennesaw-based CryoLife Incorporated can not guarantee the tissues are free of fungus or bacteria. <br> <br> Wednesday&#39;s action by the Food and Drug Administration is unusually harsh. It comes after months of failed inspections and negotiations with the company. <br> <br> CryoLife says it will appeal the FDA&#39;s order. While the company awaits a hearing to argue its case, it has quarantined all its donated soft tissue while <br> <br> Company chief executive Steven G. Anderson said, ``We are confident about the quality and safety of CryoLife processed tissue.&#39;&#39; <br> <br> The FDA ordered CryoLife to recall all the soft tissue such as cartilage and tendons that it has processed since October 3rd. That&#39;s a month before a 23-year-old Minnesota man died from a bacterial infection linked to CryoLife cartilage that he received during reconstructive knee surgery. <br> <br> Mary Malarkey is the FDA compliance officer in charge of the case. She says the company will not be allowed to resume distribution of tissue until it begins meeting federal standards to ensure the products aren&#39;t tainted. <br> <br> The order does not recall cadaver heart valves that CryoLife also sells. FDA inspectors are studying whether the donated heart valves, which typically undergo more strenuous processing than soft tissue, also may pose a risk. <br> <br> CryoLife officials did not immediately respond to a request for comment. <br> <br> Malarkey stresses that patients who have received CryoLife-sold grafts should not panic. Any infection associated with tissue should occur within days or at most weeks of the transplant. But she urged doctors to be aware of signs of infection that might be linked to a contaminated graft. <br> <br> The death of Brian Lykins of Willmar, Minnesota, touched off a major investigation by the Atlanta-based Centers for Disease Control and Prevention. That investigation found that infections from cadaver tissue used in orthopedic implants are more widespread than previously thought.