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David Fronk, vice president of clinical research at CryoLife, insists that a low level of risk is unavoidable. "This tissue cannot be sterilized and still be rendered functional," he says. "We try to minimize contamination, but we have a warning box informing surgeons that there is potential for contamination." CryoLife screens companion samples of its tissues for harmful microbes; if any are found, the entire tissue sample is discarded. The screening minimizes the risk of contamination, Fronk explains, but doesn't eliminate it. The American Association of Tissue Banks has developed its own standards for quality control, but CryoLife is not one of its 74 members.
So why would anyone choose to receive donated tissue? If there is no postoperative infection, a patient's recovery time can be much faster than if a graft is taken from his or her own body. A surgeon can more easily, and less invasively, replace knee ligaments with cadaver tissue than with a portion of a patient's own hamstring or tendon. Of course, the risk of infection can never be eliminated in any operation. But it can be managed. Ultimately, patients must weigh the risks of an implant against the benefits. It's like driving a car, says Dr. Rick Hammesfahr, an orthopedic surgeon in Atlanta. "The probability of an accident is low, and the probability of dying in an accident is lower," he says. "Does that mean we should ban cars?" --Reported by Greg Land, Greg Fulton and Stephen Majors/Atlanta and Kathie Klarreich/Miami