Deadly Transplants

By NADYA LABI

When most of us are rolled into an operating room, the last thing we want to think about (if we are conscious at all) is what the doctors are putting inside us. We don't want to know who donated the leg veins sometimes used for our coronary bypass operations or where the ligaments needed to hold a wobbly knee together were found. We want to be fixed, stitched up neatly, shipped out--and spared any gory details.

So it was more than a little disturbing last week when the Food and Drug Administration announced it was shutting down part of the facilities at CryoLife Inc., a leading supplier of donated tissue in the U.S. The FDA charged that a number of the implants, which are processed (in the industry euphemism) from dead bodies and stored in tissue banks, had not been properly handled, leading to serious infections in at least 26 patients. The agency recalled tendons, ligaments and cartilage distributed by the Georgia-based company since October.

The overwhelming majority of the 650,000 soft-tissue transplants each year go smoothly, but the problems at CryoLife highlight concerns about quality control throughout the tissue-bank industry. (By contrast, storage problems are simpler when harvesting whole organs like hearts and livers, which have to be transplanted immediately.) "It's almost like anybody with a chainsaw and a pickup truck can go into the body-harvesting business," says Don Keenan, an Atlanta attorney representing 14 clients pursuing claims against CryoLife. One of them is the family of Brian Lykins, 23, who died three days after what should have been routine orthopedic knee surgery last November. His death was caused by a strain of bacteria associated with decomposing tissue. "We know the cadaver that killed Brian was unrefrigerated for at least 19 hours, but nobody knows how long it had been dead before that," says Keenan. Another teenager who received tissue from the same cadaver that infected Lykins also developed an infection and had to have his graft removed.

Oversight of the tissue industry is spotty. At the state level, only Florida and New York require licensing and inspection of tissue banks. At the federal level, a 2001 report found that the FDA did not know how many tissue banks were operating and had never inspected 20% of the 154 facilities identified. But eventually the FDA, with help from the Centers for Disease Control and Prevention, zeroed in on CryoLife. Together the agencies charge that on at least one occasion CryoLife improperly distributed tissue from a cadaver it had learned was contaminated. (CryoLife could not confirm or deny that event.) The industry standard is not to use any tissue from a corpse where any infectious tissue has been found--even if the two tissues were harvested from opposite ends of the body. "This has been going on this year and a good part of last year," says Dr. Murray Lumpkin, an FDA commissioner. "We tried to work with CryoLife and get them in compliance, but it just didn't work."

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

With reporting by Greg Land, Greg Fulton and Stephen Majors/Atlanta and Kathie Klarreich/Miami