Body parts gone bad
A recall spotlights cadaver tissue dangers
Using cartilage, bone, and other tissues from cadavers to restore movement and strength to the living puts death in the service of life. At least it usually does. Last week's recall of human-tissue products from a company called CryoLife Inc. has turned a spotlight on how the tissue is handled and whether the industry is adequately regulated.
The recall was prompted by the death last November of Bryan Lykins, 23, who became infected with the rare bacterium Clostridium sordellii after routine knee surgery. Investigators from the Centers for Disease Control and Prevention say the infection was linked to a CryoLife product. It prompted the Food and Drug Administration to twice inspect the company's plant in Kennesaw, Ga. The agency found CryoLife had inadequate procedures for ensuring product safety. A warning letter sent June 17 says the company's response to the inspection report was "inadequate." There is "no assurance that the tissue is not bacterially or fungally infected," says Mary Malarkey, an FDA compliance chief.
David Fronk, CryoLife's vice president of clinical research, says that is the nature of cadaver tissue. "Our tissue cannot be sterilized," he says. "It would render the function of the tissue useless" by weakening it. But, he says, the company douses the tissues in antibiotic and antifungal solutions and tests them for contaminants before shipping them to hospitals.
About 650,000 patients receive soft-tissue implants per year; CryoLife supplies about 20 percent of the market. But the company's troubles may not end there. The FDA is also considering a recall of the company's cadaver heart valves. And CryoLife's vice president of regulatory affairs, James Vander Wyk, sold $410,000 worth of stock just days before the CDC report and a subsequent stock plunge. Vander Wyk says he sold the stock to pay tax bills.
With Julian E. Barnes
This story appears in the August 26, 2002 print edition of U.S. News & World Report.