By SANDRA BLAKESLEE

rthopedic surgeons reassured patients yesterday that risks of infection from cadaver tissue are small and that there were several good sources of it besides a company whose shipments were ordered halted Wednesday by the Food and Drug Administration.

The agency acted against CryoLife Inc. of Kennesaw, Ga., the nation's largest processor of donor tissue, ordering it to recall all soft tissues — ligaments, tendons and cartilage — it had sent to surgeons since Oct. 3. The agency said the company had not done enough to ensure that its tissues were free of deadly bacteria and fungi. Such tissues are widely used in orthopedic surgery to repair bad knees and other muscular or skeletal injuries.

Advertisement

"There are many excellent tissue banks that follow extremely good tissue practices," said Dr. Gary Friedlaender, professor and chairman of the department of orthopedics and rehabilitation at the Yale University School of Medicine, who is a spokesman on tissue bank safety for the American Academy of Orthopedic Surgeons. "There is no need to panic. There's no crisis in supply or confidence in these procedures."

Of the estimated 650,000 transplants each year using allografts, or donor tissue from cadavers, about 10 percent involve the kinds of tissues being recalled by CryoLife. Bones and many other allograft materials are not affected.

Dr. Warren King, an orthopedic surgeon at the Palo Alto Medical Foundation in California, said he did 400 to 500 allografts a year, mostly for sports injuries, and had only seen one serious infection in more than eight years. "These products are safe and effective," he said. "They allow us to eliminate a tremendous amount of pain and suffering."

Dr. King said patients had been calling him to ask if they should delay surgery. "I tell them that they can do more damage to the joints if they wait too long," he said."

Dr. Friedlaender said there were alternatives, with risks and benefits attached to each option, In autograft surgery, a patient's own tissues are removed in one operation and implanted in a second surgery. The tissue is compatible but there are small risks associated with two surgeries instead of one. Many patients, especially those receiving bone autografts, experience significant pain six months after the operation, he said.

Autografts work for some kinds of surgery, Dr. King said, but often there is no good tissue to use. "It's not like God gives you a spare tire when you're born in case one goes flat," he said.

Artificial materials like metal or plastic can also work quite well in some kinds of orthopedic surgery, Dr. King said, but they tend to wear out and are not well suited to younger people. Many orthopedic surgeons prefer allografts over other alternatives.

At least four or five tissue banks offer the same products as CryoLife with excellent safety records, Dr. King said. He said that, like many of his colleagues, he had avoided CryoLife tissues after it was reported in March that the company's tissues caused half of all serious infections reported to the Centers for Disease Control and Prevention.

Nevertheless, Dr. King said he still used some CryoLife products for repairing knees because he believed that the material was superior to what other companies made. For example, CryoLife frozen knee cartilage "looks better and feels better."

"They do cryopreservation, which keeps the tissue healthier and alive," he said. "Maybe that keeps some bacteria healthy and alive, too, but with proper handling the risks can be greatly reduced."

Physicians need to be more aggressive in recognizing and treating incipient infections, Dr. King said. Some wait too long to remove suspect tissue.

Several technologies are entering the market or are in the process of being developed to improve the safety of allografts, Dr. Friedlaender said. Two companies have invented processes that sterilize tissues but do not compromise the strength or integrity of them. Further away are technologies that grow human tissues in factories or produce growth factors that induce a patient's body to make new bone, ligaments or tendons.

Doing research? Search the archive for more than 500,000 articles:
	Today's News Past Week Past 30 Days Past 90 Days Past Year Since 1996