Surgeons
Offer Reassurances on Implant Tissues
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.
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"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.
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