CryoLife Heart Valve Patients Cry Foul

******!!!!!DO NOT USE DO NOT USE DO NOT USE THIS PHOTO IN ANY STORY*******!!!!!!A technician at CryoLife, Inc., in Kennesaw, Ga., prepares a saphenous vein for storage in the company's lab facility Wednesday, Feb. 3, 1999. The company provides cryopreserved heart valves and veins and other biomedical products for surgery. CBS/AP

Ken Alesescu was an avid hiker, skier and scuba diver. Now, as CBS News Correspondent Vince Gonzales reports, just getting to physical therapy is a challenge for the 50-year-old father of two.

Federal investigators believe the human heart valve implanted in his chest last summer was contaminated.

"When they opened up my chest for the second time to remove the infected heart valve, they found the heart was just covered with growth, fungal growth," he says.

The potentially fatal infection is spreading through his body, eating away his spine.

"It's devastated my life," he says, weeping. "And what I'm going thru right now with back pain, maybe paralysis. I'd just as soon be dead."

The heart valve, from a human donor, was processed by CryoLife Inc. of Georgia, which also supplies tissue for orthopedic surgeries.

The Food and Drug Administration recalled all CryoLife orthopedic tissue processed since October, after dozens of reported infections and one death after routine knee surgery. According to the FDA, "CryoLife cannot ensure that the human tissue it processes ... is free from fungal and bacterial contamination."

But the recall does not include heart valves. That came as a surprise to Ken's wife, Pam.

"How could they recall one set of tissue and not the other, when they're processed identically?" she asks.

In many cases, especially with children, a new human heart valve is the only way to save a life. And CryoLife supplies 70 percent of the heart valves implanted in the U.S. -- one of the main reasons the government decided against a recall.

"These tissue heart valves are something that are needed by patients, and CryoLife has a very large part of the market and it is important to make sure we can treat patients appropriately," says Dan Jernigan, of the Centers for Disease Control.

The FDA says the overall risk is relatively low, but now encourages doctors to use valves "from alternative manufacturers" because CryoLife patients "may be at increased risk for infection."

Since 1996, 33 infections associated with CryoLife heart valves have been reported. Four patients died, including 5-year-old Sydney Steinberg. She developed a fatal infection after receiving a CryoLife valve. Officials say many more cases go unreported. The company turned down a request for an interview.

"We said, 'You gave us an infected heart valve,' and they said, 'No, there's no way that we did that,'" says Pam Alesescu.

And despite reports from doctors, labs and the Centers for Disease Control, the company told investors there was no contamination.

In a teleconference with investors earlier this year, CryoLife stated, "It was demonstrated there were no such infections."

The company has since backed off from that claim, but for months told investors everything was fine. In fact, as health investigators were sending letters to CryoLife about the growing number of infection cases, company records show key corporate officers and directors stopped buying and began selling millions of dollars worth of stock.

Now the Securities and Exchange Commission is investigating. Shareholders are suing ... and so is Ken Alesescu.

"All I can say is damn them," he says. "They need to change what they're doing. This isn't fair for anybody to go thru this."

As Ken Alesescu feared, the infection has spread, attacking his lower spine. He's back in the hospital, scheduled for surgery Wednesday.
  • Jaime Holguin

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