Transplanting human tissue to fix a knee, a hip, or an elbow, while innovative just a few years ago, has become a routine procedure in American hospitals. But as correspondent Gloria Borger reports, a deadly side effect has turned up.
Across this country, thousands of times a day, people with a problem as simple as a bad knee have it repaired with tissue taken from a dead body. Surgeons have considered it a tremendous medical advance. But then something terrible happened.
They found that he was killed by a rare bacteria that was traced to the human tissue implanted in his knee. The tissue that had come from a dead body.
Lykins had checked into a St. Cloud, Minnesota hospital to replace the cartilage in his knee. Soon after surgery, he got desperately ill and died.
"The 23-year-old had a very sudden death," says Dr. Daniel Jernigan who is in charge of the CDC investigation into Brian Lykins' death. "Very quick, from the time of his surgery to pain in the knee to sudden cardiovascular collapse. That kind of illness is unusual after surgery, very unusual in a healthy, young person after surgery."
In a lab at CDC headquarters in Atlanta, scientists identified Brian Lykins' killer: a bacteria called Clostridium Sordellii, which is usually found in soil and farm animals. It's rarely found in humans, and only in the intestines. They traced the contaminated tissue back to the dead body it had been taken from. They discovered something troubling about how the cadaver had been handled.
"The patient's body was refrigerated 19 hours after the time of death," says Jernigan. "Most would recommend that 12 hours, a body be refrigerated within 12 hours of the time of death."
The tissue that killed Brian Lykins was supplied by a tissue bank, a place that processes tissue from dead bodies, and uses high-tech, expensive methods to make them safe. Those techniques are impressive, but not necessarily infallible.
Did surgeons generally think that these transplanted tissues would result in this kind of infection? "There was an assumption that these tissues were either extremely clean, or sterile, when, in fact, the tissues were not sterile," says Jernigan.
CDC scientists learned just how wrong that assumption was. As their investigation continued, they uncovered 41 more cases of infections from contaminated tissue - and they're still looking.
Half of those tissues came from a company called Cryolife. That's the tissue bank that provided the contaminated tissue to Lykins. Cryolife is an industry leader, and a biotech darling of Wall Street. Its business has grown along with the surgical use of transplant tissue.
More than 750,000 tissues, from many tissue banks, are transplanted every year. Surgeons put them into knees, and also into everything from hips to bones to skin.
How serious a problem is this tissue contamination? "We don't really know," says Jernigan. "This particular problem, especially with these rare kinds of bacteria, are not reportable. So in the past, we've not heard about them."
That's because tissue banks, as well as doctors and hospitals, are not required to report cases of what are called 'adverse reactions' to transplants. But Cryolife knew about the problem four years ago, long before Brian Lykins died. In 1998, a San Francisco stockbroker named Jay James had the same kind of routine knee surgery and got the same kind of tissue from Cryolife.
But the recovery did not go normally: "On the sixth day, I had swelling. By the seventh day, I couldn't stand," James says.
So he went to his doctor: "He takes a look at the knee and he goes 'Oh, jeez,' and a fire drill breaks out. And people just start coming into the room. He takes a syringe with a big cylinder, he pulled out, or drained, two of those big syringe cylinders of something out of my knee. And as he's doing that, after, between those he leans up to me and says 'Don't worry, we're gonna save your leg.'"
James had developed a clostridium infection similar to - and potentially as dangerous as – the one that killed Lykins. James had to undergo five more operations before doctors could cure his infection. But his ordeal didn't end there.
He says he has pain every step he walks. "Every step. Every step. I can deal with pain. I've had some bumps and bruises in my life. But that's really tough pain. And it's there all the time. It just works on you all the time."
James sued Cryolife, but he says the company insisted there was no link between his infection and their tissue. Cryolife settled out of court when James' doctor, Warren King, found that another doctor in a different city had a knee surgery patient with the same kind of rare infection. Both patients had received tissue from Cryolife, and, in fact, both tissues came from the same cadaver.
"I don't believe there's any way that a tissue bank can say with any degree of certainty that that graft was not contaminated with clostridia," King says.
Dr. King is an orthopedic surgeon at the Palo Alto Clinic. He performs hundreds of operations each year using transplanted tissue.
"Now, with tissue transplantation and allografting techniques, we can do surgeries that used to take three hours in 15 or 20 minutes," he says. "We can provide patients with operations and procedures that didn't exist even a few years ago.
There are risks, though: "Because the tissue is coming from a human source, there's always the possibility that that may be contaminated."
James says Cryolife had to have known about the possibility of contamination after his surgery, four years ago. "They knew they had a problem in their processing. They haven't solved the problem. They haven't even faced up to the problem. And that infuriates me."
James knows that because he read about Brian Lykins' death last winter, and then heard about the case of Alan Minvielle. Minvielle, a truck driver, competed in marathons and even triathalons on weekends. Now, he can't work, and can barely walk. A year ago he had the same kind of knee surgery, using the same kind of Cryolife tissue that James had. And, his doctor told him he had the same kind of serious infection.
"He told me it was a gangrene-type infection," says Minvielle. "I thought 'World War I' is what I thought. It doesn't sound like something you would expect in the 21st century at all."
The past year has been difficult for him: "It's been the worst year of my life, you know, by far. I walk with a real pronounced limp. I have a real small range of motion in my knee. And it's painful all the time."
Minvielle says he called Cryolife to ask about the tissue that caused his infection. He didn't get much of a response. He says they didn't take his name, nor did they call him back. But Minvielle says Cryolife did tell his doctor that the infection could not have come from their tissue. Minvielle is now suing the company.
Cryolife would not talk to 60 Minutes II on-camera. But company officials did comment on the telephone, and in several published statements said this: "(Not all of the infections found by the CDC) have been linked to the use of implanted tissue."
They also said "the risk of infection is very low," and that infections that do occur can be easily treated with anti-biotics.
The CDC says it's a lot more complicated than that. "These bacteria, when they are in certain environments, they go into a dormant form, and they sit there for a long period of time," says Jernigan. "If you don't have the correct processes to try and detect that kind of bacteria, you may not know that it's in the tissue."
The CDC team found that Cryolife's processes may not kill all clostridium bacteria in donor tissue, and Cryolife's tests don't reliably tell whether the tissue is safe.
"That ought to sound the alarm bells," says Senator Susan Collins, a Republican from Maine. She thinks there are problems in the entire tissue bank industry. She's been trying to get the government to pay attention for the last two years.
"This is a serious problem, and it's going to be a bigger and bigger problem as time goes on," she says. "We've learned through the marvels of science to engineer tissue so it can be transplanted, but the problem is that the regulation of tissue banks has lagged behind the science."
Unlike organs and blood banks, which the government monitors closely, tissue banks are largely unregulated. Surgeons like King say that what the government doesn't know can hurt you: "There's tissue banks out there the government doesn't even know exist, and have never been inspected from day one, and are totally under voluntary requirement to do more than basic testing."
The Food and Drug Administration is supposed to oversee tissue banks. Senator Collins says the FDA did propose regulations in 1997 to make tissue transplants safer. They would make tissue banks screen donor cadavers for bacteria that could infect recipients, and use methods that insure the tissues are clean and healthy. But five years later, the FDA still hasn't put those rules into effect.
Says Collins: "Normally, when something's a matter of public health and safety, the federal government acts far more quickly that five years. There is no excuse for the FDA's failure to act. The agency has come up with a good plan, with reasonable regulations that would make a real difference. And I just can't figure out why they're not acting."
Dr. Mack Lumpkin, the second in command at FDA, says the agency itself is frustrated with the length of time it has taken. "We ourselves get frustrated with the time. But I think when you're looking at the issue as complex as this is, the different kinds of tissues we're involved with, the evolutionary nature of a very new technology that's coming along, even though five years sounds like a long time, it's also the time to get it right."
The FDA is looking for a balance, Lumpkin said, between encouraging innovation in a high-tech field, and protecting public health. He says he expects the rules to be "finalized and published probably sometime next year."
"There are some areas of regulation that are very complicated, and that perhaps take years to get to the right answer. In this case, the FDA knows what needs to be done," says Collins. She believes that the rules would have saved Lykins' life, and would have prevented the other cases of serious infection.
Last week, Cryolife, the tissue bank the CDC says provided the contaminated tissue to Lykins, announced some changes in the way they process tissue. Cryolife says these changes will increase the chance of detecting clostridium bacteria. The CDC says this is a "first step" towards making tissues safer.