CHICAGO – Every year more than 1 million Americans have medical procedures that use bone or other tissue from a cadaver — like disk replacements or dental implants.
That worry caused by a ghoulish scandal in the body parts business has led to distress for hundreds of people, and some prospective patients are now reconsidering how they want their surgeries done.
Experts familiar with the situation say patients' chances of getting a disease from the suspect tissue are small, but doctors are urging them to be tested.
"This is diabolical ... if what has been alleged has been done," said Dr. Stephen Pineda, an orthopedic surgeon in Springfield, Ill. "What it does to the whole public perception of bone and all other grafts can be catastrophic."
Investigators are trying to determine if a New Jersey company, Biomedical Tissue Services of Fort Lee, sold bone and tissue illegally obtained from corpses that were too old, sick or otherwise ineligible to be donors. BTS closed last month.
The Food and Drug Administration and federal Centers for Disease Control and Prevention say the risk of infection is low but unknown. So dozens of hospitals have contacted hundreds of patients around the country who got body parts traced to the company between early 2004 and September 2005. They are being offered testing for AIDS, hepatitis and syphilis.
Those are the three illnesses that the FDA requires donor tissue to be tested for — singled out because they cause long-lasting infections that pose a greater risk of transmission through transplanted tissue than short-lived infections.
But some patients worry about tissue or bone from bodies weakened by cancer, age or other ailments. Doctors concede that's theoretically possible but unlikely to cause problems with the grafts.
Carol Yates, a Marion, Ohio grandmother, is among patients advised to get tested and has set up a Web site to give recipients of the suspect tissue a chance to share their concerns with others.
Yates, 47, said her doctor told her in December that BTS bone was used in her neck surgery a year ago.
"All it's done is caused me a lot of worry," Yates said. "I haven't taken the test yet. If it came back positive, I couldn't handle that right now."
Unused body parts linked to the case have been recalled. Companies that process the tissue for medical use are required to test and sterilize it. But still, some patients awaiting operations are scared.
In the past week, two of Pineda's patients have refused donor parts and want to use their own bone for their surgeries. It's a riskier, costlier and more painful option that Pineda said most patients used to shun. He calls their reaction "completely understandable."
"People are worried," Pineda said. "We've been fielding 10 calls a day on this from patients."
It's likely that only a tiny portion of patients who got bone or tissue grafts during the last two years received tissue from BTS, said Robert Rigney, chief executive officer at the American Association of Tissue Banks.
While Rigney hasn't heard of any widespread decline in demand for donor grafts, or in people willing to be donors, he said the case's potential impact "is something we're extremely concerned about."
The FDA and Brooklyn, N.Y., district attorney's office are investigating the case but no charges have been filed. Authorities suspect that a company employee and an associate took bone and tissue from corpses without families' knowledge, paid off New York City-area funeral homes to gain access to bodies, then sold the parts to five processors in Florida, Georgia, New Jersey and Texas.
Rigney said that each year, more than a million Americans have medical procedures using body parts and tissue from more than 25,000 donors.
The association accredits 91 tissue banks nationwide, including a few in Canada. They account for most of the cadaver tissue used for transplants, Rigney said.
BTS was not association-accredited, but the five processing companies that got BTS tissue are, Rigney said. They have strict monitoring and test tissue for communicable diseases, he said. Tissue from about 450,000 donors is rejected each year because it is diseased or otherwise ineligible, he said.
Tissue deemed disease-free is still subjected to sterilizing procedures to make it safe, Rigney said.
There have been only a handful of cases, all in the late 1980s and early 1990s, in which U.S. patients got diseases from tissue donors, he said. One caught HIV and two got hepatitis, but that was before improved blood testing methods that are now used.
FDA spokesman Stephen King said he could not discuss the number of patients and hospitals thought to be involved in the BTS case, or whether any patients have ailments that might be linked with suspect tissue.
New Jersey attorney Patrick D'Arcy said his firm near Atlantic City has been contacted by more than 200 BTS tissue recipients from 25 states, including 10 people who have tested positive for hepatitis. D'Arcy, who is suing BTS for alleged negligence and fraud, said he's still investigating whether the hepatitis cases could have resulted from surgical procedures.
Bobi Milner, a Springfield, Ill., woman who had surgery last year to fix an aging disc in her upper spine, learned last month that her graft came from suspect bone.
Her infectious disease tests came back negative, and Milner said she didn't freak out until she read a local newspaper article detailing the scam's scope. Unwitting donors included former "Masterpiece Theater" host Alistair Cooke, who died from cancer at age 95 in 2004.
"That's when I realized what the magnitude was," said Milner, 41. "I cried and sobbed the rest of the day. I thought, 'Oh, my God, what's going to happen to me?'"
Cooke "was wonderful on 'Masterpiece Theater' and no offense to his family, but he was an elderly gentleman and he would not be an eligible donor," she said.
Milner worries that if her graft came from someone sick or aged, the bone will deteriorate quickly and she'll need another operation.
Pineda, who was not her surgeon, said that could be a legitimate concern, although metal plates implanted with bone grafts in spine surgery usually bear the pressure and are durable.