'It's your worst nightmare'
After enduring 14 surgical procedures on his back, Tom Adams of Lakeside recently was notified that the donor bone he had received during his most recent surgery was part of a recall by the Food and Drug Administration. Karen Nichols/Daily Inter Lake
FDA recall of implanted bone shocks man
Tom and Judy Adams of Lakeside got the shock of their lives June 23 when a Federal Express truck delivered a letter from Tom's neurosurgeon.
The letter, from Dr. Carter Beck of Neurological Associates in Missoula, informed him that donor bone he had received during back surgery in November 2004 was part of a recall by the Food and Drug Administration.
"We didn't even know that he had received donor bone," Judy said. "I can't tell you the shock."
Until they met with Beck two weeks later, the couple feared that Tom would have to go through another surgery to have the recalled bone removed. He has endured 14 surgeries, including spinal fusion, to relieve his severe back pain.
"Of course, we were quite panicked," Tom said. "I didn't want to go through another surgery."
The information in the letter did little to lessen their anxiety. It explained that the bone "recovered" from a corpse by Biomedical Tissue Services may not have been properly screened for infectious diseases.
FDA information attached to the letter listed the diseases of concern as HIV-1 and -2 (the virus that causes AIDS), hepatitis B virus, hepatitis C virus and syphilis.
Although the letter reassured patients by saying the bone tissue went through all the testing and sterilization required, even the smallest possibility of the diseases listed was horrifying to the Adamses.
"It's like your worst nightmare," Judy said.
During their meeting June 30 with Beck, the Adamses learned that surgery to remove the bone was not required, but patients needed screening for the diseases listed.
Beck explained that he had tapped the donor bone bank after he learned that Tom didn't have sufficient vertebrae bone to serve as his own donor as planned.
After the couple consulted with Beck, blood was drawn and tests were done. It could range from seven to 21 days for them to receive test results. They were told they would hear from the doctor only if something were wrong.
A week had passed at the time of the interview, and the Adamses had heard nothing.
"I assume everything is OK," Tom said.
From their talks with Beck and additional research on the Internet, the couple learned some gruesome details behind the recall.
"The story was that a cadaver was stolen from a Florida morgue," Judy said. "Biomedical Tissue Services got the body."
Regeneration Technologies then processed the bone, called allograft bone or tissue, which was distributed by SpinalGraft Technologies, a subsidiary of Medtronic.
Since 1993, the FDA has regulated human tissue intended for transplantation. The agency requires screening for infections in a variety of ways, including securing detailed medical histories of the potential donors.
After the donor bone or tissue is removed, regulations require that processing include one or more disinfection process to kill bacteria, fungi or viruses. The bone used in Tom's surgery went through disinfection, but the medical history was missing on the stolen corpse.
An FDA inspection turned up many discrepancies in the Biomedical Tissues records. As a result, the company issued a voluntary recall Oct. 13, 2005, for "any unused tissue from its consignees."
In January, the FDA ordered Biomedical Tissues to cease manufacturing all products.
The order cited numerous discrepancies between the company's version of the death certificates and the state-issued death certificates for the donors. Many included age reductions and changes in the causes of death.
For implanted allografts from the undocumented cadaver, the FDA and Centers for Disease Control and Prevention recommended that physicians inform patients and offer blood testing.
The couple said they wanted to share their story to alert people about these problems. They want other patients to know that a surgeon may decide to use these products.
Neither had understood that was a possibility before Tom's procedure.
"We have been real cautious about anything going into my body," Tom said.
The couple had paid a substantial amount to bank blood for the operation for fear of possible diseases within the blood bank.
However, they understand the options were few if Beck were to continue the procedure.
"I'm not blaming Dr. Beck in any way, shape or form," Tom said.
A few weeks after surgery, Tom developed a life-threatening strep infection. Beck told the couple that the recalled bone wasn't the source of the infection, but Tom said the timing seemed suspicious to him.
During the next eight months, he was in and out of the hospital, flat-lining three times. He consulted an infection specialist who said the strep was hidden behind the screws in his back. Finally, Dr. William Ferril, a physician who practices holistic medicine in Whitefish, stopped the infection.
Tom remains determined to maintain his mobility. He decided to think positive and keep moving.
"I can still bend over," he said. "If I go in a wheelchair, I think I would be in it the rest of my life."
Reporter Candace Chase may be reached at 758-4436 or by e-mail at cchase@dailyinterlake.com.