Centennial, CO: From 2002 to 2005, Rebecca Crystal Frasier received three bone grafts. She didn't get a recall notice from Regeneration Technologies (RTI) regarding tissue transplants so she thought she was safe from tainted tissue. Turns out that her graft wasn't registered - the only way to get a recall!
"I have learned so much from researching this dilemma and I want everyone to know about it," says Frasier. "Some recipients of bone grafts are resting comfortably thinking they are safe because they didn't get a recall. But they could still be in danger -Regeneration Technologies sent recalls to the surgeon and he doesn't know if you are registered; only the hospital knows!
"I should start out by telling you that a lot of people don't understand that all grafts aren't registered. Everyone who has had a bone graft or tissue transplant should verify that they are registered.
Why aren't they all registered?
"For example, Regeneration Technologies sends 900 bone grafts to a hospital and they get 700 registration forms back - 200 bone grafts are not accounted for. The company assumes that the grafts have gone past their expiration date and have been discarded by the hospital - but the hospital is not returning them. Instead they are using them - they don't know that Joe Smith is going to have an auto accident on Friday and needs a bone graft on Saturday. Hospitals need tissue transplant in a hurry and the paperwork doesn't always follow.
What can I do to find out if my tissue transplant was registered?
There is only one way to find out. Go to the hospital where your surgery took place and pull your medical records. Find a paper called 'Implant Explant' and it will have the actual tissue codes recorded. Then your hospital has to track it, not your doctor. Patient service representatives can call the donating firm and verify that code is registered to you.
"My story is complicated, so bear with me," says Frasier. "I was in a car accident and suffered three crushed discs which caused severe neck pain. My first surgery was in February 2002 and I had two bone grafts. The hospital provided the fusion material and the bone graft to the surgeon. But in the middle of surgery, he switched to another fusions system.
In his surgical notes, my surgeon states that the anterior plate fit better in the second system. I learned later this was not true - these systems are made for all size necks and the plate is made to be adjusted at the time of surgery. He switched because he was doing trials on the new system. And his surgical report clearly states that he changed his mind in the middle of surgery. I have the report. When something is in trial you are supposed to sign specific papers - my bone graft was never even registered until much later.
So what does this mean?
The hospital registered me for the bone graft they think I got but that isn't what I received. In my case, there was a bone graft assigned to me that wasn't used. Instead I had tissue that was used as a test.
I saw something on TV about tissue transplants coming from unverified cadavers, so I started checking my surgical reports. My surgical reports from January 2005 stated a fusion system was removed from me other than the one that was in my first surgical report dated February 2002. It was different!
Why was it different?
I have had three fusion failures since February 2002. The rule with the FDA is that if you have a caged fusion and put the bone graft in this cage and it fails, you may not use a caged fusion a second time. But the surgeons at this hospital used a caged fusion three times.
And, since they can't find my bone graft from February 2002 it was never registered, which means I am at risk. I do know that I had three bone surgeries and the tissue came from two different companies and Regeneration Technologies is one of them. I did report all three surgeries to the FDA - whatever good that will do. My bone graft was finally registered in January 2006 from the second surgery o I had in January 2005. I had to bring it to the hospital's attention to have it registered. As for my first bone graft - they still don't know where it came from and the hospital says they only keep records for two years.
I can't emphasize enough that registration is your only protection! Only those who can verify registration are completely safe. In my case, 2 out of 3 surgeries were registered. I know my first surgery was not registered and because of that I am having blood tests to test for Hepatitis C and AIDS every six months for the next three years.
People are told by their surgeons that they are in no danger but I believe 30 percent of these surgeries are not registered - there is no code system going directly back to Regeneration Technologies - you have to find out for yourself."
Regeneration Technologies, Inc. (RTI) a Florida-based processor of orthopedic, cardiovascular and other biologic implants, issued a voluntary recall On October 14, 2005. The recall includes implants processed from donor tissue received from Biomedical Tissue Services (BTS).
Regeneration and four other processors purchased tissue from Biomedical Tissue Services of Fort Lee, New Jersey, which was shut down after it was accused of theft of cadaver tissue.
This same company distributed veteran broadcaster Alistair Cook's remains., who died in 2004. Regeneration recalled anybody who received cadaver tissue and was registered. But if, for some reason, your hospital didn't know you had that bone graft, they wouldn't have registered it.
The records for Cooke show Regeneration received the arms and legs. Previously, it was believed that only Cooke's legs were taken and provided for thousands of dollars to Regeneration. Cooke's pelvis and other tissue were also removed, but it's not clear where those parts were sent.
Regeneration says Cooke's tissue was never implanted, but about 10,000 pieces from BTS did wind up in people - which led to a lawsuit for Regeneration and several other companies. Court documents show Regeneration shipped a total of 19,446 pieces of tissue that BTS provided. The Food and Drug Administration says companies like Regeneration are responsible for ensuring their business partners, including BTS, comply with federal guidelines.