AlloOss Plus is sold to dentists by ACE Southern. It is the same product that killed 8 people two years ago due to tuberculosis infection. Recently, there has been one death and a number of systemic tuberculosis infections with the same product. Two years ago, the company was called Aziyo, but is now called Elutia. For orthopedic distribution, they sold the product called “ViBone Moldable” through a distributor of medical devices called Surgalign. They sold the same product called “alloOss Plus” to dentists through ACE. The product claims to harvest regenerative cells from cadavers, but apparently they are also harvesting diseases that you are putting in your patients.
The first outbreak of deaths happened two years ago and was thoroughly investigated, so we have the details on the donor and how the transmission occurred. The donor was an 80-year-old with multiple diseases and was in and out of the hospital for diseases such as heart disease, kidney failure, and diabetes. He also had multiple signs of tuberculosis infection, but he was so sick that the treating physicians failed to make the diagnosis. The standard donor testing for hepatitis B and C, HIV, syphilis, and human T-lymphotropic virus was found to be negative. This story is stunning on many levels. First, they are harvesting “regenerative cells” from an 80-year-old cadaver. The population of regenerative cells in our bodies drops significantly as we age and I would hope that the company would know this, but they choose to use a very sick, aged, and dying individual. There is no other explanation for this other than desperation in acquiring a body. This body not only had very few regenerative cells, but was obviously pumped with a vast array of drugs as he had multiple diseases and was in the process of dying over time. Not only did the recipients receive tuberculosis, but also the everything else that was in his body at the time of death. Most of us are willing to donate our organs upon death, but virtually none of us are will to give our bodies to a tissue harvester where everything is stripped of your body and nothing is left. If a company that is harvesting cells must resort to a very sick 80-year-old, what kind of bodies are harvested for your routine cadaver bone graft? Obviously any dead body will do.
Dentists believe cadaver tissues are safe because they are gamma radiated. While they may be safe from infection of bacteria and viruses, they are not safe from heavy metals that accumulate in our bones and they are not safe from the residual proteins that are left over after the bacteria and viruses are killed. When a bacteria or virus is killed, the residual parts of that bacteria are highly inflammatory and are considered an endotoxin. Bacterial fragments can be more inflammatory than the live bacteria itself. For instance, here at Steinerbio after using equipment for producing our bone grafts, we cannot just set aside that equipment for sterilization for when we can get around to it. If the equipment sits, bacteria can accumulate and grow. Yes, they are killed when the equipment is sterilized, but their endotoxin remains. When that equipment is used to produce a new bone grafts, that endotoxin can still be transferred. The patient may not develop an infection, but will develop a significant inflammatory response, which in our case would cause the graft to fail. The surprising finding is that the endotoxin from dead bacteria is often more serious than the live bacterial infection. Our bone grafts are rigorously tested and have been found to produce zero inflammatory reaction.
Inflammation-related residual bacterial fragments have been implicated in chronic inflammatory disease such as inflammatory bowel disease and rheumatoid arthritis. In Lyme disease, the patient can be cleared of the active infection, but it is the residual bacterial fragments that the body cannot clear, which contributes to the long standing debilitating effects of the disease. Patients with a history of Lyme disease often present with chronic brain inflammation that is caused by residual fragments of the dead bacteria that the body is unable to remove. So your gamma radiated cadaver bone graft may be safe from infection, but it is not safe from the residual bacterial particles that can be even more inflammatory and also be unable to be removed by the patient’s immune system. Of course you are taught that if a cadaver bone graft fails it is never the fault of the bone graft yet, here is another reason for why cadaver bone grafts fail. With transplanted bone, you have no way of knowing what you are putting in your patients. If there were benefits of using cadaver bone grafts that outweighed the risks, there would be some justification for using these materials. However, when studies show that modern science-based FDA cleared bone grafts outperform the cadaver grafts, then the use of these materials is not justified. The article below discusses the relative effectiveness of the various bone graft materials:
Anytime you are using a cadaver bone graft, it is a transplant and it is not regulated by the FDA. Not only do you not know if it is safe and effective, but there is no limit to the false advertising the company can spread. If fact, anything promoted by a company that sells cadaver tissue is usually unequivocally false because all they need to do is learn a few impressive words to make another sale.
The latest round of tuberculous infections and death associated with this product were sold through distributors, not the manufacturer. On the orthopedic side, the product was sold by a company called Surgalign. They make metal orthopedic parts and obviously knew nothing about bone biology. The company had been going broke long before taking on ViBone Moldable so the manufacturer found a desperate distributor to push the product because no one who knows what they are doing would ever sell this product. On the dental side, alloOss Plus was sold by ACE. The moral of the story here is you should never purchase something as invasive and with potential complications as a bone graft from a sales rep. If you need to rely on a sales rep to tell you what bone graft to use, then your patients are in danger. After the first round of deaths in 2021, the company began testing for tuberculosis contamination. The test turned out negative for the recent donor. The final assessment is that there is no effective tests for tuberculous from cadaver bone.
Who can you trust to guide you when deciding on what bone graft product to use? The following is a university professor who is a board certified periodontist promoting alloOss Plus:
Compendium, September 2022, Volume 43, Issue 8
For the safety of your patients and for your ability to be informed, you should be using an FDA cleared bone graft designed for its intended use. For a transplanted tissue, the companies can tell you anything about the product with no liability. However, here at SteinerBio just this year, the FDA has reviewed every word of our website and all of our advertising. In addition, an officer of the FDA spent two full weeks at our office combing over all information provided by our company, past and present. There is not a word or video on our website that has not been reviewed, scrutinized, and approved by the FDA. If you are interested in understanding what your bone grafts are doing inside your patients, we invite you to view the following free 2-hour CE short course on bone science:
