Cadaver Bone Graft Recalled Due to Fatal Contamination
When it comes to your dental health, choosing the right treatment options is crucial. Recently, a bone graft product called AlloOss Plus was recalled due to severe contamination issues linked to patient deaths. This alarming situation underscores the importance of understanding the materials used in medical procedures, particularly in dental implants and bone grafts.
What is AlloOss Plus?
AlloOss Plus is a bone graft product derived from cadaver bone, used in various dental procedures to promote bone regeneration. These types of grafts are intended to support new bone growth where it’s needed, often in preparation for dental implants. However, the use of cadaver bone grafts comes with significant risks, as highlighted by the recent recall.
The Contamination
The AlloOss Plus product was found to be contaminated with tuberculosis (TB), a serious bacterial infection that can be life-threatening. This contamination was traced back to the cadaver bone used to create the grafts. Despite the product undergoing gamma irradiation—a process designed to kill bacteria and viruses—residual TB bacteria remained, leading to several patient deaths. This incident isn’t an isolated case; similar issues were reported two years ago with a related product.
The fact that these grafts were contaminated despite rigorous sterilization processes raises serious concerns about the safety and reliability of cadaver bone grafts. Patients who received these grafts were unknowingly exposed to a deadly infection, underscoring the potential dangers of using human-derived materials in medical procedures.
The Risks of Cadaver Bone Grafts
Cadaver bone grafts are often chosen for ostensible regenerative properties, but they carry inherent risks. These grafts can harbor bacteria, viruses, and other pathogens, even after undergoing sterilization. The gamma irradiation process used to sterilize these grafts is not foolproof. While it can kill most bacteria and viruses, it can leave behind fragments of bacterial DNA that may cause serious inflammatory responses in the body. This inflammatory reaction can lead to complications, infections, and, in the worst cases, death.
Another risk associated with cadaver bone grafts is the potential for prion contamination. Prions are misfolded proteins that can cause severe neurological disorders, such as Creutzfeldt-Jakob disease, a rare but fatal brain disorder. Because prions are extremely resistant to sterilization, they pose an additional threat to patients receiving cadaver-derived grafts. For more information about this topic, check out this other blog post: Prion Infections, Bone Grafts, and Alzheimer’s Risk.
Safer Alternatives
Given the risks associated with cadaver bone grafts, patients and dental professionals should consider safer alternatives. Science-based bone grafts, which are created using synthetic materials offer a safer and more reliable option. These alternatives are FDA-regulated and undergo stringent testing and processing to ensure they are free of harmful contaminants, including bacteria, viruses, and prions.
Synthetic bone grafts are designed to mimic the structure and function of natural bone, promoting new bone growth without the risk of infection or contamination. These grafts are often made from materials like calcium phosphate, which is biocompatible and encourages the natural regeneration of bone. Additionally, because they are not derived from human or animal tissue, synthetic grafts eliminate the risk of transmitting diseases like TB or prion infections.
What This Means For You
If you are considering a dental procedure that involves a bone graft, it’s essential to discuss the type of graft material with your dentist. Ask whether the graft is cadaver-derived or if a synthetic could be used instead. Understanding the risks associated with each type of graft can help you make an informed decision about your treatment.
Patients who have already received an AlloOss Plus graft should contact their healthcare provider immediately for a check-up, especially if they are experiencing symptoms such as fever, fatigue, or unexplained weight loss—common signs of TB. Early detection and treatment are critical in managing the infection and preventing further complications.
The recall of AlloOss Plus serves as a stark reminder of the potential dangers associated with cadaver bone grafts. While these grafts have been used successfully in many cases, the risks of contamination and infection cannot be ignored. By opting for safer, science-based alternatives, patients can reduce their risk of complications and ensure a healthier, safer outcome for their dental procedures.
This blog post was summarized from an article intended for a professional audience of clinicians with a science and/or medical background. If you would like to further educate yourself with deeper material, read the original article here:
FAQ
AlloOss Plus was recalled due to contamination with tuberculosis, which was linked to patient deaths.
While they are commonly used, cadaver bone grafts carry risks of infection and contamination, as demonstrated by the AlloOss Plus recall.
Synthetic bone grafts are safer alternatives, as they are FDA-regulated and undergo rigorous testing to ensure they are free of harmful contaminants.
What are your options?
- Ask your dentist about using our products for your procedure
- Contact us to find a dentist near you who uses our products
- Contact us to schedule a consultation with Dr. Steiner in Roseville, CA
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American Society for Bone and Mineral Research (ASBMR)
Tissue Engineering and Regenerative Medicine International Society (TERMIS)
American Academy of Implant Dentistry (AAID)