Another Fatal Tuberculosis Outbreak Connected to Contaminated Bone Grafts
A fatal outbreak of tuberculosis (TB) has been associated with infected bone graft material in the United States, marking the second such occurrence in two years.
Health authorities in the U.S. are battling an outbreak of TB caused by tainted bone graft products, resulting in one death and infecting at least four others.
In 2021, the same category of bone repair substance utilized in spinal surgeries led to eight deaths due to contamination with TB-causing bacteria. Aziyo Biologics, the Silver Spring, Md., company implicated in both outbreaks, supplied the product.
The contaminated item was administered to a minimum of 36 patients for either surgical or dental procedures earlier this year, as stated by the Centers for Disease Control and Prevention (CDC). The situation only came to public attention when Aziyo initiated a voluntary recall on July 13, 2023.
Kathleen Conley, a CDC spokesperson, noted that all patients are receiving treatment as potential TB patients, owing to a significant number who contract severe TB through implanted bone substances.
TB is caused by the Mycobacterium tuberculosis bacterium, typically attacking the lungs but capable of infecting other body parts. Without treatment, TB can be life-threatening.
In 2021, contaminated materials were used on 113 patients, sparking numerous lawsuits and demands for more stringent regulations concerning the widely-used surgical putty, which consists of living cells obtained from cadaver bones.
During the recent outbreak, bone products sourced from a sole donor were distributed to 13 facilities across seven states: California, Louisiana, Michigan, New York, Oregon, Texas, and Virginia between February 27 and June 20, the CDC reported.
A single batch of ViBone Moldable, Aziyo’s human tissue-based bone repair product, was recalled on July 13. Though samples tested negative for TB, the CDC stated that another of Aziyo’s products used in dental procedures was also recalled.
The company has halted all bone repair product shipments from all donors. Affected patients, facilities, and states have been informed, and remaining units have been removed from inventory, the CDC announced.
Current U.S. regulations don’t necessitate tuberculosis assessments for organ or tissue donors. While products like bone repair material must be checked for communicable diseases like hepatitis, HIV, and syphilis, TB is not on the list.
Laboratory testing for TB is also not usually conducted, as revealed in a report on the 2021 outbreak, which was the largest recorded occurrence of tissue-derived TB.
In that report, federal health authorities recommended routine TB assessment for all prospective tissues and donors.
In a subsequent statement, Aziyo mentioned that neither the FDA nor the American Association of Tissue Banks mandates TB testing in cellular products. The company developed a TB test that surpasses current guidelines.
Despite negative results from the specific lot linked to the TB infections, Beverly Bliss of the American Association of Tissue Banks agreed that more sensitive testing, taking six to eight weeks, may still not reveal TB in bones. Current tests are designed for living individuals, she explained.
Both the AATB and the FDA failed to find any mistakes in Aziyo’s 2021 bone processing, but the association is preparing to release new “risk factors” to assist companies in avoiding tissue from people most likely to have TB exposure.
The FDA stated that it is collaborating with the CDC to fully grasp the recall’s implications. Infectious-disease specialists and other clinicians call for more exhaustive testing for TB, a process that might take up to eight weeks due to the slow growth of the bacteria.
This defective product, a bone graft material contaminated with Mycobacterium tuberculosis, can potentially cause severe harm and damage to the patients. Here are some potential damages that may arise with the contaminated bone grafting materials:
Health Complications: The most immediate damage caused by the contaminated product is the contraction of tuberculosis, an infectious disease that primarily affects the lungs but can also impact other parts of the body, such as the kidney, spine, and brain. Tuberculosis can be life-threatening if left untreated.
Extended Medical Treatment: Patients affected by this defective product will require extensive medical treatment to combat the disease, which might include hospitalization, long-term antibiotic therapy, and additional surgeries or procedures.
Emotional Distress: Being diagnosed with a potentially life-threatening disease such as tuberculosis can lead to significant psychological stress and emotional trauma.
Financial Strain: The cost of long-term medical treatment, additional surgeries, and potential loss of income due to the inability to work can result in substantial financial burdens.
Pain and Suffering: Patients may suffer from physical pain due to the disease itself and the necessary medical interventions. They could also face significant suffering due to the disruption to their normal life and potential impacts on their future health.
It’s important to note that each patient’s case can be different, and the exact nature and extent of the damages can vary significantly depending on multiple factors such as the patient’s health status prior to exposure, the extent of exposure to the defective product, and the individual’s response to medical treatment.
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