Health regulators in the United States are working to respond to a potential tuberculosis outbreak that's linked to a company's tainted bone graft products.
Three new cases of the highly unusual and deadly disease were identified in the U.S. last week, bringing the total number of cases to five, according to Politico. At least one person has died.
The Centers for Disease Control and Prevention said the cases appear to be linked to a single product sold by Aziyo Biologics Inc. that's used in surgical and dental procedures.
Shipments of the product were sent to over a dozen facilities in California, Louisiana, Michigan, New York, Oregon, Texas and Virginia. Regulators said product from the contaminated lot was implanted in at least 36 other people.
"CDC and FDA are working with state and local health departments, hospitals, surgical centers, and dental offices in the affected states to ensure patients are rapidly evaluated and treated, prevent further patient harm, and determine if additional measures can be taken to prevent similar outbreaks in the future," the agency said in a statement.
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Aziyo issued a voluntary recall notice for the tainted product earlier this month and the CDC says all of the unused units have been removed from inventory.
"We are taking immediate action to safeguard patients by implementing a full product recall as we work with the CDC to investigate this event," Aziyo president and CEO Dr. Randy Mills said in a statement. "The people of Aziyo care deeply about the patients we serve and will continue to work with the medical community, patients, and regulatory authorities as we gather additional information."
However, this isn't the first time the company has been linked to a deadly outbreak of the rare disease. In 2021, a different bone graft product sold by Aziyo was responsible for a tuberculosis outbreak in at least 87 patients, eight of which died.
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Tuberculosis is an infectious disease that primarily affects an infected person's lungs, but can also target other parts of the body, such as the brain, spine, or kidneys. It is transmitted through the air when an infected person coughs, sneezes, or speaks, releasing tiny droplets that contain the bacteria.
Tuberculosis is treatable and curable, but requires a specific course of antibiotics taken over several months to ensure all bacteria has been eliminated from the body. Preliminary data from the CDC shows that the number of cases in the U.S. increased by 5% in 2022 to 8,300 cases, specifically among children under 4 years of age, those who are incarcerated, and people who have immigrated from parts of the world with high rates of the disease.
The U.S. has one of the lowest tuberculosis rates in the world, thanks to large investments into domestic programs and control efforts.
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