Rare Tuberculosis Outbreak Linked to Contaminated Bone Repair Product

A rare Tuberculosis (TB) outbreak linked to a contaminated bone repair product has infected more than 100 people during spinal surgery or fracture repairs this spring. On June 2, Aziyo Biologics recalled 154 units of its FiberCel Fiber Viable Bone Matrix (FiberCel). FiberCel is a bone repair product made from human tissue that is used in orthopedic and spinal surgeries. The recalled products, which all came from a single donor or cadaver, were shipped to 37 facilities in 20 states between March 3 and April 4. Aziyo, whose products are distributed exclusively by Medtronic, issued the recall after a hospital reported post-surgical infections in seven patients who received FiberCel, including four who tested positive for TB.

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The CDC says that 136 units of FiberCel were implanted into 113 patients. All unused units of the recalled lot have been sequestered. A total of 105 patients who received FiberCel are now being treated for Tuberculosis disease. Eight people died after surgery, but the cause of death has not yet been determined. The CDC recommends that all patients who underwent surgery with FiberCel should be treated for TB disease, even asymptomatic.

According to the CDC, the last known case of this kind happened in 1953. A spokesperson for the American Association of Tissue Banks told the Washington Post that TB bacteria testing is not currently conducted because infection is so rare in bone grafts. Medtronic also says that the material is not tested.

UPDATE: A second outbreak of tuberculosis was linked to Aziyo Biologics bone repair material in 2023.

Highest Number of Tuberculosis Infections in Delaware and Indiana

Indiana and Delaware reported the highest number of Tuberculosis infections linked to FiberCel bone repair products. The Indiana Department of Health is investigating 30 cases in 19 counties. A spokesperson from the health department said that all affected patients have been notified. In Delaware, 23 patients received FiberCel bone repair products. Delaware health officials received notice of a tuberculosis cluster from a healthcare system in May.

What is Tuberculosis (TB)?

tuberculosis bacteria
Mycobacterium tuberculosis bacteria

Tuberculosis is an infectious disease caused by Mycobacterium tuberculosis bacteria that can result in either a latent TB infection or TB disease. TB mainly affects the lungs but may infect other parts of the body including the bones, kidneys, spine, and brain.

In 2019, there were almost 9,000 Tuberculosis infections in the U.S. About 80% of all TB infections are latent, which means bacteria live in the body without showing symptoms. TB disease happens when the immune system cannot stop the bacteria from multiplying. If left untreated, TB disease can be fatal. Symptoms of TB disease include:

  • A bad cough lasting three weeks or longer
  • Chest pain
  • Coughing up blood
  • Weakness or fatigue
  • Weight loss
  • Lack of appetite
  • Chills
  • Fever
  • Night sweats

About our Team of Infectious Disease Lawyers

Our team of infectious disease lawyers represents people who are infected by recalled medical products. When a death is involved, families may be able to file a wrongful death lawsuit. If you or someone you love contracted tuberculosis from a healthcare facility, you may be eligible for compensation. Please call 1-888-377-8900, text 612-261-0856, or fill out the form below for a free consultation.

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