CDC, FDA is investigating the occurrence of rare tuberculosis that may be associated with contaminated bone repair products

Centers for Disease Control and Prevention, Food and Drug Administration, and state and local health agencies are investigating the origins of several rare states. Outbreak of tuberculosis More than 100 patients may have been infected this spring during spinal surgery or fracture repair.

The procedure used a bone repair product called FiberCel Fiber Viable Bone Matrix. This is a malleable bone putty developed by the regenerative medicine company Aziyo Biologics, which uses human cells and is used in a variety of orthopedic procedures. The Washington Post.

FiberCel Fiber Survival Bone Matrix (Photo courtesy of Aziyo Biologics)

They don’t know Issue a voluntary recall notice According to the CDC, on June 2, 154 units of FiberCels, all derived from a single donor, were shipped to 37 facilities in 20 states. Post reported that a total of 113 patients received the recalled product and eight died after surgery, although the cause of death has not yet been identified.

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CDC warned at statement Patients undergoing spinal fusion or fracture repair using recalled lots of FiberCel are “probably exposed to M. tuberculosis” and can cause serious illness or death if left untreated. There is.

The agency recommends that surgeons work with their respective health department tuberculosis programs to immediately contact patients who have undergone surgery using the recalled product. Patients should start drug treatment for tuberculosis immediately, even if they are asymptomatic, in collaboration with infectious disease and tuberculosis specialists.

Hospitals and surgical centers, on the other hand, need to identify healthcare professionals who may have been exposed to MTB during surgery or patient care and report adverse effects on patients to the FDA. MedWatch Adverse Event Reporting Program.

Aziyo has confirmed that it is working with its exclusive distributors Medtronic, FDA and CDC to investigate the source of the infection. The company said, “There is no reason to believe that other units of FiberCel will be affected by this situation,” but sales of FiberCel have been suspended with great care until further notice.

“We are working on a thorough, timely and transparent investigation into the root causes of these infections,” said Ron Lloyd, President and Chief Executive Officer of Aziyo Biologics.

As of June 10, the CDC stated that all unused units affected were quarantined.

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According to the post, Delaware and Indiana report most cases of tuberculosis. Indiana health officials are investigating 30 individuals in 19 counties that received bone repair products.

“All affected individuals have been notified and appropriate public health measures have been taken,” said Megan Wade Tuxter, a spokeswoman for the Indiana Department of Health, in a statement.

In Delaware, 23 patients received bone repair products, an anonymous source familiar with the study told the post. In addition, Delaware Public Health Service spokeswoman Mary S. Fenimore was notified by the state health authorities in late May of a population of patients who developed tuberculosis after surgery “including certain products” from the healthcare system. I told the outlet that I received it.

74-year-old Richard Williams, who tested positive for tuberculosis, said Proceedings this week We are seeking damages from Aziyo and Medtronic. Retired prison officer Williams claims he had tuberculosis during a spinal fusion on April 13 at Christiana Care Hospital, which used contaminated bone grafts. The proceedings state that after Ajiyo’s voluntary recall was issued, Williams had a second operation to remove the contaminated product and insert new bone five days later.

Medtronic and Aziyo did not immediately return Fox News’ request for comment.

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The United States reported about 9,000 cases of tuberculosis in 2019. It is estimated that up to 13 million people in the United States live with latent tuberculosis infection (LTBI). According to the CDC..

Approximately 80% of tuberculosis patients in the United States are due to reactivation of latent tuberculosis infection. Many people with latent tuberculosis infection do not develop tuberculosis, but some develop tuberculosis within a few weeks of infection before the immune system fights M. tuberculosis.

Others may get sick years after their immune system weakens for another reason. For people with a weak immune system, especially those infected with HIV, the risk of developing tuberculosis is much higher than for people with a normal immune system.

Symptomatology According to the CDC, there are severe coughs, chest pain, hemoptysis, weakness and malaise, weight loss, loss of appetite, chills, fever, and night sweats that last for more than 3 weeks.