WASHINGTON - Federal and state health officials are investigating a rare tuberculosis outbreak among more than 100 patients who may have been infected after having spinal surgery or fracture repairs this spring with a bone product contaminated with the bacteria that causes TB.
Of the total, 136 were implanted into 113 patients, according to CDC officials. Eight patients died after their procedures, but the cause of death is still being determined, CDC spokeswoman Martha Sharan said Thursday. Tuberculosis is caused by a bacterium, Mycobacterium tuberculosis. It usually affects the lungs, but can attack any part of the body, including the kidney, spine and brain. Not everyone infected becomes sick, but if not treated properly, the disease can be fatal. Typical treatment for TB that is not drug-resistant is a six-month course of antibiotics.Aziyo, which processes the bone product, is responsible for ensuring it is free of contamination.
A spokesman for Medtronic, the exclusive distributor of FiberCel, said it has quality controls in place but does not test the material. The company has suspended distribution until the investigation is complete, said spokesman Ben Petok. "All affected individuals have been notified, and appropriate public health actions have been taken," Indiana Department of Health spokeswoman Megan Wade-Taxter said in a statement. "There is no risk to the public."
Petok, the Medtronic spokesman, said the company has not seen the lawsuit and could not comment on it. Aziyo did not comment on the lawsuit. "We believe our client and likely others were infected with tuberculosis due to the contaminated surgical bone product which should have been fully tested to ensure it was disease-free and suitable for implantation," Cohan said in a statement.
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