US officials are investigating rare tuberculosis (TB) infection outbreaks in patients who underwent spinal surgery. According to news reports, the cause is a potentially contaminated bone repair product.
More than one hundred patients may have been exposed to tuberculosis bacteria using the bone repair product, FiberCel, during spine surgery this spring. FiberCel is a putty-like material produced from human bone tissue and is used in orthopedic and spinal procedures.
Contaminated bone repair products used in various orthopedic procedures
The bone repair product's manufacturer has issued a recall for 154 containers of the material, a flexible bone putty containing human cells, and used in a range of orthopedic procedures. According to the Centers for Disease Control and Prevention (CDC), the items were sent to 37 sites in 20 states between March 3 and April 2.
Aziyo Biologics Inc., a regenerative medicine firm, claims that the product originated from a single donor or cadaver. The CDC confirmed 136 of the total units were implanted in 113 individuals. Eight patients died due to their operations, but the cause of death is still unknown, said the CDC spokeswoman Martha Sharan.
In a statement, Aziyo said it is continuing to work with the US Food and Drug Administration (FDA) and the CDC on an inquiry into the matter and would offer further information at the right time. Meanwhile, even if no symptoms are present, public health experts urge that the remaining individuals who got these bone repair products be treated for tuberculosis.
The CDC stated Thursday that healthcare professionals are contacting 105 individuals who used this product, and all but only four are being treated for the infection. According to the CDC, states could separate 18 of the contaminated products, preventing additional surgeries.
CDC said the bacteria can infect bone, or kill a patient without being treated
The CDC is working with state health departments, the FDA, and the firms that made and distributed the contaminated bone repair product to investigate the outbreak. Mycobacterium tuberculosis is the bacteria that causes TB.
Although it can affect any area of the body, the lungs are frequently affected, including the kidney, brain, and spine. Even if not everyone infected becomes sick, the condition can be deadly if not given treatment. A six-month course of antibiotics is the standard medication for non-drug-resistant tuberculosis, as per Washington Post via MSN.
The bone product's contamination is the responsibility of Aziyo, which processes it. However, because TB infection is so uncommon in bone transplants, testing for the bacteria that causes it is not frequently done, said Beverly Bliss, Vice President of Accreditation and Standards for the American Association of Tissue Banks. The CDC noted that the last reported incidence of this kind occurred in 1953.
A source familiar with the inquiry told the Post 23 patients in Delaware got the bone repair products. Furthermore, state health officials received notice in late May from a hospital system regarding a cluster of individuals who developed tuberculosis following surgery involving a specific product, according to Delaware Division of Public Health spokesperson Mary S. Fenimore.
Richard Williams, a 74-year-old patient, tested positive for tuberculosis. He filed a complaint against Aziyo and Medtronic this week, seeking damages. Williams, a retired correctional officer, alleges he acquired TB after spinal fusion surgery on April 13 at a ChristianaCare hospital that used the contaminated bone repair product. Per Fox News, Williams underwent a second operation five days after Aziyo's voluntary recall was made to remove the infected product and install a replacement bone, said the lawsuit.