The investigation follows an outbreak that happened this past spring and has since possibly affected more than 100 people who may have been infected after undergoing spinal surgery that used a single lot of a bone repair product, according to a statement by the U.S. Centers for Disease Control and Prevention (CDC).
The Washington Post reported that the product used during the surgery was FiberCel Fiber Viable Bone Matrix (“FiberCel”), which was voluntarily recalled in early June by the product maker, Aziyo Biologics Inc., according to a statement issued by the U.S. Food and Drug Administration (FDA) on June 2.
FiberCel is a biocompatible compound developed from human bone tissue. It is used in a variety of orthopedic and spinal surgeries to give regenerative growth a chance.
On June 2, Aziyo Biologics issued the recall of their product voluntarily in an urgent notification letter following a complaint that initially reported “post-surgical infection in 7 of the 23 patients” that had received the product.
The product was shipped to 37 facilities across 20 states, according to the CDC. As of June 10, all unused units of this product lot were sequestered.
In an updated report by CDC officials, who are investigating the outbreak together with the FDA, there are now 113 patients that have “likely” been exposed to Mycobacterium TB (MTB), which is the bacteria that causes TB, the Post reported. MTB can cause severe disease and death if untreated.
The CDC is recommending that all patients who received the recalled product undergo treatment for TB disease—even if asymptomatic. The procedure typically involves taking antibiotics for six to nine months.
Federal health authorities are also advising hospitals and surgical centers to identify health care personnel who may have been exposed to MTB during surgical procedures or during patient care.
Ron Lloyd, the CEO and president of Aziyo Biologics, said in a statement the company is “committed to a thorough, timely and transparent investigation” into the origins of the outbreak.
Indiana and Delaware have seen the most cases of TB, according to the Post. Health authorities in Indiana are investigating 30 people in over a dozen counties who received FiberCel.
TB is a respiratory infectious disease that usually causes lung infection. Those with latent TB infection don’t have symptoms. Without proper treatment in time, 10 percent of patients with latent infection will progress to active TB, with a fatality rate of 50 percent, according to the World Health Organization.
From NTD News