The product, made by Aziyo Biologics Inc., a regenerative medicine company, came from a single donor, or cadaver, the company said.
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.
Aziyo said in a statement it is “continuing to collaborate with FDA and the CDC on an investigation into the matter and at the appropriate time, we will provide more information.”
In the meantime, public health officials are recommending that the remaining patients who received these bone repair products be treated for tuberculosis even if they are not showing symptoms. Health-care providers are contacting 105 patients who used this product and all but four are being treated for the disease, the CDC said in a statement Thursday.
States were able to sequester 18 of the affected products to prevent additional surgeries, the CDC said. The agency is investigating the outbreak with state health departments, the Food and Drug Administration and the companies that manufactured and distributed the product.
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. But testing for the bacteria that causes tuberculosis is not currently conducted because that infection is so rare in bone grafts, said Beverly Bliss, vice president of accreditation and standards for the American Association of Tissue Banks. The last known case of this kind occurred in 1953, according to the CDC.
Typically, laboratories hired by processing companies test for HIV, hepatitis C and other infections that are more commonly spread by implantation of human tissue, Bliss said.
In addition, the organizations that collect bone and human tissue assess donors and interview family to determine the risk of infection and prevent pathogens from entering the system, she said.
Recovered tissue is typically frozen in 48 hours, Bliss said. The product, called FiberCel, is shipped frozen, according to a description of the product.
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.
Aziyo said it issued a voluntary recall June 2 for a single lot of FiberCel. The company said it received a complaint from an unidentified hospital that reported post-surgical infections in seven of 23 patients who received FiberCel from one lot of the product, according to the FDA’s urgent recall notification. Four patients tested positive for tuberculosis, the FDA said.
Aziyo said its voluntary recall was issued to hospitals that received product from the specific lot after the company learned of post-surgical infections in patients treated with FiberCel, “including some patients that tested positive for tuberculosis.”
Genetic sequencing from some of the patients show the bacteria came from the same source, CDC officials said.
Indiana and Delaware have reported the most cases.
Indiana state health officials said they are working with local health departments and providers to investigate 30 individuals in 19 counties who received the bone repair product.
“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.”
In Delaware, 23 patients received the bone repair products, according to an official familiar with the investigation, who spoke on the condition of anonymity because of the ongoing probe.
In late May, Delaware health officials received notification from a health-care system of a cluster of patients who developed tuberculosis after surgery “involving a specific product,” Delaware Division of Public Health spokeswoman Mary S. Fenimore said in a statement.
One Delaware patient who tested positive for tuberculosis is Richard Williams, 74, who filed a lawsuit this week seeking damages from Aziyo and Medtronic. Williams, a retired corrections officer, says he contracted tuberculosis during a spinal fusion operation at a ChristianaCare hospital that used the contaminated bone graft.
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.
Williams had his surgery on April 13, 2021, according to his lawsuit. Five days after Aziyo issued its recall, Williams had a second surgery to remove the contaminated product and to insert new bone, the lawsuit states.
Williams was not available to comment because he is “still suffering greatly after a second unnecessary surgery,” said Lawrence Cohan, one of his attorneys. Lawyers for Williams said the man received his diagnosis and learned that the product was contaminated before the official recall.
Williams is being treated with antibiotics, and will require “extensive and invasive medical protocols to manage manifestation of disease,” the lawsuit states.
“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.
Cohan said there are additional clients but declined to specify a number. The health-care system used the product in nearly two dozen orthopedic surgeries, according to the law firms’ news release.
Shane Hoffman, a spokesperson for ChristianaCare, said in late May the health system identified “a small number of patients who tested positive for tuberculosis infection” following surgery involving a specific product. Hoffman said the health system’s infection prevention team alerted patients, state health officials and the FDA, and is working with the state and the CDC to ensure patient safety.
FiberCel is made from human bone and “engineered to be like natural tissue,” according to the company’s website.
The CDC is working with the FDA, which regulates bone and tissue designed for implantation into humans, to determine how the contamination happened.
“At this point, the available evidence suggests that TB was transmitted through the product,” according to the CDC statement.
It’s possible for the bacteria to infect bone, and for someone infected to die without being treated. Once that bone is harvested and transplanted into someone, “the body becomes a nurturing environment” for TB to grow, said a CDC official who spoke on the condition of anonymity because of the ongoing investigation.
About 80 percent of TB cases that occur in the United States happen when bacteria that have been living quietly in a person’s body reactivate and cause disease. Many people who have a latent tuberculosis infection never develop the disease. For people with weakened immune systems, especially those with HIV infection, the risk of developing tuberculosis is much higher than for people with normal immune systems.
The United States reported nearly 9,000 cases of tuberculosis in 2019. Up to 13 million people in the United States are estimated to be living with latent TB infection, according to the CDC.