CDC investigating TB cases linked to tainted bone repair product
The CDC is investigating an outbreak of tuberculosis (TB) in patients who have recently undergone spinal surgery that included the use of bone repair product, FiberCel. Left untreated, TB can cause an infection that impacts the respiratory system as well as potentially damaging the kidneys, spine and brain and could even lead to death. Below, the Maryland medical device liability attorneys at Peter Angelos Law provide more detail on the outbreak as well as provide guidance for patients.
Overview of the FiberCel Outbreak and Recall
More than 100 people have been exposed to TB bacteria via FiberCel use in spinal surgeries. Manufactured by FiberCel Aziyo Biologies, Inc., FiberCel is a putty-like substance made from human bone tissues. It is used during various orthopedic and spinal surgeries, including bone grafting and reconstruction.
On June 2, 2021, Aziyo issued a voluntary recall notice after one hospital reported that seven of the 23 spinal surgery patients who received FiberCel developed post-surgical infections. Four of those patients tested positive for TB. A total of 113 patients received the recalled product, with the most suspected cases of infection in Indiana and Delaware.
The recalled FiberCel lot, Lot #NMDS210011 is linked to a single donor cadaver. Aziyo reported that the recalled lot consisted of 154 units of FiberCel that were shipped to 20 facilities in the United States. Out of an abundance of caution, Aziyo is suspending the sale of FiberCel until further notice.
“Patient health and safety are our highest priority. Accordingly, we have implemented this voluntary recall and instructed hospitals that received FiberCel product from this specific donor lot to immediately quarantine and return any remaining product to us,” said Ron Lloyd, Aziyo’s president and chief executive officer, in a statement released by the company in June. “We are committed to a thorough, timely, and transparent investigation into the root cause of these infections.”
Risk of TB
TB is caused by a bacterium called Mycobacterium tuberculosis (MTB), which requires a high level of oxygen in its metabolism. Because of this, the bacteria typically manifests in the oxygen-rich environment of lung tissue. It is rare that MTB grows in the bone because of the oxygen-poor environment bone cells and tissues provide the bacterium.
The risk of spreading infection of TB through bone tissue is so low that many regenerative medicine companies similar to Aziyo are not required to test their bone products for MTB. According to The Washington Post, the last time an infection similar to this one occurred was in 1953. It is still unclear how the contamination of the FiberCel lot occurred.
MTB can attack any part of the body, not just the lungs. According to the CDC, MTB can impact the kidneys, spine, and brain. Infection can lead to death.
In addition, not all individuals infected with MTB become sick. TB manifests itself in two conditions: latent TB infections and TB disease. Latent TB infections occur when MTB lives in the body without making an individual sick. Those with latent TB have no symptoms and are not contagious, but they typically test positive for TB and have the risk of developing TB disease. Individuals with a compromised immune system are especially susceptible to the progression of Latent TB into TB disease.
TB disease occurs when the immune system cannot stop the MTB cells from growing. Individuals with TB disease are extremely contagious and present with symptoms such as incessant coughing, pain in the chest, coughing up blood, weakness or fatigue, weight loss, no appetite, chills, fever, and night sweats.
CDC Recommendations for Patients:
The CDC has issued the following recommendations for those who were possibly in contact with the affected FiberCel lot:
- Patients who underwent surgeries using the FiberCel lot #NMDS210011 should undergo evaluation and treatment. These patients should immediately begin drug treatment for TB disease, even if they present as asymptomatic. All treatment should be coordinated with infections disease and TB experts
- If you are unsure if you are affected by the recall, contact your surgical team to determine if the recalled lot of FiberCel was utilized in your surgery.
Seek Guidance From a Maryland Medical Device Liability Attorney
Undergoing major surgery is always a stressful occasion, and patients trust that the medical materials and devices they’re encountering are safe. When a medical device manufacturer puts patients at risk, the patients may be entitled to compensation. While a monetary award cannot erase the pain and suffering of illness or complications, it can aid with the mounting medical bills that often accompany these issues. If you believe that you came in contact with the affected FiberCel lot and are concerned about your risk of developing TB, the experienced team of medical device liability attorneys at Peter Angelos Law is ready to help you. Contact us today for a free consultation by calling 1-800-556-5522 or filling out the form below.