Aziyo Biologics, Inc. issued a voluntary recall on June 2, 2021, pertaining to a single donor lot of its FiberCel Fiber Viable Bone Matrix after learning of post-surgical infections in several patients treated with the product, including some patients that tested positive for tuberculosis.
Samples of the recalled product have now undergone PCR analysis by a lab contracted by the CDC and tested positive for Mycobacterium tuberculosis. Cell culture testing of the recalled product is being conducted by the same lab to corroborate the PCR testing results.
Based on information from the CDC, 136 units within this product lot were implanted into 113 patients in 20 states. Of the 113 patients, the CDC has identified at least 72 patients who have exhibited clinical or diagnostic findings consistent with tuberculosis infection. Eight patients who received the product from this lot have died, however, the cause of death is still being determined. Working with state health agencies, the CDC has contacted all patients treated with this lot of FiberCel to help ensure they are directed to appropriate medical treatment.
Hospital staff may have been infected with Tuberculosis after taking part in spinal surgery or fracture repairs. If you believe that you were exposed to Tuberculosis while caring for a patient, or taking part in a surgery involving a FiberCel bone graft, we are committed to obtaining all the results you need and deserve. Contact us today.
WHAT IS FIBERCEL FIBER VIABLE BONE MATRIX?
FiberCel is a fiber-based bone repair product made from human tissue and engineered to maintain characteristics of natural tissue. It is used in orthopedic or reconstructive bone grafting procedures in combination with autologous bone or other forms of allograft bone or alone as a bone graft.
Additionally, FiberCel provides handling properties that are critical for use as a bone void filler in various orthopedic and spinal procedures. FiberCel contains cancellous bone particles with preserved living cells and demineralized cortical bone fibers to facilitate bone repair and healing.
FIBERCEL AND TUBERCULOSIS – POST-SURGERY INFECTION RISKS?
The typical method of contracting tuberculosis is to breathe in the bacteria called “Mycobacterium tuberculosis.” However, in the case of patients with bone graft and other orthopedic/reconstruction surgeries, their bodies may be more susceptible to infections of all kinds and the tuberculosis bacteria, if included in the lot of FiberCel bone grafts, could find a suitable host in which to proliferate.
FIBERCEL WAS USED IN MY PROCEDURE – WHAT SHOULD I DO?
If you believe you received FiberCel as part of your (or a loved one’s) medical treatment, such as a bone graft for orthopedic or reconstructive purposes, and have developed an infection or tuberculosis, contact us immediately.
The attorneys at Saltz Mongeluzzi & Bendesky and Morris James have partnered to effectively represent those who have been affected by this lawsuit.
What is the FiberCel Patient Reimbursement Program?
If patients have out-of-pocket expenses for tuberculosis testing and treatment related to the tainted FiberCel product that are not covered by either their personal or government health insurance or their state’s tuberculosis funding, they may be eligible for reimbursement through this program. Contact us to learn more.
Do you represent individuals who contracted tuberculosis after receiving a FiberCel implant during surgery?
Yes, we currently represent more than 20 individuals who contracted tuberculosis after being implanted with the contaminated lot of FiberCel. We continue to investigate additional cases.
If you believe you received contaminated FiberCel as part of your (or a loved one’s) medical treatment, such as a bone graft for orthopedic or reconstructive purposes, we are committed to obtaining all the results you need and deserve. Contact us today.
Is my surgeon or hospital at fault?
No. Based on our initial investigation, your doctor and hospital were not aware that one lot of FiberCel was contaminated with tuberculosis. The manufacturer had a duty to warn of this risk, and they never did. We are not filing lawsuits against the surgeons or hospitals that treated the individuals who became infected with TB.
Why didn’t they test the FiberCel product?
Our investigations are ongoing, and we hope to learn more about what happened and why it happened through the litigation process.
Who are potential defendants?
We have filed suit against the manufacturer and distributor of FiberCel. We are currently investigating additional entities to determine if they might share responsibility for the contamination.
What is tuberculosis (TB)?
According to the CDC, “Tuberculosis (TB) is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. Not everyone infected with TB bacteria becomes sick. As a result, two TB-related conditions exist: latent TB infection (LTBI) and TB disease. If not treated properly, TB disease can be fatal.”
How did tuberculosis get into FiberCel bone product?
Bone repair products like FiberCel are made using donations from cadavers. In the case of FiberCel Lot # NMDS210011, the person who donated their cadaver likely had tuberculosis prior to their death and donation. However, our investigation remains ongoing.