On June 2, 2021, Silver Spring, Maryland-based medical company Aziyo Biologics announced a voluntary recall of 154 units of the company’s FiberCel Fiber Viable Bone Matrix.
The voluntary recall was issued after it came to Aziyo’s attention that hospitals were seeing post-surgical infection in some patients treated with FiberCel Viable Bone Matrix—including some positive tuberculosis cases. The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are currently coordinating with Aziyo and its distributor in investigation of the infection’s source.
Hospitals were informed and any unused units were recalled. FiberCel Fiber Viable Bone Matrix is a bone repair product made from human tissue and used in a variety of spinal and orthopedic procedures.
“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 company President and Chief Executive Officer Ron Lloyd. When OTW reached out for more info on the number of potential individuals affected, Aziyo stated, “A total of 154 units were distributed and we are collecting unused units from hospitals as part of the recall. As this process is ongoing, we are unable to comment on specific numbers at this time.”
The 154 FiberCel units were derived from one single donor, or human cadaver. They were shipped to medical facilities and hospitals in 20 states. Aziyo has reported that they are in the process of recalling all unused FiberCel units yet have no cause to suspect further infected units outside of this specific lot.
Post-surgical Tuberculosis in FiberCel Treated Patients
Tuberculosis (TB), caused by bacterium called Mycobacterium tuberculosis, is treated by antibiotics. A potentially life-threatening bacterial disease, it primarily affects lung tissue. TB is classified as a communicable disease, with high risk of community exposure through airborne droplets from the patient coughing or sneezing. For this reason, cases are by law required to be reported to local and state health departments.
Despite primarily affecting the lungs, tuberculosis can also attack other parts of the body such as the spine, kidney or brain. Once upon a time a common illness, TB is today considered rare. There are fewer than 200,000 cases per year in the U.S. The majority of U.S. cases occur when a dormant TB infection becomes active and causes illness. Some patients with latent tuberculosis may never actually develop symptoms. Active symptoms may include chest pain, severe and long-lasting cough, appetite loss, night sweats fatigue, fever, chills and coughing up blood. Due to its highly contagious nature, TB presents a high risk level for spread within a given hospital population.
Lloyd has stated, “We are committed to a thorough, timely and transparent investigation into the root cause of these infections.” All sales of FiberCel will also reportedly be suspended by Aziyo until further notice. The company is also suspending its revenue guidance for 2021, due to potential impact to business.
Aziyo Biologics and FiberCel Fiber Viable Bone Matrix
Aziyo is a commercial-stage regenerative biotechnology company focused on regenerative medicine. Founded in 2015, the company’s portfolio includes products used by specialists in orthopedic, reconstructive and cardiovascular settings. The company web page states, “We’re focused on improving patient outcomes, mitigating device complications, and reducing cost of healthcare.”
Aziyo reported total net sales of $42.7 million for the full 2020 year, despite the adverse market impact of the COVID-19 pandemic.
FiberCel Fiber Viable Bone Matrix is derived from donated cancellous bone particles, preserved living cells and demineralized cortical bone fibers to promote bone healing. According to Aziyo marketing materials, FiberCel “maximize availability of the natural growth factors in bone resulting in bone formation.” The company has “designed the process to protect native elements of bone, including growth factors and osteoprogenitor cells that are known to be biologically active and critical for successful bone formation.”
Because the natural bone repair product is engineered to foster the grafting and healing characteristics needed post-surgery, it is utilized widely as an effective ortho surgical tool. Although used successfully in spinal and orthopedic bone grafting procedures, FiberCel Fiber Viable Bone Matrix, like any human tissue-derived product, also carries a risk of disease contamination.
Aziyo’s company website Safety and Regulatory statement has maintained that: “All Aziyo tissue undergoes rigorous testing before being released for transplant or distribution to our partners. Aziyo is proud to meet or exceed all industry benchmarks for quality assurance and testing, and maintains compliance with regulatory agencies, including the American Association of Tissue Banks (AATB) and the U.S. Food and Drug Administration (FDA).”
Beverly Bliss, vice president of accreditation and standards for the American Association of Tissue Banks, told The Washington Post that while med tech companies are responsible for ensuring contamination-free bone products, testing for tuberculosis-related bacteria is not done due to the fact that infection is highly uncommon in bone grafts. Bliss said that labs typically test for common transmittable tissue infections including hepatitis C and HIV.
Litigation
Richard Williams, a 74-year-old retired correctional officer in Delaware is one patient who was affected by the tainted product lot. Williams reportedly underwent cervical spine surgery in April and received a FiberCel implantation. His surgical wound later tested positive for TB. In June 2021, Williams required revision surgery to replace the FiberCel with an alternative bone product. He has filed a lawsuit and is seeking trial by jury as well as damages. Aziyo Biologics and company distributor Medtronic, Inc. are both named as defendants.
The suit was filed in the Delaware Superior Court. Williams is represented by attorneys from Morris James, LLP and Saltz, Mongeluzzi & Bendesky P.C. Lawrence Cohan, one of Williams’ attorneys, stated that additional patients are clients but gave no further detail.
Other law firms, such as Wagner Reese of Indiana, have released public statements of investigation into the FiberCel recall. Attorney Jeff Gibson of Wagner Reese said, “When patients agree to undergo complex medical procedures such as orthotic and spinal surgeries, they place an enormous amount of trust in their doctors. And while it’s clear that there is some inherent risk in surgical intervention, patients wholeheartedly expect their health to improve after the procedure is completed. When this doesn’t happen, and in fact they end up with new ailments, it’s only normal for them to seek answers regarding what went wrong.”
Center for Disease Control Recommendations
The Center for Disease Control has reported that 136 product units were implanted into 113 patients. Martha Sharan, CDC spokeswoman, reported that 8 of these patients died post-surgical procedure but their causes of death have yet to be determined.
Medical providers are currently contacting 105 patients of concern who received FiberCel, and that the large majority are now being treated for the disease whether symptomatic or not. According to the CDC, the last known case of tuberculosis contraction via bone graft was in 1953.
CDC officials have also stated that genetic sequencing from some of these patients was utilized to confirm that the recent cases all came from one source. Delaware and Indiana have reported the highest number of FiberCel related TB cases to date.
