On June 2nd, 2021, the US Food & Drug Administration (FDA) announced the voluntary recall of Aziyo Biologics' FiberCel Fiber Viable Bone Matrix.
The urgent notification came after one of Aziyo's customers, a hospital, complained that 7 of 23 patients that had received the FiberCel Fiber Viable Bone Matrix graft had developed a post-surgical infection. Of those, four were tested and found to be positive for tuberculosis.
Tuberculosis, often referred to as tb, is a potentially deadly infectious disease that attacks the lungs. It is highly contagious and, if it cannot be properly contained, can wreak havoc on a hospital's population.
For the time being, sales of FiberCel were voluntarily suspended by the manufacturer. Only one donor lot is believed to be responsible for the infections. All customers who are recorded as having taken delivery of said lot were ordered to quarantine the product and ship it back to Aziyo as soon as possible. Affected patients should have also been notified by the hospital of the increased health risks.
Attorney contributor Jeff Gibson, an experienced drug and medical device lawyer, has previously represented individuals who have fallen victim to the negligence of medical device manufacturers. Jeff's law firm, Wagner Reese LLP of Indiana, has been retained by clients to investigate the recent recall of Aziyo Biologics' FiberCel Fiber Viable Bone Matrix (VBM).
"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."
"Medical technology has advanced significantly over recent years. This rapid advancement has seen innovative products come onto the market, many of which have had enormous success. Among these new technologies are products that employ donor tissue as a foundation for healing. In other words, the tissue from one individual is used to create a product that is then grafted or implanted into someone else, all with the goal of helping the transplantee to heal faster than ever before."
"Such technology has helped to save many lives. Yet, positive health outcomes should by no means allow the manufacturer of these products to relax their safety standards. Whenever cells, tissue, or blood are transplanted from one individual to another, immense care has to be taken to avoid passing on undesired viruses, bacteria, and other diseases. Tragically, it is now alleged that the use of Aziyo Biologics' FiberCel Fiber Viable Bone Matrix (VBM) resulted in unsuspecting patients suffering post-surgery infections, with some even contracting tuberculosis."
"This end result is absolutely unacceptable and it is exactly why I, along with the team at Wagner Reese LLP, are currently investigating these claims. Our team of experienced legal professionals always aims to get to the bottom of such issues and, if negligence on behalf of any parties is found to have been the culprit, we are proud to stand up and fight to get victims the justice they deserve."