FDA Recalls FiberCel Fiber Viable Bone Matrix (Aziyo Biologics Inc.) After Patients Test Positive For TB

US FDA: Recall Of FiberCel Fiber Viable Bone Matrix By Aziyo Biologics, Inc.

The United States Food & Drug Administration (FDA) is the regulatory body in charge of "ensuring the safety, efficacy, and security of human... drugs, biological products, and medical devices." 

On June 2nd, 2021, the FDA issued an urgent voluntary notification regarding a specific lot of Aziyo Biologics' FiberCel Fiber Viable Bone Matrix (“FiberCel”). In their notification, the FDA expressed concern with the following products from Lot# NMDS210011:

• VBM9901
• VBM9905
• VBM9910

The recall was issued after one of Aziyo's customers placed a complaint. Initially, the hospital reported that 7 of 23 patients who had received FiberCel bone grafts suffered post-surgery infections. Four of these patients also tested positive for TB.

Tuberculosis & FiberCel Bone Grafts

Tuberculosis is an infectious disease that results when bacteria is introduced into the body. More specifically, the bacteria that causes TB is Mycobacterium tuberculosis.

TB is highly contagious and mostly affects the lungs and respiratory organs, though it can cause damage to other tissues. Since it can be spread through respiratory droplets, such as those produced by coughing or sneezing, hospitals take extreme measures whenever they encounter evidence that a patient within their facility could be infected with TB. Tuberculosis cases are so significant that they must be reported to local or state-level health departments.

It's critical to understand that simple contact with Mycobacterium tuberculosis will not necessarily cause a patient to develop TB. The bacteria must be introduced into the body (it's usually breathed in) and then it must proliferate within the new host.

There is much concern surrounding patients testing positive for TB after FiberCel bone grafts because they are already in a compromised health state due to the surgical procedure they were subjected to. Orthotic procedures produce a lot of trauma in a patient, so their body is in a relatively weakened state and working overtime to heal. If an aggressive bacterium such as Mycobacterium tuberculosis is inadvertently introduced into the patient, and more specifically at the site of the surgery, there is a high likelihood that TB will take hold and possibly kill the patient.

FiberCel Lawsuit: Has A Class-Action Been Filed Against Aziyo Over The Recall?

At the time of this writing, Aziyo Biologics, Inc. has faced no legal repercussions for the adverse health effects produced in patients who received FiberCel Fiber VBM grafts. It is only recently that the voluntary recall was issued and that the public has been made aware of the issues with the product. Additionally, substantial investigations must be completed, both by the manufacturer and regulatory bodies, to determine whether FiberCel grafts were indeed responsible for the infections. 

Yet, it's clear that FiberCel's manufacturer understands the gravity of the situation. While only a single donor lot of FiberCel is believed to be the possible culprit in post-surgical infections, Aziyo has completely suspended sales of FiberCel by distributors. The single lot of 154 units of FiberCel are also understood to have been shipped to facilities in as many as 20 separate states throughout the nation.

Lastly, the manufacturer has also postponed the announcement of their revenue guidance for the rest of the year, potentially pointing to the fact that they expect legal claims to be levied against them by affected parties.

Attorney Investigations Into FiberCel Fiber VBM Recall

Wagner Reese LLP, a law firm based in Indiana, has already announced that they have been retained to investigate claims that FiberCel bone grafts led to post-surgical infections, including some cases of tuberculosis. On their website, the firm states that: "At Wagner Reese, we hold negligent medical device manufacturers accountable when their products harm patients who only wanted to get better."

In many cases, filing a civil lawsuit against the manufacturer of a medical device is the only way for victims and their loved ones to get justice. Complications from medical procedures, especially complicated ones such as orthotic surgeries, can be life-altering in the instances when they aren't outright deadly. Victims and family members can be overcome with unexpected medical bills and with negligent parties who simply refuse to take responsibility for their carelessness.]

By filing a lawsuit, it is almost guaranteed that an incredibly thorough investigation will be conducted not only by the plaintiff but also by the defendant. It is these kinds of investigations that often produce important changes in the manufacturing and use of medical devices and ultimately prevent other innocent victims from suffering injuries or death down the line.

If you have questions regarding your legal options after a medical device or drug is recalled, contact The Product Lawyers today for a free case consultation.