Infections and Deaths Linked to FiberCel Bone Repair Product
On June 2, 2021, the U.S. Food & Drug Administration announced a voluntary product recall by regenerative medicine company Aziyo Biologics of their “FiberCel Viable Bone Matrix,” a fiber-based bone repair product made from human tissue.
Thirty percent (7 out of 23) of surgery patients treated with FiberCel at one hospital developed a postoperative infection, and four of them subsequently tested positive for tuberculosis.
Elsewhere, others treated with FiberCel died. While the causes of death are still being investigated and officially determined, it is thus far known that out of a total of 113 patients treated with the tainted bone repair product, eight subsequently died.
FiberCel Bone Graft Lawsuit
If you or a loved one received FiberCel during a bone graft, reconstructive surgery, spine surgery, or other medical procedure, you have full legal recourse available to you. While nothing can replace the life of a lost loved one, the experienced and unwavering Chicago defective medical device attorneys at Meyers & Flowers will do everything in their power to fight on your behalf for full and fair recourse and to secure maximum damages awarded. Contact us today.
What Is FiberCel Viable Bone Matrix?
Manufactured by Delaware biotech company Aziyo Biologics, Inc. and Medtronic as an exclusive distributor. FiberCel is a malleable bone repair putty made from human tissue. It is used in various orthopedic procedures and spinal surgeries.
Because the putty includes human cells from donors and isn’t tested for tuberculosis, it is presently believed that patients who received surgeries in which the product was used have developed a severe infection or contracted tuberculosis.
Following the recall of FiberCel, the U.S. Centers for Disease Control subsequently recommended that all patients who received treatment in which the affected product lot was used should undergo treatment for tuberculosis.
FiberCel’s Link to Tuberculosis
Tuberculosis is a potentially serious disease typically transmitted by airborne respiratory droplets of a bacteria called Mycobacterium tuberculosis when an infected individual coughs or sneezes. The disease may be asymptomatic for some patients, while for others, it affects the lungs most commonly and may also attack the kidneys, spine, brain, and other parts of the body. Not properly treated, it can be fatal. Treatment typically involves a long-term course of treatment with a number of antibiotics.
Aziyo Biologics is ultimately fully responsible for ensuring its FiberCel Fiber Viable Bone Matrix is free of contamination. Yet, they failed to test it for the bacteria that causes tuberculosis because the infection is so rare in bone and tissue grafts. These grafts don’t involve or create respiratory droplet transmission but, as in the case of FiberCel, could involve transmission through the direct use of infected human tissue.
FiberCel Bone Graft Tuberculosis Outbreak
An official investigation is ongoing into a rare outbreak of tuberculosis that may have affected more than 100 patients who received spinal or orthopedic surgery in which FiberCel Viable Bone Matrix was used.
On June 2, 2021, Aziyo Biologics recalled 154 containers of FiberCell shipped to 37 different facilities in 20 U.S. states between March 3 and April 2, 2021. By June 10, all unused units of the product had been removed from circulation. The biologics company has no reason to believe that another FiberCel is tainted, yet out of an abundance of caution, it has suspended all sales of the product.
The reported FiberCel infections and deaths occurred in patients treated with a single batch of the product (FiberCel lot #NMDS210011), which contained infected tissue from a single donor cadaver.
Schedule A Consultation
Top Chicago Attorneys practicing locally & nationally
How Meyers & Flowers Can Help You
If you or a loved one underwent surgery or received a bone graft in which FiberCel was used, we can help. Meyers & Flowers intimately understands what it takes to fight successfully on behalf of those injured by defective medical and biological products and has spent more than two decades helping clients seek and receive justice for themselves and their loved ones. For more information on your legal recourse options, call or email our team of experienced Chicago personal injury lawyers today.
