This content was updated at 4 p.m. EDT on June 25, 2021.
At Wagner Reese, we believe it’s unacceptable when patients see their health worsen after receiving treatments that were supposed to make them better. Unfortunately, that’s exactly what happened to some patients who received FiberCel Fiber Viable Bone Matrix, a bone repair product that’s made from tissue derived from human donors. Sadly, the Herald-Times reports that 30 of those patients live right here in the Hoosier State in 19 different counties.
The product’s manufacturer, Aziyo Biologics Inc., recalled the FiberCel product after some patients who received them during orthopedic and spinal procedures suffered post-surgical infections, including tuberculosis. This voluntary recall affects one lot of 154 units of the product, all of which were obtained from a single donor and shipped to medical facilities in 20 different states.
What Is FiberCel Fiber Viable Bone Matrix Used For?
The product, which is made from human tissue and designed to facilitate bone repair and healing, is primarily used in bone grafting procedures associated with orthopedic and spinal surgeries. However, because it is derived from human donors, it can put recipients in danger of infections, just as donated organs and other tissue can.
What Risks Do Patients Who Received the Product Face?
Thus far, Aziyo Biologics Inc. has received reports of patients developing infections and testing positive for tuberculosis after receiving implanted FiberCel tissue. Tuberculosis is caused by bacteria, and because of the public health dangers it poses, all cases must be reported to local or state health departments’ tuberculosis programs.
What Is Aziyo Biologics Inc. Doing About the Risk?
The manufacturer of FiberCel announced a full recall of the product and suspension of all sales. In addition, the company is working to determine the source of the post-surgical infections alongside the product’s distributor, the U.S. Food and Drug Administration, and the Centers for Disease Control and Prevention. Potentially affected but unused product is being shipped back to the Aziyo Biologics Inc.
We’re Working Hard for Victims of This Unforgivable Mistake
When human tissue is used or implanted in other people’s bodies, the manufacturers, distributors, and others associated with the process must be 100% certain that the tissue is free from disease, infection, and unnecessary risk factors. When full precautions aren’t taken, innocent patients may develop severe health problems.
Our attorneys are already hard at work on four claims related to this dangerous error, including one involving a man who wasn’t even told his bone repair procedure would utilize transplanted human tissue and then developed tuberculosis from it. Medical product injuries are always unacceptable, but they’re even worse when patients aren’t even given a chance to consent to potentially harmful procedures.
At Wagner Reese, we hold negligent medical device manufacturers accountable when their products harm patients who only wanted to get better. If you or someone you love may have been harmed by Aziyo Biologics Inc.’s FiberCel Fiber Viable Bone Matrix, we’re here to help victims throughout the U.S. Contact our defective medical device lawyers today.