Tipp City, OH. (June 25, 2021) – Michelle Weethee, 52, of Tipp City, Ohio, joins over 100 other patients affected by a bone repair product found to be tainted with Mycobacterium tuberculosis (Mtb), the bacteria that causes tuberculosis (TB) disease. The product, FiberCel, was voluntarily recalled on June 2 by Aziyo Biologics, Inc. of Silver Spring, Maryland after it learned of post-surgical infections in patients treated with the product, including some patients that tested positive for tuberculosis.
FiberCel is a bone repair product designed to promote bone formation. Donor eligibility determinations are purportedly made in compliance with FDA regulations and American Association of Tissue Bank Standards. In this instance, the recalled product, consisting of one lot, was derived from a single donor. It has been reported that most of the 154 units comprising this lot have already been implanted.
On March 24, Ms. Weethee underwent a spinal fusion in which the now-recalled FiberCel was used to promote bone regeneration. Following the surgery, Weethee’s wound failed to heal. Eventually, cultures from the wound confirmed the presence of Mycobacterium tuberculosis and TB disease was diagnosed. Weethee has undergone three subsequent surgeries to disinfect the surgical site and eradicate the tainted bone grafting material.
Weethee, a wife and mother of two, remains on an aggressive TB disease treatment regimen and continues to have difficulty with healing her surgical wound. Generally active and healthy, she must rely on the help and support of her family through her prolonged recovery.
The Centers for Disease Control and Prevention (CDC) has reportedly identified at least 72 patients implanted with the recalled FiberCel who have signs and symptoms consistent with tuberculosis infection. 74-year-old Richard Williams of Bear, Delaware has already filed a lawsuit against Aziyo and Medtronic (the distributor) alleging that his TB disease is related to an April 13 spinal fusion in which the recalled FiberCel was used.
The CDC is investigating the FiberCel-linked outbreak and recommends that all affected patients – even if asymptomatic – be treated for TB disease. The disease is treated by taking a regimen of drugs for 6 to 12 months (and sometimes longer). The treatment often has serious side effects, and in some cases, the bacteria may even become drug-resistant. While TB disease is typically associated with the lungs, Mycobacterium tuberculosis can attack any part of the body.