Lawsuits on behalf of a Florida woman and a Delaware man were filed against Aziyo Biologics after they received a tainted FiberCel implant.
Deborah Rice had spine surgery using a FiberCel implant at Miramar Beach, Fla.-based Ascension Sacred Heart Hospital March 29 and learned June 8 that she tested positive for tuberculosis, according to a July 2 news release from her law firm.
Jean Georges, 46, is among the youngest patients to be sickened. Mr. Georges, of Newark, Del., had surgery with the bone-graft material March 8. He had additional surgery to remove and replace spinal fluid, and he is under care for the effects of tuberculosis.
The first lawsuit against Aziyo Biologics was filed on behalf of Richard Williams, of Delaware, June 16, and 91 patients have been treated for tuberculosis. Aziyo voluntarily recalled a lot of its FiberCel product June 2.
Aziyo Biologics is working with the FDA and CDC to investigate the implants, according to a spokesperson.
"We have reviewed our procedure for screening donors and producing this product and have not identified any deviations from our established protocols, which are based on industry standards and government requirements," according to a statement provided to Becker's Spine Review. "We are evaluating adjustments to our donor screening and testing methodology and process to broaden detection of disease beyond existing industry standards."
The company declined to comment on the lawsuits.
Note: This article was updated July 6 to include a statement emailed to Becker's Spine Review.