Bone Graft Transmission of TB Has Michigan Lawmakers Petitioning FDA
Four Michigan lawmakers signed a letter to FDA Commissioner Califf seeking new regulation of human tissue transplant products following an outbreak of tuberculosis (TB) from which one patient died after receiving an implant of Aziyo Biologics’ viable bone matrix product.
The letter from the two U.S. Senators, Debbie Stabenow (D-Mich.) and Gary C. Peters (D-Mich.) and Reps. John R. Moolenaar (R-Mich.) and Debbie Dingell (D-Mich.) explains that this is the second TB contamination incident with the company.
In 2021, “a similar outbreak occurred where TB was transmitted via bone graft. The contamination of the infected donor product was placed in up to 100 patients and eight patients lost their lives,” the letter says.
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