According to FDA official, Margaret Glavin, close examination of practices at BTS, revealed significant anomalies in the manufacturing processes which would only magnify and pose a risk to public health. What was perhaps even more disconcerting, was the forging of death certificates by BTS with fictitious age and cause of death of 8 donors in the least, investigated and verified against official death certificates. According to the Chicago tribune, 10 Chicago-area hospitals have notified 62 patients about impending risks.
Subsequent to the ban imposed by the FDA, three patients who have undergone transplants with the tissue from BTS, were informed about the potential risk. Five recipient companies of biomedical tissues have ensured that the tissues are not transplanted into patients, soon after the FDA sought to investigate the matter in October.
According to Kim McCullough of the Gift of Hope Organ and Tissue Donor Network., regulation has been extremely stringent in recent years to prevent any threat of contamination to transplant patients, ensuring they lead a normal life.