Mounting reports of serious injuries in pediatric patients (younger than 18) who have received some types of bone graft substitutes have prompted the Food and Drug Administration (FDA) to issue a Safety Communication warning doctors that the safety and efficacy of these devices in pediatric patients has not been reviewed or approved and poses unique risks to patients younger than 18 years of age. The issue involves bone graft substitutes containing recombinant proteins or synthetic peptides, which have caused serious injuries in patients younger than 18 such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling. While these events ... Read More
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