Adverse events following injection laryngoplasty: An analysis of the MAUDE database

Abstract Objective Injection laryngoplasty (IL) is considered safe in both the operating room and clinical setting. However, safety data is limited to single-institution studies with reduced sample sizes. The objective of this study is to examine a national database for adverse events related to IL in an effort to further confirm the safety of this procedure and better characterize potential complications. Materials and methods Retrospective analysis of the Manufacturer and User Facility Device Experience (MAUDE) database for reported adverse events of IL procedures utilizing calcium hydroxyapatite (CAHA), hyaluronic acid (HA) and carboxymethylcellulose (CMC) implants from 2009 to 2020. Results and analysis We identified 47 reported adverse events. The average patient age was 54 years old. 59.3% of patients were female. Adverse events more frequently involved the use of CAHA compared to HA or CMC (n = 27, 57.4%, n = 13, 27.7% and n = 7, 14.9%, respectively). The most common adverse events were laryngeal edema (n = 18, 39.1%), improper placement of injected material (n = 12, 26.1%), persistent dysphonia (n = 13, 28.3%), and post-injection dysphagia or odynophagia (n = 11, 23.9%). Major events, defined as requiring emergency room treatment, hospitalization, or surgical intervention accounted for 29 (60.4%) of cases. Four cases of edema required intubation, and one patient necessitated a surgical airway. Conclusion Complications arising from IL range from minor events to airway obstruction and may happen with a variety of injectable materials including CAHA, HA and CMC. Few cases of airway obstruction requiring immediate intervention were identified, confirming the safety of IL in both the operative and office setting.