The objectives of this study were to examine adverse clinical events after the use of the Invisalign system and to provide an overview of the actions taken by the manufacturer to address these events.Methods:
A retrospective analysis of the Manufacturer and User Facility Device Experience database of the United States Food and Drug Administration was used. All medical device reports reported to the United States Food and Drug Administration pertaining to products of Align Technology from November 1, 2006, to November 30, 2016, were analyzed. Qualitative content analysis was conducted of event descriptions and manufacturer narrative reports.Results:
A total of 173 medical device reports were reported in the Manufacturer and User Facility Device Experience database: 169 (97.7%) were designated as adverse event reports, and 45 (26%) were deemed by the treating doctor to be serious or life threatening. The most medical device reports that reported a serious or life-threatening event were in 2014 (50%). The most frequently reported adverse event was difficulty breathing (56 events) followed by sore throat (35 events), swollen throat (34 events), swollen tongue (31 events), hives and itchiness (31 events), anaphylaxis (30 events), swollen lips (27 events), and feeling of throat closing/tight airway/airway obstruction/laryngospasm (24 events).Conclusions:
Serious or life-threatening events could be associated with use of Invisalign systems. Health care providers should be aware of these events and know how to handle them if they arise in their practices.