Learning curves: historical trends of FDA-reported adverse events for dermal fillers.

Dermal fillers are medical devices regulated by the US Food and Drug Administration (FDA); therefore, reported adverse events (AEs) are publicly available via OpenFDA. Evaluation of historical AE data trends may help distinguish between AEs related to expected learning curves associated with a new type of filler from AEs related to inherent characteristics of a product. In this study, the full history of AE data was evaluated to establish reproducible learning curves for FDA-approved dermal fillers. Reactions to AEs for new fillers that garner FDA approval or are awarded new indications should be in response to analysis of AE rate data and determination of whether they fit on a historically normal learning curve.