Global Registry of Adverse Clinical Events (GRACE©): A Prospective, Multicenter, Observational Cohort Evaluating Complications Associated with Aesthetic Injectables.

Abstract

Background: A review of Health Canada's post-market surveillance database has revealed that the reporting of adverse events (AEs) following aesthetic injectable treatments is significantly underreported. To increase reporting, investigators have recently developed a novel Electronic Data Capture system: The Global Registry of Adverse Clinical Events (GRACE^©).

Objective: To identify the incidence of AEs associated with aesthetic injectable treatments.

Methods: Aesthetic clinicians from 10 Canadian sites were recruited. Demographic and clinical data were recorded within the database, which included over 45 patient variables.

Results: Throughout the active phase of the trial (duration: 27 months), 123,124 injectable treatments were conducted. One hundred and eleven patients, experiencing a total of 235 AEs, were entered into the portal. This equated to an AE incidence rate of 0.19%, per treatment. Thirty unique products were associated with AEs. In total, there were 112/235 (47.66%) mild, 88/235 (37.45%) moderate, and 35/235 (14.90%) severe AEs. The most common complication (n = 48/235; 20.43%) was swelling, with a prevalence of 0.04%. Of the documented AEs, only 5 were reported to other sources, including 1 case being reported to Health Canada and 4 cases to the respective product manufacturer.

Conclusions: The initial feasibility of a registry assessing safety outcomes following injectable treatment has been demonstrated. Findings support that the implementation of the GRACE Portal is an effective outreach strategy for increasing AE reporting by health care professionals. The data represent a more accurate depiction of the safety profile of approved aesthetic injectables in Canada.