(0526) Postmarket Safety of Dermal Fillers: A Comprehensive Analysis of the U.S. Food and Drug Administration Adverse Event Database

Introduction: Dermal fillers have become increasingly popular for cosmetic and reconstructive purposes, prompting the need for an in-depth investigation into their safety profiles after entering the market. This study presents a thorough examination of reported adverse events (AE) of dermal fillers through a comprehensive analysis utilizing the FDA Adverse Event Reporting System (FAERS) database.

Methods: AEs data for two prominent dermal fillers, Juvederm and Radiesse, reported in the FAERS database from 2010 to 2023 were extracted. Data mining techniques, including the reporting odds ratio and proportional reporting ratio, were employed for analysis. Simultaneously, a thorough review of case reports was conducted to explore adverse events associated with the utilization of dermal fillers in cosmetic procedures.

Results: A total of 244 AE reports related to two dermal fillers, Juvederm and Radiesse, were collected. Patients involved were predominantly females (95%), and the age range was 18-64 years (47%). Analysis revealed 40 cases of serious injuries, 8 hospitalizations, 2 permanent disability and one reported death. The most frequently reported AEs associated with dermal fillers were primarily linked to poisoning and procedural complications (87 cases), as well as eye-related injuries such as swelling, ptosis, and blurred vision (49). Skin-related AEs, including rash, pruritus, and erythema, were also noted (43). Additionally, there were reports of infection (31), headache (23), dyspnea, and respiratory discomforts (15 cases), as well as nausea (11).

Conclusions: While the utilization of dermal fillers in facial procedures is generally regarded as a safe practice in cosmetic applications, there have been documented instances of AEs. Increasing awareness of potential complications can contribute to more effective patient counseling during the informed consent process and assist healthcare providers in making informed clinical decisions.