Risk profiles of different injectable fillers: results from the Injectable Filler Safety Study (IFS Study).

Author: Zielke H, Wolber L, Wiest L, Rzany B

Author affiliation: Division of Evidence-Based Medicine (dEBM), Department of Dermatology, Charite-Universitatsmedizin Berlin, Campus Charite Mitte, Berlin, Germany.

Publication date & source: 2008.03, Dermatol Surg., 34(3):326-35

Publication type: Research Support, Non-U.S. Gov't

BACKGROUND: Injectable fillers are widely used in aesthetic medicine. Although most materials are considered to be safe, adverse events occur. Our knowledge on frequency and potential risk factors is limited. OBJECTIVE: The aim of this study was to describe adverse reactions to injectable fillers based on a partly population-based case series. METHODS: Dermatologists, plastic surgeons, and maxillofacial surgeons in Berlin were asked to report patients with adverse reactions. Additional patients were obtained from a private practice. A standardized questionnaire was used to assess all data. All data were analyzed by descriptive measures. RESULTS: Fifty-six patients (age, 48+/-11.2 (SD) years) who had been treated with nine different fillers were assessed. In 48 patients treated with only one filler, 167 areas had been treated. In 129 (77.3%) areas adverse reactions occurred 12.2+/-15.6 (SD) months after injection. Adverse reactions to biodegradable fillers occurred after 4.9+/-5.8 (SD) months, and reactions to nonbiodegradable fillers after 18.3+/-19.0 (SD) months (p=.005). As adverse events, continuing pain, swelling, nodules, pigmentation, abscess formation, and erythema were found. CONCLUSION: Adverse reactions can be documented for all injectable fillers. Time until reaction as well as type of reaction, however, vary between different fillers. Further research is necessary to evaluate potential risk factors.

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