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


CONCLUSIONS
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.
Zielke
Hendrik
H
Division of Evidence-Based Medicine (dEBM), Department of Dermatology, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany.
Wölber
Linn
L
Wiest
Luitgard
L
Rzany
Berthold
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects*; D003357:Cosmetic Techniques / Q000009:adverse effects; D005260:Female; D005549:Foreign-Body Reaction / Q000209:etiology*; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects*; D007279:Injections, Subcutaneous; D008297:Male; D008689:Methacrylates / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D011108:Polymers / Q000008:administration & dosage / Q000009:adverse effects*; D012306:Risk; D015595:Skin Aging / Q000187:drug effects*
D001672:Biocompatible Materials; D008689:Methacrylates; D011108:Polymers; C005044:hydroxyethyl methacrylate; D006820:Hyaluronic Acid