The spectrum of adverse reactions after treatment with injectable fillers in the glabellar region: results from the Injectable Filler Safety Study.
BACKGROUND
For the glabellar region, severe partly vascular adverse events have been reported after treatment with injectable fillers.


METHODS
For this study, data from the Injectable Filler Safety Study, a German-based registry for those reactions, was analyzed to characterize adverse events seen in the glabellar region. Patients were analyzed descriptively.


RESULTS
Forty of 139 registered patients reported adverse events in the glabellar region. All patients were female, with an average age of 52.3. Nineteen patients with adverse reactions to hydroxyethylmethacrylate (HEMA) and ethylmethacrylate (EMA) in a fixed combination with hyaluronic acid (HA) and 10 patients with adverse reactions to different hyaluronic acid products were reported; five patients reacted to poly-L-lactic acid (PLA). The most common adverse reactions to HEMA/EMA in HA and PLA were nodules and hardening. In HA-treated patients, erythema and inflammation, swelling, and pain were most frequent. The adverse reactions to HEMA/EMA in HA were severe in 50% of the patients. Severe adverse reactions were found to a lesser extent in patients treated with HA and PLA. Potential vascular complications were documented in only two patients.


CONCLUSIONS
Adverse reactions seen in the glabella are overwhelmingly product associated and to a lesser extent location associated. Vascular complications with necrosis and ulceration were rare.
Bachmann
Frank
F
Division of Evidence Based Medicine, Department of Dermatology, Charité-Universitätsmedizin Berlin, Berlin, Germany. frank.bachmann@charite.de
Erdmann
Ricardo
R
Hartmann
Vanessa
V
Wiest
Luitgard
L
Rzany
Berthold
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects*; D002921:Cicatrix / Q000139:chemically induced; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D004338:Drug Combinations; D004890:Erythema / Q000139:chemically induced; D005145:Face; D005260:Female; D005546:Forehead; D005858:Germany / Q000453:epidemiology; D015745:Granuloma, Foreign-Body / Q000139:chemically induced* / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects; D015994:Incidence; D007249:Inflammation / Q000139:chemically induced; D007271:Injections, Intradermal; D007279:Injections, Subcutaneous; D019344:Lactic Acid / Q000008:administration & dosage / Q000009:adverse effects; D008768:Methylmethacrylates / Q000008:administration & dosage / Q000009:adverse effects; D008863:Microspheres; D008875:Middle Aged; D009915:Orbit; D011091:Polyesters; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D011108:Polymers / Q000008:administration & dosage / Q000009:adverse effects; D011109:Polymethacrylic Acids / Q000008:administration & dosage / Q000009:adverse effects; D012720:Severity of Illness Index; D015595:Skin Aging / Q000187:drug effects*
D001672:Biocompatible Materials; D003879:Dermatologic Agents; D004338:Drug Combinations; D008768:Methylmethacrylates; C521570:PEG-HEMA; D011091:Polyesters; D011108:Polymers; D011109:Polymethacrylic Acids; D019344:Lactic Acid; D011092:Polyethylene Glycols; C033616:poly(lactide); C009931:poly(ethylmethacrylate); D006820:Hyaluronic Acid