Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Abstract

Injectable cosmetic wrinkle fillers are soft-tissue fillers approved as medical devices by the U.S. Food and Drug Administration (FDA). These devices are injected into the skin for correcting soft-tissue contour defects, such as moderate and severe wrinkles and folds, and for restoring the signs of facial fat loss in people with human immunodeficiency virus. Although the aesthetic treatment with injectable dermal fillers is considered to be safe, adverse events are involved with this minimally-invasive treatment. The FDA received 930 post-marked reports of adverse event from 2003 through 2008, of which 823 were deemed severe and 638 required medical treatment and follow-up.

Evaluation of the long‐term safety and biodegradability of hyaluronic acid dermal fillers (YVOIRE®) for the correction of nasolabial folds: Two multicenter, prospective, observational cohort studies

“…The AE profiles of YVOIRE ® classic s and YVOIRE ® volume s were as expected for a well‐tolerated HA dermal filler 12,21,22 . Injection‐site pain, bruising, swelling, and redness, which were the most common AEs in both studies, are all anticipated reactions to HA filler injection and can increase with the viscosity of the filler 12 6,21,23,24 …”

“…Few studies have followed subjects for more than 12 months after administration of HA dermal filler for the correction of NLFs 37,38 . In the absence of long‐term studies that follow subjects until the HA filler product is totally biodegraded, definitive statements regarding the longer‐term safety of such products should not be made 12 …”

“…There were no treatment-related AEs during the 12-to 24-month post-treatment period after injection of YVOIRE ® classic s. The AE profiles of YVOIRE ® classic s and YVOIRE ® volume s were as expected for a well-tolerated HA dermal filler. 12,21,22 Injection-site pain, bruising, swelling, and redness, which were the most common AEs in both studies, are all anticipated reactions to HA filler injection and can increase with the viscosity of the filler. 12 The injectionsite reaction rates were well within the range of those occurring in other clinical studies of HA dermal fillers for the treatment of NLFs, in which injection-site reactions were reported in up to 50% to 100% of subjects.…”

“…12,21,22 Injection-site pain, bruising, swelling, and redness, which were the most common AEs in both studies, are all anticipated reactions to HA filler injection and can increase with the viscosity of the filler. 12 The injectionsite reaction rates were well within the range of those occurring in other clinical studies of HA dermal fillers for the treatment of NLFs, in which injection-site reactions were reported in up to 50% to 100% of subjects. 6,21,23,24 Pain and swelling accounted for the slightly higher incidence of local injection-site reactions with YVOIRE ® volume s.…”

“…2,5 Although the overall incidence of complications associated with HA dermal fillers is low when used appropriately and the safety profile is favorable, adverse events (AEs) can occur. 7,9,11,12 According to Signorini et al vascular infarction and compromise, inflammatory reactions, injection-related events, and inappropriate placement of filler material were early adverse reactions to HA fillers. 7 Delayed AEs, which can occur months to years after the injection of HA fillers, include nodules, granulomas, and skin discoloration.…”