Postmarket Safety Surveillance of Delayed Complications for Recent FDA-Approved Hyaluronic Acid Dermal Fillers.

OBJECTIVE: To review postmarketing data for delayed (≥14 days post-treatment) adverse events (AEs) of interest (inflammatory and noninflammatory nodules, hypersensitivity, granulomas) for newer hyaluronic acid (HA) fillers FDA-approved within the last 5 years (2016-2020). METHODS: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database were extracted for HAREF, HADEF, HAKYS, HAVER, HAVLR, HAVOB, HARH2, HARH3, and HARH4 from January 2016 to January 2021. Keywords from event narratives were used to identify and categorize AEs and then verified through inclusion/exclusion criteria. Percentages are based on the total combined events of interest to provide an overall perspective of the events reported during the search period. RESULTS: Of 585 MAUDE reports, there were 195 (33.3%) delayed AEs of interest. Of those, 71.8% were nodules (42.1% inflammatory and 29.7% noninflammatory), 21.5% hypersensitivity, and 6.7% granulomas. The combined total events of interest, ordered by frequency reported, were HAVLR (74.4%), HAVOB (12.3%), HADEF (5.1%), HARH4 (3.6%), HAREF (2.6%), and HARH2 (2.1%), with no reports for HARH3, HAVER, and HAKYS. CONCLUSION: Although delayed nodules and inflammatory events are rare, reports for these events were extracted from the MAUDE database from 2016 to 2020 for HAVLR, HAVOB, HADEF, HARH4, HAREF, and HARH2 (most to least frequent).

An Objective, Quantitative Assessment of Flexible Hyaluronic Acid Fillers in Lip and Perioral Enhancement.

BACKGROUND: HARK is an FDA-approved flexible filler designed for lips. OBJECTIVE: To quantitatively evaluate subject outcomes by measuring the change in lip texture, color (redness), lip fullness, and lip and perioral surface stretch (dynamic strain) after treatment. METHODS AND MATERIALS: In this 8-week open-label, Phase IV multicenter study, subjects were treated with HARK in the lips and HARR and/or HARD in perioral wrinkles and folds as add-on treatment. Assessments included 2D photographic analyses of lip texture and color, and 3D photographic assessments of lip enhancement and dynamic strain. RESULTS: HARK significantly improved lip texture (p ≤ .002), lip redness (p < .001), and added fullness to the lips (lip enhancement measurements; p < .001), at Week 8 after treatment. In addition, lower lip wrinkles were significantly reduced (p = .007) and there was a reduction in upper lip wrinkles (not statistically significant). Surface stretch (dynamic strain) in the lip and perioral region was significantly increased after treatment (p < .001). CONCLUSION: This analysis provides an objective measure of the beneficial effects of flexible hyaluronic acid fillers in lip augmentation and perioral enhancement and demonstrates a significantly improved lip texture, red color, and fullness. A significant increase in surface stretch (dynamic strain) is indicative of tissue expansion and improvement in lip smoothness.

A Multicenter Study to Evaluate Subject Satisfaction With Two Treatments of AbobotulinumtoxinA a Year in the Glabellar Lines.

BACKGROUND: Real-world re-treatment intervals for botulinum toxins vary, but most subjects receive treatment less frequently than the manufacturer-recommended minimum intervals. In subjects receiving treatment with AbobotulinumtoxinA (ABO) less frequently, high levels of satisfaction and psychosocial improvements in well-being, self-confidence, and quality of life are observed. OBJECTIVE: To evaluate subject satisfaction with a twice yearly re-treatment schedule. METHODS AND MATERIALS: This open-label, multicenter, interventional study evaluated subject satisfaction following injections of ABO 50 U in the glabellar lines at baseline and 6 months. The primary end point was subject satisfaction at 12 months. Secondary endpoints included subject satisfaction, FACE-Q scales, and glabellar line severity scale (GLSS). RESULTS: Ninety-five percent of the 120 subjects were "highly satisfied" or "satisfied" with their treatment outcomes at 12 months. FACE-Q total scores suggested that subjects were less bothered by glabellar lines and felt better about their facial appearance with each treatment versus baseline. Approximately half of subjects had ≥1-grade improvement from baseline in GLSS at 12 months. Median onset of effect was 2 days. CONCLUSION: The majority of subjects (95%) were satisfied with ABO treatment every 6 months; results were supported by high subject satisfaction, long duration, rapid onset, natural-looking results, and overall psychological wellness and safety.