A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study of Hyaluronic Acid Filler Effectiveness and Safety in Lip Fullness Augmentation

Abstract

Supplemental Digital Content is Available in the Text.

Clinical Experience with PEGylated Hyaluronic Acid Fillers: A 3-year Retrospective Study

“…Hyaluronic acid (HA) fillers are the most used worldwide, this is mainly related to the high biocompatibility and safety profile of HA, moreover, HA is the only substance that can be "dissolved" thanks to the use of hyaluronidase (HYAL) that induce an enzymatic hydrolytic effect [1], [2], [3], [4], [5]. The possibility to hydrolyze HA, once injected, is useful in cases of unpleasant results, however, its main advantage is related to the possibility to treat unwanted side effects such as nodules, and especially vascular problems such as impending necrosis [6], [7].…”

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

“…Each product uses various manufacturing technologies, providing them with unique characteristics, which maximize versatility and aesthetic outcomes. Clinical trials have established the safety and efficacy of the fillers in this review [12][13][14][15][16][17][18][19][20] ; however, AEs occur in clinical practice for all medical devices, and thus, there is a need for postmarketing safety surveillance to establish a long-term safety profile.…”

“…[8][9][10][11] Several clinical trials have established the efficacy and safety of each product. [12][13][14][15][16][17][18][19][20] Additionally, each product has postmarketing surveillance (PMS) data available in the Manufacturer and User Facility Device Experience (MAUDE) FDA database.…”

A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up

“…Hence, by defocusing the attention from a main defect and adopting a global rejuvenation approach, subject satisfaction was achieved with a limited amount of filler. 24,25 The reality of routine practice, where the injector is limited by patient finances, may further explain these small injection volumes. Primary Endpoint: Proportion (with 95% CI) of "improved" or "much improved" GAIS at Month 3 (PI and subject assessment)…”