How Much Does Filler Apparatus Influence Ease of Injection (and Hence, Potential Safety)?

Abstract

To document the relative contributions of intrinsic filler fluid dynamics versus delivery systems for ease of injection-specifically, to measure extrusion force variability across different syringes and needles (with the characterization of intrinsic rheological fluid properties vs. delivery apparatus contributions to ease of injection). Six different fillers were tested: Belotero balance (Bel), Juvederm Voluma XC (Vol), Revanesse Versa (Rev), Restylane Lyft (Res), Radiesse (Rad), and Teosyal RHA3 (RHA). Extrusion force was measured in Newtons (N) for each by testing using the provided injection apparatus (needle + syringe), and also by standardizing all fillers to the same syringe and then varying needle sizes (30-ga, 27-ga, 25-ga/1.5-inch, 25-ga/2-inch, and 22-ga). Five trials were conducted for each scenario, with comparison via t -test (2-tailed, unpaired, assuming unequal variance). The following results were noted: (1) in order of least to highest extrusion force in box-provided syringe + needle at 0.2 ml volume, the following were noted: Vol < RHA = Bel (27-ga) < Bel (30-ga) < Rev < Res = Rad; (2) for each filler (except for Vol which was similar), the box-provided syringe involved greater extrusion force than the standardized syringe used in this study (each 1-cc, p < 0.05); (3) for 27-ga and 30-ga needles, after standardization of delivery syringe at 0.2 ml volume, a significant difference was noted (proportional to increasing resistance): Bel = Vol = RHA3 < Res < Rev < Rad (for needles of 30-ga [ p < 0.05] and 27-ga [ p < 0.01]); (4) for testing cannulas after standardization of syringes no reproducible order was noted with increasing resistance when using 25-ga/1.5-inch long, 25-ga/2-inch, and 22g/2-inch cannulae; and (5) confirming expectation (validating study technique), the extrusion force was significantly higher for smaller needles and longer needles. The delivery apparatus appeared to be the most influential contributor to filler injection extrusion force, with significant changes in ease of injection correlated to the filler's intrinsic rheological properties, such as viscosity (when standardized to the same syringe for needles tested). Knowledge of such data could influence the injector's ability to maximize patients' safety and clinical results.