Mona Sadeghpour1,2, Nicola A Quatrano1, Lauren Meshkov Bonati1, Kenneth A Arndt1,3,4, Jeffrey S Dover1,3,5, Michael S Kaminer1,3,5. 1. SkinCare Physicians, Chestnut Hill, Massachusetts. 2. Department of Dermatology, University of Colorado, Aurora, CO. 3. Department of Dermatology, Brown Medical School, Providence, RI. 4. Department of Dermatology, Dartmouth-Hitchcock, Lebanon, NH. 5. Department of Dermatology, Yale University School of Medicine, New Haven, CT.
Abstract
BACKGROUND: Robust and long-term data on true incidence of delayed-onset nodules and immune tolerance of hyaluronic acid (HA) fillers are lacking. OBJECTIVE: To characterize the incidence of delayed nodules in Vycross (VYC) HA fillers compared with previously reported FDA and non-FDA data of all HA fillers. METHODS AND MATERIALS: The incidence of delayed nodules in all patients who had received VYC fillers in a 12-month period was assessed through a retrospective chart review. Nodule incidence for currently approved nonanimal-stabilized hyaluronic acid (NASHA) fillers was assessed using the FDA Summary of Safety and Effectiveness Data. RESULTS: Overall, 1,029 patients received 1,250 VYC filler treatments. Five patients developed delayed nodules to VOB, with an incidence of 1.0% per patient and 0.8% per syringe. No nodules were observed in patients who received VLR or VOL. All nodules were treated successfully using a combination of intralesional triamcinolone and hyaluronidase. Compared with other currently approved NASHA fillers, VOB is associated with a higher incidence of nodule formation. CONCLUSION: The introduction of VYC HAs has introduced a new variable that may be changing the immune tolerance of these substances, resulting in a higher incidence of delayed nodules than previously expected.
BACKGROUND: Robust and long-term data on true incidence of delayed-onset nodules and immune tolerance of hyaluronic acid (HA) fillers are lacking. OBJECTIVE: To characterize the incidence of delayed nodules in Vycross (VYC) HA fillers compared with previously reported FDA and non-FDA data of all HA fillers. METHODS AND MATERIALS: The incidence of delayed nodules in all patients who had received VYC fillers in a 12-month period was assessed through a retrospective chart review. Nodule incidence for currently approved nonanimal-stabilized hyaluronic acid (NASHA) fillers was assessed using the FDA Summary of Safety and Effectiveness Data. RESULTS: Overall, 1,029 patients received 1,250 VYC filler treatments. Five patients developed delayed nodules to VOB, with an incidence of 1.0% per patient and 0.8% per syringe. No nodules were observed in patients who received VLR or VOL. All nodules were treated successfully using a combination of intralesional triamcinolone and hyaluronidase. Compared with other currently approved NASHA fillers, VOB is associated with a higher incidence of nodule formation. CONCLUSION: The introduction of VYC HAs has introduced a new variable that may be changing the immune tolerance of these substances, resulting in a higher incidence of delayed nodules than previously expected.
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Authors: Ofir Artzi; Joel L Cohen; Jeffrey S Dover; Atchima Suwanchinda; Tatjana Pavicic; Marina Landau; Greg J Goodman; Sahar Ghannam; Firas Al Niaimi; Jani A J van Loghem; Kate Goldie; Sonja Sattler; Daniel Cassuto; Ting Song Lim; Rungsima Wanitphakdeedecha; Ines Verner; Tanja C Fischer; Vivian Bucay; Eli Sprecher; Dana Shalmon Journal: Clin Cosmet Investig Dermatol Date: 2020-05-18