Evaluating Real-world Use and Adverse Events From 3262 Patients Treated With 18,203 Cycles of Cryolipolysis for Localized Fat Reduction: A Multilocation Practice Retrospective Chart Review

Abstract Background Cryolipolysis is an established method for noninvasive focal subcutaneous fat reduction. Objectives The aim of this study was to highlight the safety and real-world use of this technology. Methods The electronic medical records of all patients treated with a commercially available cryolipolysis technology (CoolSculpting and CoolSculpting Elite, Allergan Aesthetics, Irvine, CA) between January 2016 and June 2023 at a multilocation group practice were retrospectively reviewed. Extracted procedure-related data included number of total sessions and cycles, number of sessions and cycles per body area, and treatment-related adverse events. A cycle was defined as 1 applicator treating 1 body area. Results In total, 3262 patients (2797 female, 465 male) treated with 18,203 cycles across 6245 sessions were included. The mean [standard deviation] age at first treatment was 45.0 [12.8] years (range, 15-83 years). The mean number of cycles per patient was 5.6 [6.5] (range, 1-177), with a median of 4 cycles per patient. The mean number of sessions per patient was 1.9 [1.7] (range, 1-38), with a median of 1 session per patient. The most commonly treated area was the lower abdomen (n = 1761, 4734 cycles), and the most frequently treated body area combination was the upper/mid + lower abdomen (n = 937, 5140 cycles). Dual submental treatment was more common than single applicator therapy. Eighty-seven patients exhibited 180 adverse events (2.05% of cycles), including 3 body areas (n = 2) with paradoxical adipose hyperplasia. Conclusions This retrospective chart review of cryolipolysis treatment, among the largest to date, demonstrates its overall safety and broad use across numerous body areas. The paradoxical adipose hyperplasia risk per cycle is between 0.018% (1 in 5501) and 0.048% (1 in 2063), depending on the calculation method. Level of Evidence: 4 (Therapeutic)