Evaluating Real-World Use and Adverse Events from 3262 Patients Treated with 18,203 Cycles of Cryolipolysis for Localized Fat Reduction: A Multi-Location Practice Retrospective Chart Review.

Background: Cryolipolysis is an established method for noninvasive focal subcutaneous fat reduction.

Objectives: To highlight the safety and real-world use of this technology.

Methods: Electronic medical records of all patients treated with a commercially available cryolipolysis technology (CoolSculpting and CoolSculpting Elite, Allergan Aesthetics, Irvine, CA) between 01/2016 and to 06/2023 at a multi-location group practice was 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: 3262 patients (2797 female, 465 male) treated with 18,203 cycles across 6245 sessions were included. Mean age at first treatment was 45.0±12.8 (15-83) years. Mean number of cycles per patient was 5.6±6.5 (1-177), with a median of 4 cycles per patient. Mean number of sessions per patient was 1.9±1.7 (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 (PAH).

Conclusions: This retrospective chart review of cryolipolysis treatment, among the largest to-date, demonstrates its overall safety and broad use across numerous body areas. PAH risk per cycle is between 0.018% (1 in 5501) and 0.048% (1 in 2063), depending on the calculation method.