Adverse Events Associated with Cryolipolysis Treatment for Body Contouring: A Prospective Observational Study with 3-Month Follow-Up.

Abstract

Many clinical studies have recently assessed the efficacy and safety of cryolipolysis, a nonsurgical procedure for body contouring. This study aimed to analyze the incidence and duration of transient adverse events (AEs) after cryolipolysis treatment. This was a prospective observational study of outpatients in aesthetic medical group clinics. The patients were recruited as monitors who provided feedback on the device used for treatment and agreed to cooperate with this investigation after 3 months. For this study, monitored patients could choose to visit on a day between July and August of 2023 at one of the authors' clinics throughout Japan. The overall AE rate decreased from 71.6% immediately after treatment to 1.3% at the 3-month follow-up. Paradoxical adipose hyperplasia and deep vein thrombosis were not observed in this study. The submental area and upper arms required the fewest (13.6 days [ n = 54]) and the greatest (18.0 days [ n = 371]) mean number of days, respectively. Pain disappeared within 1 month; numbness persisted for approximately 3 months. The highest AE rates were observed in the submental area (after treatment), the flank (1 week after treatment), the banana roll (1 month after treatment), and the upper arms (3 months after treatment). This study collected AE data from the Asia-Pacific region to assess the safety of cryolipolysis in cosmetic dermatology.