Literature review of adverse events associated with cryolipolysis.

Background: Cryolipolysis is a noninvasive procedure for localized fat reduction and body contouring. This technique utilizes controlled cooling to induce adipocyte apoptosis without damage to overlying skin and other tissue. Although the procedure was once thought to be relatively harmless, recent studies have shed light on the risks of adverse effects (AEs).

Aims: The aim of this article was to review AEs in cryolipolysis as published in clinical data.

Methods: A comprehensive search was performed in PubMed, using relevant keywords such as "cryolipolysis," "CoolSculpting," "adverse effects," "complications," and "side effects" with no set data range. The search was limited to studies published in English. The selected studies encompassed a variety of study designs, including randomized controlled trials, prospective cohort studies, case series, case reports, and reviews.

Conclusions: Since its FDA approval in 2010, our understanding of the potential risks and complications associated with cryolipolysis has grown significantly, and shown that the procedure may not be as harmless as once thought. Continued post-market surveillance of cryolipolysis devices combined with documenting of AE cases help providers better understand the true risks associated with this procedure. As "cryolipolysis" and "CoolSculpting" are often used interchangeably, further research is needed to understand if AEs such as paradoxical adipose hyperplasia (PAH) that occur both inside and outside the United States are CoolSculpting cases or linked to other devices. Additionally, further studies are needed to understand the pathophysiology of such sequelae as PAH, and to better recognize the risks and potential complications associated with cryolipolysis so that we can more accurately inform patients.