CoolSculpting is the brand name for a type of cryolipolysis procedure. Cryolipolysis is a non-invasive method of fat removal which uses extreme cold to freeze subcutaneous adipose tissue in certain localized areas of the body to reduce areas of fat.[1] [2] [3] It is Food and Drug Administration (FDA)-approved for treatment of the submental area, under the jawline, the upper arms, lumbar rolls, brassiere rolls, flank area, abdomen, thighs, and under the buttocks. CoolSculpting is among the most widely used forms of cryolipolysis. Often the terms "cryolipolysis" and "CoolSculpting" are used synonymously or interchangeably.[4]
Effectiveness data provided by the manufacturer of CoolSculpting indicates that following 1 to 3 treatments on 7 different areas and follow-up of 3 to 6months after final treatment, before-and-after photos were classified correctly 84 to 91% of the time by independent physician raters, fat layer thickness measured by ultrasound was reduced by 1.9 to 3.9mm (0.075–0.15inches), and subject satisfaction was 62 to 93%.[5] A 2015 systematic review of 19 studies and case reports of cryolipolysis found mean reductions in caliper-measured skinfold thickness of 14.7 to 28.5%, reductions in ultrasound-measured skinfold thickness of 10.3 to 25.5%, and high rates of patient satisfaction.[6] A 2023 review of 18 studies of cryolipolysis found average reduction in fat thickness of 2.0 to 5.1mm or 16.6 to 32.3% on ultrasound and of 2.3 to 7mm or 14.9 to 21.5% with caliper. The review concluded that cryolipolysis is safe and modestly effective for reducing focal adiposity, but that the quality of available data was low.
Complications of cryolipolysis include erythema (30%), numbness (19%), swelling (15%), bruising (11%), paresthesia (11%), and pain (8%). These side effects are rated as mild to negligible in severity and generally resolve after a few weeks. No cases of persistent ulcerations, scarring, paresthesias, hematomas, blistering, bleeding, hyperpigmentation, or hypopigmentation were identified in the 2015 systematic review of 19 studies and case reports. A subsequent 2023 review found the incidences of persistent skin discoloration, wound formation, and infection to be very low. More serious adverse reactions like severe/persistent pain, dysesthesia, skin hyperpigmentation, motor neuropathy, and Paradoxical adipose hyperplasia (PAH) may occur less commonly.[7] [8] PAH is a rare reaction characterized by fatty enlargement of the treatment area months after application. A 2023 review found 4 cases in the reviewed studies, or an incidence of about 0.12% across 3,445 treatment cycles in 976 patients. However, the incidence of PAH may be underestimated, with some centers finding rates of 0.67 to 1.0%.[9] PAH can be treated with surgical liposuction and/or abdominoplasty.
CoolSculpting was developed and marketed by Zeltiq Aesthetics and was introduced for use in the United States in 2010.[10] It was originally approved for use on the flanks and abdomen, but it was cleared for use on the thighs in April 2014 and other areas subsequently. Litigation has occurred due to adverse effects of cryolipolysis.[11]