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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. [1] CoolSculpting is among the most widely used forms of cryolipolysis. [1] Often the terms "cryolipolysis" and "CoolSculpting" are used synonymously or interchangeably. [4] [2]
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 6 months 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 3.9 mm (0.075–0.15 inches), 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 5.1 mm or 16.6 to 32.3% on ultrasound and of 2.3 to 7 mm or 14.9 to 21.5% with caliper. [2] The review concluded that cryolipolysis is safe and modestly effective for reducing focal adiposity, but that the quality of available data was low. [2]
Complications of cryolipolysis include erythema (30%), numbness (19%), swelling (15%), bruising (11%), paresthesia (11%), and pain (8%). [2] [6] These side effects are rated as mild to negligible in severity and generally resolve after a few weeks. [2] [6] 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. [6] A subsequent 2023 review found the incidences of persistent skin discoloration, wound formation, and infection to be very low. [2] 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. [8] 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. [2] However, the incidence of PAH may be underestimated, with some centers finding rates of 0.67 to 1.0%. [8] [9] PAH can be treated with surgical liposuction and/or abdominoplasty. [8]
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 [10] and other areas subsequently. [1] Litigation has occurred due to adverse effects of cryolipolysis. [11]
This article contains content that is written like
an advertisement. (April 2024) |
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. [1] CoolSculpting is among the most widely used forms of cryolipolysis. [1] Often the terms "cryolipolysis" and "CoolSculpting" are used synonymously or interchangeably. [4] [2]
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 6 months 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 3.9 mm (0.075–0.15 inches), 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 5.1 mm or 16.6 to 32.3% on ultrasound and of 2.3 to 7 mm or 14.9 to 21.5% with caliper. [2] The review concluded that cryolipolysis is safe and modestly effective for reducing focal adiposity, but that the quality of available data was low. [2]
Complications of cryolipolysis include erythema (30%), numbness (19%), swelling (15%), bruising (11%), paresthesia (11%), and pain (8%). [2] [6] These side effects are rated as mild to negligible in severity and generally resolve after a few weeks. [2] [6] 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. [6] A subsequent 2023 review found the incidences of persistent skin discoloration, wound formation, and infection to be very low. [2] 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. [8] 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. [2] However, the incidence of PAH may be underestimated, with some centers finding rates of 0.67 to 1.0%. [8] [9] PAH can be treated with surgical liposuction and/or abdominoplasty. [8]
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 [10] and other areas subsequently. [1] Litigation has occurred due to adverse effects of cryolipolysis. [11]