Volume 26, Issue 8 e13925
REVIEW
Open Access

Cryolipolysis and associated health outcomes, adverse events, and satisfaction: A systematic review and meta-analysis

Roshan Ravindran

Corresponding Author

Roshan Ravindran

KLNIK, The Colony, Wilmslow, Cheshire, UK

Correspondence

Roshan Ravindran, KLINK, Altrincham Rd, Wilmslow SK9 4LY, Cheshire, UK.

Email: [email protected];

Lee Smith, Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK.

Email: [email protected]

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Damiano Pizzol

Damiano Pizzol

Health Unit, Eni, San Donato Milanese, Italy

Health Unit, Eni, Rome, Italy

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Masoud Rahmati

Masoud Rahmati

School of Medicine - La Timone Medical Campus, AP-HM, Aix-Marseille University, UR3279: Health Service Research and Quality of Life Center (CEReSS), Marseille, France

Department of Physical Education and Sport Sciences, Faculty of Literature and Humanities, Vali-E-Asr University of Rafsanjan, Vali-E-Asr University of Rafsanjan, Iran

CRSMP, Center for Mental Health and Psychiatry Research – PACA, Marseille, France

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Susanna Caminada

Susanna Caminada

Health Unit, Eni, Rome, Italy

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Dong Keon Yon

Dong Keon Yon

Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea

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Jae Il Shin

Jae Il Shin

Department of Pediatrics, Yonsei University College of Medicine, Seoul, South Korea

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Nicola Veronese

Nicola Veronese

Faculty of Medicine, Saint Camillus International University of Health Sciences, Rome, Italy

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Pinar Soysal

Pinar Soysal

Department of Geriatric Medicine, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey

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Guillaume Fond

Guillaume Fond

School of Medicine - La Timone Medical Campus, AP-HM, Aix-Marseille University, UR3279: Health Service Research and Quality of Life Center (CEReSS), Marseille, France

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Laurent Boyer

Laurent Boyer

School of Medicine - La Timone Medical Campus, AP-HM, Aix-Marseille University, UR3279: Health Service Research and Quality of Life Center (CEReSS), Marseille, France

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José Francisco López-Gil

José Francisco López-Gil

One Health Research Group, Universidad de Las Américas, Quito, Ecuador

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Karel Kostev

Karel Kostev

University Clinic, Philipps-University Marburg, Marburg, Deutschland, Germany

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Julia Gawronska

Julia Gawronska

Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK

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Lee Smith

Corresponding Author

Lee Smith

Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK

Correspondence

Roshan Ravindran, KLINK, Altrincham Rd, Wilmslow SK9 4LY, Cheshire, UK.

Email: [email protected];

Lee Smith, Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK.

Email: [email protected]

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First published: 11 April 2025
Citations: 1

Damiano Pizzol and Masoud Rahmati contributed equally to this work.

Funding information: The authors received no financial support for the research, authorship, and publication of this article.

Summary

Background

Cryolipolysis is a nonsurgical adiposity reduction treatment that is increasing in popularity globally. The aim of this paper was to carry out a systematic review with meta-analysis on cryolipolysis and associated health outcomes, adverse events (AE) and patient satisfaction.

Methods

Major databases were searched from inception until April 4, 2024. Meta-analysis was performed using random-effect models to calculate the pooled effects size and 95% confidence interval (CI) of each finding. The systematic review protocol was registered on PROSPERO, CRD-42024548077.

Results

A total of 30 studies were included, including 3158 participants. The result of meta-analyses showed reduced body mass index (mean differences [MD] = −1.80, 95% confidence interval [CI] −2.98, −0.62, p = 0.0003), waist-to-hip ratio (MD = −0.09, 95% CI −0.16, −0.02, p = 0.001), mean abdominal circumference (cm) (MD = −3.56, 95% CI −4.98, −2.15, p = 0.000001), and mean suprailiac fat thickness (FT) (mm) (MD = −5.22, 95% CI −9.03, −1.42, p = 0.0007), 12 weeks after cryolipolysis as compared with baseline values. The satisfaction rate was 80.4% and the AE of cryolipolysis was 49.5% for numbness, 44.5% for erythema, 30.5% for edema, 28.8% for pain, 25.4% for sensitivity, 15.2% for tingling, and 2% for hyperpigmentation.

Conclusion

In the present study, it was found that cryolipolysis was associated with a reduction in the number of adiposity parameters at 3 months follow-up. A relatively high level of minor AEs was reported; however, patient satisfaction was high suggesting that the treatment is well tolerated.

1 INTRODUCTION

Non-invasive procedures for fat reduction have become increasingly popular and requested as an aesthetic treatment over the last decade. Cryolipolysis (commonly known as CoolSculpting Allergan Aesthetics [Irvine, CA], an AbbVie Company [North Chicago, IL]) has become a cornerstone treatment for body sculpting treatments in aesthetic clinics as they can be done in office, with the oversight of a medical practitioner and little to no down time. Cryolipolysis is a nonsurgical technique that uses cold temperature to reduce fat deposits targeted at specific body regions.

In 1970, Epstein and Oren coined the term “popsicle panniculitis” after observing a red, firm nodule followed by temporary fat necrosis in the cheek of an infant who had been sucking on a popsicle.1 Originally described in infants, cold-induced panniculitis has also been noted in adult patients.2 These findings suggest that fat-rich tissues are more prone to cold injury than the surrounding water-rich tissues. Inspired by these historical observations, Manstein et al. introduced a novel noninvasive fat-reduction technique in 2007, known as cryolipolysis.3 This method involves applying a cooling device to the targeted area at a specific temperature for a set duration. This process targets fat cells while preserving the skin, nerves, blood vessels, and muscles.

Importantly, adipocytes are more susceptible to damage from cold temperatures than other cells. The cold temperature injures the adipocytes. The injury triggers an inflammatory response, which results in the apoptosis of the adipocyte cells. Macrophages then remove the dead fat cells and debris from the body and thus may reduce levels of adiposity.4 The beneficial aesthetic outcome of cryolipolysis is observed as a result of this selective disruption to adipocyte cells and their subsequent removal from the body. Owing to a potential reduction in adiposity, it is thus feasible that cryolipolysis has a positive impact on other health outcomes such as hypercholesterolemia.5 Other noninvasive device-based body sculpting treatments, which differ in mode of action from cryolipolysis and are offered in aesthetic clinics include radio frequency (RF) and high-intensity ultrasound (HIFU) or high-intensity muscular stimulation (HIFEM). Additional minimally invasive injectable treatments such as deoxycholic acid (Aqualyx or Kybella) can also be considered.

These treatments are considered for patients who wish to avoid the downtime or cost of surgical liposuction, or the risks associated with such a procedure especially if the patient has concurrent comorbidities that may potentially render them unsuitable for surgical anesthetic intervention.

The US Food and Drug Administration has approved cryolipolysis to treat visible fat bulges in the submental and submandibular areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks, and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.6 Cryolipolysis is increasingly sought as an alternative treatment to surgical fat-removal procedures because it may produce high patient-satisfaction levels without the same risks and recovery time.7-15 According to the Aesthetic Society's Aesthetic Plastic Surgery National Databank, nonsurgical fat-reduction procedures totaled 140,314 in 2020 and were among the top 5 nonsurgical procedures performed in 2019.16, 17

There is also an emerging body of literature on potential adverse events (AE) in relation to cryolipolysis. Reported AEs include treatment site erythema, numbness/paresthesia, bruising, and oedema. With more serious complications including severe/persistent pain, dysesthesia, skin hyperpigmentation, motor neuropathy, and paradoxical adipose hyperplasia (PAH).18 These more serious complications question the utility of cryolipolysis. However, the true rate of such complications is not known.

Despite the potential health benefits of cryolipolysis and its emerging popularity among the general public, its influence on health outcomes, potential AEs, and patient satisfaction is not clearly known, as to date no attempt has been made to collate, synthesize, and evaluate the extent of the literature. Given this background, the aim of the present study was to carry out a systematic review and meta-analysis on associations between cryolipolysis and studied health outcomes, AEs, and patient-satisfaction levels.

2 MATERIALS AND METHODS

This systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)19 and Meta-analysis Of Observational Studies in Epidemiology (MOOSE)20 statements and followed a structured protocol registered on International Prospective Register of Systematic Reviews (PROSPERO), CRD-42024548077.

2.1 Data sources and literature search strategy

Two investigators (MR and DP) independently conducted a literature search using PubMed/MEDLINE, Scopus, Embase, and Web of Science from inception until April 4, 2024. Any inconsistencies were resolved by consensus with a third author (LS). In PubMed, the following search strategy was used: “CoolSculpting OR cryolipolysis OR lipocryolysis.”

Conference abstracts and reference lists of included articles were hand-searched to identify any potential additional relevant work.

2.2 Study selection

Following the participants, intervention, controls, outcomes, and study design (PICOS) criteria, we included studies assessing the effects of cryolipolysis on health, AEs, and satisfaction in observational (case–control, cross-sectional, cohort) studies.

Studies were excluded if the data were not analyzable; in vitro studies; or if they did not clearly report data regarding cryolipolysis effects on health, AEs, or satisfaction. No language restriction was a priori applied. Screening of the articles was independently performed by two reviewers (MR and DP), and discord was resolved through discussion with a third reviewer (LS).

2.3 Data extraction

For each eligible study, two independent investigators (MR and DP) extracted: name of the first author and year of publication, setting, sample size, mean age of the population, mean body mass index (BMI), mean abdominal circumference, skin folds, and fat thickness (FT) in different anatomic sites, biochemical blood parameters, patients satisfaction, and side effects such as pain, sensitivity disorders, edema, hyperpigmentation, erythema, numbness, and tingling. Any inconsistencies were resolved by consensus with a third author (LS).

2.4 Outcomes

The primary health outcomes considered were BMI, mean abdominal circumference, and mean skin fold suprailiac fat, from baseline to 3-month follow-up; further considered outcomes included patient-satisfaction levels and AEs. All parameters were reported in the original papers as mean with standard deviations (SDs).

2.5 Assessment of study quality

Two independent authors (MR and LS) carried out the quality assessment of included studies' using the Newcastle-Ottawa Scale (NOS).21 The NOS assigns a maximum of 9 points based on three quality parameters: selection, comparability, and outcome.22 Any inconsistencies were resolved by consensus with a third author (DP).

2.6 Data synthesis and statistical analysis

Outcomes were pooled and expressed as mean difference (MD) with corresponding 95% confidence intervals (CI) based on one-stage approach and the random-effects estimate using the DerSimonian-Laird method. Moreover, the meta-analysis prevalence of AE and rate of patient satisfaction was calculated using MedCalc 20.104 software (MedCalc®) with a 95% CI and random-effect model. The degree of between-study heterogeneity that could not be ascribed to sampling error was explored using Cochran's Q statistics and I-squared (I2; low: <25%, moderate: 25%–50%, moderate-to-substantial: 50%–75%, and substantial: >75%) to estimate heterogeneity. Further, the potential for publication bias was assessed using funnel plots with Egger's linear regression and Begg's rank tests, when the sufficient number of studies (n > 10) was available.23 Finally, to assess the robustness of summary estimates and to detect if any particular study accounted for a large proportion of heterogeneity, sensitivity analysis was performed by the one study removed method. All meta-analyses in the current study were conducted using Review Manager (version 5.4; The Nordic Cochrane Centre, Copenhagen, Denmark) and MedCalc software version 20.104 (MedCalc software Ltd, Acacialaan 22 8400 Ostend-Belgium). Finally, a two-sided p-value less than 0.05 was considered statistically significant.

3 RESULTS

3.1 Literature search

As shown in Figure 1,777 articles were initially screened, and 57 full texts were retrieved. Among them, 30 studies were finally included in the systemic review.

Details are in the caption following the image
PRISMA flow diagram of study selection.

3.2 Descriptive findings and quality assessment

The majority of included studies were carried out in North America (n = 11) followed by Europe and Middle East (6 each), Asia (4), and South America (3). Overall, 3158 participants (range: 4–2114) were included having a mean age, for studies with available data, of 32.8 years (range: 14–51.4) (Table 1).

TABLE 1. General characteristics of included studies.
Study Design Country Group (Gender: %F) Age (year) Number of treatments Sites of treatment Duration/temperature
Abdel-Aal, 202024 RCT Egypt 30 (100) 45.7 ± 1.86 90 Hypogastrium 60 min/−5°C
Adjadj, 201711 Cohort France 48 (100) 38 ± 11 48 Saddlebags 55 min/−2°C
Altmann, 202225 Cross-sectional Germany 91 (84) 45.5 ± NR 91 Various NR
Azab, 202026 Cohort Egypt 46 (0) 37.2 ± 9.1 138 Suprapubic 30–60 min/0 to −5°C
Carruthers, 201727 Cohort Canada 60 (100) 45.7 ± 1.5 60 Arms 35 min/−11°C
Coiante, 202328 Cohort France 54 (100) 35 ± 1.3 108 Abdomen 55 min/−5°C
Eldesoky, 201529 Case–control Egypt 20 (70) 33.3 ± 5.33 80 Abdomen 30 min/NR
Falster, 201930 RCT Brazil 17 (100) 24.9 ± 5.04 17 Abdomen 50 min/−10°C
Faulhaber, 201931 Cohort Germany 4 (100) 33.8 ± 4.8 4 Abdomen or flank NR
Faulhaber, 201931 Cohort Germany 10 (80) 40.4 ± 15.6 10 Abdomen or flank NR
Garibyan, 201414 RCT USA 11 (55) 37.6 ± 8.4 11 Flank 60 min/NR
Hong, 202232 Cohort South Korea 15 (0) 33 ± 7.89 30 Breast 40 min/−7°C
Hwang, 202033 RCT South Korea 15 (30) 38.31 ± 10.84 15 Abdomen 60 min/−7°C
Jalian, 202234 RCT USA 16 (62.5) 43 ± NR 32 Submental 45 min/−11°C
Kandula, 202135 Cohort USA 12 (NR) 51.17 ± 6.5 12 Abdomen Ice slurry 30% ice content
Keaney, 201536 Cross-sectional USA 125 (78.4) 44.5 ± NR 554 Various 60 min/NR
Khedmatgozar, 202037 Cohort Iran 30 (100) NR 30 Abdomen 60 min/−5°C
Kilmer, 201538 Cohort USA 60 (80) NR 60 Submental 50 min/−10°C
Kilmer, 201639 Cohort USA 19 (NR) 46.7 ± NR 19 Flank 60 min/−10°C
Klein, 200940 Cohort USA 40 (80) 40.9 ± 10.5 40 Flanks 30 min/NR
Klein, 201741 Cohort USA 35 (77) 45.2 ± 2.2 35 Abdomen or flank 30 min/−10°C
Leal Silva, 201742 Cohort Mexico 15 (80) 46.2 ± NR 30 Submental 30–45 min/ −15–−12°C
Luze, 202243 Cohort Austria 29 (100) 39.5 ± 13.4 812 Abdomen Belt, 1 h per day/18°C
Meyer, 202144 RCT Brazil 32 (100) NR 64 Abdomen 75 min/−4°C
Mostafa, 201645 RCT Egypt 15 (60) 14 ± 1.9 120 Abdomen 60 min/NR
Mostafa, 202146 RCT Egypt 15 (60) 33.48 ± 3.91 45 Abdomen 60 min/NR
Nikolis, 202047 Cross-sectional Canada 2114 (NR) NR 8658 Various NR
Ponga-Manson, 202148 Cohort Spain 30 (100) 51.4 ± 3.4 150 Abdomen 60 min/−5°C
Savacini, 201849 Cohort Brazil 21 (85.7) 34 ± 9 NS Abdomen and flanks 60 min/−8°C
Tan, 202150 Cohort Singapore 112 (74.1) 42.5 ± 9.86 NS Abdomen and flanks 45 min/NR
Wanitphakdeedecha, 201551 Cohort Thailand 17 (100) 30.2 ± 5.8 40 Arms and thigs 60 min/NR
  • Abbreviations: NR, not reported; NS, not specified; RCT, randomized controlled trial.

The median quality of the studies was 5.8 (range: 4–8), indicating an overall good quality of the studies, according to the NOS (Table 2S).

TABLE 2. Results of the quantitative synthesis.
Factor Total sample MD/proportion 95% CI p-Value

Heterogeneity

(I2p-value)

Egger's test p-value Begg's test p-value
BMI 256 −1.80 (−2.98, −0.62) 0.003 94%—0.00001 0.65 0.22
WHR 60 −0.09 (−0.16, −0.02) 0.01 96%—0.00001 0.78 0.52
Mean abdominal circumference (cm) 211 −3.56 (−4.98, −2.15) 0.00001 11%—0.35 0.76 0.22
Mean thigh circumference (cm) 102 −1.28 (−3.06, 0.49) 0.16 44%—0.18 NA NA
Mean subcutaneous FT (mm) 131 −0.66 (−1.49, 0.16) 0.11 87%—0.004
Mean thigh FT (mm) 83 −0.10 (−0.22, 0.02) 0.12 0%—0.84 NA NA
Mean suprailiac FT (mm) 52 −5.22 (−9.03, −1.42) 0.007 89%—0.0001 0.55 0.12
Total cholesterol (mg/dL) 126 −7.75 (−25.79, 10.28) 0.40 90%—0.00001 0.58 0.31
Triglyceride (mg/dL) 126 −4.99 (−27.27, 17.28) 0.66 88%—0.0001 0.72 0.38
HDL (mg/dL) 126 5.07 (−10.12, 20.25) 0.51 98%—0.00001 0.64 0.14
LDL (mg/dL) 126 −5.85 (−21.24, 9.53) 0.46 91%—0.00001 0.78 0.65
ALT (mg/dL) 126 −2.51 (−10.27, 5.25) 0.53 93%—0.00001 0.52 0.54
AST (mg/dL) 126 −1.85 (−9.33, 5.53) 0.62 94%—0.00001 0.64 0.54
Abdominal sonography FT (cm) 79 −0.66 (−1.58, 0.26) 0.16 98%—0.00001 0.48 0.24
Satisfaction 479 80.4% 67.2–90.7 NA 90%—0.0001 0.8 0.18
Pain 324 28.8% 15.2–44.8 NA 86%—0.0001 0.17 0.09
Sensitivity 59 25.4% 13.9–98.2 NA 97%—0.0001 NA NA
Hyperpigmentation 175 2% 0.006–7.53 NA 60%—0.08 0.14 0.12
Erythema 388 44.5% 22.2–68.1 NA 95%—0.0001 0.80 0.27
Edema 228 30.5% 14.8–49.1 NA 87%—0.0001 0.78 0.90
Numbness 217 49.5% 25.5–73.6 NA 92%—0.0001 0.50 1.00
Tingling 205 15.2% 4.5–30.5 NA 83%—0.0001 0.14 0.24
  • Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; CI, coefficient interval; FT, fat thickness; HDL, high-density lipoprotein, LDL, low-density lipoprotein; MD, mean difference; NA, not applicable; WHR, waist-to-hip ratio.

3.3 Main outcomes

Overall pooled analyses showed reduced BMI (MD = −1.80, 95% CI -2.98, −0.62, p = 0.0003; Figure S1), WHR (MD = −0.09, 95% CI −0.16, −0.02, p = 0.001; Figure S2), mean abdominal circumference (cm) (MD = −3.56, 95% CI −4.98, −2.15, p = 0.000001; Figure S3), and mean suprailiac FT (mm) (MD = −5.22, 95% CI −9.03, −1.42, p = 0.0.007; Figure S4), 12 weeks after cryolipolysis as compared with baseline values (Table 2).

However, the beneficial effects of cryolipolysis 12 weeks after treatment did not reach to significancy for mean thigh circumference (cm) (MD = −1.28, 95% CI −3.06, 0.49, p = 0.16; Figure S5), mean subcutaneous FT (mm) (MD = −0.66, 95% CI −1.49, 0.16, p = 0.11; Figure S6), mean thigh FT (mm) (MD = −0.10, 95% CI −0.22, 0.02, p = 0.12; Figure S7), total cholesterol (mg/dL) (MD = −7.75, 95% CI −25.79, 10.28, p = 0.40; Figure S8), triglyceride (mg/dL) (MD = −4.99, 95% CI −27.27, 17.28, p = 0.66; Figure S9), HDL (mg/dL) (MD = 5.07, 95% CI −10.12, 20.25, p = 0.51; Figure S10), LDL (mg/dL) (MD = −5.85, 95% CI −21.24, 9.53, p = 0.46; Figure S11), ALT (mg/dL) (MD = −2.51, 95% CI −10.27, 5.25, p = 0.53; Figure S12), AST (mg/dL) (MD = −1.85, 95% CI −9.33, 5.53, p = 0.62; Figure S13), and abdominal sonography FT (cm) (MD = −66, 95% CI −1.58, 0.26, p = 0.16; Figure S14), as compared with baseline values.

The result of random-effect meta-analysis showed that the proportion of patient satisfaction was 80.4% (95% CI 67.2–90.7) (Figure S15). Moreover, the proportion of random-effect meta-analysis for AEs of cryolipolysis was 49.5% for numbness (95% CI 25.5–73.6) (Figure S16), 44.5% for erythema (95% CI 22.2–68.1) (Figure S17), 30.5% for edema (95% CI 14.8–49.1) (Figure S18), 28.8% for pain (95% CI 15.2–44.8) (Figure S19), 25.4% for sensitivity (95% CI 13.9–98.2) (Figure S20), 15.2% for tingling (95% CI 4.5–30.5) (Figure S21), and 2% for hyperpigmentation (95% CI 0.006–7.53) (Figure S22).

4 DISCUSSION

The present study is the first systematic review and meta-analysis on the association between cryolipolysis and health outcomes, AEs, and patient satisfaction. A total of 30 studies were evaluated, including 3158 participants. The findings suggest that cryolipolysis is associated with significant reductions in BMI, WHR, mean abdominal circumference, and mean suprailiac fat, at 3 months of follow-up. Such results indeed suggest that cryolipolysis is an effective nonsurgical treatment for reduction in some adiposity parameters. The study found a relatively high level of minor AEs with numbness, erythema, edema, and pain being the most frequent. Importantly, the present analysis found a high level of patient satisfaction in relation to the cryolipolysis procedure.

The mechanisms by which cryolipolysis reduce adiposity are well understood. When cryolipolysis is performed, it is thought that vacuum suction with regulated heat extraction impedes blood flow and induces crystallization of the targeted adipose tissue.3, 52 In turn, this cold ischemic injury may promote cellular injury in adipose tissue via cellular oedema, reduced Na-K-ATPase activity, reduced adenosine triphosphate, increased lactic acid levels, and mitochondrial free radical release.53 Moreover, the initial insult of crystallization and cold ischemic injury because of cryolipolysis is compounded by ischemia reperfusion injury, resulting in the release of reactive oxygen species, increased cytosolic calcium levels, and activation of apoptotic pathways.53 This crystallization and cold ischemic injury of adipocytes results in apoptosis and an inflammatory response, thus removal of adipocytes within the following weeks.3, 54, 55 Indeed, histological studies show that within 3 months, macrophages are mostly responsible for clearing the damaged cells and debris.54, 56 Moreover, both animal and human studies showed no abnormal lipid levels or liver function despite the induced adipocyte damage due to cryolipolysis.57

To date, there have been over 17+ million CoolSculpting® procedures (one piece of equipment used to carry out cryolipolysis) performed worldwide.58 Thus, the low-risk safety profile of cryolipolysis is well established. The common minor and moderate localized AEs such as numbness, erythema, sensitivity, tingling, hyperpigmentation, edema, and pain14 have also been reported without representing particular concern and discomfort for patients with often spontaneous resolution.38, 42, 51 Rare moderate-to-severe complications described in the wider literature include PAH59 and cold burns.60 The development of PAH may be related to a combination of dynamics, including older models of cryolipolysis units and applicators, as well as individual characteristics that predispose certain patients.47 It is generally accepted that adherence to the correct protocols and procedures while using the newer CoolSculpting models per se reduce AEs. Importantly, reported patient satisfaction with cryolipolysis was high at 80.4%, suggesting that patients are overall satisfied with the outcomes of the procedure and suggesting the procedure is generally well tolerated.

Owing to the findings from this meta-analysis cryolipolysis could be recommended for targeted adiposity reduction within the adult population. Importantly CoolSculpting states that the procedure is not a weight loss procedure; however, the meta-analysis shows a significant reduction in BMI with cryolipolysis (MD = −1.80, p = 0.003). This challenges some of the current aesthetic community beliefs. While the present work shows that cryolipolysis as an independent treatment for adiposity reduction may be effective, a greater reduction in adiposity could be achieved with the combination of cryolipolysis with nutrition and targeted exercise intervention. However, to date there is a scarcity of research in this area. Moreover, future research is needed to understand the true efficacy of cryolipolysis across the lifespan, including older adults and whether adiposity reduction with cryolipolysis influences other health outcomes such as quality of life.

4.1 Strengths and limitations

This is the first study to systematically review and evaluate the literature on the relationship between cryolipolysis and health outcomes, AEs, and patient satisfaction and benefits from a relatively large number of studies and participant sample. The variety of search databases utilized, and extensive reference searches have reduced the risk of bias. However, findings from the present study must be interpreted in light of its limitations. Firstly, there is the potential influence of publication bias, with negative and null findings remaining in the “file drawer.” Secondly, only a few health outcomes in relation to cryolipolysis procedure have been studied to date, and its impact on other health outcomes such as quality of life have not been studied. Thirdly, data were recorded over a relatively short follow-up period, 3 months; future studies should look to extend such follow-up periods to 12 months and beyond to garner an understanding of the long-term indications of this procedure.

5 CONCLUSIONS

In conclusion, in this systematic review with meta-analysis consisting of 30 studies and 3158 participants, it was found that cryolipolysis was associated with a reduction in a number of adiposity parameters at 3 months follow-up. Importantly a statistically significant reduction in BMI was observed, thus challenging the current paradigm thinking in aesthetics on this key health parameter. A relatively high level of minor AEs was reported in studies. However, patient satisfaction was high suggesting that the treatment is well tolerated and potentially effective for the treatment of localized fat reduction.

ACKNOWLEDGMENTS

We would like to thank all members of the research team who contributed to the data analysis, content, and writing of the manuscript.

    CONFLICT OF INTEREST STATEMENT

    Dr Ravindran provides CoolSculpting as a treatment option to patients in his clinics.

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