noninvasive body contouring - scmsjournal.com

Noninvasive body contouringNicole Y Lee, MD, MPH1 and Deanne Mraz Robinson, MD2,3

Noninvasive body contouring has quickly become one of the most sought-out procedures in surgical dermatology. In a 2016 American Society for Dermatologic Surgery (ASDS)

consumer survey, excess weight remained one of the primary con-cerns of cosmetic patients. Indeed, 387,000 body sculpting proce-dures were performed by ASDS members in 2016.1,2 In response to this growing demand, many devices have been developed, promis-ing the safe reduction of unwanted body fat with variable clinical evidence of efficacy. Marketing claims often supersede the clinical data, thereby making it difficult to discern between the advertising and science of each device. In this paper, we review the literature of 7 of the most popular noninvasive body contouring therapies (Table 1 and Figure 1) in hopes of providing clarity.

CryolipolysisSince its introduction in 2007, cryolipolysis (CoolSculpting; Zeltiq Aesthetics, Pleasanton, CA) has become one of the most popular procedures for noninvasive body contouring. Cryolipolysis is ap-proved by the US Food and Drug Administration (FDA) for fat re-duction of the flanks, abdomen, outer and inner thighs, submental region, arms, bra bulge, back, and “banana roll” beneath the but-tock. The mechanism behind cryolipolysis is based on the principle of adipocyte susceptibility to extreme cold temperatures, unlike its neighboring cutaneous structures, which allow for selective fat reduction. Preclinical studies demonstrated that cold exposure in-

duces delayed fat cell apoptosis, which leads to an inflammatory response.3,4 Histology has confirmed the beginning of an inflam-matory infiltrate on day 3, peaking on day 14, and subsequent phagocytosis extending to day 30.4 Between days 60 and 90, the inflammatory response starts to subside, and thickened fibrous sep-tate begin to replace the lost adipocytes.4

The device has evolved over the years, with the addition of multiple different applicators for use on various parts of the body. Most of the applicators require suction and thus necessitate that the treated areas be “pinchable” in order for adequate tissue acquisi-tion (Figure 2). Target tissues are cooled to a goal temperature of −10°C for a duration of 35 to 90 minutes depending on the ap-plicator. Newer applicators have less curved cup designs that have improved the overall treatment experience by requiring less suction and increasing the surface area of the skin in contact with the cool-ing plates. Nonsuction applicators are also now available as well. This results in less discomfort, less bruising, improved efficacy, and shorter treatment times.

Multiple studies have confirmed its efficacy, with the average reported improvement ranging from a 20% to 25% reduction in fat per session.5 Dover et al performed a multicenter, prospective, nonrandomized clinical study that demonstrated fat reduction in all participants, with an average reduction of 22.4% at 4 months by ul-trasound examination.6 Garibyan et al used 3-dimensional photog-raphy to demonstrate a mean volume reduction of 39.5 mL after a single flank treatment in comparison with the contralateral control.7 The degree of improvement is dependent on the area being treated; the abdomen and flanks appear to have the greatest degree of im-provement.8 Carruthers et al performed a comprehensive review over 3 years and found that there was also notable improvement of skin texture, laxity, and cellulite with cryolipolysis.9

Most patients begin to notice improvement 2 months after treat-ment, with changes continuing for up to a total of 6 months post-treatment. Boey and Wasilenchuk demonstrated that massaging immediately after applicator removal improved efficacy by 68% at 2 months and 44% at 4 months, as demonstrated in photos and on diagnostic ultrasound.10 In our practice, we separate consecutive treatments by 2 to 3 months. Cryolipolysis is well tolerated, with the most common side effects including temporary erythema for up to 90 minutes (depending on applicator), bruising, tenderness, decreased sensation (lasting on average for 3.6 weeks),11 and hyper-pigmentation in darker skin types.

Other notable side effects include late-onset pain and paradoxi-cal adipocyte hyperplasia (PAH). Late-onset pain is not uncommon and occurs around 3 days after treatment, with a mean duration of 11 days, and is most often seen in women.12 The underlying etiol-ogy is unknown; however, it is hypothesized that a combination of transient altered sensation of sensory nerves and inflammation of the nerves, fascia, and fat contribute to the delayed onset of pain.12 It

■ AbstractIn a society where stigma surrounds cosmetic procedures and yet a thin and sculpted physique is idealized, nonin-vasive body contouring satisfies the demand to reduce excess and undesired body fat in areas that persist despite exercise and diet. Numerous devices are available to meet this need; however, choosing the “perfect” device is challenging because the science and data are often limited with variable results. In this paper, we review 7 US Food and Drug Administration-approved noninvasive body contouring therapies in hopes of providing some clarity to this area.

Semin Cutan Med Surg 36:170-178 © 2017 Frontline Medical Communications

1Wesson Dermatology, Great Neck, New York.2Connecticut Dermatology Group, Norwalk, Connecticut. 3Yale School of Medicine, Yale University, New Haven, Connecticut. Disclosures: All authors certify that the work reported in this manuscript has not received financial support from any pharmaceutical company or com-mercial source.Correspondence: Nicole Y Lee, MD, MPH; [email protected]

1085-5629/13$-see front matter © 2017 Frontline Medical Communications https://doi.org/10.12788/j.sder.2017.043

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is self-limited and often resolves without therapy, but it can be miti-gated with topical agents, such as lidocaine or low-dose gabapen-tin. PAH is a rare and unfortunate sequelae with only 16 reported cases in the literature. It presents at 3 to 6 months after treatment with a propensity to occur in men, those of Latin descent, and in abdominal and pectoral fat pads.13 The specific process is unclear; however, multiple theories have been proposed. The negative vac-uum pressure of the suction applicators, hypoxia-induced stimula-tory factors, and the incomplete death of some adipocytes may have a stimulatory effect resulting in hyperplasia.14,15 The histology of PAH demonstrates fascial thickening, possibly representing a reac-tive process.16 The current recommendation is to avoid other nonin-vasive fat-removal devices and to treat with liposuction.

Cryolipolysis offers a safe and effective option for body contour-ing without any “downtime.” It is useful for debulking larger areas and for the treatment of isolated prominent subcutaneous fat bulges. Multiple new handpieces are being and have been developed that allow for the customization of treatment. Although long-term stud-ies are lacking, the current consensus is that the results are per-manent and maintained even with fluctuations in weight. Relative contraindications for cryolipolysis include cold-induced conditions, such as cryoglobulinemia, cold urticaria, Raynaud syndrome, and paroxysmal cold hemoglobinuria, as well as pregnancy, underlying hernia, or active dermatitis in the area to be treated.17 The limita-tions of cryolipolysis include the need for “pinchable” fat, the cost of a consumable “cycle,” the cost of purchasing the device and mul-tiple handpieces, PAH, late-onset pain, dysesthesias, and the time it takes to treat multiple areas. As with all noninvasive body contour-ing devices, ideal candidates are individuals at or near their target weight. These procedures are not a treatment for obesity and are not a replacement for diet and exercise because they do not result in any meaningful weight loss. Patients must have realistic expectations for a nonsurgical procedure and be willing to wait 3 to 6 months to appreciate the full results of a single treatment.

1060-nm diode laser lipolysisThe 1060-nm diode laser (SculpSure; Cynosure, Westford, Massa-chusetts) is the first and only FDA-approved hyperthermic device for noninvasive fat removal specifically cleared by the FDA for the treat-ment of the abdomen, flanks, back, and inner and outer thighs. The mechanism by which the diode induces adipocyte destruction is via selective thermal heating of adipocytes at a controlled temperature of 42°C to 47°C. The 1060-nm wavelength is unique in that it is min-imally absorbed by the dermis and melanin. This allows for selective targeting of the subcutaneous tissue without injury of the overlying dermis and for the safe treatment of all Fitzpatrick skin types.

At 42°C to 47°C, adipocyte plasma membranes lose their struc-tural integrity, which leads to delayed adipocyte death.18 Decorato et al confirmed the clinical efficacy of thermal energy on adipose tis-sue with histologic evidence.19 Two weeks after treatment, a dense lymphocytic infiltrate with sparse macrophages surrounds injured fat cells. Over the course of the ensuing several months, the inflam-matory infiltrate removes the damaged adipocytes, and new colla-gen is produced as the treated site heals. Clinically, patients begin to notice improvement at 6 weeks, with optimal results often seen by week 12. Multiple studies have demonstrated a 13% and 16% re-duction in fat thickness of the flanks and abdomen, respectively, at 12 weeks after a single treatment via ultrasound measurements.20,21

The device consists of 4 nonsuction applicators that can be cus-tomized into various configurations, allowing for treatment versa-tility (Figure 3). Because the applicator is flat and does not require suction, it allows nonpinchable areas to be treated, such as outer thighs or slimmer abdomens. Each individual applicator has a grad-ual “feathering of heat” beyond its contact with the skin, which allows for a continuous zone of treatment without sharply demar-cated untreated areas.22 The surface of the applicator has a sapphire contact cooling plate to protect the surface of the skin during the 25-minute procedure. Repeated treatments can be performed at least 1 month apart in order to optimize results.23

Decorato et al compared 1060-nm laser therapy to cryolipolysis and found the results to be equivalent; magnetic resonance imaging findings of average fat volume reduction at 3 months and 6 months with laser therapy were 24% and 21% compared with 22% and 19% with cryolipolysis, respectively.24 Posttreatment massaging is not required, and notable skin tightening after treatment has also been anecdotally noted. The treatments are generally well tolerated. Patients report a warm sensation during treatment. Adverse events include burns, nodules, discomfort during treatment, and localized, mild tenderness that lasts 1 to 3 weeks posttreatment.

The limited data is promising for the 1060-nm diode laser, spe-cifically for those who have pinchable and nonpinchable subcuta-neous adipose tissue, and, as noted by one study, the laser appears to be equivalent to cryolipolysis in efficacy. It is a relatively new therapeutic option for body contouring that requires further ran-domized controlled studies as well as long-term evaluation for the demonstration of maintenance, efficacy, and side effects. Current data demonstrate the maintenance of fat reduction at 6 months post-treatment.25 Contraindications for hyperthermic treatment include pregnancy, scars in the treated areas, active dermatitis, hernia, dias-tasis recti, or tattoo of the treated skin. In conclusion, we feel that the 1060-nm diode laser offers an adequate treatment option for body contouring; however, the device is relatively new, and further studies are needed for evaluation.

Because of the FDA-cleared indications for the treatment of the abdomen, flanks, back, and inner and outer thighs, a shorter treat-ment time than cryolipolysis, and a nonsuction-based applicator; the 1060-nm diode device is a formidable option in the body con-touring arena. More studies examining additional treatment areas and the ability to target both subdermal tissue for tightening as well as subcutaneous adipose tissue may enhance current treatment abilities.

Deoxycholic acid Deoxycholic acid (ATX-101; Kybella; Kythera Biopharmaceu-ticals, Inc., Westlake Village, California [an affiliate of Allergan plc, Dublin, Ireland]) is the first FDA-approved injectable therapy for the effective reduction of submental fat and improvement of the cervicomental contour of the neck. ATX-101 is a chemically synthesized deoxycholic acid that is biologically equivalent to its endogenous form. Multiple Phase 3 clinical trials (REFINE-1 and REFINE-2) have demonstrated its efficacy through provider, pa-tient, and objective measures.26,27 Subjects received up to 6 monthly treatments; ≥1 grade composite response was achieved in 70%, and ≥2 grade composite response was achieved in 13.4%.26 Not only is there a reduction of submental fullness, an improvement in skin laxity has also been reported as well.

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■ ■ ■ Noninvasive body contouring

Upon injection, ATX-101 is rapidly absorbed by the subcutane-ous tissue and induces adipocyte lysis via the physical disruption of the cell membrane; the protein-poor adipocyte cells are particu-larly susceptible to ATX-101, unlike their neighboring structures, such as the dermis and muscle.28,29 Histologic evaluation indicates that fat lysis is evident within 24 hours. By day 3, there is a local-ized and dense neutrophilic infiltrate that is then replaced by mac-rophages on day 7. The inflammatory process is mostly resolved after 4 weeks, at which time neocollagenesis and fibrous septate thickening can be seen.30 Open-label Phase I trials have shown that, in healthy individuals, deoxycholic levels rapidly increase immediately after injection; however, the levels remain within physiologic range, return to baseline within 12 to 24 hours, and are without any clinically meaningful effect on lipids and inflammatory mediators.31,32

The optimal dose to achieve efficacy with minimal adverse events was found to be 2 mg/cm². As a result, the current treatment

recommendation is 0.2 cc of drug injected at 1-cm intervals with a maximum of 10 ml per treatment session. A temporary tattoo grid is provided to assist with guiding the injections. Multiple treatments are required to achieve a meaningful clinical response, which often ranges between 2 to 4 sessions on average with less product re-quired with each subsequent visit.

ATX-101 is well tolerated by patients. In the REFINE trials, the side effects reported were primarily related to localized inflamma-tion from the injection and included pain (70%), bruising (72%), and edema/swelling (87%) that subsequently decreased in incidence and severity with subsequent sessions.26,33 Ulceration can occur if the injections are placed too superficially. In an exploratory Phase III-b clinical study, Dover et al reported that pain peaked within the first 5 minutes after treatment and was considered by most subjects as a mild, “throbbing,” “aching,” “tender,” or as a “heavy” sensa-tion.34 The addition of topical/local anesthesia, nonsteroidal anti-inflammatory drugs (NSAIDs), and antihistamines provided a 40%

■ TABLE 1. Popular noninvasive body contouring therapies

Cryolipolysis 1060-nm diode ATX-101 HIFU Pulsed focused ultrasound Monopolar RF Multipolar RF

Trade names Coolsculpting; Zeltiq Aesthetics, Pleasanton, CA

SculpSure; Cynosure, Westford, MA Kybella; Kythera Biopharmaceuticals, Inc., Westlake Villgae, CA (an affiliate of Allergan plc, Dublin, Ireland)

Liposonix; Solta Medical, San Francisco, CA

UltraShape Power; Syneron Candela, Irvine, CA

truSculpt; Cutera, Brisbane, CA Vanquish; BTL Industries, Framingham, MA

Mechanism Selective freezing of fat to −10°C resulting in membrane instability and delayed adipose apoptosis

Selective thermal heating of fat to 42°C-47°C resulting in membrane instability and delayed adipose apoptosis

Synthetic ATX-101 induces adipocyte lysis via physical disruption of fat cell membranes

Thermo-mechanically disrupt adipose cell membranes resulting in apoptosis and coagulative necrosis

Mechanically induces adipocyte cell membrane lysis

Electromagnetic waves to selectively heat the subcutaneous adipose tissue to 45°C resulting in fat cell membrane instability and delayed apoptosis


Treatment duration 35-90 minutes 25 minutes 10 minutes 60-90 minutes 30-60 minutes 30-60 minutes 30 minutes

Applicator Suction and nonsuction Nonsuction N/A Handpiece Handpiece Handpiece Noncontact panels

Applicator surface area Dependent on the applicator 4 applicator heads that are each 4 cm x 6 cm in size

N/A; maximum 10 cc to be used per session

0.8-cm or 1.3-cm depth 1.5-cm depth 16 cm2

40 cm2

Abdomen 890 cm2

Legs 393 cm2

Operator Independent Independent Dependent Dependent Dependent Dependent Independent

Consumables Yes Yes Yes (product) Yes Yes Yes No

FDA indications

Flanks, abdomen, thighs, submental region, arms, back, bra bulge, “banana roll”

Abdomen, flanks, back, thighs Submental fat Circumferential waist reduction Circumferential waist reduction Circumferential waist reduction Circumferential waist reduction

Clinical outcome

20%-25% fat reduction with each treatment; 40-cc fat reduction of flanks after single treatment

13% and 16% reduction of fat thickness of flanks and abdomen, respectively

52% of patients reported >1 grade improvement in Clinician-Reported Submental Fat Rating Scale after 1 treatment

1-cm-4.6-cm reduction in circumference with 2-3 passes per session

2.16-cm reduction in fat thickness and 4.15 cm in abdominal circumference

1.9-cm reduction in fat thickness of abdomen and flanks

4.93-cm reduction of abdominal circumference; 2.43-cm and 3.86-cm reductions reported for thigh circumference in 2 studies

Number of treatments 1 1 treatment for above results, usually done in series of 2 treatments for optimal results

2-4 1 3 treatments spaced either bimonthly or monthly

1 4 weekly sessions

Side effects

Erythema, dysesthesia, bruising, hyperpigmentation, delayed-onset pain, paradoxical adipose hyperplasia

Burns, nodules, discomfort during treatment, localized and/or mild tenderness

Pain, bruising, edema, induration, marginal mandibular paresis

Pain during treatment, bruising, edema, focal induration, 1 case report of painful panniculitis-like fibrosis

Pain or tingling sensation during treatment, mild erythema, bruising, erosions, and blisters

Pain, erythema, edema, tenderness with palpation, palpable nodules

Erythema, edema, hypersensitivity to heat, localized hyperhidrosis

Abbreviations: ATX-101, deoxycholic acid injection; FDA, Food and Drug Administration; HIFU, high-intensity focused ultrasound; RF, radiofrequency.

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reduction in pain compared with ice packs alone. Swelling varied from patient to patient and did not improve with antihistamines, NSAIDs, or postprocedural pressure. Bruising was reduced with epinephrine from injectable anesthesia. Dover et al also evaluated the presence of induration, which peaked at hour 4 post treatment, subsided the following day, and then peaked again on day 7.34

The adverse event of most concern is marginal mandibular pare-sis, which was reported in 4% of subjects in the REFINE trials and in 2.9% of subjects in all clinical trials. All cases resolved without intervention or sequelae.30 The incidence is extremely uncommon. However, it is important to be aware of the submental anatomy to minimize its occurrence because nerves are ensheathed in fat and, as a result, at risk for potential injury. Therefore, treatment guide-lines recommend marking the anterior, lateral, and posterior bor-ders of the submental region prior to treatment.

ATX-101 is an effective, noninvasive treatment option for the reduction of submental fullness. Because of its efficacy, future ap-

plications may also include its off-label use in the removal of cos-metically unwanted fat elsewhere on the body, such as preaxillary, upper arm, knee, and smaller pockets of abdominal fat.35 However, ATX-101 is not inexpensive and can be cost prohibitive to many patients because of the number of sessions and amount of product that may be required for optimal results, while other noninvasive, more affordable body contouring options are available without the associated downtime expected with ATX-101. In our experience, ATX-101 is most effective when treating a localized area of the sub-mental region, not extending to the lateral neck, and for those able to afford the downtime associated with treatment. Optimal patients are those not interested in undergoing surgical procedures, such as liposuction, and who have realistic expectations of nonsurgical treatment. Additionally, patients with marked laxity are not ideal candidates. While some skin tightening is noted posttreatment, it is not a skin-directed therapy and will not address moderate and/or severe laxity.

■ TABLE 1. Popular noninvasive body contouring therapies

Cryolipolysis 1060-nm diode ATX-101 HIFU Pulsed focused ultrasound Monopolar RF Multipolar RF

Trade names Coolsculpting; Zeltiq Aesthetics, Pleasanton, CA

SculpSure; Cynosure, Westford, MA Kybella; Kythera Biopharmaceuticals, Inc., Westlake Villgae, CA (an affiliate of Allergan plc, Dublin, Ireland)

Liposonix; Solta Medical, San Francisco, CA

UltraShape Power; Syneron Candela, Irvine, CA

truSculpt; Cutera, Brisbane, CA Vanquish; BTL Industries, Framingham, MA

Mechanism Selective freezing of fat to −10°C resulting in membrane instability and delayed adipose apoptosis

Selective thermal heating of fat to 42°C-47°C resulting in membrane instability and delayed adipose apoptosis

Synthetic ATX-101 induces adipocyte lysis via physical disruption of fat cell membranes

Thermo-mechanically disrupt adipose cell membranes resulting in apoptosis and coagulative necrosis

Mechanically induces adipocyte cell membrane lysis



Treatment duration 35-90 minutes 25 minutes 10 minutes 60-90 minutes 30-60 minutes 30-60 minutes 30 minutes

Applicator Suction and nonsuction Nonsuction N/A Handpiece Handpiece Handpiece Noncontact panels

Applicator surface area Dependent on the applicator 4 applicator heads that are each 4 cm x 6 cm in size

N/A; maximum 10 cc to be used per session

0.8-cm or 1.3-cm depth 1.5-cm depth 16 cm2

40 cm2

Abdomen 890 cm2

Legs 393 cm2

Operator Independent Independent Dependent Dependent Dependent Dependent Independent

Consumables Yes Yes Yes (product) Yes Yes Yes No

FDA indications

Flanks, abdomen, thighs, submental region, arms, back, bra bulge, “banana roll”

Abdomen, flanks, back, thighs Submental fat Circumferential waist reduction Circumferential waist reduction Circumferential waist reduction Circumferential waist reduction

Clinical outcome

20%-25% fat reduction with each treatment; 40-cc fat reduction of flanks after single treatment

13% and 16% reduction of fat thickness of flanks and abdomen, respectively

52% of patients reported >1 grade improvement in Clinician-Reported Submental Fat Rating Scale after 1 treatment

1-cm-4.6-cm reduction in circumference with 2-3 passes per session

2.16-cm reduction in fat thickness and 4.15 cm in abdominal circumference

1.9-cm reduction in fat thickness of abdomen and flanks

4.93-cm reduction of abdominal circumference; 2.43-cm and 3.86-cm reductions reported for thigh circumference in 2 studies

Number of treatments 1 1 treatment for above results, usually done in series of 2 treatments for optimal results

2-4 1 3 treatments spaced either bimonthly or monthly

1 4 weekly sessions

Side effects

Erythema, dysesthesia, bruising, hyperpigmentation, delayed-onset pain, paradoxical adipose hyperplasia

Burns, nodules, discomfort during treatment, localized and/or mild tenderness

Pain, bruising, edema, induration, marginal mandibular paresis

Pain during treatment, bruising, edema, focal induration, 1 case report of painful panniculitis-like fibrosis

Pain or tingling sensation during treatment, mild erythema, bruising, erosions, and blisters

Pain, erythema, edema, tenderness with palpation, palpable nodules

Erythema, edema, hypersensitivity to heat, localized hyperhidrosis

Abbreviations: ATX-101, deoxycholic acid injection; FDA, Food and Drug Administration; HIFU, high-intensity focused ultrasound; RF, radiofrequency.

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High-intensity focused ultrasound Traditionally, high-intensity focused ultrasound (HIFU) has been used as a nonsurgical method for the treatment of kidney stones, uterine fibroids, and internal tumors, but recently, it has garnered attention as a noninvasive therapy for fat reduction and body con-touring. Since 2012, HIFU (Liposonix; Solta Medical, San Fran-cisco, CA) has been an FDA-approved therapy for circumferential waist reduction. It uses high-frequency, intense ultrasound waves to thermomechanically ablate areas in the subcutaneous adipose tis-sue without injuring neighboring structures.36 HIFU causes selec-tive adipocyte destruction in 2 manners. The vibration and shear forces mechanically disrupt adipocyte plasma membrane while also rapidly increasing the temperature of focal subcutaneous tissue to 55°C, resulting in coagulative necrosis and adipocyte death.37 An inflammatory response subsequently occurs to then phagocytose and remove dead fat cells.38

Clinical studies have demonstrated HIFU’s safety and efficacy in reducing waist circumference. The reported improvements have ranged from 1 to 4.6 cm, with most reporting an average of just over a 2-cm reduction.38-40 Treatments were generally conducted as 2 to 3 passes (about 60 J/cm² with each pass) with a goal energy between

128 to 177 J/cm². Results are seen as early as week 4 post treatment but continue on to week 12. The procedure is often associated with notable discomfort and pain during treatment. Other side effects include temporary localized tenderness, ecchymosis, edema, and focal induration, which usually resolve within 4 to 8 weeks.41-43 Ad-ditional studies have demonstrated that treating at a lower fluence with multiple passes towards a targeted total energy level maintains efficacy while modestly improving patient comfort during and af-ter the procedure.44,45 In a recent publication, Greenshaw and Cook described a case of delayed painful panniculitis-like fibrosis of the treated site that presented 3 months after HIFU and responded to prednisone but has required long-term hydroxychloroquine.46 Con-traindications include pregnancy, scars in the treated areas, active dermatitis, tattoo, or hernia of the treatment area.

Although HIFU has been shown to be an effective and safe op-tion for circumferential waist reduction, patient comfort and tol-erability during the procedure is a limiting factor of treatment. In our experience, a topical anesthetic and oral anxiolytic are required prior to treatment. Because HIFU is an operator-dependent proce-dure, combined with issues of pain management, HIFU is a less desirable body contouring device.

■ FIGURE 1. Demonstrating locations for ideal applicator placement. The cartoon image illustrates the most commonly treated areas for body contouring. Used with permission from Zeltiq Aesthetics.

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Focus pulsed ultrasoundFocus pulsed ultrasound (UltraShape; Syneron Candela, Irvine, CA) is FDA approved for circumferential waist reduction. Un-like HIFU, this technology emits low-frequency, focal ultrasound waves to mechanically and nonthermally disrupt subcutaneous fat cells. Preclinical histologic studies on porcine models have shown clusters of cavitary holes in the subcutaneous layer with adipocyte lysis after treatment.47 In clinical studies, Moreno-Moraga et al demonstrated a reduction of 2.16 cm and 4.15 cm in fat thickness and abdominal circumference, respectively, af-ter 3 monthly treatments.48 In a multicentered study, Teitelbaum et al reported a reduction of 2 cm in circumference and 2.9 mm in skin fat thickness after a single treatment; these results were present at 2 weeks posttreatment and maintained at 12 weeks.49 Another study noted a 3.58-cm reduction in circumference at 3 months after 3 bimonthly sessions.50 Although these stud-ies have demonstrated its clinical efficacy, Shek et al found the technology to be ineffective in a study conducted on South Asian patients.51

In July 2016, the FDA approved a newer, smaller, and more powerful model (Ultrashape Power; Syneron Candela, Irvine, CA)

for abdominal fat reduction that is reported to deliver 20% more energy (660 W/cm2) than its predecessor (550 W/cm2). A single-center, nonrandomized study of 43 patients reported a mean ab-dominal fat reduction of 31.5% ± 8.3% at the 12-week follow-up after having received 3 treatments spaced at 2-week intervals.52 Subjects also reported an average pain score of 0.67 (on a scale from 1 to 10), indicating treatment tolerability.

Focus pulsed ultrasound is well tolerated but is operator-de-pendent and can be time-consuming, requiring about 1 hour for treatment (Figure 4). There is no evidence of subcutaneous fat apoptosis with treatment, only lysis, which makes this a less de-sirable treatment option for body contouring. Reported side ef-fects include pain and/or a tingling sensation during treatment, mild erythema, sparse purpuric lesions, blisters, and superficial erosions.49 Contraindications for treatment include pregnancy, localized scars, tattoo of treatment site, hernias, and active im-plants, such as a pacemaker, defibrillator, or cochlear implant. Al-though the focus pulsed ultrasound allows for the customization of treatment, the treatments are operator-dependent, time con-suming, and require multiple sessions to achieve similar results as compared to single-treatment devices.

■ FIGURE 2. Cryolipolysis applicators. This figure demonstrates the variety of applicators to allow for customization of treatment. (A) CoolAdvantage Plus; (B) CoolAdvantage; (C) CoolSmooth, (D) CoolMini, (E) CoolPetite. Used with permission from Zeltiq Aesthetics.

C

D

E

A

B

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RadiofrequencyRadiofrequency (RF) devices have traditionally been known for their effective treatment of skin laxity but are also recognized for their role in body contouring, specifically in areas of fat reduction and cellulite treatment. However, the current available data is quite limited and variable.

RF devices emit energy as electromagnetic waves that rely on the impedance of targeted tissue to induce oscillation and collision of cellular structures to create heat.53 The subcutaneous fat has a much higher impedance than surrounding tissues and thus is much more sensitive and selective to RF-induced heating than its neighboring adnexal and dermal structures.54 Similar to other heating devices previously mentioned, the increase in temperature induces fat cell membrane instability. While many RF devices exist, we will focus on monopolar and multipolar devices.

Monopolar RF devices function by the concept of controlled volumetric heating of the tissue. The FDA has approved the use of monopolar RF (truSculpt; Cutera, Brisbane, CA) for the reduction of abdominal waist circumference. Franco et al demonstrated that a controlled, electric field that is perpendicular to the skin–fat inter-face is selective in heating subcutaneous adipose tissue.55 The de-vice applicator is unique in that it consists of multiple tightly spaced concentric rings designed to directly couple energy into the tissue, allowing for the even and uniform heating of the treatment area (Figure 5).56 The frequency of the device can be adjusted to custom-ize the amount of energy delivered; for example, lower frequencies can provide bulk heating, while higher frequencies can target small-er areas. An in vivo study on preabdominoplasty patients demon-strated delayed fat apoptosis with the presence of foamy histiocytes on histology at day 9 after treatment.55 A recent pivotal study dem-onstrated a mean fat thickness reduction of 1.9 cm at 3 months after a single treatment of the abdomen and flanks.57 Treatment duration was 4 minutes at a goal temperature of 45°C with 50% overlap. Pre-liminary clinical studies have shown its efficacy; however, the treat-ment is operator dependent, and pain is a limiting factor. In 1 study, there was a mean pain level of 5/10 in severity during treatment.58 Other transient side effects include erythema, edema, soreness upon palpitation, and palpable nodules.58

Since 2015, a multipolar, high-frequency, noncontact RF device (Vanquish; BTL Industries, Framingham, MA) has been an FDA-approved therapy for noninvasive waist reduction. Weiss et al per-formed a preclinical study on 3 Vietnamese pigs that illustrated its efficacy and safety in decreasing abdominal adipose tissue with a notable 70% reduction.59 This was confirmed on ultrasound and his-

■ FIGURE 4. Focus pulsed ultrasound applicator. Used with per-mission from Syneron Candela.

■ FIGURE 5. Monopolar radiofrequency applicator. Used with permission from Cutera.

■ FIGURE 3. 1060-nm diode laser applicator. Used with permis-sion from Cynosure.

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tology. The device panels are placed 1 cm from the treatment area, which allows for the treatment to be operator independent (Figure 6). The epidermis is heated to a safe temperature of 42°C, while the subcutaneous tissue is selectively heated to an apoptotic tempera-ture of 44°C to 45°C.60 A clinical study of 40 subjects demonstrated a mean abdominal circumference reduction of 4.93 cm, ranging from 1 cm to 13 cm, after the completion of 4 weekly 30-minute sessions to the abdomen and flanks.61 Two nonrandomized clinical studies have also demonstrated its efficacy in treating thigh circum-ference with a reported statistically significant mean reduction of 2.43 cm and 3.86 cm.62,63 Overall, the treatment is well tolerated with few side effects, including temporary erythema, swelling, hy-persensitivity to heat, and excess sweating at the end of treatment.

The limited data is promising for RF. However, both monopolar and multipolar RF are still relatively new therapeutic options for body contouring that require further randomized controlled studies as well as long-term evaluation of maintenance, efficacy, and side effects. Contraindications include the presence of a metal implant in the treatment area, active dermatitis, scars in the treated area, hernia, pregnancy, or an active implant, such as a pacemaker, defi-brillator, or cochlear implant.

ConclusionsNoninvasive body contouring has quickly become one of the most popular and sought-out cosmetic procedures. In response to this increasing demand, many devices are now available, promising to deliver the safe and effective removal of unwanted fat, but there is variable clinical evidence. When choosing between devices, multi-ple factors must be taken into consideration. One must first consider

the science and mechanism behind the technology—apoptosis ver-sus coagulative necrosis versus cavitation—as well as the literature and reproducibility of results. The next important factor is the type of applicator and device; specifically, if it requires suction, if the device necessitates the purchase of multiple handpieces in order to offer customized treatment options, and a consideration of the cost of consumables. Depending on the type of practice and local legis-lation, the delegation of treatment may guide the decision in choos-ing between an operator-independent and an operator-dependent device, such as cryolipolysis and HIFU, respectively. Because pa-tients are looking for minimally invasive procedures, “downtime” is another extremely important consideration at the initial consulta-tion when considering such treatments, such as ATX-101. Lastly, although these devices do not yet have the ability to match the re-sults of liposuction, results can be optimized with multiple sessions or even a combination of more than one modality. For instance, one can debulk with cryolipolysis followed by ATX-101 for any resid-ual adipose tissue. The flexibility to customize treatment sessions for each individual patient makes noninvasive body contouring a dynamic and evolving field in surgical dermatology.

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■ FIGURE 6. Multipolar radiofrequency device. Used with permis-sion from BTL Medical.

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