Comprehensive Evaluation of the BeShape One Device: Assessing Thermal Safety in Noninvasive Body Contouring Using Advanced Techniques.

OBJECTIVES: This study aims to assess the thermal safety profile of the BeShape One Device, a noninvasive, high-intensity, non-focused ultrasound device designed for reducing waist circumference. This device possesses several features that distinguish it from other commercial ultrasound-based fat reduction devices. The study focuses on evaluating temperature-related physiological changes through thermal safety analysis and histopathology in a swine model. MATERIALS AND METHODS: The study utilized three types of applicators-active, demo, and modified-to comprehensively assess the device's impact on various skin layers. Five female Large White X Landrace swine were involved in the study, and the BeShape One Device was applied to designated treatment sites using a specific treatment protocol. The assessment included clinical observations, skin reaction evaluations, gross pathology, histopathological analyses, and advanced temperature measurement techniques, including needle thermocouples, thermal cameras, COMSOL modeling, and CEM43 analysis. RESULTS: Clinical observations indicated the animals' overall well-being throughout the study. Skin reactions, including erythema, edema, bruising, and crust formation, were temporary and resolved over time. Gross pathology revealed no treatment-related pathologies, except for a discoloration related to a tattoo procedure. Histopathological analyses at 30 and 90 days posttreatment demonstrated an absence of heat-related lesions in skin layers. Needle thermocouples and thermal camera measurements supported the device's ability to maintain consistent thermal homogeneity. COMSOL modeling and CEM43 analysis predicted no thermal damage to the skin, confirming the safety of the BeShape One Device. CONCLUSIONS: Under the experimental conditions, the BeShape One Device demonstrated a favorable safety profile. Clinically and histopathologically, no adverse effects were observed. The device's ability to achieve thermal homogeneity in skin layers was validated through advanced temperature measurement techniques. COMSOL modeling and CEM43 analysis further supported the conclusion that the device is safe, making it a promising option for noninvasive body contouring procedures.

Evaluation of Non-invasive Fat Reduction Using a Resistive Electric Transfer-based Radiofrequency Device With Multi-channel Handpieces.

BACKGROUND/AIM: Various devices for non-invasive body shape correction are being developed along with the growth of the beauty industry. Radiofrequency (RF) can selectively reduce subcutaneous fat without causing skin damage. The efficacy of the procedure can be improved by applying RF to a large area simultaneously with multiple handpieces. This study evaluated the safety and efficacy of a new RF device with multi-channel handpieces. MATERIALS AND METHODS: In ex vivo experiments, the RF device was used to treat porcine tissue comprising the skin, subcutaneous, and muscle layers. The device's safety was evaluated by temperature measurements of porcine tissue and histological analysis. In in vivo experiments, the dorsal skin of pigs was treated with the RF device. The safety and efficacy of the device were evaluated by measuring the skin temperature, subcutaneous fat layer thickness, and conducting histological analysis. RESULTS: The skin temperature did not exceed the set temperature during treatment, and skin damage was not observed in histologic analysis in both ex vivo and in vivo experiments. In in vivo experiments, the subcutaneous fat layer thickness and subcutaneous lipocyte size were decreased after treatment. In addition, the fibrous tissue between subcutaneous lipocytes was increased in the RF treatment group compared with the non-treatment group. CONCLUSION: The RF device used in this study effectively reduced the size of subcutaneous lipocytes and increased fibrous tissue without skin damage. Therefore, the safe and effective use of this device for non-invasive fat reduction may be possible in clinical settings.

Body contouring effects of at-home beauty device equipped with suction, radiofrequency, and electrical muscle stimulation functions.

BACKGROUND: With the rise in interest and demand for body contouring, beauty devices have continuously developed. Suction can aid in increasing the rate of fat breakdown by inducing a massage-like effect, thereby increasing blood flow. Moreover, radiofrequency (RF) can boost fibroblast activity and help reduce cellulite. In addition, electrical muscle stimulation (EMS) can use electrical stimulation to induce muscle contraction, leading to an athletic, and skin elasticity-increasing effect. AIMS: This study aimed to assess the effects of body contouring, such as cellulite and swelling, in healthy Korean women to objectively prove the efficacy of an at-home beauty device equipped with suction, RF, and EMS functions. METHODS: For 8 weeks, 21 participants used the at-home beauty device 3 days a week on their abdomen, thighs, and left calf. Validity assessments and subjective surveys were conducted at 4 and 8 weeks, including the first visit. RESULTS: The results of the validity assessments revealed that cellulite, swelling, elasticity, femoral skin texture, and dermal density were significantly (p < 0.05) improved in the experimental group compared with those at the baseline. CONCLUSIONS: The results of this study demonstrate that the combination of suction, RF, and EMS function is effective for body skin, fat, and body shape management. For better body-contouring effects, combining the beauty device with regular exercise and healthy eating habits is recommended.

Simultaneous Application of High-Intensity Focused Electromagnetic and Synchronized Radiofrequency for Fat Disruption: Histological and Electron Microscopy Porcine Model Study.

BACKGROUND: Radiofrequency (RF) and high-intensity focused electromagnetic (HIFEM) technologies are used for noninvasive body shaping as standalone modalities. OBJECTIVE: To examine the effects of novel synchronized RF and HIFEM on subcutaneous adipose tissue in a porcine animal model. MATERIALS AND METHODS: Seven large white pigs aged 6 months received 3 abdominal treatments of simultaneous application of synchronized RF and HIFEM (30 minutes, once per week). Punch biopsies of treated and control subcutaneous tissue were collected at the baseline, 4 days, 2 weeks, 1 month, and 2 months. Specimens were examined by light and scanning electron microscopy. Adipocyte volume was analyzed. Fat tissue temperature was measured in situ (fiber optic probes) and superficially (thermal imager). RESULTS: Fat layer was heated to temperatures of 42 to 45°C. Signs of fat apoptosis (shape alternations and pyknotic nuclei) appeared at day 4 and peaked between 2 weeks and 1 month. Adipocyte volume decreased significantly (p < .001) by 31.1% at 2 weeks, 1 month (-23.6%), and 2 months (-22.0%). Control samples showed healthy adipocytes. Scanning electron microscopy micrographs corroborated histology findings, showing flattened, volume-depleted and disrupted adipocytes. CONCLUSION: Synchronized RF with HIFEM procedure resulted in a significant and sustained fat reduction with no adverse events.

Calf Reduction by Partial Resection of Gastrocnemius Using a Suction-Assisted Cartilage Shaver.

BACKGROUND: Long-term aesthetic reduction of the legs in Asians is gaining increasing popularity among cosmetic patients. Current treatment options include botulinum toxin injection, radiofrequency, neurectomy, and total, subtotal, or partial muscle resection of the gastrocnemius. Partial resection using Kelly forceps was introduced in 2000. This article presents the use of a suction-assisted cartilage shaver to perform partial resection, describing the procedures and shaver modifications and evaluating its use. METHODS: A retrospective review of 71 cases with a minimum 6-month follow-up (average, 36.5 months; range, 6 to 160 months) was performed. Twenty partial calf reductions were performed with a short shaver, 27 with a long shaver, and 24 with an endoscope-guided long shaver. RESULTS: Mean reduction of calf circumference was 2 cm (range, -1 to 6 cm); the mean preoperative and postoperative calf circumferences were 35.8 cm and 33.8 cm, respectively. Mean tissue reduction per calf was 110 g (range, 25 to 300 g).Two patients developed larger calves after surgery, one because of weight gain and the other because of weight training. Complications included surface irregularity (n = 4, 5.6 percent), numbness over the lateral ankle or lateral foot (n = 9, 12.7 percent), hematoma clot requiring surgical evacuation (n = 11, 15.5 percent), prolonged seroma (n = 2, 2.8 percent), and left ankle plantar-flexion contracture due to tight, sustained postsurgery bandaging (n = 1, 1.5 percent). Scar-related complications were hyperpigmentation (n = 6, 8.5 percent), depressed scars (n = 5, 7 percent), and hypertrophic scars (n = 2, 2.8 percent). CONCLUSIONS: Short, long, and endoscope-guided long suction-assisted cartilage shavers for partial resection of calf muscles can be used effectively to reduce the calf. Several mostly treatable complications were noted. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Subcutaneous Migration: A Dynamic Anatomical Study of Gluteal Fat Grafting.

BACKGROUND: Recent anatomical studies have demonstrated that fat placed subjacent to the fascia of the gluteus maximus muscle can migrate deep through the muscle into the submuscular space, possibly causing tears in the gluteal veins, leading to fat embolisms. The purpose of this study was to define and to study subcutaneous migration and to determine whether fat placed in the subcutaneous space under a variety of pressures and fascial integrity scenarios can indeed migrate into the deep submuscular space. METHODS: Four hemibuttocks from two cadavers were used. Proxy fat was inserted using syringes with various fascia scenarios (1: fascia intact; 2: cannula perforations; 3: 6mm fascia defects) or using expansion vibration lipofilling (4: fascia intact). Subcutaneous pressures were recorded. After injections, anatomical dissections were performed to evaluate the migration of the proxy fat for each of the scenarios. RESULTS: Scenario 1: pressure reached approximately 125 to 150 mmHg and then plateaued and all the proxy fat remained in the subcutaneous space. Scenario 2: pressure reached a 199-mmHg plateau and no proxy fat spread deeper into the muscle or beneath it. Scenario 3: pressure gradually rose to 50 mmHg then fell again and the submuscular space contained a significant amount of proxy fat. Scenario 4: pressure rose to a maximum of 30 mmHg and all of the proxy fat remained in the subcutaneous space. CONCLUSIONS: The gluteus maximus fascia is a stout wall that sets up the dangerous condition of deep intramuscular migration with subfascial injections and the protective condition of subcutaneous migration with suprafascial injections. These persuasive findings are profound enough to propose a new standard of care: no subfascial or intramuscular injection should be performed, and all injections should be performed exclusively into the subcutaneous tissue.

The First Reported Case of Gluteal Implant-Associated Anaplastic Large Cell Lymphoma (ALCL).

Anaplastic large-cell lymphoma (ALCL) is a very rare but life-threatening complication that has largely been demonstrated to be associated with breast implants (BIA-ALCL). Patients are at risk of BIA-ALCL with the placement of breast implants for either cosmetic or reconstructive purposes, with the highest risks associated with textured breast implants. In the past decade, an increasing number of publications have focused on BIA-ALCL, but there has yet to be a reported case outside of the breast. Here, we describe a unique instance of gluteal implant-associated ALCL (GIA-ALCL) in a middle-aged woman. The patient received bilateral textured silicone gluteal implants only a year prior to her diagnosis of GIA-ALCL. The patient later presented to the Plastic and Reconstructive Surgery Department at our institution with ulceration at the site of her gluteal implants. Unfortunately, her condition deteriorated before explanation could be performed. Biopsy of a left lung mass demonstrated "hallmark" cells of ALCL ("horseshoe"-shaped nuclei). The diagnosis was verified by immunohistochemical testing that revealed expression of CD30, CD4, CD43, BCL6, Perforin, and Ki67 in a population of abnormal cells. The goals of this case report are thus to demonstrate that all patients undergoing implantation of textured silicone implants are at risk of developing ALCL and to provide evidence for the possible new diagnosis of GIA-ALCL. Level of Evidence: 5.

Double stacking cryolipolysis treatment of the abdominal fat with use of a novel contoured applicator.

Background: Cryolipolysis is a noninvasive method for the selective reduction of subcutaneous fat. The abdomen and flank area are most commonly treated sites and now the treatment efficacy became the important issue. Objectives: To evaluate the effectiveness and safety of double stacking cryolipolysis treatment with the novel contoured applicator for abdominal fat reduction. Materials and methods: 12 healthy Korean were treated using cryolipolysis contact device. The device was applied on participant's left lower abdomen. Performance was held for 35 minutes and immediately repeated the second performance. The right abdomen was left untreated. Participants were examined with high resolution ultrasound and the depth of subcutaneous fat layer was measured initially and 8 weeks after the sessions. Any adverse events were assessed during the entire study period. Results: The subjective reduction of abdominal fat was noted in most participants. No serious adverse events was reported. Reduction of subcutaneous fat layer depth was confirmed in high resolution ultrasound after 8 weeks of treatment. Conclusion: The results of this study indicate that abdominal fat can be reduced effectively by the novel cryolipolysis applicator. With subjective satisfaction of participants our study shows that double stacking treatment appears safe and well tolerated with enhanced treatment outcomes.

The Architecture of Fat Grafting II: Impact of Cannula Diameter.

BACKGROUND: Fat grafting has emerged as the treatment of choice for soft-tissue augmentation and reconstruction. Variability of volume retention remains the greatest challenge for this technique, often requiring multiple operations to achieve the desired volume. Graft that is placed greater than 2 mm from the recipient bed will undergo necrosis. Improved understanding of the architecture of fat within the recipient bed is paramount to improving outcomes. The impact of cannula diameter on graft architecture is unknown. METHODS: Fat was harvested by liposuction and stained with methylene blue. Stained fat was grafted into 4 × 2 × 1-cm sections of excised abdominal tissue with 12-, 14-, 16-, and 19-gauge Coleman cannulas at three different volumes: 0.1, 0.5, and 1.0 cc. Each tissue block was sectioned for stained graft visualization. The diameter of each deposit and percentage with a radius greater than 2 mm were recorded. RESULTS: With an injection volume of 0.1 cc, no fat deposits had a radius greater than 2 mm, regardless of cannula size. A graft volume of 0.5 cc created globules greater than 2 mm with larger cannulas (0 percent with 19-gauge, 2.9 percent with 16-gauge, 6.1 percent with 14-gauge, and 4.3 percent with 12-gauge). Injecting 1.0 cc resulted in a significant increase in the percentage of fat parcels expected to undergo central necrosis (16 percent with 19-gauge, 21 percent with 16-gauge, 26 percent with 14-gauge, and 44 percent with 12-gauge). CONCLUSIONS: Injection cannulas of 14-gauge or larger are more likely to create deposits with dimensions that may be susceptible to central necrosis when injecting 1.0 cc per pass. Smaller cannula sizes or lower volumes per pass should be considered. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Combined Hyperthermic 1060nm Diode Laser Lipolysis With Topical Skin Tightening Treatment: Case Series.

BACKGROUND: As body contouring procedures have become more popular, post-procedural skin laxity is a concern. Non-invasive body contouring technologies may effectively reduce body fat, but modestly affect skin tightening. OBJECTIVE: To assess the efficacy and safety of a topical skin tightening agent in combination with hyperthermic diode laser lipolysis. METHODS: Herein, we describe five patients in which a skin tightening concentrate of 5% yeast extract, 2% hydrolyzed rice protein content, and 2.5% tripeptide was used after 1500-2100 J/cm2 of hyperthermic 1060 nm diode laser. RESULTS: Overall, all patients had a subjective positive response and high satisfaction with the combined treatment results of improvement in skin laxity and fat reduction. In all five cases, patients demonstrated visible fat reduction and skin improvement on photographs taken between weeks 6-18 compared to baseline. Blinded investigators correctly predicted the order of the photographs based on treatment results. No adverse events were reported. CONCLUSION: This case series demonstrated that a combined topical skin tightening concentrate with a hyperthermic laser lipolysis device may achieve improved aesthetic outcomes without adverse events. J Drugs Dermatol. 2018;17(7):780-785.

Soft Tissue Contraction in Body Contouring With Radiofrequency-Assisted Liposuction: A Treatment Gap Solution.

Radiofrequency-assisted liposuction is a relatively new concept in energy-assisted body contouring techniques and has received instrument approval. This supplemental article reviews the clinical application of electromagnetic energy via the BodyTite (InMode Corporation, Toronto, Canada) device on soft tissues during suction lipectomy, its effect on soft tissue contraction, and its use in aesthetic body contouring in various clinical scenarios.

Cellulite: A Surgical Treatment Approach.

BACKGROUND: Cellulite is one of the most common skin and subcutaneous tissue conditions, affecting predominantly the thighs and hips in postadolescent women. Its etiology is not well defined, and multiple available treatments show variable efficacy. OBJECTIVES: To describe a technique for treatment of cellulite of the gluteal region, thighs, and hips through superficial liposuction utilizing a special cannula, combined with subcutaneous autologous fat grafting. METHODS: A retrospective review was performed of patients treated over 26 years at the Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil. Patients underwent pretreatment evaluation as to the extent of their cellulite, and pretreatment and posttreatment photographs were obtained for visual evaluation of the results. RESULTS: Procedures were performed on 126 patients: 121 (96%) women and 5 (4%) men. The majority considered their results good or excellent. The complication rate was low, with the most common complications being ecchymosis, contour irregularities, partial recurrence of cellulite, seroma, and numbness. CONCLUSIONS: We describe an effective method for the treatment of cellulite. Whereas subcision techniques utilize a needle or microblade to cut fibrous septa, we utilize a special cannula; larger areas can be treated than with subcision. Fat grafting is utilized to correct depressions and improve skin quality, which are added benefits compared to traditional subcision. Considering the multiple available cellulite treatments and their limitations, and the high patient satisfaction rate we achieved, with a low recurrence and complication rate, this technique can be a safe and effective option for patients with cellulite.

Safest Practices for Autologous Buttock Augmentation With Fat Grafting Using a Roller Pump Injection Technique.

BACKGROUND: Autologous buttock augmentation with fat grafting has emerged as one of the preeminent modalities for body contouring employed by plastic surgeons today. Since 2009, we have used the roller pump injection technique. OBJECTIVES: This procedure can be performed safely without specialized equipment and eliminates the tasks of manual graft preparation and injection. We describe our technique and standard safety measures. The anatomy of and complications associated with liposuction and fat grafting were recorded and reviewed. METHODS: Retrospective chart review of 916 patients who underwent autologous buttock augmentation by this method from February 2009 to November 2016 was performed. All procedures were performed under general anesthesia at the same surgical center. Liposuction was performed and using a roller pump, the fat layer was propelled through an open-ended cannula into the recipient site. RESULTS: Mean volume of fat removed and fat grafted in each patient was 3156 mL and 1807 mL per patient, respectively. There were complications in 13 patients for a rate of 1.4% with 10 (1.1%) related to fat grafting. Fourteen patients (1.5%) had subsequent procedures for volume and four patients (0.44%) for asymmetry. There were no venous thrombolic events, fat embolic events, or deaths. CONCLUSIONS: The roller pump injection technique for buttock augmentation with fat grafting is safe and efficient. This technique minimizes preparatory effort and does not require additional equipment. We were unable to identify variables associated with complication risk due to the power of this study and the low percentage of complications.

Noninvasive body contouring.

In a society where stigma surrounds cosmetic procedures and yet a thin and sculpted physique is idealized, noninvasive 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.

Treating multiple body parts for skin laxity and fat deposits using a novel focused radiofrequency device with an ultrasound component: Safety and efficacy study.

BACKGROUND AND OBJECTIVES: Growing demand for noninvasive skin tightening and reduction in fat results in an increasing pressure for devices with good clinical efficacy, consistency of results, and high patient comfort. The objective was to validate clinical efficacy and versatility of a novel device, which combines radiofrequency (RF) and ultrasound for treating skin laxity and fat deposits. METHODS: We treated 34 subjects with facial skin laxity and/or abundant body or arm fat deposits. Subjects were divided based on their indications. Ten subjects received treatments to the face, 7 subjects to arms, 8 subjects to thighs, and 9 subjects on abdomen. All patients received 4 treatments on a weekly basis. Photographs of patients were assessed by blinded evaluators to recognize the baseline images from the 3-month follow-up images. Patient comfort and satisfaction were evaluated using a 5-point Likert scale questionnaire. Any adverse events were recorded. RESULTS: Patient images were correctly recognized in >90% of cases in all study groups. Patient questionnaires showed overall satisfaction with the therapy course and results. On a scale of 1 to 5, the patients agreed (4.1) that they are satisfied with the results that the treatment is comfortable (4.1) and that they are satisfied with the treatment time (4.1). No adverse events were reported. CONCLUSIONS: Consistent clinical efficacy was confirmed across all the treated areas, together with high patient comfort and satisfaction. We conclude the device is a highly versatile solution that can deliver results across body parts and different indications.

Long-term follow-up on patients treated for abdominal fat using a selective contactless radiofrequency device.

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate how abdominal circumferential reduction achieved after using a noninvasive radiofrequency device (BTL Vanquish, BTL Industries Inc., Boston, MA) evolves over a 4-year period. METHODS: This is a follow-up on patients who were treated in our practice for abdominal fat in an earlier published multicenter prospective study. Patients were recalled for biometric data collection 4 years (±60 days) after the last treatment. Body and weight measurements were compared to the historical data. Digital images of the treated area were taken. Independent panelists were asked to recognize the original baseline images from the 4-year follow-up images. RESULTS: The evaluation encompasses 13 subjects. In the original study, these patients lost on average 5.88 ± 4.14 cm of waist circumference (P < .001) while losing on average 1.29 kg. After 4 years, the same subjects had an average reduction of 4.42 ± 2.85 cm (P < .001) compared to the baseline, while gaining on average 0.50 kg. In both cases, the waist change was statistically independent of the weight change (P < .01). The patients preserved on average 75.2% of the original body contouring effect after 4 years as measured by circumference. None of the patients grew in circumference when compared to the baseline. Reviewers recognized the baseline patient images from the follow-up patient images in 82.1% cases. No long-term side effects were observed that would relate to the treatments. CONCLUSIONS: In the study group, patients with ordinary weight changes preserved most of the original waist reduction after 4 years.

The safety and efficacy of thermal lipolysis of adipose tissue via ultrasound for circumference reduction: An open label, single-arm exploratory study.

BACKGROUND AND OBJECTIVE: To better understand adipocyte sensitivity under hyperthermic conditions, the ULTIMA system (also known as MUST) was designed to induce the thermal destruction of fat cells using ultrasound, radiofrequency, and vacuuming. This clinical study assessed the safety and efficacy of ULTIMA in non-invasive reductions of abdominal circumference. STUDY DESIGN: This open-label, single-arm exploratory study monitored the response of 21 patients to a single fat reduction treatment session with the ULTIMA system. Male and female patients between the ages of 18 and 65 who presented with a subcutaneous adipose fat thickness >2.5 cm as measured with a caliper and 2 cm as measured by ultrasound were eligible to participate in the study. Patients with a history of surgery in the target region and who had previous fat/circumference reduction treatments within the previous 6 months were excluded. Efficacy measures evaluated at the 1-, 2-, and 3-month post-treatment visits included the following: photographs of before and after treatment as evaluated by two blinded reviewers, changes from the baseline abdominal circumference and fat layer thickness, and subjective physician and patient assessments. Immediate skin responses were recorded for up to 30 minutes post-treatment, and adverse events were recorded throughout the study. RESULTS: An average of 10 zones per patient were subjected to ULTIMA treatment and 87.5% of the pre-treatment photographs were correctly rated by two independent blinded reviewers. A statistically and clinically significant reduction in the abdominal circumference was observed at 3 months post-treatment. The changes in circumference (represented as the mean ± SE) of the baseline of the anterior superior iliac spine (ASIS), umbilicus, and maximal circumference during this period were -3.2 ± 0.7 cm, -3.9 ± 0.7 cm, and -3.3 ± 0.8 cm, respectively. Physician-based assessments classified all patients (100%) as "improved" within 3 months of treatment, and self-assessment questionnaires completed by the patients demonstrated that 92% of them classified their conditions as either improved or much improved within this same time period. Any immediate skin reactions observed fell within the expected norms and were short-lived and self-resolving. CONCLUSIONS: A single ULTIMA treatment session effectively and safely resulted in visual appearance improvement and in a significant reduction in the patients' abdominal circumference, which persisted for 3 months. Additional investigations will be required to further optimize the treatment regimen and assess its long-term sustainability. Lasers Surg. Med. 48:734-741, 2016. © 2016 Wiley Periodicals, Inc.