High intensity focused electromagnetic therapy evaluated by magnetic resonance imaging: Safety and efficacy study of a dual tissue effect based non‐invasive abdominal body shaping

Abstract

Objectives This study introduces an initial evaluation of a novel High‐Intensity Focused Electromagnetic (HIFEM) technology. The primary goal is to quantify any effects the treatments may have on abdominal tissues, as well as to establish hypotheses for future research of this technology. Methods Twenty‐two patients received four abdominal treatments using the EMSCULPT device (BTL Industries Inc., Boston, MA). Anthropometric evaluations were recorded and digital photographs were taken at baseline, at 2 months, and at 6 months post‐treatments. The MRI without contrast determined by vertertebras T12 and S1 (FIESTA and FSPRG sequences) was used to measure dimensions in coronal cross‐sectional images of abdominal muscle and fatty tissues, in order to assess any anatomical changes induced by the application. Results Analysis of the same MRI slices verified by tissue artefacts showed a statistically significant (all P < 0.0001) average 18.6% reduction of adipose tissue thickness, 15.4% increase in rectus abdominis muscle thickness, and 10.4% reduction in rectus abdominus separation (diastasis recti) as measured from the medial border of the muscle 2 months post‐treatment. More significant improvements were observed in patients with BMI 18.5–24.9 (classified as “normal”). MRI data from 6‐month follow‐up suggest the changes can be preserved in longer term. Tape measurements showed on average 3.8 cm subumbilical circumference reduction. The weight of the subjects did not change significantly (average −0.5 lb; P > 0.05). No adverse events were reported. Conclusions MRI, considered as a highly precise diagnostic method, revealed simultaneous muscle growth, fat reduction and reduced abdominal separation at 2 months and at 6 months post treatments, unrelated with dieting. Further research should investigate the exact physiological processes which stand behind the tissue changes observed in this study. Lasers Surg. Med. 51:40–46, 2019. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Review of non‐invasive body contouring devices for fat reduction, skin tightening and muscle definition

“…High‐intensity focused electromagnetic field received FDA approval in 2018 for contouring of the buttocks and abdomen. The treatment uses electromagnetic energy to stimulate supramaximal muscle contractions of approximately 20 000 pulses within one 30‐min session . The physiological mechanism behind both the adipose and muscular benefits is incompletely understood; however, current data suggest that these contractions trigger intensive lipolysis within fat cells, which releases a large volume of free‐fatty acids that damage surrounding adipose tissue .…”

“…The physiological mechanism behind both the adipose and muscular benefits is incompletely understood; however, current data suggest that these contractions trigger intensive lipolysis within fat cells, which releases a large volume of free‐fatty acids that damage surrounding adipose tissue . Apoptosis ensues following adipocyte injury, as evidenced by the 91.7% increase in the apoptotic index of 120 histological samples . This yields a desirable reduction in fat.…”

“…The stress of rapid nerve firing and muscle fibre contractions also leads to compensatory muscle thickening. Recent studies have demonstrated a gradual increase in muscle thickness and strength over the course of 6 months; however, further investigation of the long‐term sustainability of muscular changes is warranted . Another unique muscular benefit of HIFEM body contouring is a reduction in the distance between the large abdominal muscles.…”

“…The strength of contractions can be adjusted from 0 to 100% with the Emsculpt ® (BTL Industries, Inc., New York, NY, USA) device and is increased to the highest level tolerated by the patient to yield optimal effects. Stimulation intensities of 90 to 100% are commonly reached and sustained by a majority of patients . The treatment is described as comfortable by most patients; however, some individuals report sensations of painful, gripping muscle contractions or brief electric shocks.…”

Science and peace

“…Several new technologies are evaluated in this issue. Brian Kinney and Paula Lozanova at the University of Southern California evaluated high‐intensity focused electromagnetic technology utilizing magnetic resonance imaging and demonstrated a reduction in adipose tissue and an increase in muscle thickness (https://onlinelibrary.wiley.com/doi/10.1002/lsm.23024). Robert Weiss and Jan Bernardy investigated induction of fat apoptosis with high‐intensity electromagnetic technology and provide additional information about mechanism of observed effects (https://onlinelibrary.wiley.com/doi/10.1002/lsm.23039).…”