High-Intensity Focused Electromagnetic (HIFEM) Energy With and Without Radiofrequency for Noninvasive Body Contouring: A Systematic Review

Background: Emsculpt Neo (EmSculpt NEO Device, BTL Industries, Inc.) is a FDA-cleared noninvasive body contouring treatment for increasing muscle tone and/or reducing fat. The device uses high-intensity electromagnetic energy to stimulate muscle contractions and to build muscle mass (Emsculpt) or a combination of electromagnetic energy with radiofrequency (Emsculpt NEO) to produce a synergistic effect of building muscle mass and reducing fat. In this study, we conduct a high-quality systematic review to evaluate outcomes for Emsculpt and Emsculpt NEO treatments for noninvasive body contouring.

Methods: An electronic search was performed of the PubMed, MEDLINE, Embase, and Web of Science databases using the key terms "High intensity focused electromagnetic therapy; HIFEM; Emsculpt; Emsculpt NEO; BTL Industries." The search included all articles published in English through January 2023. Inclusion criteria included articles noninvasive body contouring and reporting at least one outcome of interest (clinical or patient-reported outcomes). Methodological quality and risk of bias were assessed using the GRADE criteria. Articles involving applications other than for body contouring, animal studies, and review articles were excluded.

Results: Of the 159 articles identified in the initial search strategy, 51 met relevance based on abstract screening. Fifteen clinical studies were identified, including Emsculpt (n=11) and Emsculpt NEO (n=2). The typical protocol involved four treatments given over a 2-4-week period (range 3-8 treatments) with increase to 100% intensity setting and 1-6-month follow-ups. No complications were reported. Abdominal measurements were obtained using imaging were reported in eight studies. Treated areas included the buttocks (n=4), thighs (n=3), arms or calves (n=1), and abdomen (n=11). For abdominal contouring, mean reductions of fat thickness were 5.5 mm, muscle thickness of 2 mm, and rectus diastasis improvement of 3.0 mm. No studies reported weight change before and after treatment. All studies with patient-reported outcomes report high patient satisfaction. Two studies report marginal or no benefit of treatment. Certain studies failed to report comorbidities or demographic characteristics other than age and sex, which precludes analysis of specific subgroups that may benefit from treatment. Furthermore, certain studies failed to address how missing data or the final study population was analyzed.

Conclusion: This systematic review reports on currently published evidence regarding the efficacy and safety of Emsculpt and Emsculpt NEO for body contouring. High-quality level data reporting with patient-reported outcomes will optimize shared decision-making and informed consent.

Level of evidence ii: Therapeutic study. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .