Statement on the Safety of Cosmetic Ultrasound

Ultrasound is used for diagnosing skin disorders¹ as well as cosmetic treatment of the skin and subcutis² and detecting or supporting the management of any complications of cosmetic procedures. For these purposes, there are different types of ultrasound devices that each need trained operators.

Among the cosmetic treatments supported by ultrasound are skin cleansing, facilitating conditioner absorption, skin rejuvenation/tightening, and fat reduction (lipolysis).³ This statement focuses on methods for body contouring and wrinkle reduction with high-intensity focused ultrasound (HIFU) devices that do not involve surgical incisions and therefore exclude technologies such as liposuction even if accompanied by ultrasound-assisted liposuction.^4–6 High-intensity focused ultrasound is effective for targeted destruction of adipose tissue to achieve an alteration in the body shape. Micro-focused ultrasound (MFU) is a form of HIFU that targets the dermis and subdermal tissue.⁷ Micro-focused ultrasound thermally coagulates selective volumes of connective tissue, such as collagen, leading to neocollagenesis and a more robust structural organization.⁸ High-intensity focused ultrasound and MFU are popular because they do not involve surgical incision.

High-intensity focused ultrasound and MFU induce tissue effects via thermal or mechanical mechanisms. Tissue heating is mainly due to the absorption of ultrasound energy⁸ and is thought to be a primary mechanism for face and neck skin-subcutaneous tissue tightening with MFU. High-intensity focused ultrasound and MFU aim to selectively heat tissue between 60°C and 70°C. The region of maximal tissue heating with HIFU and MFU is found in an ellipsoidal volume at the focus of the transducer source. As the ultrasound frequency increases, the focal volume decreases (resulting in greater localization), the heating rate increases (due to higher absorption), and the penetration depth decreases (again due to higher absorption).⁹  Ultrasound-based lipolysis is thought to rely on acoustic cavitation (ie, creation of oscillating bubbles that agitate tissue) to disintegrate fatty tissue. Cavitation may be generated more easily in fatty tissues than other soft tissues.¹⁰ Side effects of HIFU and MFU such as pain, tingling, erythema, and edema have been described, albeit mostly temporary.^11,12

Recommendations:

• High-intensity focused ultrasound and MFU can cause undesired tissue damage if applied for an excessive duration or if they include unintended anatomic structures.
• High-intensity focused ultrasound and MFU should only be used by appropriately licensed and trained practitioners.
• Continued research is advised with longitudinal data to elucidate the long-term bioeffects, safety, clinical efficacy, and durability of using this technology in patient care.

References

1. Wortsman X, Alfageme F, Roustan G, et al. Guidelines for performing dermatologic ultrasound examinations by the DERMUS group. J Ultrasound Med 2016; 35:577–580.

2. Mazzoni D, Lin MJ, Dubin DP, et al. Review of non-invasive body contouring devices for fat reduction, skin tightening and muscle definition. Australas J Dermatol 2019; 60:278–283.

3. Toivo T, Orreveteläinen P, Kännälä S, et al. Survey on limiting exposure to ultrasound. Semanticscholar website. https://pdfs.semanticscholar.org/4fb6/4b91f8a3511ab647eaf0584bacd367d7b20d.pdf. Accessed December 9, 2019.

4. Zocchi M. Ultrasonic liposculpturing. Aesthetic Plast Surg 1992; 16:287–298.

5. Heymans O, Castus P, Grandjean FX, Van Zele D. Liposuction: review of the techniques, innovations and applications. Acta Chirurg Belg 2006; 106:647–653.

6. Scuderi N, Paolini G, Grippaudo FR, Tenna S. Comparative evaluation of traditional, ultrasonic, and pneumatic assisted lipoplasty: analysis of local and systemic effects, efficacy, and costs of these methods. Aesthet Plast Surg 2000; 24:395–400.

7.Dobke MK, Hitchcock T, Misell L, et al. Tissue restructuring by energy-based surgical tools. Clin Plast Surg 2012; 39:399–408.

8. Gliklich RE, White WM, Slayton MH, et al. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg 2007; 9:88–95.

9. Wells PN. Review: absorption and dispersion of ultrasound in biological tissue. Ultrasound Med Biol 1975; 1:369–376.

10. Bader KB, Vlaisavljevich E, Maxwell AD. For whom the bubble grows: physical principles of bubble nucleation and dynamics in histotripsy ultrasound therapy. Ultrasound Med Biol 2019; 45:1056–1080.

11. Fonseca VM, Campos PS, Certo TF, et al. Efficacy and safety of noninvasive focused ultrasound for treatment of subcutaneous adiposity in healthy women. J Cosmetic Laser Ther 2018; 20:341–350.

12. Jewell ML, Weiss RA, Baxter RA, et al. Safety and tolerability of high-intensity focused ultrasonography for noninvasive body sculpting: 24-week data from a randomized, sham-controlled study. Aesthet Surg J 2012; 32:868–876.