Journal of Aesthetic & Reconstructive Surgery

Safety of Gynecomastia Procedures in Combination with Helium-Based Plasma Technology: A Retrospective Review

Background: The goal of treating gynecomastia is to restore a normal chest wall contour with few complications and minimal scar formation. The helium-based plasma technology (Renuvion; Apyx medical), that was used in combination with the gynecomastia procedures in this retrospective study, received 510(k) clearance on July 18, 2022 from the U.S. Food and Drug Administrations (FDA) for the use of the Renuvion APR hand piece for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax skin in the neck and submental region.

Objectives: To evaluate safety and procedure data for the treatment of gynecomastia in which a helium plasma device was used to coagulate and contract soft tissue.

Methods: A retrospective chart review was conducted in five medical centers to identify eligible subjects, adverse events, procedures, and follow-up time. Eligible subjects were males ≥21 years of age whose treatment included liposuction and the use of a helium-based plasma device (Renuvion; Apyx medical). Most subjects also underwent liposuction in other body areas (abdomen, thighs, arms, chin, neck, flanks, back, scapular rolls, mons pubis, buttocks, infra-axillary region) during the same treatment session. Demographic data, procedure details, and treatment settings were collected. Treatment-related complications and Adverse Events (AEs) were also recorded and evaluated.

Results: No serious adverse events were observed. Devicerelated adverse events were noted in 4 out of 84 subjects (5%) and totaled 6 events; 3 seroma and 3 hematoma events. All subjects with adverse events were treated with a co0mbination of devices (liposuction and Renuvion) during the gynecomastia procedure. All adverse events resolved.

Conclusions: The data collected supports the use of the helium plasma device as safe when used in combination with gynecomastia correction procedures.

Author(s): Paul Ruff1*, Rikesh Parikh2, Arian Mowlavi3, Edward Zimmerman4 and Jonathan Lebowitz5

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