ITEM TYPE:

Journal Article

AUTHORS:

Vaishali Doolabh, MD

ABSTRACT:

Background: Reduction mammaplasty and mastopexy are currently some of the most performed breast procedures. Techniques typically involve deepithelialization of the nipple-areola complex pedicle. Traditionally, scalpel or scissor dissection is performed below the basal skin layer to remove the germinal epithelium but above the subcutis to preserve the subdermal vascular plexus. Deepithelialization thus leaves a strong dermal “leash” for the pedicle while preserving the subdermal blood supply. This process is time intensive and bloody, and often an assistant is required for countertraction. Previously, authors have described laser-assisted breast reduction surgery as an alternative to traditional cold knife techniques. The advent of helium plasma generators offers another option for deepithelialization. This study is a preliminary assessment of the safety and efficacy of this application.

Objectives: The authors performed a prospective pilot study of 10 patients who underwent outpatient, inferior pedicle, breast reduction mammaplasty, or mastopexy surgery by a single surgeon. Outcomes were assessed for safety and efficacy. Representative tissue samples were evaluated by an independent pathology group.

Methods: All patients received standard outpatient perioperative care. Deepithelialization was performed using the Renuvion helium plasma device (Apyx Medical, Clearwater, FL), and standard breast reduction or mastopexy was performed.

Results: No major complications occurred in our series. Minor complications occurred in 1 patient (10%). No inclusion cysts were recorded in any patients.

Conclusions: Helium plasma energy for deepithelialization in breast reduction was found to be safe, efficient, and effective. Decreased operating room time and blood loss suggest that helium plasma is a potential alternative for surgeons who have access to this technology.

APYX® MEDICAL DISCLOSURES:

FINANCIAL & CONTENT DISCLOSURE
The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. No funding was received for this article. Drs DiBernardo, Bharti, and Kortesis are paid consultants for Apyx Medical, and Dr Duncan is a member of Apyx Medical’s Medical Advisory Board. The opinions contained herein are those of the authors and do not necessarily represent the official position or policies of Apyx Medical, Inc.

MANUFACTURING DISCLOSURE
Apyx Medical manufactures and owns the Renuvion®/J-Plasma® technology discussed in this article.

INDICATIONS FOR USE & INTENDED USE DISCLOSURES

• • The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation, and ablation of soft tissue during open surgical procedures.
  • The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
  • The Renuvion APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).
  • Apyx Medical wants to present you with current scientific discourse. Specific usage outside of the cleared indications may not be safe or effective.
  • The use of Renuvion with liposuction has not been approved or cleared by the FDA.

RISKS

• • As with all energy devices there are inherent risks associated with its use. Risk associated with the use of the Renuvion APR may include: helium embolism into the surgical site due to inadvertent introduction into the venous or arterial blood supply system, unintended burns (deep or superficial), pneumothorax, temporary or permanent nerve injury, ischemia, fibrosis, infection, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain, bleeding, hematoma, seroma, subcutaneous induration, pigmentation changes, increased healing time, scarring, asymmetry and/or unacceptable cosmetic result.

As with any procedure, individual results may vary. As with all energy devices there are inherent risks associated with its use, refer to the IFU for further information.