Hybrid Implant: Initial Study with 279 Units of an Innovative Breast Implant

Abstract

Introduction

Breast augmentation remains one of the most performed surgical procedures in the world, with wide use of implants for aesthetic and reconstructive purposes. However, current implants still present limitations, including the risk of displacement and restricted mobility.

Objective

To evaluate the safety and efficacy of a new hybrid breast implant, developed by the author, that combines two coating surfaces (cohesive silicone gel with a microtextured or smooth base and polyurethane).

Materials and Methods

The implant is patented and, after authorization from the Brazilian National Health Surveillance Agency (ANVISA, from the Portuguese Agência Nacional de Vigilância Sanitária), we conducted a pilot single-group interventional clinical trial from April 2020 to June 2022 at a private institution. In total, 135 women received 279 units of the implant and underwent follow-up for 2 years.

Results

The results showed a favorable safety profile, with low rates of postoperative complications. The most common occurrences were mastalgia (4.3%) and skin rash (2.1%). There were no reports of complications such as capsular contracture, implant rupture, or gel migration throughout the follow-up period. Moreover, the satisfaction rate was high among patients and the surgeon. The cases of dissatisfaction referred to the volume of the implant, leading some patients to opt for an exchange for larger sizes.

Conclusion

These findings show that the hybrid implant is an innovative and safe alternative in breast surgery, providing a more efficient technique and potentially reducing long-term complications.

Keywords

breast - breast implants - clinical trial, phase III - mammaplasty - prostheses and implants

Ethics Committee number

71569416.0.0000.5440

Publication History

Received: 08 January 2025

Accepted: 14 July 2025

Article published online:
07 February 2026

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