Scaffold-based breast conserving surgery in patients with non-malignant breast lesions: long-term follow-up of a first-in-human pilot study on the REGENERA™ biomimetic breast implant.

Abstract

Background: Frequently, the breast surgeon must employ complex oncoplastic techniques (OBS) to guarantee optimal cosmetic results. The success of the REGENERA™ implant in combining the benefits of OBS with the simplicity of breast conserving surgery (BCS) has been previously reported in five patients with short follow-up. The goal of this study was to build on these promising data by reporting safety and efficacy results in a larger population with a longer follow-up.

Methods: Fifteen females with non-malignant breast lesions who underwent lumpectomy and implantation of REGENERA™ device, followed-up for six months, were included in this interventional FIH study. Fourteen of these, were included in a long-term observational study (LTFU) and followed-up for 24 months. Safety (incidence of adverse events [AEs]) and performance (changes in breast appearance, interference with imaging) of the device, and investigator and patient satisfaction were evaluated. Data from these two studies are reported herein. (Registered on clinicaltrials.gov: NCT05533099 and NCT04131972).

Results: A total of 113 AEs were reported. Only 3 (2.6%) were considered possibly device-related. The great majority (91,2%) were mild/moderate and only in one case the device was explanted. The REGENERA™ implant demonstrated high levels of performance, with an aesthetic score of 'Excellent' in 85.7% of patients, no interference with imaging, and high levels of patients and investigator satisfaction.

Conclusions: Data continue to be strongly supportive of the use of the REGENERA™ implant in BCS, further paving the way for an innovative surgical approach.