Multicentric Retrospective Study on Smooth Opaque Silicone Breast Implants: Over-2-Year Outcomes in Primary Augmentation and Revision Surgery

Background and Objectives: The withdrawal of macrotextured breast implants following their association with BIA-ALCL has accelerated the adoption of modern smooth implant technology. A round, smooth silicone device with a proprietary biomimetic surface (average roughness approximately 5 micrometres) designed to optimise tissue–implant biocompatibility has been evaluated in this study. This study aimed to report complication rates, Kaplan–Meier complication-free survival, and patient-reported outcomes of this implant over a minimum follow-up of 24 months in a multicentre Italian cohort, with separate analysis of primary augmentation (n = 351) and revision surgery (n = 114) as distinct subgroups. Materials and Methods: A retrospective, observational, non-comparative multicentre cohort study was conducted across three Italian breast surgery units. Patients undergoing bilateral primary augmentation or revision surgery with smooth opaque silicone breast implants with a minimum follow-up of 24 months were included. Data were analysed using Kaplan–Meier survival analysis with log-rank testing and Fisher’s exact test. Patient-reported outcomes were assessed at 12 months using the BREAST-Q augmentation module. Results: A total of 465 patients were included: 351 primary augmentation (702 implants) and 114 revision surgery (216 implants). In the primary augmentation group, the Kaplan–Meier complication-free survival reached a stable plateau of 93.2% at 4 months and remained constant through 36 months, with all 24 complication events (6.8%) occurring within the first 4 months post-surgery. In the revision group, complication-free survival reached 74.5% after 24 months. Conclusions: The Smooth Opaque Silicone Breast implant demonstrated a favourable safety and patient satisfaction profile in both primary augmentation and revision surgery across a multicentre Italian cohort. A stable complication-free survival of 93.2% was achieved in the augmentation group from month 4 onwards, with no late adverse events. BREAST-Q scores were uniformly high, indicating a consistent and reproducible level of patient-reported satisfaction.