Long-Term Observational Follow-Up of Euromi Biosciences Silicone Gel-Filled Breast Implants for Reconstruction and Aesthetic Surgery

What this Trial Is About

Researchers are conducting a prospective observational follow-up study to monitor the outcomes of breast reconstruction and augmentation using Euromi Biosciences pre-filled silicone gel breast implants. This study aims to collect long-term safety and performance data over a 10-year period, focusing on complications such as implant rupture and capsular contracture in female participants aged 18 to under 60 years. The study observes participants who have received at least one Euromi Biosciences silicone gel implant during breast reconstruction after mastectomy or for aesthetic breast surgery. There is no intervention or treatment assigned by the study rather, it follows participants naturally after their implant procedure to evaluate outcomes and any related events. During participation, individuals are monitored for the rate of capsular contracture, post-surgery rupture, implant survival, frequency of adverse events, quality of life, satisfaction with aesthetic results, and reoperation rates. Follow-up extends up to 10 years post-implantation, with ongoing assessments to gather comprehensive data on implant performance and participant wellbeing throughout this period.

Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants