Long-Term Safety and Satisfaction Study of Silimed4 Breast Implants with Textured and Polyurethane Coated Surfaces in Women Undergoing Primary or Secondary Breast Augmentation

What this Trial Is About

This research aims to observe the safety and performance of Silimed4 silicone gel breast implants with two different surfaces textured and polyurethane coated. The study focuses on female patients who have undergone either primary or secondary breast augmentation using these implants and follows them for a period of 10 years. The purpose is to assess both known and unexpected short- and long-term risks or adverse events related to each type of implant, as well as to evaluate patient satisfaction and quality of life after implantation. The study involves two groups of women those who received Silimed4 Textured Silicone Gel-Filled Breast Implants and those who received Silimed4 Polyurethane Foam Covered Silicone Gel-Filled Breast Implants. Participants are followed up every three years over the 10-year duration to monitor safety and performance outcomes. Both types of implants are being studied as devices, and the research tracks how each implant surface affects patient experiences and outcomes. Participants will have regular assessments every three years throughout the study to document expected and unexpected adverse events, satisfaction with aesthetic results and general satisfaction, evaluator satisfaction, and quality of life. These evaluations help researchers understand the long-term effects of the implants and how they impact patients well-being. The total follow-up period spans 10 years, providing a comprehensive view of implant safety and patient satisfaction over time.

An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants