Safety and Satisfaction Study of Silimed Smooth Surface Breast Implants in Women Undergoing Primary and Revision Augmentation with 10-Year Follow-up

What this Trial Is About

Researchers are evaluating the safety and performance of Silimed4 brand smooth surface breast implants in women who need primary or secondary revision breast augmentation. The study aims to monitor known and unexpected adverse events and assess patient satisfaction and quality of life following implantation. This observational study will follow participants for 10 years to gather long-term information about the implants effects. Women in the study will receive Silimed4 smooth surface breast implants either for initial breast augmentation or for revision surgery. There are two groups one for primary augmentations and another for secondary or revision augmentations. The study does not involve any experimental treatments but observes outcomes after these implants are placed. Participants will be followed up every three years over the 10-year study period. During these visits, researchers will collect data on expected and unexpected adverse events, patient satisfaction with aesthetic results and overall experience, evaluator satisfaction, and quality of life. The study will also monitor safety by recording any adverse events reported by patients throughout the follow-up period.

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