The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Expected Adverse Events
Timeframe: Every three years through the 10 years length of the study.
Unexpected Adverse Events
Timeframe: Every three years through the 10 years length of the study.