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

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.

NCT Number	NCT03356132
Lead Sponsor	Silimed Industria de Implantes Ltda
Conditions	Breast Implant; Complications, Quality of Life, Satisfaction
Enrollment	632 participants
Start Date	2018-07-31
Primary Completion	2036-12 (estimated)
Study Completion	2036-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-16