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

The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.

NCT Number	NCT05345821
Lead Sponsor	Silimed Industria de Implantes Ltda Collaborators: Centro Universitário Saúde ABC
Conditions	Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
Enrollment	384 participants
Start Date	2022-10-05
Primary Completion	2036-08 (estimated)
Study Completion	2036-08 (estimated)
Updated on ClinicalTrials.gov	2026-03-16