clinical trial · NCT05345821
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
Silimed Industria de Implantes Ltda·—·recruiting·n = 384
Breast Implant; ComplicationsQuality of LifeSatisfactionSafety and Performance
brief summary
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.
started
Oct 5, 2022
primary completion
Aug 1, 2036
completion
Aug 1, 2036
last updated
Mar 16, 2026
official title
Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol