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

Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 384 (estimated)
• Sponsor: Silimed Industria de Implantes Ltda · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Implant; Complications
• Quality of Life
• Satisfaction
• Safety and Performance

Timeline

• Start date: 2022-10-05
• Primary completion: 2036-08-01
• Completion: 2036-08-01
• First posted: 2022-04-26
• Last updated: 2026-03-16

Locations

1 site across 1 country: Brazil