NCT03356132

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

Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 632 (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® 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.

Conditions

• Breast Implant; Complications
• Quality of Life
• Satisfaction

Interventions

Type	Name	Description
DEVICE	Silimed® Textured Silicone Gel-Filled Breast Implant	Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
DEVICE	Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant	Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.

Timeline

• Start date: 2018-07-31
• Primary completion: 2036-12-01
• Completion: 2036-12-01
• First posted: 2017-11-29
• Last updated: 2026-03-16

Locations

1 site across 1 country: Brazil