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RECRUITING
NCT03356132

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

Sponsor: Silimed Industria de Implantes Ltda

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

632

Start Date

2018-07-31

Completion Date

2036-12

Last Updated

2026-03-16

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Perfektua Serviços Médicos Ltda

Niterói, Rio de Janeiro, Brazil