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

NCT03356132 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 632

Last updated 2026-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Silimed Industria de Implantes Ltda

    lead INDUSTRY

Principal Investigators

  • Celso EJ Boechat, MD · Perfektua Serviços Médicos Ltda

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2036-12-31
Completion
2036-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356132 on ClinicalTrials.gov