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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 With Smooth Surface

NCT05345821 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 384

Last updated 2026-03-16

No results posted yet for this study

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

Sponsors & Collaborators

  • Centro Universitário Saúde ABC

    collaborator OTHER

  • Silimed Industria de Implantes Ltda

    lead INDUSTRY

Principal Investigators

  • André Luiz P de Freitas · Fundação do ABC - Centro Universitário FMABC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2036-08-31
Completion
2036-08-31

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 NCT05345821 on ClinicalTrials.gov