Actively Recruiting
Post-market Monitoring and Control of Safety and Efficacy of Silimed4 Breast Implants With Textured Surface and Polyurethane Foam-coated Surface
Led by Silimed Industria de Implantes Ltda · Updated on 2026-03-16
632
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the safety and performance of Silimed4 silicone gel breast implants with two different surfaces: textured and polyurethane coated. The study focuses on female patients who have undergone either primary or secondary breast augmentation using these implants and follows them for a period of 10 years. The purpose is to assess both known and unexpected short- and long-term risks or adverse events related to each type of implant, as well as to evaluate patient satisfaction and quality of life after implantation. The study involves two groups of women: those who received Silimed4 Textured Silicone Gel-Filled Breast Implants and those who received Silimed4 Polyurethane Foam Covered Silicone Gel-Filled Breast Implants. Participants are followed up every three years over the 10-year duration to monitor safety and performance outcomes. Both types of implants are being studied as devices, and the research tracks how each implant surface affects patient experiences and outcomes. Participants will have regular assessments every three years throughout the study to document expected and unexpected adverse events, satisfaction with aesthetic results and general satisfaction, evaluator satisfaction, and quality of life. These evaluations help researchers understand the long-term effects of the implants and how they impact patients' well-being. The total follow-up period spans 10 years, providing a comprehensive view of implant safety and patient satisfaction over time.
CONDITIONS
Brief Title
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Female at birth
- Be 18 years of age or older
- Have received breast implant(s) for primary or secondary augmentation up to 21 days before enrollment
- Have received a Silimed4 breast implant with a textured surface or polyurethane foam-coated surface
- Ability to comply with the protocol throughout the follow-up period
You will not qualify if you...
- Mammary reconstruction in at least one breast or augmentation after previous reconstruction
- Pregnancy or breastfeeding at the time of inclusion
- Advanced fibrocystic disease at the time of implantation
- Untreated or ongoing neoplasia of any type at the time of implantation
- Active infection not yet treated at any site at the time of implantation
- Prior adverse reactions or intolerance to polyurethane or silicone before implantation
- Immune diseases affecting active connective tissue (e.g., lupus erythematosus, discoid lupus, scleroderma) at implantation
- Signs of inflammation of the breast or implant site at implantation
- Increased risk of postoperative complications due to illicit drug or medication use
- Participation in another clinical study within 6 months prior to implant placement
- Any condition that may prevent informed consent, compromise protocol adherence, interfere with study outcomes, or make participation unsafe based on investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 21 days before enrollment
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 21 days before enrollment
Participants undergo breast augmentation surgery using Silimed® breast implants with either a textured or polyurethane foam-coated surface.
1 surgical implantation visit (in-person)
Duration - Every three years through the 10 years length of the study
Participants are monitored for expected and unexpected adverse events and assessed for satisfaction and quality of life related to their breast implants.
Visits every 3 years for up to 10 years (in-person or remote)
Trial Site Locations
Total: 1 location
1
Perfektua Serviços Médicos Ltda
Niterói, Rio de Janeiro, Brazil, 24230-052
Actively Recruiting
Research Team
L
Ludmila C Donato
M
Maria Clara M Sodré
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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