Actively Recruiting
Post-market Monitoring and Control of Safety and Efficacy of Silimed4 Breast Implants With Smooth Surface
Led by Silimed Industria de Implantes Ltda · Updated on 2026-03-16
384
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Silimed Industria de Implantes Ltda
Lead Sponsor
C
Centro Universitário Saúde ABC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of Silimed4 brand smooth surface breast implants in women who need primary or secondary (revision) breast augmentation. The study aims to monitor known and unexpected adverse events and assess patient satisfaction and quality of life following implantation. This observational study will follow participants for 10 years to gather long-term information about the implant's effects. Women in the study will receive Silimed4 smooth surface breast implants either for initial breast augmentation or for revision surgery. There are two groups: one for primary augmentations and another for secondary or revision augmentations. The study does not involve any experimental treatments but observes outcomes after these implants are placed. Participants will be followed up every three years over the 10-year study period. During these visits, researchers will collect data on expected and unexpected adverse events, patient satisfaction with aesthetic results and overall experience, evaluator satisfaction, and quality of life. The study will also monitor safety by recording any adverse events reported by patients throughout the follow-up period.
CONDITIONS
Brief Title
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
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 a complaint of hypomastia
- Have an indication for breast augmentation with silicone implants
- Ability to comply with the protocol throughout the follow-up period.
You will not qualify if you...
- Replacement of breast implants due to a complication
- Breast reconstruction in at least one breast
- Informed pregnancy or breastfeeding at the time of inclusion
- Sequelae of mastopexy
- Ptosis requiring mastopexy
- Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms
- Advanced fibrocystic disease at the time of implantation
- Neoplasia of any type not yet treated or undergoing treatment at the time of implantation
- Active infection not yet treated or undergoing treatment at any site at the time of implantation
- Report or record of adverse reactions or intolerance to silicone prior to implantation
- Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation
- Signs of inflammation of the breast or implant site at the time of implantation
- Increased risk of post-implantation complications caused by illicit drug use or medication use
- Having participated in another clinical trial within 6 months prior to implant placement
- Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 years
Participants who have undergone breast augmentation with Silimed® smooth surface Breast Implants are observed for adverse events and satisfaction outcomes.
Visits every three years for up to 10 years
Trial Site Locations
Total: 1 location
1
Fundação do ABC - Centro universitário FMABC
Santo André, São Paulo, Brazil, 09060-870
Actively Recruiting
Research Team
L
Ludmila C Donato
J
Julia Maria V Roberto
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here