Actively Recruiting
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
Led by Silimed Industria de Implantes Ltda · Updated on 2026-03-16
384
Participants Needed
1
Research Sites
721 weeks
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
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
Official 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 - immediate surgical 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
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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
CONTACT
J
Julia Maria V Roberto
CONTACT
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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