Actively Recruiting
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
Led by Silimed Industria de Implantes Ltda · Updated on 2026-03-16
632
Participants Needed
1
Research Sites
956 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 implants for primary or secondary augmentation within 21 days before enrollment.
- Have received breast implants with a textured surface or polyurethane foam coating from Silimed4.
- Ability to comply with the study protocol during follow-up.
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 enrollment.
- Advanced fibrocystic disease at time of implantation.
- Untreated or ongoing neoplasia of any type at implantation.
- Untreated or ongoing infection at any site at implantation.
- History of adverse reactions or intolerance to polyurethane or silicone before implantation.
- Immune diseases affecting connective tissue (e.g., lupus erythematosus, discoid lupus, scleroderma) at implantation.
- Signs of inflammation at the breast or implant site at implantation.
- Increased risk of immediate postoperative complications due to illicit drug or medication use.
- Participation in another clinical study within 6 months before implant placement.
- Any condition that the investigator believes prevents informed consent, makes participation unsafe, affects adherence, complicates data interpretation, or interferes with study goals.
AI-Screening
AI-Powered Screening
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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
CONTACT
M
Maria Clara M Sodré
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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