Actively Recruiting
Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
Led by Silimed Industria de Implantes Ltda · Updated on 2026-03-13
152
Participants Needed
3
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction. The safety of the breast tissue expander will be evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physician after implantation.
CONDITIONS
Official Title
Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Female sex at birth
- Be 18 years of age or older
- Have an indication for reconstruction with breast expander and breast implant(s)
- Plan to receive an expander and implant with textured surface from the Silimed4 brand
- Ability to comply with the protocol throughout the follow-up period
You will not qualify if you...
- Breast augmentation without reconstruction in at least one breast
- Untreated or currently treated neoplasia of any type except breast neoplasia, or requiring surgical removal at implantation time
- Pregnancy or breastfeeding at the time of implantation
- Smoking, uncontrolled diabetes, obesity grade 2 or higher, and ASA III/IV
- Active infection not treated or being treated at any site at implantation time
- History of adverse reactions or intolerance to silicone prior to implantation
- Active immune diseases affecting connective tissue (e.g., lupus erythematosus, discoid lupus, scleroderma) at implantation
- Use of illicit drugs or medications increasing risk of immediate post-surgical complications
- High surgical risk or immediate post-surgery complications estimated before implantation
- Tissue characteristics clinically inconsistent with successful implantation (e.g., excessive fibrosis, compromised vascularization)
- Participation in another clinical study within 6 months before expander placement unless deemed acceptable by researcher
- Previous treatment with radiotherapy
- Any condition preventing informed consent, making participation unsafe, compromising protocol adherence, complicating data interpretation, or interfering with study objectives based on researcher opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hospital de câncer HCIII (INCA)
Rio de Janeiro, Rio de Janeiro, Brazil
Actively Recruiting
2
Fundação do ABC - Centro universitário FMABC
Santo André, São Paulo, Brazil
Not Yet Recruiting
3
Irmandade Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil, 01221-020
Actively Recruiting
Research Team
R
Renata R M Figueira
CONTACT
L
Ludmila C Donato
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
1
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