Status:
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
Lead Sponsor:
Silimed Industria de Implantes Ltda
Collaborating Sponsors:
Centro Universitário Saúde ABC
Conditions:
Breast Implant; Complications
Quality of Life
Eligibility:
FEMALE
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT05345821
Start Date
October 5 2022
End Date
December 1 2035
Last Update
December 3 2024
Active Locations (1)
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1
Fundação do ABC - Centro universitário FMABC
Santo André, São Paulo, Brazil, 09060-870