An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
STEPS S
Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)
1 other identifier
observational
384
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2036
March 16, 2026
March 1, 2026
13.8 years
April 20, 2022
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Expected Adverse Events
Estimate the known short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Every three years over the 10-year duration of the study
Unexpected Adverse Events
Estimate the unknown short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Every three years over the 10-year duration of the study
Secondary Outcomes (4)
Patient's Satisfaction in Relation to Aesthetic Result
Every three years over the 10-year duration of the study
Patient's Satisfaction in General
Every three years over the 10-year duration of the study
Evaluator's Satisfaction in Relation to Aesthetic Result
Every three years over the 10-year duration of the study
Patient's Quality of Life
Every three years over the 10-year duration of the study
Study Arms (2)
primary augmentation group
Women undergoing primary breast augmentation with Silimed® smooth surface Breast Implant.
secondary (revision) augmentation group
Women undergoing secundary or revision breast augmentation with Silimed® smooth surface Breast Implant.
Eligibility Criteria
Born females with indication of primary and secondary augmentation (revision).
You may qualify if:
- 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 may not qualify if:
- Replacement of breast implants due to a complication
- Breast reconstruction in at least one breast
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundação do ABC - Centro universitário FMABC
Santo André, São Paulo, 09060-870, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
André Luiz P de Freitas
Fundação do ABC - Centro Universitário FMABC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2022
First Posted
April 26, 2022
Study Start
October 5, 2022
Primary Completion (Estimated)
August 1, 2036
Study Completion (Estimated)
August 1, 2036
Last Updated
March 16, 2026
Record last verified: 2026-03