Breast Implant; ComplicationsSTEPS SNCT05345821
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
An observational study of Breast Implant; Complications and Quality of Life, run by Silimed Industria de Implantes Ltda at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implant; Complications, Quality of Life, Satisfaction
- How many people
- 384 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Oct 2022to Aug 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Born females with indication of primary and secondary augmentation (revision).
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Fundação do ABC - Centro universitário FMABC
Santo André, São Paulo, 09060-870
David E Uip
About this study
Official title: Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)
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.
- Keywords
- Breast Implant, satisfaction, qualify of life, smooth surface, post-market, safety, efficacy
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expected Adverse Events
Estimate the known short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Measured: 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®
Measured: Every three years over the 10-year duration of the study
Secondary outcomes (4)
Patient's Satisfaction in Relation to Aesthetic Result
Estimate the performance of Silimed® breast implant with smooth surface through the satisfaction of the patient regarding the aesthetic result after breast augmentation. The assessment of patient's satisfaction will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely satisfied, 2 = satisfied, 3 = slightly satisfied, 4 = slightly dissatisfied and 5 = definitely unsatisfied.
Measured: Every three years over the 10-year duration of the study
Patient's Satisfaction in General
Estimate the performance of Silimed® breast implants with smooth surface after breast augmentation by means of a questionnaire, the Breast Self-Assessment Questionnaire (BEQ-Brazil), which consist of 55 questions related to satisfaction and comfort with the overall appearance of the breasts.
Measured: Every three years over the 10-year duration of the study
Evaluator's Satisfaction in Relation to Aesthetic Result
Estimate the performance of Silimed® breast implant with smooth surface througt the satisfaction of the evaluator regarding the aesthetic result after patient's breast augmentation. The assessment of evaluator's satisfaction will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely satisfied, 2 /= satisfied, 3= slightly satisfied, 4 = slightly dissatisfied and 5 = definitely unsatisfied.
Measured: Every three years over the 10-year duration of the study
Patient's Quality of Life
Estimate the performance of Silimed® breast implant with smooth surface through the quality of life of the patient after breast augmentation. The assessment of patient's quality of life will be done by means of the Rosemberg Global Self-Esteem Scale, in order to evaluate the overall self-esteem of the sample.
Measured: Every three years over the 10-year duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start5 Oct 2022
- Primary completionAug 2036 (estimated)
- Study completionAug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silimed Industria de Implantes Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Universitário Saúde ABC
- Responsible party
- Sponsor
- Investigators
- André Luiz P de Freitas, Principal investigator, Fundação do ABC - Centro Universitário FMABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345821
- Sponsor's protocol ID
- 6001022
- Acronym
- STEPS S
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)
- ClinicalTrials.gov ID
- NCT05345821
- Acronym / sponsor ID
- STEPS S / 6001022
- Keywords
- Breast Implant, satisfaction, qualify of life, smooth surface, post-market, safety, efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Silimed Industria de Implantes LtdaIndustry (pharma, biotech, devices)
- Collaborators
- Centro Universitário Saúde ABC
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- Aug 2036 (estimated)
- Study completion
- Aug 2036 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Born females with indication of primary and secondary augmentation (revision).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expected Adverse Events
Time frame: Every three years over the 10-year duration of the study
Estimate the known short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Unexpected Adverse Events
Time frame: Every three years over the 10-year duration of the study
Estimate the unknown short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
4 secondary outcomes
Patient's Satisfaction in Relation to Aesthetic Result
Time frame: Every three years over the 10-year duration of the study
Patient's Satisfaction in General
Time frame: Every three years over the 10-year duration of the study
Evaluator's Satisfaction in Relation to Aesthetic Result
Time frame: Every three years over the 10-year duration of the study
Patient's Quality of Life
Time frame: Every three years over the 10-year duration of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
André Luiz P de Freitas principal investigator
Fundação do ABC - Centro Universitário FMABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications and Quality of Life, run by Silimed Industria de Implantes Ltda at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludmila C Donato (+552198399-0573 ext. 2184-2771, Pesquisaclinica@silimed.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expected Adverse Events (time frame: Every three years over the 10-year duration of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.