Breast Implant; ComplicationsSTEPS ANCT03356132
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
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® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. 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
- What is being tested?
- Silimed® Textured Silicone Gel-Filled Breast Implant and Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
- Type of treatment
- Medical device
- How many people
- 632 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jul 2018to Dec 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: Women aged 18 years old or older who have undergone breast augmentation using Silimed® silicone gel-filled breast implants with textured surface or Silimed® silicone gel-filled breast implants with polyurethane foam coated surface.
Who may be able to join
- provide written informed consent.
- female at birth
- be 18 years of age or older
- have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
- having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam
- ability to comply with the protocol throughout the follow-up period.
Who cannot join
- mammary reconstruction in at least one breast or augmentation after previous reconstruction,
- pregnancy informed or breastfeeding at the inclusion moment,
- advanced fibrocystic disease at the time of implantation,
- neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
- reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
- immune diseases affecting active connective tissue or (eg, lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation,
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- signs of inflammation of the breast or implant site at the time of implantation,
- Increased risk of immediate postoperative complications due to use of illicit drugs or medications,
- Increased risk of immediate post-surgical complications caused by illicit drug use or medication use,
- have participated in another clinical study up to 6 months prior to the placement of the implant,
- any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes 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
Perfektua Serviços Médicos Ltda
Niterói, Rio de Janeiro, 24230-052
Celso EJ Boechat, MD, +55 21 99624-2604, ceboechat@gmail.com
Celso EJ Boechat, MD
About this study
Official title: Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface
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
- Breast Implant; Complications, Quality of Life, Satisfaction
- Being tested
- Silimed® Textured Silicone Gel-Filled Breast Implant, Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
- Keywords
- breast implant, complication, satisfaction, quality of life, augmentation, textured, polyurethane
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silimed® Textured Silicone Gel-Filled Breast ImplantDevice
Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast ImplantDevice
Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.
| Study group | Role | What they receive |
|---|---|---|
| Textured Group | Women undergoing primary and secondary breast augmentation with Silimed® Textured Silicone Gel-Filled Breast Implant. Receives: Device: Silimed® Textured Silicone Gel-Filled Breast Implant | |
| Polyurethane Group | Women undergoing primary and secondary breast augmentation with Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant Receives: Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled 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 Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface
Measured: Every three years through the 10 years length of the study.
Unexpected Adverse Events
Estimate the unknown short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface
Measured: Every three years through the 10 years length of the study.
Secondary outcomes (4)
Patient's Satisfaction in Relation to Aesthetic Result
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered 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 through the 10 years length of the study.
Patient's Satisfaction in General
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered 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 through the 10 years length of the study.
Evaluator's Satisfaction in Relation to Aesthetic Result
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface through 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 through the 10 years length of the study.
Patient's Quality of Life
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered 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 through the 10 years length 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 posted29 Nov 2017
- Study start31 Jul 2018
- Primary completionDec 2036 (estimated)
- Study completionDec 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
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silimed Industria de Implantes Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Celso EJ Boechat, MD, Principal investigator, Perfektua Serviços Médicos Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356132
- Sponsor's protocol ID
- 6002030
- Acronym
- STEPS A
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2017
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
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 Textured Surface and Polyurethane Foam-coated Surface
- ClinicalTrials.gov ID
- NCT03356132
- Acronym / sponsor ID
- STEPS A / 6002030
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction
- Keywords
- breast implant, complication, satisfaction, quality of life, augmentation, textured, polyurethane
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Silimed Industria de Implantes LtdaIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 29 Nov 2017 (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® 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Textured Group | – | Device: Silimed® Textured Silicone Gel-Filled Breast ImplantWomen undergoing primary and secondary breast augmentation with Silimed® Textured Silicone Gel-Filled Breast Implant. |
| Polyurethane Group | – | Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast ImplantWomen undergoing primary and secondary breast augmentation with Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years old or older who have undergone breast augmentation using Silimed® silicone gel-filled breast implants with textured surface or Silimed® silicone gel-filled breast implants with polyurethane foam coated surface.
Key inclusion criteria (6 listed)
- provide written informed consent.
- female at birth
- be 18 years of age or older
- have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
- having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam
Key exclusion criteria (11 listed)
- mammary reconstruction in at least one breast or augmentation after previous reconstruction,
- pregnancy informed or breastfeeding at the inclusion moment,
- advanced fibrocystic disease at the time of implantation,
- neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
- reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silimed® Textured Silicone Gel-Filled Breast ImplantWomen undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant. | Device | Textured Group |
| Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast ImplantWomen undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface. | Device | Polyurethane Group |
Primary outcome
Expected Adverse Events
Time frame: Every three years through the 10 years length of the study.
Estimate the known short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface
Unexpected Adverse Events
Time frame: Every three years through the 10 years length of the study.
Estimate the unknown short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface
4 secondary outcomes
Patient's Satisfaction in Relation to Aesthetic Result
Time frame: Every three years through the 10 years length of the study.
Patient's Satisfaction in General
Time frame: Every three years through the 10 years length of the study.
Evaluator's Satisfaction in Relation to Aesthetic Result
Time frame: Every three years through the 10 years length of the study.
Patient's Quality of Life
Time frame: Every three years through the 10 years length 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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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.
Celso EJ Boechat, MD principal investigator
Perfektua Serviços Médicos Ltda
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 11 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, 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 through the 10 years length 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.