An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants (STEPS A)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Satisfaction; Breast Implant; Complications
• Intervention / Treatment: Device: Silimed® Textured Silicone Gel-Filled Breast Implant; Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant

• Study Type: Observational
• Enrollment (Estimated): 632

Contacts and Locations

• Study Contact: Name: Ludmila C Donato; Phone Number: +552198399-0573; Email: pesquisaclinica@silimed.com.br
• Study Contact Backup: Name: Maria Clara M Sodré; Phone Number: +55212784-2764; Email: pesquisaclinica@silimed.com.br

Study Locations

• Brazil
  • Rio de Janeiro
    • Niterói, Rio de Janeiro, Brazil, 24230-052
      • Recruiting
      • Perfektua Serviços Médicos Ltda
      • Contact: Celso EJ Boechat, MD; Phone Number: +55 21 99624-2604; Email: ceboechat@gmail.com
      • Principal Investigator: Celso EJ Boechat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Textured Group; Women undergoing primary and secondary breast augmentation with Silimed® Textured Silicone Gel-Filled Breast Implant.	Device: Silimed® Textured Silicone Gel-Filled Breast Implant; Women undergoing primary and secondary breast augmentation using 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	Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant; Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Every three years through the 10 years length of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Every three years through the 10 years length of the study.

Collaborators and Investigators

• Sponsor: Silimed Industria de Implantes Ltda
• Investigators: Principal Investigator: Celso EJ Boechat, MD, Perfektua Serviços Médicos Ltda

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; satisfaction; complication; augmentation; breast implant; textured; polyurethane
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction
• Other Study ID Numbers: 6002030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be shared.
• IPD Sharing Time Frame: The IPD will be shared starting 6 months after the end of the study.
• IPD Sharing Access Criteria: It was not defined yet.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No