An observational study in Breast Implant; Complications, Quality of Life and Satisfaction, sponsored by Silimed Industria de Implantes Ltda. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Silimed Industria de Implantes Ltda · Observational
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.
541 studies on the registry are indexed under Personal Satisfaction; 93 are open to participants now.
This study's planned enrollment of 632 is above the median of 180 across 115 observational studies indexed under Personal Satisfaction.
Browse Personal Satisfaction studies →Silimed Industria de Implantes Ltda is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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® Textured Silicone Gel-Filled Breast Implant.
Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.
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
Time frame: 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
Time frame: Every three years through the 10 years length of the study.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Every three years through the 10 years length of the study.
Plan to share: Yes — All IPD that underlie results in a publication will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The IPD will be shared starting 6 months after the end of the study.
Access criteria: It was not defined yet.
No publications or documents are linked to this record.
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Silimed Industria de Implantes Ltda