An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface

Study Overview
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Brief Summary
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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.

Official Title
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Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)

Conditions
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Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| primary augmentation group<br>Women undergoing primary breast augmentation with Silimed® smooth surface Breast Implant. | |
| secondary (revision) augmentation group<br>Women undergoing secundary or revision breast augmentation with Silimed® smooth surface Breast Implant. | |

What is the study measuring?
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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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Every three years over the 10-year duration of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Implant, satisfaction, qualify of life, smooth surface, post-market, safety, efficacy