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.
Provide written informed consent
Female at birth
Be 18 years of age or older
Have a complaint of hypomastia
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
Born females with indication of primary and secondary augmentation (revision).
Cohort
Prospective
Not listed
Expected Adverse Events
Estimate the known short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Unexpected Adverse Events
Estimate the unknown short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
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.
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.
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.
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.
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Silimed Industria de Implantes Ltda
Lead sponsor
Centro Universitário Saúde ABC
Collaborator
