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.
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)
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,
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.
Cohort
Prospective
Silimed® Textured Silicone Gel-Filled Breast Implant
DeviceWomen undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
DeviceWomen 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
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
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.
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.
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.
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.
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