The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction. The safety of the acellular matriz will be evaluated by estimating known and unexpected adverse event rates assessed by clinical evaluations and patient reports of adverse events after implantation in addition to monitoring integration by Magnetic Resonance Imaging (MRI). The performance of Silimed® brand acellular matriz will be evaluated by clinical effectiveness of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Secondary performance outcomes include: assessment of body image-related quality of life, self-esteem assessment, aesthetic and functional breast assessment, and participant satisfaction level.
Provide written informed consent;
Female sex at birth;
Be 18 years of age or older;
Have an indication for reconstructive surgeries requiring reinforcement, repair, regeneration, and reconstruction of tissues in the breast region;
Breast augmentation without reconstruction in at least one breast;
Neoplasia of any type that is not yet treated, or is under treatment, or requires surgical removal at the time of implantation*;
Pregnancy or breastfeeding at the time of implantation;
Smoking, uncontrolled diabetes, obesity (grade 2 or higher) or ASA (American Society of Anesthesiology) pre-surgical classification III/IV (ANNEX I);
Single group
Acellular matrix
DeviceSilimed® brand acellular matrix
Adverse events of the combination of acellular matrix + Silimed® brand breast implants.
To estimate the risk and rate of expected and unexpected adverse events from the combination of acellular matrix + Silimed® brand breast implants
Performance of the combination of acellular matrix + Silimed® brand breast implants.
Evaluation of the clinical efficacy of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Acellular Matrix is indicated for the reinforcement, repair, regeneration, and reconstruction of breast tissue in reconstructive surgeries. Its adequate integration into the recipient tissue is an essential parameter of the expected clinical performance, as it enables the incorporation of the material into the surgical bed and the success of the reconstructive process. Matrix integration will be evaluated by magnetic resonance imaging in approximately one-third of the study population. It should be noted that the degree and time of integration may vary between patients, influenced by individual factors such as biological characteristics, inflammatory response, and local.
Evaluator's Satisfaction
Satisfaction with the aesthetic outcome will be assessed at all planned in-person follow-up visits. A Likert scale will be used to measure satisfaction, with the following options available: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, and 5 = definitely satisfied. In the case of responses 1 and 2, the reasons for dissatisfaction will be collected for a qualitative analysis of the conditions that determine the dissatisfaction.
Participant's Satisfaction
Satisfaction with the aesthetic outcome will be assessed at all planned in-person follow-up visits. A Likert scale will be used to measure satisfaction, with the following options available: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, and 5 = definitely satisfied. In the case of responses 1 and 2, the reasons for dissatisfaction will be collected for a qualitative analysis of the conditions that determine the dissatisfaction.
Patient's Quality of Life
The assessment of patient's self-esteem will be done by means of the Rosemberg Global Self-Esteem Scale, in order to evaluate the overall self-esteem of the sample. Also, the Breast Evaluation Questionnaire will be filled by them to assess breast satisfaction and changes in quality of life.
Assessment of body image
For the assessment of body image in the sample of this study, the Hopwood Body Image Scale (BIS) will be used. This instrument is a scale developed specifically for assessing body image as a dimension of quality of life.
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