The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction. The safety of the breast tissue expander will be evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physician after implantation.
provide written informed consent
female sex at birth;
be 18 years of age or older;
have an indication for reconstruction with breast expander + breast implant(s);
breast augmentation without reconstruction in at least one breast;
neoplasia of any type (except breast neoplasia), not yet treated or under treatment, or requiring surgical removal at the time of implantation;
pregnancy or breastfeeding at the time of implantation;
smoking, uncontrolled diabetes, obesity (from grade 2) and ASA III/IV;
Born females with indication of breast reconstruction using Silimed brand breast tissue expander.
Cohort
Prospective
Breast tissue expander
DeviceSilimed brand breast tissue expander
Adverse events
Estimate adverse events rate for breast tissue expander
Evaluator's Satisfaction in Relation to expansion
Estimate the performance of Silimed® brand breast tissue expander with through the satisfaction of the evaluator (investigator) regarding the result of the expansion so far. The assessment will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely unsatisfied, 2 = unsatisfied, 3 = slightly satisfied, 4 = satisfied and 5 = definitely satisfied.
Evaluator's Assessment of tissue quality
The assessment of tissue quality is clinical and will occur at every visit, including the final assessment. Estimate the performance of Silimed® brand breast tissue expander with textured surface throught the satisfaction of the evaluator regarding the vascularization, innervation, color and texture of and quality of the expanded tissue. To measure satisfaction, a Likert scale where the following satisfaction options can be marked: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied and 5 = definitely satisfied. Satisfaction will be measured in percentages of each category of the Likert scale in each follow-up time. Values from 0 to 20 will be considered poor results, bad results from 21 to 40, intermediate results from 41 to 60, good results from 61 to 80, and excellent results from 81 to 100.
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