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;