Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy/expander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer.
Requested answers:
* how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment, * how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants, * how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material, * which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).
Understands and agrees to comply with the study procedures and provides informed consent as documented by signature
Female subjects aged ≥ 18 years at time of consent
INDICATION: Breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy OR ductal carcinoma in situ (DCIS) diagnosis without neoadjuvant chemotherapy AND / OR positive genetic counseling for high-risk family history of breast cancer
RECONSTRUCTION MODALITIES: planned uni- or bilateral NSME or SSME with simultaneous prepectoral tissue expander-based breast reconstruction due to malignancy OR Planned prophylactic bilateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction. Planned unilateral NSME or SSME and planned prophylactic contralateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction
Subject with implanted device that may be affected by magnetic fields (pacemaker)
Known presence of HIV, viral hepatitis (patient-reported)
Presence of autoimmune disease(s) or immunocompromised subject due to immunosuppressive or steroid therapy
The subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study.
Parallel
intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy
RadiationPatients who are scheduled for tissue expander-based breast reconstruction will be randomized in one of two expander groups (Arm 1= Motiva Flora® Tissue Expander \& Arm 2 = SILTEX™ BECKER™ expander). Subjects, who are routinely scheduled for radiotherapy (collective I) will subsequently undergo two additional visits. Subjects without scheduled radiotherapy (collective II), will continue without additional visits - unless they need to change their collective for therapeutic reasons. Assesments: 1. efficacy and safety of therapeutic and prophylactic comparative tissue expander-based breast reconstruction 2. structural and functional changes in comparative tissue expanders following exposure to radiotherapy vs. non-radiotherapy
Number of Participants with treatment-related skin flap thickness in case of using two different expanders outside their intended use.
Breast magnetic resonance imaging (MRI) will be routinely performed before surgery (diagnostic MRI, OP1 - Baseline). MRI and Ultrasound will be study specific performed before radiotherapy at Screening, Visit 5 (pre RT Coll 1, ), Visit7 (pre OP2 Coll1) and Visit 5 (pre OP2 Coll 2). Furthermore in order to analyze skin flap thickness, seroma formation, expander and port dislocation the thickness of the capsule formed around the expanders at defined spots (12 o'clock, 3, 6 and 9 o'clock). Additionally, some patients will receive after mastectomy/expander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer.
Aesthetic outcome assessment by Breast Aesthetic Scale and tissue analysis
For comparative analysis of the aesthetic outcome, the applyed standardized "Breast Aesthetic scale" assessment tool by evaluating standardized preoperative and postoperative photo documentation will be used. Additionaly BIS (Body Image Scale), EORTC-QLQ-SH22, BREAST-Q are patient-reported outcome measures (PROM). Capsular tissue will be excised two times 6x2cm at OP2, if patients have Mentor expanders implanted.
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