Motiva Flora® Aesthetic Breast Recon® Clinical Study

Exclusion Criteria

• •1. Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.
• •2. Abnormal hematological and biochemical values after chemotherapy.
• •3. High surgical risk according to the investigator.
• •4. Breast width larger than 18 cm
• •5. Tumor residues in or near the area where tissue expansion is performed.
• •6. Subjects with metastatic breast cancer
• •7. Significant Breast ptosis or poor skin quality
• •8. Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing, or mastectomy scar deformity.
• •9. Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.
• •10. Current or previous infection in the area where the expansion occurs.
• •11. Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.
• •12. Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
• •13. History of silicone sensitivity.
• •14. Active smokers
• •15. Previous attempts of breast reconstruction
• •16. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population
• •17. Subjects with affiliation to the Sponsor, sites or investigators, including relatives.
• •18. Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.
• •19. Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study