Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.
• Genetically female, aged 18 years or older.
• Subjects who had provided written informed consent form.
• The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.
• Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.
• Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.
• Complete radiotherapy and chemotherapy at least one year before surgery.
• BMI between 18.5 and 30.0 (average classified weight).
• Physical and cognitive capacity to understand and follow the surgeon's recommendations.
• To be able and willing to comply with all study requirements, including attending follow-up appointments.
• Only Sub study participants
⁃ Provide additional consent to undergo an MRI with contrast.