Overview
A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.
Eligibility
Inclusion Criteria:
- Female gender
- Age of 18 years and older
- History or in candidate for a mastectomy procedure in the near future
- Patients undergoing preventive mastectomy
- Patients' choice to undergo a breast reconstruction
- Wanting to participate in this study
- Patient is able to wear the external expansion device
Exclusion Criteria:
- Active smoker or a history of smoking 4 weeks prior to surgery
- Current substance abuse
- History of lidocaine allergy
- History of silicone allergy
- 4 weeks or less after chemotherapy
- History of radiation therapy in the breast region
- Oncological treatment includes radiotherapy after mastectomy
- Kidney disease
- Steroid dependent asthma (daily or weekly) or other diseases
- Immune-suppressed or compromised disease
- Uncontrolled diabetes
- BMI>30
- Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
- Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
- The treating plastic surgeon has strong doubts on the patient's treatment compliance