Clinical Research Directory

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