Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy

PRIMARY OBJECTIVES: I. To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction. SECONDARY OBJECTIVES: I. Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications. OUTLINE: After mastectomy, participants undergo 2-staged implant-based breast reconstruction (IBR) with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant. After completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months