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

Inclusion Criteria:

- Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation
and/or strong family history of breast cancer), both unilateral or bilateral
mastectomy

- No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation

- Ability to understand and the willingness to sign a written informed consent document

- No life expectancy restrictions

- Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be
employed

- No requirements for organ and marrow function

Exclusion Criteria:

- Recent steroid use

- No major medical comorbidities (defined as American Society of Anesthesiologists [ASA]
III or greater)

- No connective tissue disorder

- Prior breast surgery, excluding biopsy and lumpectomy

- History of or plan for breast radiation

- Pregnancy and nursing patients will be excluded from the study

- No restrictions regarding use of other investigational agents

- No exclusion criteria related to history of allergic reactions

- No exclusion criteria relating to concomitant medications or substances that have the
potential to affect the activity or pharmacokinetics of the study agent

- No other agent-specific exclusion criteria

- No exclusion of cancer survivors or those who are human immunodeficiency virus
(HIV)-positive