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

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