AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Inclusion Criteria:

Subject is female between the ages of 18-70
Subject requires tissue expansion as part of breast reconstruction
Subject is able to provide written informed consent
Subject is able and willing to comply with all of the study requirements
Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen

Exclusion Criteria:

Subject's tissue integrity is unsuitable for tissue expansion
Subject has residual gross malignancy at the intended expansion site
Subject has current or prior infection at the intended expansion site
Subject has a history of failed tissue expansion or breast reconstruction
Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)
Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).