AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

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).