Study of AeroForm Tissue Expander for Breast Reconstruction

The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria

Inclusion criteria

• Subject is female between the ages of 18 - 70.
• Subject has elected two stage breast reconstruction with tissue expanders.
• Subject's tissue is amenable to tissue expansion.
• 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 has residual gross malignancy following mastectomy.
• Subject has a current infection at the intended expansion site.
• Subject has clinically significant radiation fibrosis at the expansion site.
• Subject has planned radiation at the intended expansion site during the time the expander is implanted.
• 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 currently participating in a concurrent investigational drug or device study.
• Subject is a current tobacco smoker.
• Subject is overweight with a BMI > 33.
• Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
• Subject is pregnant or planning to become pregnant during the study period.
• Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

-