External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

Inclusion Criteria:

• Female
• Age 23-69
• BMI 18-35 - stable weight, no fluctuations
• Have undergone a total mastectomy at least 3 months prior the study, whethertherapeutic or prophylactic, whether unilateral or bilateral, with no resection of thepectoralis muscle
• Agrees to have reconstruction at the time of study involving only autologous fatgrafting (AFT)
• Assessed by surgeon to have enough donor fat
• Passes a 20-minutes tolerance test with EVEBRA Device. (Patient will be fitted,instructed on the use, and given the EVEBRA Device to try in the office for 20minutes. She passes if she tolerates its use, feels comfortable wearing it, and isable to comply with the required wear of the device.)

Exclusion Criteria:

• untreated breast cancer
• history of radiation therapy on the involved breast, even if it was part of a previousbreast conservation procedure
• completed chemotherapy course less than 2 months prior (acceptable to still be onaromatase inhibitors)
• except for the biopsy leading to the diagnosis of cancer, had surgery to breast priorto the mastectomy (e.g., multiple biopsies, implant augmentation, mastopexy, fatgrating)
• had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection
• mastectomy defect/scar has significant skin excess and deep folds adherent to thechest wall
• has a pacemaker or aneurysm clips
• pregnancy or breastfeeding
• had a cardiac stent placed within the last 2 months
• claustrophobic, as reported by patient
• known current substance abuse, as reported by patient
• history of silicone allergy, as reported by patient
• history of Gadolinium allergy, as reported by patient
• history of lidocaine allergy, as reported by patient
• bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarettesmoker and/or Smokeless cigarette smokers, as reported by patient
• medical conditions that preclude breast reconstruction including uncontrolledhypertension or diabetes, renal failure, steroid dependent asthma, and on immuno-suppressant medications, as reported by patient