AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast

Prospective, multi-center, non-randomized, open-label, post-market clinical study evaluating adipose graft retention over time from lipoaspirate processed using the AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System.

Augmentation Subjects Inclusion Criteria: * Female patients \> 22 years and \< 65 years of age. * Patients with a BMI \< 35. * Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or without a breast implant. * Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits. * Patients must be non-smokers. * Patients with available/adequate harvest sites for fat grafting. * Anticipated harvested fat volume between 200 and 700 cc. * Anticipated fat injection volume between 50 and 350 cc per breast. * Anticipated breast implant volume between 200 and 550 cc. * Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study. Exclusion Criteria: * Skin rash in the treatment area. * Patients who smoke or use nicotine products. * Patients with bleeding disorders or currently taking anticoagulants. * Patients with history of trauma or surgery to the treatment area. * Patients with history of breast cancer. * Active, chronic, or recurrent infection. * Compromised immune system. * Hypersensitivity to analgesic agents. * Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements. * Untreated drug and/or alcohol abuse. * Pregnant or breastfeeding. * Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation. * Patients who do not wish to have the study area (breast) photographed. Reconstruction Subjects Inclusion Criteria: * Female patients \> 18 years and \< 65 years of age. * Patients with a BMI \< 35. * Patients undergoing a fat grafting procedure to the breast in a second or third stage of a staged breast reconstruction, with or without a breast implant. * Patient is at least 1 year post-completion of chemotherapy. * Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits. * Patients must be non-smokers. * Patients with available/adequate harvest sites for fat grafting. * Anticipated harvested fat volume between 200 and 700 cc. * Anticipated fat injection volume between 50 nd 350cc per breast. * Anticipated breast implant volume (if applicable) between 200 and 550 cc. * Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study. Exclusion Criteria: * Skin rash in the treatment area. * Patients who smoke or use nicotine products. * Patients with bleeding disorders or currently taking anticoagulants. * Patients undergoing active treatment for breast cancer. * Active, chronic, or recurrent infection. * Compromised immune system. * Hypersensitivity to analgesic agents. * Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements. * Untreated drug and/or alcohol abuse. * Pregnant or breastfeeding. * Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation. * Patients who do not wish to have the study area (breast) photographed.