Clinical Research Directory

Inclusion Criteria: * Female subjects greater or equal to 22 years of age. * Subject is considered a candidate for nipple sparing mastectomy by the breast and plastic surgeon * First-time breast reconstruction post-mastectomy for target breasts. * Subject is planning to undergo bilateral nipple-sparing mastectomy with immediate, implant-based, subpectoral or prepectoral breast reconstruction. * Mastectomy performed to address ductal carcinoma-in-situ (DCIS) or for cancer prophylaxis. * An informed consent form is signed by subject * Subject is capable of following protocol procedures and complying with follow-up visit requirements. Exclusion Criteria: * Subject has undergone prior radiation therapy to the reconstruction site or chest wall. * Subject has a BMI \> 35. * Subject has a known diagnosis of diabetes with a HbA1c \> 7.0mmol/L within 30 days of the mastectomy * Subject is a tobacco/nicotine user within 30 days prior to Index Surgery. * Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction. * Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up. * Subject is currently participating or planning to participate in another investigational drug, biologic, or medical device study that may interfere with compliance of this study requirements or may confound this study data/outcomes. * Subject is pregnant or lactating at the time of the mastectomy. * If the patient has a diagnosis of DCIS, there no radiographic evidence of DCIS within 1 cm of the skin or nipple or foci suspicious for microinvasion. * Patients with a diagnosis of grade III DCIS.