FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Inclusion Criteria: * Females at least 22 years of age * Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction * Willing to provide Informed Consent * Able to return for all required study visits * Must read and understand English language Exclusion Criteria: * Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure * Has a residual gross tumor at the intended reconstruction site * Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy * Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site * Completed chemotherapy within 3 weeks prior to surgery * Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications * Has a Body Mass Index (BMI) \>35 * Has used nicotine products within 1 month of screening * Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study