Study of the Safety and Effectiveness of Motiva Implants®

Inclusion Criteria * Genetic female. * Patient is seeking one of the following procedures: Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction * Patient has adequate tissue available to cover implant(s). * Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent. * Agrees to have device returned to Establishment Labs if explanted. * Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised. Exclusion Criteria: * Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type. * Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing). * Has an abscess or infection. * Is pregnant or nursing or has had a full-term pregnancy or lactated within 6 months of enrollment. * Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and or significant postoperative complications. * Has any medical condition such as obesity (BMI ≥ 40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and or significant postoperative complications. * Has any connective tissue/autoimmune disorder or rheumatoid disease, s…