Mia® Clinical Study

Inclusion Criteria: * Genetic females, ≥ 18 years. * AA to C cup size, evaluated according to Triumph international guidelines. * Participants with Class I and II risk according to the American Society of Anesthesiologists (ASA) * Participants seeking a primary breast augmentation to increase the size of their breasts by one cup size. * Body Mass Index between 18.5 and 24.9 (normal weight). * Adequate tissue for covering the implant(s). * Willingness to follow all study requirements and attending all necessary follow-up visits. * Agreement to return the device to the sponsor in case it is explanted Exclusion Criteria: * Current costal lesions. * Breast ptosis or poor skin quality. * Inadequate tissue (for example, radiation damage, ulcers, compromised vascularity, history of inadequate wound scaring). * History of abscesses or infections in the breast area. * Currently pregnant or breastfeeding, or pregnancy or breastfeeding to term in the six months prior to recruitment. * History of silicone sensitivity. * Use of any medications that interfere with coagulation or that may imply a high risk and/or significant post-surgical complication. * Any medical condition, such as low weight or obesity according to the inclusion criteria, diabetes, autoimmune disease, chronic lung disease or serious cardiovascular disease that may result in an excessively high surgical risk and/or important post-surgical complications. * Any condition that precludes the use of magnetic resonance imag…