Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Inclusion Criteria Subjects are admitted into the study only if all of the following eligibility is true: * Female * Age limitation specific to the indication: * Primary Augmentation: Must be 18 years or older * Primary Reconstruction: No age limit * Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older. * Adequate tissue available to cover implant(s) * Willingness to follow study requirements (informed consent form, follow-up visits) * Candidate for primary augmentation, primary reconstruction, or revision Exclusion Criteria Subjects are not eligible if any of the following criteria exist: * Advanced fibrocystic disease, considered to be pre-malignant without mastectomy * Inadequate or unsuitable tissue * Active infection in the body at the time of surgery * Pregnant or lactating * Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator * Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications * Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure * Determination by physical examination that the subject does have any connective tissue/autoimmune disorder * Existing carcinoma of the breast without acc…