A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction

Inclusion Criteria: * Subject is female and is at least 18 years old * A candidate for: * Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction \[tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement\] to replace breast tissue post-mastectomy) * Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement) * Subject understands and signs the Informed Consent * Subject agrees to return device to Mentor if device is explanted * Subject agrees to comply with follow-up procedures, including returning for all follow-up visits * Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width Exclusion Criteria: * Subject is pregnant at time of enrollment * Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment * Currently has uncontrolled diabetes (at ti…