Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant

Inclusion Criteria: * Subject is Genetic female and is at least 18 years old * A candidate for: * Primary breast augmentation (for general breast enlargement) * Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity) * Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants) * Signs the Informed Consent * Agrees to return device to Mentor if device is explanted * Agrees to comply with follow-up procedures, including returning for all follow-up visits Exclusion Criteria: * Subject is pregnant * Has nursed a child within three months of study enrollment * Been implanted with any silicone implant other than breast implants * Confirmed diagnosis of rheumatic disease * Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects) * Subject in Augmentation cohort and has diagnosis of active cancer of any type, except low-grade non-metastasizing skin cancer * Infection or abscess anywhere in the body * Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity) * Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk. * Anatomic or physiologic abnormality which could lead to significant postoper…