Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial

Inclusion Criteria: * Subject is genetic female, 18 years of age or older * A candidate for: * Primary breast augmentation (general breast enlargement) * Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry) * Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants) * Signs the Informed Consent * Agrees to return device to Mentor if explant necessary * 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 (e.g. silicone artificial joints or facial implants) * Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome * 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. (Exception is low-grade non-metastasizing skin cancer) * Infection or abscess anywhere in the body * Demonstrates tissue char…