Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses

Inclusion Criteria: * Subject is Genetic female and at least 18 years old * A candidate for: * Primary breast augmentation (for post-lactational mammary involution or 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 follow the procedures for explant analysis * Agrees to comply with follow-up procedures, including returning for all follow-up visits Exclusion Criteria: * Patient 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, infections arthritis, spondylarthropathies, any other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue syndrome * Currently has a condition that could compromise or complicate wound healing (except reconstruction patients) * Patient in Augmentation cohort and has diagnosis of active cancer of any type * Infection or abscess anywhere in the body * Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting f…