Spectra Breast Implant Study

Inclusion Criteria: * Subject is genetic female and is at least 22-years-old * A candidate for primary breast augmentation (general breast enlargement, post-lactational involution, asymmetry) or augmentation revision (previous augmentation 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 * Patient is a US citizen with a Social Security Number 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, spondyarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome * Currently has a condition that could compromise or complicate wound healing * Has diagnosis of active cancer of any type * Infection or abscess anywhere in the body * Demonstrates tissue characteristics which are clinically incompatible with implant placement (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity) * Possesses any condition, or is under treatment for any condition whic…