Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Inclusion Criteria: * Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate. * Females seeking revision augmentation or revision reconstruction, where problems exist * Have any of the following conditions or situations present: * Post mastectomy surgical removal of the breast for cancer or other disease; * Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity; * Severe ptosis requiring reconstruction; * Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity. * Adequate tissue available to cover implants. * Saline-filled implants are not an appropriate choice. Exclusion Criteria: * Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy. * Existing carcinoma of the breast, without mastectomy. * Abscess of infection in the body at the time of enrollment. * Pregnant or nursing. * Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability. * Show tissue characteristics which are clinically incompatible with mammaplasty. * Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk. * Are not willing to undergo further surgery for revision, if medically required. * Diagnosis of lupus or scleroderma…