McGhan Medical Silicone-Filled Breast Implant Adjunct Study

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). * Have any of the following conditions or situations present: * Post mastectomy surgical removal of the breast for cancer or other diseases; * Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity.(for any reason); * Severe ptosis requiring reconstruction (i.e. mastopexy);. * Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity. This does not include normal variants of asymmetry. Examples include, but are not limited to:Pectus excavatum, Pectus carinatum; Thoracic hypoplasia (Poland's syndrome, Scoliosis; Isolated rib deformities; Tuberous breasts; Congenital absence * Revision of implant procedure due to any of the following circumstances; * Previous augmentation or reconstruction with silicone- or saline-filled implants where problems exist, such as implant. rapture or significant capsular contracture (Baker Grade III or IV) requiring revision; * Contralateral mammaplasty in unaffected breast as a result of the affected breast requiring surgery (for one of the aforementioned circumstances), when medically indicated to provide symmetry. * Adequate tissue available to cover implants. * Saline-filled implants are not an appropriate choice. * Willingness to follow all study requirements, such as agreeing to all required follow-up visits, and acceptance of the risks involved as indicated by signing of the Patient Informed Consent document. Exclusion Criteria: * Advanced fibrocystic disease considered to be premalignant-without accompanying subcutaneous mastectomy. * Existing carcinoma of the breast, without mastectomy. * Abscess or 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, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration. * Have, or under treatment for, any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk. * Show psychological characteristics which, in the opinion of the surgeon, may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation. * Wish to have augmentation mammaplasty, but do not have at least one of the diagnoses identified in Patient Inclusion Criteria item G #2, pages 7 \& 8. * Are not willing to undergo further surgery for revision, if medically required. * Diagnosis of lupus or scleroderma. * Replacement of saline-filled implants solely for a less than desirable cosmetic outcome, such as wrinkling.