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.
