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.