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.
• •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.