McGhan Medical Silicone-Filled Breast Implant Adjunct Study

This prospective clinical study is being undertaken to document the safety of McGhan Medical Silicone-Filled Breast Implants. Patients will be evaluated pre-operatively, intraoperatively, and at one, three and five years following implant surgery. Safety of McGhan Medical Silicone-Filled Breast Implants will be assessed based on the incidence of medical complications, implant failure and serious adverse effects.

This prospective clinical study of McGhan Medical Silicone-Filled Breast Implants is part of an ongoing research effort to document the safety and effectiveness of 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).
• 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.