Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Inclusion Criteria

Subjects are admitted into the study only if all of the following eligibility is true:

- Female

- Age limitation specific to the indication:

- Primary Augmentation: Must be 18 years or older

- Primary Reconstruction: No age limit

- Revision: If original surgery was primary reconstruction, then no age limit. If
original surgery was primary augmentation, then must be 18 years or older.

- Adequate tissue available to cover implant(s)

- Willingness to follow study requirements (informed consent form, follow-up visits)

- Candidate for primary augmentation, primary reconstruction, or revision

Exclusion Criteria

Subjects are not eligible if any of the following criteria exist:

- Advanced fibrocystic disease, considered to be pre-malignant without mastectomy

- Inadequate or unsuitable tissue

- Active infection in the body at the time of surgery

- Pregnant or lactating

- Medical condition that might result in unduly high surgical risk and/or significant
postoperative complications, in the judgment of the Investigator

- Use of drugs, including any drug that would interfere with blood clotting, that might
result in high risk and/or significant postoperative complications

- Demonstrated psychological characteristics that are unrealistic or unreasonable given
the risks involved with the surgical procedure

- Determination by physical examination that the subject does have any connective
tissue/autoimmune disorder

- Existing carcinoma of the breast without accompanying mastectomy

- MRI scan is prohibited because of implanted metal device, claustrophobia, or other
condition.