Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation

Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.

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.