Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Sientra

Status: Completed

Conditions: Breast Reconstruction; Breast Revision; Breast Augmentation

Treatments: Device: Silimed Gel-Filled Mammary Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905645

G010193

Details and patient eligibility

About

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

Enrollment: 1,788 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,788 participants in 4 patient groups

Primary Augmentation

Experimental group

Description:

Silimed Gel-Filled Mammary Implant

Treatment:

Device: Silimed Gel-Filled Mammary Implant

Revision-Augmentation

Experimental group

Description:

Silimed Gel-Filled Mammary Implant

Treatment:

Device: Silimed Gel-Filled Mammary Implant

Primary Reconstruction

Experimental group

Description:

Silimed Gel-Filled Mammary Implant

Treatment:

Device: Silimed Gel-Filled Mammary Implant

Revision-Reconstruction

Experimental group

Description:

Silimed Gel-Filled Mammary Implant

Treatment:

Device: Silimed Gel-Filled Mammary Implant