Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

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

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

Conditions
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Breast Augmentation, Breast Reconstruction, Breast Revision

Intervention / Treatment
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* Device: Silimed Gel-Filled Mammary Implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Augmentation<br>Silimed Gel-Filled Mammary Implant | Device: Silimed Gel-Filled Mammary Implant<br> <br> |
| Experimental: Primary Reconstruction<br>Silimed Gel-Filled Mammary Implant | Device: Silimed Gel-Filled Mammary Implant<br> <br> |
| Experimental: Revison<br>Silimed Gel-Filled Mammary Implant | Device: Silimed Gel-Filled Mammary Implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local complications | Assessment of the safety of the Study Implants is based on incidence and method of resolution for Breast Pain on a per-implant and per-patient basis using Kaplan-Meier (KM) risk rates through 10 years. | 10 Years | 
| Local complications | Assessment of the safety of the Study Implants is based on incidence and method of resolution for Baker grade III/IV Capsular Contracture on a per-implant and per-patient basis using Kaplan-Meier (KM) risk rates through 10 years. | 10 Years | 
| Local complications | Assessment of the safety of the Study Implants is based on incidence and method of resolution for Rupture on a per-implant and per-patient basis using Kaplan-Meier (KM) risk rates through 10 years. | 10 Years | 
| Local complications | Assessment of the safety of the Study Implants is based on incidence and method of resolution for Explantation with or without replacement for either cosmetic, medical, or surgical reasons on a per-implant and per-patient basis using Kaplan-Meier (KM) risk rates through 10 years. | 10 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction determined by patients | Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. | 10 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants