Post Market Clinical Experience Study of Sientra 207 Breast Implants

Study Overview
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Brief Summary
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A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants

Detailed Description
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This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.

Official Title
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Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants

Conditions
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Breast Augmentation, Breast Revision-Augmentation

Intervention / Treatment
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* Device: Sientra 207 Silicone Gel Breast Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a candidate for primary or revision breast augmentation and is at least 22 years of age, Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12. Exclusion Criteria: Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Augmentation<br>Subjects undergoing general breast enlargement receiving Sientra Style 207 Silicone Gel Breast Implant. | Device: Sientra 207 Silicone Gel Breast Implant<br>* The Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill.<br>|
| Revision Augmentation<br>Subjects undergoing revision surgery with Sientra Style 207 Silicone Gel Breast Implant to revise or improve the result of a primary breast augmentation surgery. | Device: Sientra 207 Silicone Gel Breast Implant<br>* The Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Overall Satisfaction Questionnaire | The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device. | 3 months | 
| Investigator Overall Satisfaction Questionnaire | The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device. | 6 months | 
| Investigator Overall Satisfaction Questionnaire | The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Augmentation, Breast Revision-Augmentation