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Low enrollment
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A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Augmentation | Subjects undergoing general breast enlargement receiving Sientra Style 207 Silicone Gel Breast Implant. |
| |
| Revision Augmentation | Subjects undergoing revision surgery with Sientra Style 207 Silicone Gel Breast Implant to revise or improve the result of a primary breast augmentation surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sientra 207 Silicone Gel Breast Implant | Device | The Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women who receive Sientra Silicone 207 Gel Breast Implants for primary augmentation or revision augmentation
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| Name | Affiliation | Role |
|---|---|---|
| Sientra, Inc. | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sientra, Inc. | Santa Barbara | California | 93117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29595717 | Result | Schwartz MR, Haws MJ, Phillips G. Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):40S-48S. doi: 10.1097/PRS.0000000000004353. |
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