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This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel Participants | |||
| Control Participants |
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| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of Sientra Silicone Gel Breast Implants in women | 10-years |
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Inclusion Criteria:
Exclusion Criteria:
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Women who receive Sientra Silicone Gel Breast Implants for augmentation, revision augmentation, reconstruction, and revision reconstruction. Control participants are candidates for and undergo aesthetic surgery other than implantation with Silicone Gel Breast implants.
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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 |
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