Sientra Post-Approval Study
This trial is active, not recruiting.
|Conditions||breast augmentation, breast reconstruction, breast revision|
|Start date||April 2012|
|End date||March 2025|
|Trial size||5000 participants|
|Trial identifier||NCT01639053, CP-1007|
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.
Long-term safety of Sientra Silicone Gel Breast Implants in women
time frame: 10-years
Female participants at least 18 years old.
Inclusion Criteria: 1. Genetic female with US residency 2. Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation 3. Agrees to Sientra study requirements Exclusion Criteria: 1. Has an active infection anywhere in body 2. Has active cancer without adequate treatment 3. Currently pregnant or nursing 4. Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements 5. If control participant, has undergone breast implant surgery with silicone gel-filled breast implants
|Official title||U.S. Postapproval Study of Sientra Silicone Gel Breast Implants|
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