Breast AugmentationBreast ReconstructionBreast Revision
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Long-term safety of Sientra Silicone Gel Breast Implants in women — 10-years
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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