Sientra Post-Approval Study



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/16/2018
Start Date:April 2012
End Date:March 2025

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

U.S. Postapproval Study of Sientra Silicone Gel Breast Implants

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.


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
We found this trial at
1
site
Sientra, Inc.
Santa Barbara, California 93117
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials