The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Genetic female with US residency
Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation
Agrees to Sientra study requirements
Has an active infection anywhere in body
Has active cancer without adequate treatment
Currently pregnant or nursing
Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements
If control participant, has undergone breast implant surgery with silicone gel-filled breast implants