Sientra Post-Approval Study

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Augmentation Breast Reconstruction Breast Revision

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sientra, Inc.

Santa Barbara, California, 93117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Long-term safety of Sientra Silicone Gel Breast Implants in women

Time frame: 10-years

Sponsors and collaborators

Lead sponsor

Tiger Biosciences, LLC.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2025
Study completion: 2026
First posted: Jul 12, 2012
Registry last updated: Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting