Sientra Post-Approval Study

Active, not recruiting

• Conditions: Breast Revision; Breast Augmentation; Breast Reconstruction

• Registration Number: NCT01639053
• Lead Sponsor: Sientra, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-29
• Last Update Posted: 2023-05-03
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 5498

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term safety of Sientra Silicone Gel Breast Implants in women	10-years

Trial Locations

Locations (1)

Sientra, Inc.; 🇺🇸 Santa Barbara, California, United States