Sientra Post-Approval Study

NCT01639053 | Active Not Recruiting

• 1 other identifier: CP-1007
• Study Type: observational
• Target: 5,498
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Augmentation; Breast Reconstruction; Breast Revision

Keywords

Breast Augmentation; Breast Reconstruction; Breast Revision; Silicone breast implants

Outcome Measures

Primary Outcomes (1)

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

  10-years

Study Arms (2)

Gel Participants

Control Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead

Study Sites (1)

Sientra, Inc.

Santa Barbara, California, 93117, United States

Location

Study Officials

• Sientra, Inc.

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)