f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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US Post-Approval Study (US-PAS)


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General
Study Status Delayed
Application Number /
Requirement Number
P070004 / PAS003
Date Original Protocol Accepted 03/09/2012
Date Current Protocol Accepted 05/26/2023
Study Name US Post-Approval Study (US-PAS)
Device Name SIENTRA SILICONE GEL BREAST IMPLANTS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The US-PAS is a 10-year post-approval cohort study to examine local complications and common diseases recommended by FDA for inclusion in the PAS. Common diseases were defined as conditions with incidence rates greater than 10/100,000. For evaluation of common diseases; reproductive outcomes, and suicide/attempted suicide, external comparisons will be made between the breast implant group and population-based disease rates derived from reliable data sources, from disease rate estimates available from other registries or epidemiologic studies, or from preoperative data. Internal comparisons will be made to baseline observations for quality of life endpoints. For the analysis of rheumatologic and neurologic signs and symptoms, the internal comparison group will be participants undergoing other aesthetic surgery.

The study will enroll women who receive Sientra Silicone Gel Breast Implants for augmentation, revision augmentation, reconstruction, and revision reconstruction (these patients are referred to as “Gel participants”) in the naturally occurring proportions of these procedures at participating study sites. Participants will be followed over a 10-year period following breast implant surgery for common outcomes and all local complications. Gel participants will be evaluated by the Investigator at baseline and years 1, 5, and 9 and will complete questionnaires at baseline and years 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10. A concurrent control group of women undergoing other aesthetic surgery (these patients are referred to as Control participants) will also be enrolled and will complete questionnaires at baseline and years 2, 4, 6, and 8.
Study Population The device group will be women who received Sientras silicone breast implants as indicated for primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction of the female breast. The control group will be women undergoing other aesthetic surgery.
Sample Size The study will enroll 4,782 women receiving Sientras silicone breast implants and 300 women undergoing other aesthetic surgery as the comparison group.
Key Study Endpoints The following safety outcomes will be evaluated: connective tissue diseases (CTDs), rheumatologic and neurologic signs and symptoms, cancer (lung and breast, including the potential of breast implant interference with mammography and delay of breast cancer detection), suicide/attempted suicide, local complications, reoperation and implant removal, reproductive and lactation complications. Effectiveness will be assessed based on quality of life (QOL) assessments and subject satisfaction.
Follow-up Visits and Length of Follow-up 10 years
Investigator evaluations of breast implant participants will occur at baseline and years 1, 5, and 9. Additional study data will be obtained via questionnaires completed by the breast implant and Control participants. Breast implant participants will complete a baseline questionnaire, a condensed follow-up questionnaire at years 1, 5, and 9, and a standard follow-up questionnaire at years 3, 7 and 10. At years 2, 4, 6, and 8 they will complete a QOL and Signs/Symptoms questionnaire regarding QOL, suicide/attempted suicide, participant satisfaction, rheumatologic and neurologic signs and symptoms.

Control participants will complete a baseline questionnaire. At years 2, 4, 6, and 8 they will complete a Signs/Symptoms questionnaire that will collect information on rheumatologic and neurologic signs and symptoms. The subgroup of 1,000 breast implant participants will receive additional reproductive outcome questions at years 1, 3, 5, 7, 9 and 10.
Interim or Final Data Summary
Actual Number of Patients Enrolled 5,498 total subjects
5,197 Sientra OPUS® Silicone Gel Breast Implant subjects
301 Control subjects
Actual Number of Sites Enrolled 131
Patient Follow-up Rate The 3 year follow-up rates are:
61% - Sientra OPUS Silicone Gel Breast Implant cohort
The Control population did not have a visit at the 3 year timepoint


US Post-Approval Study (US-PAS) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
quarterly report 06/08/2012 06/08/2012 On Time
six month report 09/07/2012 09/07/2012 On Time
quarterly interim report 12/09/2012 12/07/2012 On Time
one year report 03/09/2013 03/07/2013 On Time
15 month report 06/08/2013 06/07/2013 On Time
18 month report 09/07/2013 09/09/2013 Overdue/Received
two year report 03/09/2014 03/07/2014 On Time
three year report 03/09/2015 03/09/2015 On Time
four year report 03/08/2016 03/09/2016 On Time
five year report 03/08/2017 03/08/2017 On Time
six year report 03/08/2018 03/12/2018 Overdue/Received
seven year report 03/08/2019 03/08/2019 On Time
progress report 03/20/2020 03/20/2020 On Time
10 year report 03/20/2021 07/15/2021 Overdue/Received
unsolicited report 08/02/2021 08/02/2021 On Time
11 year report 03/20/2022 03/09/2022 On Time
milestone report 07/29/2022 07/29/2022 On Time
follow-up report 01/24/2023 01/24/2023 On Time
12 year report 03/20/2023 03/08/2023 On Time
quarterly report 07/27/2023 07/27/2023 On Time
quarterly report 01/23/2024 01/23/2024 On Time
13 year report 03/20/2024    
quarterly report 07/31/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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