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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-US Post-Approval Study (US-PAS)


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General
Application Number P070004 / PAS003
Current Plan Approved 05/29/2012
Study Name OSB Lead-US Post-Approval Study (US-PAS)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description The device group will be women who received Sientra¿s 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 Sientra¿s silicone breast implants and 300 women undergoing other aesthetic surgery as the comparison group.
Data Collection 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.



OSB Lead-US Post-Approval Study (US-PAS) Schedule

Report 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 03/08/2016 On Time
five year report 03/08/2017    
final report 08/18/2025    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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