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

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OSB Lead-BIFS (Large PAS)

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Application Number P020056 / PAS001
Current Plan Approved 08/03/2015
Study Name OSB Lead-BIFS (Large 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 large PAS is a 10-year multi-center, prospective cohort study designed to compare targeted safety outcomes of 39,390 subjects who elect to receive unilateral or bilateral silicone gel-filled breast implants to 15,240 subjects who elect to receive unilateral or bilateral saline-filled breast implants (control subjects).
Study Population Description The study population is as per device indication. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast Augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the results of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
Sample Size The study will enroll 54,630 female subjects who elect to receive unilateral or bilateral breast implant, including: - 39,390 subjects who receive silicone gel-filled breast implant, 15,240 subjects who receive saline-filled breast implants (control subjects).
Data Collection 1. The long-term safety profile of silicone breast implants, especially as it relates to connective tissue diseases (CTD), neurological diseases, cancer (brain, lung, breast, and cervical/vulvar), and suicide and their associated signs and symptoms. 2. The impact of silicone breast implants on reproductive health (e.g., live vs. non-live births) and offspring health (i.e., congenital and neonatal anomalies and diseases of offspring conceived post-implant, including autoimmune diseases, cancer, and neurological diseases) 3. The impact of silicone breast implants on detection of breast cancer with mammography 4. Complications associated with silicone breast implants 5. The effect of silicone breast implants on overall feeling of satisfaction with life and with the decision to have implant surgery
Follow-up Visits and Length of Follow-up There are 4 follow up clinic visits at 1 wk post surgery, 1 year, 4 years and 10 years. Additionally, there is a patient questionnaire that is assessed annually.
Final Study Results
Interim Safety Information Collection of the information needed to accurately calculate the risk of complications and outcomes of implant surgery, will not be complete until all study participants have completed the 1st year of follow-up. The incidence of these complications will be calculated and posted on this site after complete data on participants experience at the 1-year follow-up and 2 year follow-up becomes available.

OSB Lead-BIFS (Large PAS) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Large PAS 3 month report 02/16/2007 03/09/2007 Overdue/Received
Large PAS 6 month report 05/18/2007 05/16/2007 On Time
Large PAS 9 month report 08/17/2007 08/16/2007 On Time
Large PAS 1 year report 11/17/2007 11/13/2007 On Time
Large PAS 15 month report 02/16/2008 02/12/2008 On Time
Large PAS 18 month report 05/17/2008 05/08/2008 On Time
Large PAS 21 month report 08/16/2008 08/13/2008 On Time
Protocol Deviations report 10/24/2008 10/24/2008 On Time
Large PAS 2 year report 11/16/2008 11/12/2008 On Time
Large PAS 27 month report 02/15/2009 02/13/2009 On Time
Large PAS 30 month report 05/17/2009 05/15/2009 On Time
Large PAS 33 month report 08/16/2009 08/14/2009 On Time
Large PAS 3 year report 11/16/2009 11/10/2009 On Time
Large PAS 39 month report 02/15/2010 02/12/2010 On Time
Large PAS 42 month report 05/17/2010 05/13/2010 On Time
Large PAS 45 month report 08/16/2010 08/11/2010 On Time
Large PAS 4 year report 11/16/2010 11/12/2010 On Time
Large PAS 51 month report 02/15/2011 02/11/2011 On Time
Large PAS 54 month report 05/17/2011 05/12/2011 On Time
Large PAS 57 month report 08/16/2011 08/15/2011 On Time
Large PAS 5 year report 11/16/2011 11/17/2011 Overdue/Received
Large PAS 63 month report 02/15/2012 02/10/2012 On Time
Large PAS 66 month report 05/16/2012 05/14/2012 On Time
Large PAS 69 month report 08/15/2012 08/09/2012 On Time
Large PAS 6 year report 11/19/2012 11/27/2012 On Time
Large PAS 7 year report 11/15/2013 11/14/2013 On Time
Large PAS 8 year report 11/15/2014 11/06/2014 On Time
Large PAS 9 year report-final 11/15/2015 11/13/2015 On Time

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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