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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-Device failure Study

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Application Number P020056 / PAS005
Current Plan Approved 11/17/2006
Study Name OSB Lead-Device failure Study
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this bench lab study is to better understand modes of gel implant failure in vivo, which could lead to improved designs or surgical techniques.
Study Population Description All explanted devices are to be returned to Allergan and analyzed and tested
Sample Size All explanted silicone breast implants
Data Collection 1. Device Identification, 2. Device Analysis, 3. Data review and summary
Follow-up Visits and Length of Follow-up There are no follow up visits in this study
Final Study Results
Interim Safety Information This is a non-clinical study which does not directly involve patients. However, 70 devices used in the Core Allergan study were returned to the Device Failure Laboratory. 35.7% of these returned devices from the Core had an unidentified opening (10% with surgical damage). There were 26 devices from the Large Post Approval study that have been returned. Of these, 17 (65%) had failure modes associated with surgical damage. The total number of all devices returned from the start of the study (July 31, 2000) until the time of the report date cutoff (June 30, 2009) totaled 2,665 (this includes those from the Core and those from the BIFS). Surgical damage was the leading cause of failure at 17% among all devices. The devices retrieved from the Large post-approval study are potentially experiencing surgical damage at a higher rate, but this has not been statistically confirmed.

OSB Lead-Device failure Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
2 year report 11/16/2008 10/27/2008 On Time
3 year report 11/16/2009 11/13/2009 On Time
4 year report 11/16/2010 11/10/2010 On Time
5 year report 11/16/2011 11/09/2011 On Time
6 year report 11/15/2012 11/14/2012 On Time
7 year report 11/15/2013 11/13/2013 On Time
Change in Report and Study Status 09/05/2014 09/05/2014 On Time

* Sponsor is reporting failure study data in the regular PMA Annual Report.

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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