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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

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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Application Number P030053
Current Protocol Accepted 10/01/2014
Study Name OSB Lead-Large PAS
Study Status Revised/Replaced Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Large post-approval study is a 10-year cohort study to address specific issues for which   show the rest ...
Study Population Description Study Population consists of women who receive MemoryGel and saline breast implants for augmentation, revision-augmentation,   show the rest ...
Sample Size 41,900 MemoryGel and 1,000 saline patients
Data Collection Baseline data will be collected from the study subjects using patient self-administered questionnaire during the   show the rest ...
Followup Visits and Length of Followup 3 surgeon visits (1, 4-6 and 9-10 years post-implantation) and 10 annual follow-up questionnaire completed   show the rest ...
Final Study Results
Actual Number of Patients Enrolled A total of 41,452 MemoryGel participants were enrolled in the study.

Enrollment by indication was:   show the rest ...
Actual Number of Sites Enrolled 2,342
Patient Followup Rate At year 7, the overall follow-up rate was 20.1%.

Follow-up rate by indication was: 19.2% primary   show the rest ...
Final Safety Findings Participant Reported Complications and Reoperations

For MemoryGel participants in the primary augmentation cohort, the cumulative incidence   show the rest ...
Final Effectiveness Findings There were no study objectives related to effectiveness. The information that follows is a continuation   show the rest ...
Study Strengths and Weaknesses Overall, there are a total of 255,541 person-years of follow-up among MemoryGel participants. However, results   show the rest ...
Recommendations for Labeling Changes Due to very low follow-up rate, labeling changes are not recommended.

OSB Lead-Large PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
Large PAS 3 month report 02/16/2007 02/16/2007 On Time
Large PAS 6 month report 05/18/2007 05/18/2007 On Time
Large PAS Semi-annual Report 05/18/2007 05/18/2007 On Time
Large PAS 9 month report 08/17/2007 08/17/2007 On Time
Large PAS 1 year report 11/17/2007 11/16/2007 On Time
Large PAS 15 month report 02/16/2008 02/15/2008 On Time
Large PAS 18 month report 05/17/2008 05/16/2008 On Time
Large PAS 21 month report 08/16/2008 08/18/2008 Overdue/Received
Large PAS 2 year report 11/16/2008 11/10/2008 On Time
Large PAS 27 month report 02/15/2009 02/17/2009 Overdue/Received
Large PAS 30 month report 05/17/2009 05/18/2009 Overdue/Received
Large PAS 33 month report 08/16/2009 08/14/2009 On Time
Large PAS 3 year report 11/16/2009 11/16/2009 On Time
Large PAS 39 month report 02/15/2010 02/12/2010 On Time
Large PAS 42 month report 05/17/2010 05/17/2010 On Time
Large PAS 45 month report 08/16/2010 08/16/2010 On Time
Large PAS 4 year report 11/16/2010 11/16/2010 On Time
Large PAS 51 month report 02/15/2011 02/15/2011 On Time
Large PAS 54 month report 05/18/2011 05/18/2011 On Time
Large PAS 57 month report 08/16/2011 08/16/2011 On Time
Large PAS 5 year report 11/16/2011 11/17/2011 On Time
Large PAS 63 month report 02/15/2012 02/15/2012 On Time
Large PAS 66 month report 05/16/2012 05/15/2012 On Time
Large PAS 6 year report 11/15/2012 11/07/2012 On Time
Large PAS 7 year report 11/15/2013 11/12/2013 On Time
Large PAS 8 year report 11/15/2014 11/13/2014 On Time
final report 05/31/2015 05/28/2015 On Time

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