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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Device Failure Study


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General
Study Status Other
Application Number /
Requirement Number		 P030053 / PAS002
Date Original Protocol Accepted 11/17/2006
Date Current Protocol Accepted 11/17/2006
Study Name Device Failure Study
Device Name MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
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 Objectives The Device failure study is still ongoing. The data is submitted to the FDA in PMA Annual Reports.
Study Population All explanted devices are to be returned to Mentor and analyzed and tested
Sample Size All returned devices are analyzed.
Key Study Endpoints An analysis was performed on the following categories to identify specific trends correlating to device failures: device type, size, clinical variables, visual observations, in-vivo time, surgical approach, device placement, incision size, pocket irrigation usage. Explanted devices underwent the following physical testing to assess the physical characteristics of the explanted devices: tension set, joint strength, ultimate elongation, gel cohesion.
Follow-up Visits and Length of Follow-up There is no patient follow-up in this study


Device Failure Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 11/16/2008 11/14/2008 On Time
3 year report 11/16/2009 11/16/2009 On Time
4 year report 11/16/2010 11/09/2010 On Time
5 year report 11/16/2011 11/09/2011 On Time
6 year report 11/15/2012 11/15/2012 On Time
7 year report 11/15/2013 11/12/2013 On Time

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



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

Additional Resources

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