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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-Breast Implant Case Control Studies


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General
Application Number P030053 / PAS007
Current Plan Approved 04/18/2014
Study Name OSB Lead-Breast Implant Case Control Studies
General Study Protocol Parameters
Study Design Case Control Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Five case]control studies will be conducted in Denmark, Germany, and the United Kingdom for 5 rare disease outcomes: rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma.
Study Population Description Women in Denmark, Germany, and the United Kingdom with the studied rare diseases (i.e., rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma) as cases and women without any of the 5 studied rare diseases from the same countries as controls.
Sample Size For each of the 5 case]control studies, 1,150 cases of women diagnosed with studied rare disease identified from the specialized medical centers and cancer registries in Denmark, Germany and the UK will be enrolled. A total of

5,000 females identified from the same neighborhood as cases without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.

Data Collection Data will be collected by using questionnaires as well as electronic information provided by the cancer registries/tumor centers. The same questionnaires will be used for cases and controls. The participating women will fill in the questionnaires on potential confounders (e.g., life] style related covariates) and exposure to breast implants. Similar questionnaires have been successfully used in previous case]control studies with self]administered questionnaires.
Follow-up Visits and Length of Follow-up N/A


OSB Lead-Breast Implant Case Control Studies Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/18/2014 09/08/2014 On Time
one year report 04/18/2015 03/06/2015 On Time
18 month report 10/18/2015   Overdue
two year report 04/18/2016   Overdue
three year report 04/18/2017    
four year report 04/18/2018    
five year report 04/18/2019    


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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