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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.

Links

Contact Information

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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General
Application Number P070004
Most Recent Protocol Version Approved 05/29/2012
Study Name Post-Approval Continued Access Study (PACAS)
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Continued Access Study (CAS) was initiated under an FDA-approved investigational device exemption to provide   show the rest ...
Study Population Description Women who received Sientra¿s silicone breast implants and were enrolled in the premarket augmentation cohorts   show the rest ...
Sample Size A total of 2,497 subjects have been enrolled in Sientra¿s PACAS at 33 sites throughout   show the rest ...
Data Collection The safety endpoints include local complications, implant rupture, connective tissue diseases (CTDs), CTD signs and   show the rest ...
Followup Visits and Length of Followup 5 years

Annually

Final Study Results
Actual Number of Patients Enrolled 2,524
Actual Number of Sites Enrolled 31
Patient Followup Rate 48.5% for both primary and revision augmentation cohorts at Year 5
Final Safety Findings The Kaplan쳌]Meier risk rate of any complication at Year 5 was 34.8% in the primary   show the rest ...
Final Effectiveness Findings In the primary augmentation cohort, 88.8% of patients increased their bra cup size by at   show the rest ...
Study Strengths and Weaknesses The Continued Access Study (CAS) was designed to provide supplemental safety and effectiveness data

for the   show the rest ...
Recommendations for Labeling Changes No labeling change recommended at this time. The labeling will be updated based on the   show the rest ...


Post-Approval Continued Access Study (PACAS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
final report 03/09/2013 03/11/2013 Overdue/Received

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