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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
The US-PAS is a 10-year post-approval cohort study to examine local complications and common diseases
recommended by FDA for inclusion in the PAS. Common diseases were defined as conditions with incidence rates greater than 10/100,000. For evaluation of ?common diseases?, reproductive outcomes, and suicide/attempted suicide, external comparisons will be made between the breast implant group and population-based disease rates derived from reliable data sources, from disease rate estimates available from other registries or epidemiologic studies, or from preoperative data. Internal comparisons will be made to baseline observations for quality of life endpoints. For the analysis of rheumatologic and neurologic signs and symptoms, the internal comparison group will be participants undergoing other aesthetic surgery.
Study Population Description
The device group will be women who received Sientra?s silicone breast implants as indicated for
primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction of the female breast. The control group will be women undergoing other aesthetic surgery.
Sample Size
The study will enroll 4,782 women receiving Sientra?s silicone breast implants and 300 women undergoing
other aesthetic surgery as the comparison group.
Data Collection
The following safety outcomes will be evaluated: connective tissue diseases (CTDs), rheumatologic and neurologic signs
and symptoms, cancer (lung and breast, including the potential of
breast implant interference with mammography and delay of breast cancer detection), suicide/attempted suicide, local complications, reoperation and implant removal, reproductive and lactation complications. Effectiveness will be assessed based on quality of life (QOL) assessments and subject satisfaction.
Followup Visits and Length of Followup
10 years
Investigator evaluations of breast implant participants will occur at baseline and years 1, 5,
and 9. Additional study data will be obtained via questionnaires completed by the breast implant and Control participants. Breast implant participants will complete a baseline questionnaire, a condensed follow-up questionnaire at years 1, 5, and 9, and a standard follow-up questionnaire at years 3, 7 and 10. At years 2, 4, 6, and 8 they will complete a QOL and Signs/Symptoms questionnaire regarding QOL, suicide/attempted suicide, participant satisfaction, rheumatologic and neurologic signs and symptoms.
Control participants will complete a baseline questionnaire. At years 2, 4, 6, and 8 they will complete a Signs/Symptoms questionnaire that will collect information on rheumatologic and neurologic signs and symptoms. The subgroup of 1,000 breast implant participants will receive additional reproductive outcome questions at years 1, 3, 5, 7, 9 and 10.
