f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail

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.

Learn more...


Re-Op Phase

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Completed
Application Number /
Requirement Number
P020056 / PAS007
Date Original Protocol Accepted 01/16/2015
Date Current Protocol Accepted 01/16/2015
Study Name Re-Op Phase
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives On August 30th -31st, 2011, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (link) met to discuss updates on the postmarket experience of silicone gel-filled breast implants and to make recommendations on issues related to the monitoring of silicone gel-filled breast implants. The Advisory Panel recommended more efficient approaches to assessing the performance of silicone gel-filled breast implants than continuing new enrollment in the large prospective studies. Their recommendations included conducting a systematic literature review and re-designing the Large Post-Approval Studies (PAS) to have more efficient methodologies to assess rare outcomes. In response, FDA entered a collaboration with the American Society of Plastic Surgeons (ASPS), the Plastic Surgeons Foundation (PSF), breast implant manufacturers and patient advocate groups, to establish the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant anaplastic large cell lymphoma (BI-ALCL)). Tufts University was tasked with conducting a systematic literature review to look at rare endpoints (listed below) and silicone gel-filled breast implants. Details on the literature review methodology and findings can be found here (Balk EM, et al., Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016. 2;164(3):164-75).
This Re-Op Phase Study requirement was designed as part of the re-design of the LARGE PAS for the Natrelle® Silicone Gel Breast Implant. In this Re-Op Phase, data will be collected when subjects with Natrelle® silicone breast implants have secondary surgical procedures/re-operations. This requirement will serve as a bridge between the Large PAS and NBIR.
Study Population The NBIR arm consists of subjects implanted with round responsive devices or saline devices who were originally enrolled in the BIFS study but were not selected to remain in the smaller 10-year follow-up cohort study (BIFS arm).
Sample Size 37,390 subjects with Natrelle silicone gel-filled breast implants and 14,995 subjects with saline-filled breast implants.
Key Study Endpoints Implant removal and reoperation rates; Reasons for reoperation.
Follow-up Visits and Length of Follow-up The follow-up data will be collected when the participant requires a secondary procedure/reoperation.
Interim or Final Data Summary
Actual Number of Patients Enrolled 50,584 subjects
Actual Number of Sites Enrolled 953 sites
Patient Follow-up Rate n/a (no active follow up); follow up for 10 years total
Final Safety Findings There were a total of 190 reoperations reported in the NBIR arm of the BIFS-001 Study. In the Silicone cohort, reoperations were reported for 180 subjects (0.5%). In the Saline cohort, reoperations were reported for 10 subjects (<0.1%).
Final Effect Findings Not assessed
Study Strengths & Weaknesses Data was passively collected, as there was no active follow up in the study. Patients were only followed up if they required a reoperation. This was only recorded in the study if the patient followed up with the original surgeon and that information was submitted.
- By the end of the study, there were only 318 sites that were active (653 sites were inactive). Approximately 20,000 patients were considered “completed due to site closure.” If the site was closed or inactive, even if a patient received a reoperation, it would not have been reported.
- The reported reoperation rates in this study do not seem to be consistent with other previous studies. Given the passively collected data, this suggests that there is missing data, which is a significant limitation to this study.
Recommendations for Labeling Changes The significant limitations of the study design given the fact that this was passive surveillance should be mentioned as a caveat of the study data. Interpretation of this study data is limited given the amount of missing data.

Re-Op Phase Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 07/16/2015 07/16/2015 On Time
one year report 01/16/2016 01/15/2016 On Time
18 month report 07/16/2016 07/15/2016 On Time
two year report 01/16/2017 01/17/2017 Overdue/Received
three year report 01/16/2018 01/16/2018 On Time
four year report 01/16/2019 01/16/2019 On Time
five year report 01/16/2020 01/16/2020 On Time
six year report 01/16/2021 01/15/2021 On Time
final report 04/01/2022 03/31/2022 On Time

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