• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • 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
General
Study Status Progress Adequate
Application Number P020056 / PAS007
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
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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 Description 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.
Data Collection 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.


Re-Op Phase Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    


Contact Us

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

Related Links

-
-