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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Re-Op Phase


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General
Study Status Progress Adequate
Application Number P030053 / PAS009
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 No 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 study requirement was designed as part of the re-design of the LARGE PAS for the MemoryGel® breast implants. In this Re-Op Phase of the study, data will be collected when the subjects with MemoryGel® breast implants have secondary surgical procedures/re-operations. This Re-Op Phase will serve as a bridge between the Large PAS and NBIR.
Study Population Description Women with MemoryGel breast implants who were enrolled in the Large PAS.
Sample Size 41,900
Data Collection Implant removal and reoperation rates; Reasons for reoperation.
Follow-up Visits and Length of Follow-up The follow쳌]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 07/09/2015 On Time
one year report 01/16/2016 01/15/2016 On Time
18 month report 07/16/2016 07/14/2016 On Time
two year report 01/16/2017 01/11/2017 On Time
three year report 01/16/2018 01/16/2018 On Time
four year report 01/16/2019    


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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