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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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Case Control Studies


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General
Study Status Terminated
Application Number P040046 / PAS004
Date Current Protocol Accepted  
Study Name Case Control Studies
General Study Protocol Parameters
Study Design Case Control Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population 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 associated anaplastic large cell lymphoma (BIA-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).



The case-control study requirements originally were designed to study the following endpoints: rare connective tissue diseases, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. The PAS case-control study requirements were put on-hold while the systematic literature review was conducted. The systematic literature review showed insufficient evidence of association between silicone gel-filled breast implants and lymphoma, brain cancer, cervical cancer, rare connective tissue diseases (CTDs), or rare neurological events. Therefore, the PAS case-control studies were terminated because using case-control studies to evaluate these rare adverse events among patients with silicone breast implants would not provide additional value.



The FDA continues to monitor for these rare adverse events using other postmarket surveillance tools and real-world data (e.g. MDRs, NBIR, PROFILE).

Study Population Description Women in the UK with the studied rare diseases (i.e., rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma) as cases and women in the UK without any of the 5 studied rare diseases as controls.
Sample Size For each of the 5 case-control studies, 1,500 cases of women diagnosed with each specific studied rare disease will be identified from the GPRD. A total of 4000 women identified from the GPRD without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
Data Collection Patient data will be collected from three sources: the GPRD database, directly from the patient via a structured questionnaire, and if the patient had silicone breast implants, directly from the surgeon who performed the implantation procedure. The study data will be entered into an electronic data capture system (EDC) using an electronic case report form (eCRF). Available data will be abstracted from the GPRD database and entered into the eCRF. The de-identified completed patient questionnaires will also be entered into the EDC. For patients who had breast implants, the surgeon who performed the implantation procedure will be contacted directly to obtain the data on the manufacturer and style of silicone breast implant.

Information obtained from both the cases and controls will include the following:

¿ Data collected from the GPRD database will include date of birth, date at diagnosis (all cases), date of identification from database (controls), socioeconomic status (census area-level based on post code), history of breast cancer, history of oral contraceptive use, tobacco use history, body mass index (BMI), number of live births, age at first pregnancy, age at first live birth

¿ Data collected from the patient will include ethnicity, for cases family history of the studied rare disease (cases), for controls family history of any of the five studied rare diseases, breast implant history (i.e., indication, type, shape, date of implantation, contact information of the surgeon), smoking history, alcohol use history, for controls sexual history

¿ Data collected from the surgeon (if patient had implants) will include date of implant, manufacturer of Implant, style of Implant

Cases will be identified among the diagnoses starting 2004 to allow about 10 years of exposure to the silicone breast implants from the GPRD database.

Follow-up Visits and Length of Follow-up There is no prospective follow-up for case-control studies


Case Control Studies Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/21/2013 08/20/2013 On Time
one year report 02/20/2014 02/11/2014 On Time
18 month report 08/27/2014 08/26/2014 On Time
two year report 02/20/2015 02/20/2015 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

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