|
|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P030053 / PAS007 |
| Date Original Protocol Accepted |
04/18/2014
|
| Date Current Protocol Accepted |
04/18/2014
|
| Study Name |
Breast Implant Case Control Studies
|
| Device Name |
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Case Control Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent & Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| 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 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 MDRs, NBIR, PROFILE).
|
| Study Population |
Women in Denmark, Germany, and the United Kingdom with the studied rare diseases (i.e., rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma) as cases and women without any of the 5 studied rare diseases from the same countries as controls.
|
| Sample Size |
For each of the 5 case]control studies, 1,150 cases of women diagnosed with studied rare disease identified from the specialized medical centers and cancer registries in Denmark, Germany and the UK will be enrolled. A total of
5,000 females identified from the same neighborhood as cases without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
|
| Key Study Endpoints |
Data will be collected by using questionnaires as well as electronic information provided by the cancer registries/tumor centers. The same questionnaires will be used for cases and controls. The participating women will fill in the questionnaires on potential confounders (e.g., life] style related covariates) and exposure to breast implants. Similar questionnaires have been successfully used in previous case]control studies with self]administered questionnaires.
|
| Follow-up Visits and Length of Follow-up |
N/A
|
