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| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P060028 / PAS004 |
| Date Original Protocol Accepted |
06/14/2013
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| Date Current Protocol Accepted |
06/14/2013
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| Study Name |
Breast Implant Case-Control Studies
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| Device Name |
MENTOR MEMORYSHAPE BREAST IMPLANTS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent & Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| 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, NBIR, PROFILE).
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| 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 cases.
Inclusion criteria for cases:
¿Alive at the time of enrollment
¿Between 22 and 60 years of age at the time of enrollment
¿Identified with one of the ICD10 codes included in the protocol for the 5 studied diseases
¿Valid histological or staging information (for cases with brain cancer, cervical/vulvar cancer and lymphoma
Exclusion criteria for cases:
¿Women with a history of malignancy, connective tissue disease or neurological disease at the time of diagnosis
Women who either refuse to give permission to use their registry information, or do not live in the respective country or do not speak English, Danish or German, respectively
Inclusion criteria for the controls:
¿Between 22 and 60 years of age at the time of enrollment
¿Willing to provide the necessary information on their medical history (including the exposure to breast implants) and potential confounders
Exclusion criteria for cases:
¿Women who either refuse to give permission to use their registry information, or do not live in the respective country or do not speak English, Danish or German, respectively
¿Women with a history of any condition studied in the array of five case-control studies.
¿Women who provide unclear information that cannot be clarified by the interviewers
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| 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.
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| 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.
The documented information will include:
-Country code
-Study site number
-Case/control ID number
-Date of birth
-Age at menarche
-History of pregnancies
-Regular menstrual bleeding
-Start of menopause
-History of breast implant
-Reason for breast implant (cosmetic, reconstruction, other)
-Names, types, and dates for breast implants
-Reasons for switch or stop of breast implant
-History of hormonal contraception
-History of hormone replacement therapy
-History of infection with HIV, Helicobacter pylori, or EBV
-Frequency of routine medical check-up in the decade before diagnosis of rare disease studied
-Number of lifetime x-rays, including computerized tomography
-Staging and histological information on lymphoma
-Date of lymphoma diagnosis
-History of other cancer
-History of other severe diseases
-History of treatment with immunosuppressive drugs
-Family history lymphoma
-Marital status
-Educational level achieved
-Professional exposure to radiation
-Postal code as proxy for size of town or city
-Body height
-Body weight
-Smoking status
-Alcohol consumption
-Level of physical exercise
-Date of completion of questionnaire
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| Follow-up Visits and Length of Follow-up |
There is no follow-up for case-control studies.
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