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| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P070004 / PAS004 |
| Date Original Protocol Accepted |
03/09/2012
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| Date Current Protocol Accepted |
03/09/2012
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| Study Name |
Post-Approval Case-Control Studies(PACCS)
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| Device Name |
SIENTRA SILICONE GEL BREAST IMPLANTS
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| General Study Protocol Parameters |
| Study Design |
Case Control Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
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 |
The case-control studies will be conducted in metropolitan urban areas of Southern Brazil.
Sientra¿s Silicone Gel Breast Implants have been widely used in Brazil for more than a decade, providing the opportunity to evaluate rare disease outcomes, and its potential association in women with Sientra¿s Implants.
Inclusion criteria for cases:
¿ Between 24 and 70 years of age at the time of enrollment
¿ The rare disease outcomes were identified and/or treated at a clinic collaborating in Sientra¿s post-approval study
Exclusion criteria for cases:
¿ Deceased since diagnosis
¿ Diagnosis prior to March 1997
Inclusion criteria for the controls:
¿ Female
¿ Between 24 and 70 years of age at the time of enrollment
¿ Free from any of the diseases that will be evaluated as part of Sientra¿s post-approval study (i.e., rheumatic disease, neurological diseases, cancers of the cervix or brain, or lymphomas)
¿ Within selected age range of case definitions (frequency matched in 5-year age ranges)
¿ Within the general geographic region from which cases are recruited
¿ Currently a patient at one of the hospitals or clinics that provided cases for the studies.
Exclusion criteria for the controls:
¿ Previous diagnosis of one or more of the conditions of interest (i.e., rheumatic disease, neurological diseases, cancers of the cervix or brain, or lymphomas)
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| Sample Size |
For each of the 5 case-control studies, 1,280 cases of women diagnosed with studied rare disease at medical centers and hospitals in metropolitan urban areas of Southern Brazil will be enrolled. A total of 3,800 female hospital or clinic patients 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 |
During enrollment, each study participant will complete a self-administered questionnaire. Information obtained from both the cases and controls will include the following:
¿ Standard demographic data (e.g., name, mailing address, date of birth, race/ethnicity, marital status, educational attainment, occupation, family income, name of hospital/clinic of enrollment)
¿ Personal characteristics (e.g., menopausal status, smoking status, alcohol consumption, medical/surgical history, hours per day in the sun, sexual history)
¿ Disease/medication history (e.g., previously diagnosed with scleroderma, systemic lupus erythematosus (SLE), Sjogren¿s syndrome, multiple sclerosis, dermatomyositis/polymyositis, brain cancer, cervical/vulvar cancer, or lymphoma, family history of those diseases, previous treatment for any type of cancer with chemotherapy, oral contraceptive use, and previous diagnosis with Epstein-Barr virus, inflammatory bowel disease, HIV/AIDS, hepatitis B, hepatitis C, Helicobacter pylori, Chlamydia, or HPV
¿ Reproductive history (i.e., number of pregnancies, ages of children, maternal age at first birth)
The medical records of each study participant will be reviewed by designated study personnel. The following information will be abstracted from the records of both the cases and controls:
¿ Use of specific prescription medications (specific list to be developed)
¿ Type, date, and results of radiology or imaging
¿ Date of last pap smear
¿ Date of any diagnoses of scleroderma, SLE, Sjogren¿s syndrome, multiple sclerosis, dermatomyositis/polymyositis, brain cancer, cervical/vulvar cancer, or lymphoma
¿ Date of breast implantation, any revisions made to the breast implant, manufacturer and type of breast implant
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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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