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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P040046 / PAS003 |
| Date Original Protocol Accepted |
02/20/2013
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| Date Current Protocol Accepted |
07/26/2021
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| Study Name |
Natrelle and 410 Combined Cohort
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| Device Name |
NATRELLE HIGHLY COHESIVE SILICONE-FILLED 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 |
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 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 Combined Cohort study was designed as part of the re-design of the LARGE PAS. This is a smaller cohort study to primarily address safety outcomes (i.e., including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problems, effects on mammography, effects on patient satisfaction with breasts and psychosocial well-being, and silicone subject compliance with magnetic resonance imaging (MRI) recommendations. This re-structured PAS, once completed as designed, would satisfy the post-approval requirements for both the Natrelle® (P020056) and Natrelle® 410 (P040046) silicone breast implants. The Round Responsive and Style 410 implants will be compared with saline implants or national norms.
In addition, information gained from the NBIR will help strengthen the general understanding of implantation rates and certain risks associated with breast implants.
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| Study Population |
Study Population
Subjects who have received Allergan silicone gel-filled breast implants or saline implants will be eligible to participate in the study.
INCLUSION:
Subjects must meet all of the following inclusion criteria at the time of surgery:
1) Female, age 18 years or older (age 22 or older for breast augmentation subjects)
2) Exhibit fluency and literacy in English or Spanish
EXCLUSION:
Subjects who meet any of the following criteria are not eligible for enrollment in the study:
1) Are transgender
2) If a saline implant subject, have a current or past unilateral or bilateral silicone gel-filled breast implant
3) Investigator decision that subject is not a suitable candidate for a long-term observational study
CONTINUATION (BIFS ARM ONLY):
Subjects are eligible to continue in the BIFS arm if they meet all of the following criteria:
1) Have complete baseline and years 1, 2, 3, and 4 follow-up questionnaires available (including the Satisfaction with Breasts and Psychosocial Well-Being modules of the BREAST-Q). Saline reconstruction and revision reconstruction do not need to have complete BREAST-Q questionnaires at baseline.
2) Meet all enrollment criteria, specifically the minimum age requirements for silicone implants (18 or older for reconstruction subjects and 22 or older for augmentation subjects), and were free of all target diseases at baseline
3) Are enrolled at a site that is selected in the cluster sampling to continue in the BIFS arm under Amendment 5.
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| Sample Size |
2,000 subjects with Allergan Round Responsive silicone gel filled breast implants and 245 subjects with saline implants selected from the Breast Implant Follow-up Study (BIFS) cohorts, and 530 newly enrolled Style 410 highly cohesive silicone breast implants.
The BIFS continuation arm will be targeted to include 20 saline revision augmentation, 11 saline reconstruction, and 11 saline revision-reconstruction subjects. If the cluster sampling results in insufficient subjects from these groups, additional subjects (who would otherwise not qualify for the BIFS arm) will be selected from continuing sites at random to meet the targets.
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| Key Study Endpoints |
Adverse events (including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problem, effects on mammography, effects on satisfaction with breasts and psychosocial well쳌]being, and silicone subject compliance with MRI recommendations.
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| Follow-up Visits and Length of Follow-up |
10 years.
Subject questionnaire will be collected annually. Office visits at Year 1, 4 and 10 for participants enrolled in the device group.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
60 sites currently active – 10 in 410-arm
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| Actual Number of Sites Enrolled |
A total of 531 subjects are enrolled in the 410-arm, including 470 prospectively enrolled subjects and 61 retrospectively enrolled subjects. By surgical indication, there are 267 augmentation subjects, 185 reconstruction subjects, 42 revision-augmentation subjects, and 37 revision-reconstruction subjects. A control group of 257 saline subjects were used for comparison to the 410-arm (silicone group).
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| Patient Follow-up Rate |
Compliance with completing the annual questionnaire at Years 1, 2 and 3 was 67.7%, 57.4%, and 45.2%, respectively.
Interim compliance with the Year 4, 5, 6, and 7 questionnaires
were 49.1%, 46.5%, 46.6%, and 39.4% respectively.
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