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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020056 / PAS007 |
| Date Original Protocol Accepted |
01/16/2015
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| Date Current Protocol Accepted |
01/16/2015
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| Study Name |
Re-Op Phase
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| Device Name |
NATRELLE 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 Control
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| Analysis Type |
Descriptive
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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 Re-Op Phase Study requirement was designed as part of the re-design of the LARGE PAS for the Natrelle® Silicone Gel Breast Implant. In this Re-Op Phase, data will be collected when subjects with Natrelle® silicone breast implants have secondary surgical procedures/re-operations. This requirement will serve as a bridge between the Large PAS and NBIR.
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| Study Population |
The NBIR arm consists of subjects implanted with round responsive devices or saline devices who were originally enrolled in the BIFS study but were not selected to remain in the smaller 10-year follow-up cohort study (BIFS arm).
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| Sample Size |
37,390 subjects with Natrelle silicone gel-filled breast implants and 14,995 subjects with saline-filled breast implants.
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| Key Study Endpoints |
Implant removal and reoperation rates; Reasons for reoperation.
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| Follow-up Visits and Length of Follow-up |
The follow-up data will be collected when the participant requires a secondary procedure/reoperation.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
50,584 subjects
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| Actual Number of Sites Enrolled |
953 sites
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| Patient Follow-up Rate |
n/a (no active follow up); follow up for 10 years total
|
| Final Safety Findings |
There were a total of 190 reoperations reported in the NBIR arm of the BIFS-001 Study. In the Silicone cohort, reoperations were reported for 180 subjects (0.5%). In the Saline cohort, reoperations were reported for 10 subjects (<0.1%).
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| Final Effect Findings |
Not assessed
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| Study Strengths & Weaknesses |
Data was passively collected, as there was no active follow up in the study. Patients were only followed up if they required a reoperation. This was only recorded in the study if the patient followed up with the original surgeon and that information was submitted.
- By the end of the study, there were only 318 sites that were active (653 sites were inactive). Approximately 20,000 patients were considered “completed due to site closure.” If the site was closed or inactive, even if a patient received a reoperation, it would not have been reported.
- The reported reoperation rates in this study do not seem to be consistent with other previous studies. Given the passively collected data, this suggests that there is missing data, which is a significant limitation to this study.
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| Recommendations for Labeling Changes |
The significant limitations of the study design given the fact that this was passive surveillance should be mentioned as a caveat of the study data. Interpretation of this study data is limited given the amount of missing data.
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