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| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P020056 / PAS001 |
| Date Original Protocol Accepted |
11/17/2006
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| Date Current Protocol Accepted |
08/03/2015
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| Study Name |
BIFS (Large PAS)
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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 & 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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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
* NOTE: The PAS001 (BIFS Large PAS) were revised and replaced with two ongoing PASs, i.e. PAS007 (Re-Op Phase, i.e. the NBIR arm selected for Re-Op study), and PAS008 (Natrelle and 410 combined cohort).
55,279
The evaluable subjects by indications are summarized in table below:
Subjects by Indication 39,069 Silicone 14,487 Saline
augmentation 28,365 (72.6%) 13,379 (92.4%)
revision augmentation 5,662(14.5%) 896 (6.2%)
reconstruction 4,386(11.2%) 171 (1.2%)
revision reconstruction 656(1.7%) 41 (0.3%)
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| Actual Number of Sites Enrolled |
873
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| Patient Follow-up Rate |
The follow-up rates from year 1 to 8 are 70.2%, 74.8%, 74.4%, 69.4%, 60.5%, 55.1%, 50.8%, and 63.2% for Silicone cohort, and 46.1%, 53.8%, 60.9%, 58.6%, 52.9%, 46.0%, 42.0%, and 50.0% for Saline cohort, respectively. . Follow-up rate is calculated as [actual observed subjects/(yearly cohort - completed study without data in visit window)].
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| Final Safety Findings |
Deaths
There were 367 deaths (311 silicone and 56 saline) reported, which represents 0.7% of the analyzed population with a calculated event rate of 25 per 10,000 subject years. The most common cause of death was breast cancer (0.2%). Less than 0.1% of subjects in each cohort committed suicide. None of the deaths were related to the implant.
Very rare adverse events
All collected data (including any data on events occurring through Year 7) encompassing a total of > 157,000 observed subject years. For augmentation, reconstruction, and revision-augmentation cohorts, no event rate was twice as high in silicone subjects compared to national norms. Higher standard incidence ratios (SIRs) were observed in the revision-reconstruction cohort for scleroderma, Sjogren’s syndrome, and dermatomyositis/polymyositis.
Rare target adverse events
All collected data (including any data on events occurring through Year 7) encompassing a total of > 157,000 observed silicone subject years and > 14,000 observed saline subject years. No adverse event demonstrated an increased risk (adjusted risk ratios) associated with the NATRELLE Silicone-filled Breast Implants compared to saline breast implants since all the 90% confidence interval included 1.0.
Local complications
The Year 5 Kaplan Meier rates for local complications as well as rates of reoperation and implant removal with and without replacement are compared with Allergan’s Core study. In the Augmentation, Reconstruction, and Revision-Augmentation cohorts, no rate was higher in the BIFS study compared to the Core Study. Higher local complication rates were observed in the Revision-Reconstruction cohort that had smaller sample sizes (699 in BIFS study and 15 in Core study). The Kaplan-Meier estimated cumulative incidence rates at 5 years for less frequent, but severe complications were infection (0.3%-1.9%), rupture (1.4%-2.6%), removal without replacement (1.1%-2.4%). Rheumatologic Signs & Symptoms
There was no clear pattern to reports of rheumatologic signs and symptoms, although there were ~500 possible events in silicone vs less than 5 events occur in saline, and some symptoms occurred more frequently in the silicone cohort compared to the saline cohort, even after an age-adjusted analysis.
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| Final Effect Findings |
A total of 12,758 (32.6%) Silicone subjects and 1,393 (9.6%) saline subjects completed the year 4 questionnaire. On the 100-point BREAST-Q scale, median satisfaction with breasts was 33.3 for both the Silicone and Saline cohorts at baseline and improved to 94.4 in both cohorts at year 1. At year 4, the median satisfaction with breasts decreased slightly to 88.9 for both cohorts.
The medians of psychosocial well-being scores were 66.7 for Silicone and 58.3 for Saline at baseline and improved to 97.2 for each cohort at year 1. At year 4, psychosocial well-being scores were 91.7 for Silicone and 88.9 for saline.
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| Study Strengths & Weaknesses |
Strength:
This is a large cohort study.
Weakness:
The follow-up rates are low (~40-60% from years 5-8) and the percentages of censoring/missing data are high (94% saline and 54% Silicone at year 1). Missing data and/or loss to follow-up introduce study bias and limit the interpretation of the study results.
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| Recommendations for Labeling Changes |
Due to very low follow-up rates after 5 years post-implant, labeling changes are not recommended
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