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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020056 / PAS002 |
| Date Original Protocol Accepted |
11/17/2006
|
| Date Current Protocol Accepted |
11/17/2006
|
| Study Name |
Core
|
| Device Name |
NATRELLE SILICONE-FILLED BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
715 patients including 455 primary augmentation, 147 revision-augmentation, 98 primary-reconstruction and 15 revision-reconstruction patients.
|
| Actual Number of Sites Enrolled |
23
|
| Patient Follow-up Rate |
The follow-up rates for each cohort varied, but the overall rate was above 65% at Year 10. The follow-up rate was highest in the revision-reconstruction group and lowest in the revision-augmentation group. Specifically, the follow-up rate at Year 10 by cohorts were as follows; 66.8% in the augmentation cohort 63.8% in the revision-augmentation, 75.4% in the reconstruction and 80.0% in the revision-reconstruction cohort.
|
| Final Safety Findings |
The most commonly reported complications for all cohorts include capsular contracture, breast pain, swelling, symmetry, wrinkling and implant malposition. The overall implant rupture rates by patient were 9.5% in the augmentation, 6.3% revision-augmentation, 27.2% in the reconstruction, and 6.7% in the revision-reconstruction cohort. The rate of any reoperation by 10 years post-implant was highest in the reconstruction cohort (71.5%), followed by revision cohorts (46.7% in the revision-reconstruction and 46.0% in the revision-augmentation cohorts), and lowest in the augmentation cohort (36.1%). The most frequently reported reason for reoperation varied with the indication. The most common primary reasons for reoperation were asymmetry, capsular contracture, device rupture, implant malposition, need for biopsy, patient request for style/size change and ptosis. Specifically for the revision-reconstruction patients, nipple complications were reported as the most common reason for reoperation. The incidence of breast implant removal by 10 years post-implant was highest in the reconstruction cohort (53.8%), followed by in the revision-augmentation cohort (32.4%), in the augmentation cohort (18.6%) and in the revision-reconstruction cohort (13.3%). The most common reasons for replacement/removal vary depending on the indication group. The most common reasons for implant replacement and removals are as follow: Asymmetry, capsular contracture, device rupture, implant malposition and patient request for style/size change.
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| Final Effect Findings |
Majority of the patients and physicians were satisfied with the surgical outcome. In the augmentation cohort, the patient and physician satisfaction was 93% and 94%, respectively, 84% and 83% in the augmentation revision cohort, 84% and 86% in the reconstruction cohort, 72% and 80% in the revision-reconstruction cohort
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| Study Strengths & Weaknesses |
One of the study strength is that the study is a prospective, multicenter study that provides long term data up to 10 years on the safety and effectiveness of the device. The weaknesses of the study were the lack of a comparison group and lack of statistical power to detect rare events due to the small sample size
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| Recommendations for Labeling Changes |
The labeling will be updated based on the safety and effectiveness results reported in the final PAS report.
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