|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040046 / PAS002 |
| Date Original Protocol Accepted |
02/20/2013
|
| Date Current Protocol Accepted |
|
| Study Name |
Continued Access Study (Natrelle 410 CAS)
|
| Device Name |
NATRELLE HIGHLY COHESIVE 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
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multicenter, prospective, nonrandomized study to evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Full and Moderate Height/Projection Breast Implants in women who have undergone breast implant augmentation, reconstruction, or revision surgery.
|
| Study Population |
Subjects signed informed consent documents and underwent implantation and some follow-up as part of the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study. Subjects who have not yet completed the 5-year timepoint and who are not lost to follow-up will be re-consented to participate in the 410CA-002 Clinical Study.
|
| Sample Size |
The sample size of approximately 3,500 subjects across approximately 110 sites is based on the number of subjects previously enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study who were implanted with NATRELLE® 410 approved implant styles and who have not yet completed the 5-year timepoint nor have been lost to follow-up.
|
| Key Study Endpoints |
At all post-implantation visits, the Investigator will evaluate the occurrence of local complications that occurred between office visits and inquire whether the subject has received a magnetic
resonance imaging (MRI) examination since the last scheduled visit to screen for implant rupture (including the dates of the MRIs), the subject will complete the Activities and Lifestyle questionnaire, the subject and Investigator will assess satisfaction with the implants,
and subjects who have undergone breast augmentation or reconstruction surgery will complete the Quality of Life questionnaire. Breast photographs will be taken at Year 1.
Additionally, a subset of subjects who were enrolled in the serial MRI cohort to evaluate the occurrence of asymptomatic rupture will undergo the final MRI at 5 years post-implantation.
Subjects enrolled in the MRI cohort who have both original study implants removed will not attend any subsequent MRI. Complications, reoperations, explantations, cancer, connective tissue disease (CTD), and reproduction and lactation outcomes will be captured at each study visit, and at any time during the study, as reported.
|
| Follow-up Visits and Length of Follow-up |
Subjects will continue to be evaluated at their remaining follow-up visits 1, 2, and 5 years after primary implant surgery.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 7274 subjects were enrolled who reached the 5-year follow-up window: 3267 Augmentation,
1390 Revision-Augmentation, 1753 Reconstruction, and 864 Revision-Reconstruction.
The serial MRI cohort consisted of 158 subjects: 76 Revision-Augmentation, 37 Reconstruction, and 45
Revision-Reconstruction. There were no Augmentation subjects in the serial MRI cohort.
|
| Actual Number of Sites Enrolled |
52
|
| Patient Follow-up Rate |
At year 5, the follow-up rates by cohort were: 62.3% Augmentation, 54.7% Revision-Augmentation,
48.3% Reconstruction, and 54.7% Revision-Reconstruction.
Year 5 compliance for the MRI cohort was: 55.4% Revision-Augmentation, 55.9% Reconstruction, and
63.6% Revision-Reconstruction.
|
| Final Safety Findings |
Following are the observed Year 5 Kaplan-Meier rates with 95% confidence intervals for key complications at the subject level by cohort:
Augmentation ¿ Reoperation 13.28% (12.06, 14.62); Implant removal with replacement 5.34% (4.55, 6.27); Implant removal without replacement 1.28% (0.93, 1.78); Implant rupture MRI cohort N/A; Implant rupture Non-MRI cohort 0.91% (0.59, 1.38); Capsular contracture, Baker Grade III/IV 3.88% (3.20, 4.70);
Revision-Augmentation ¿ Reoperation 29.29% (26.69, 32.09); Implant removal with replacement 16.78% (14.63, 19.21); Implant removal without replacement 4.42% (3.34, 5.84); Implant rupture MRI cohort 4.75% (1.56, 14.05); Implant rupture Non-MRI cohort 1.73% (0.99,
2.99); Capsular contracture, Baker Grade III/IV 8.70% (7.09, 10.65);
Reconstruction ¿ Reoperation 33.91% (31.38, 36.58); Implant removal with replacement
13.85% (12.04, 15.92); Implant removal without replacement 5.35% (4.24, 6.75); Implant rupture MRI cohort 3.45% (0.49, 22.05); Implant rupture Non-MRI cohort 1.19% (0.66, 2.14); Capsular contracture, Baker Grade III/IV 7.87% (6.42, 9.64);
Revision-Reconstruction ¿ Reoperation 33.79% (30.25, 37.62); Implant removal with replacement 17.16% (14.37, 20.42); Implant removal without replacement 6.49% (4.78, 8.78);
Implant rupture MRI cohort 0% (N/A); Implant rupture Non-MRI cohort 2.53% (1.45, 4.39); Capsular contracture, Baker Grade III/IV 8.89% (6.83, 11.54).
|
| Final Effect Findings |
n/a
|
| Study Strengths & Weaknesses |
The Continued Access Study (CAS) was initiated to allow for continued physician experience with the device before device approval and to collect additional safety data. The post-approval Continued Access Study was designed to evaluate 5-year device safety performance in subjects who underwent implantation and some follow-up as part of the 410 Continued Access (CA) Clinical Study or 410
Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study. The overall patient follow-up rate was 52.8% at Year 5. This follow-up rate limits the interpretation of the available safety results.
|
| Recommendations for Labeling Changes |
No labeling change is recommended at this time. The labeling contains 3, 5, 7 and 10 year data from the extended pivotal cohort study (Core Post-Approval Study).
|
