|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020056 / PAS004 |
| Date Original Protocol Accepted |
11/17/2006
|
| Date Current Protocol Accepted |
11/17/2006
|
| Study Name |
Adjunct
|
| 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 |
Descriptive
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 84, 329 patients were enrolled in the study; 45,055 in the reconstruction cohort and
39,274 in the revision cohort
|
| Actual Number of Sites Enrolled |
2,696 sites
|
| Patient Follow-up Rate |
Reconstruction cohort: 54.3% at Year 1, 29.8% at Year 3, 17.8% at Year 5
Revision cohort: 47.9% at Year 1, 26.1% at Year 3, 15.7% at Year 5
|
| Final Safety Findings |
The most commonly observed complications in the reconstruction and revision cohorts were capsular contracture, asymmetry, implant palpability/visibility, implant malposition and wrinkling. The cumulative 5-year risk rate for these complications in reconstruction and revision were as follows, respectively; capsular contracture (15.0%, 21.5%), asymmetry (11.1%, 10.6%),
implant palpability/visibility (7.1%, 11.5%), implant malposition (6.5%, 7.1%) and wrinkling (5.6%,
8.9%).
The rate of any reoperation at 5 years post-implantation was 34.4% in the reconstruction cohort and 30.1% in the revision cohort.
The most common reasons by cohort for reoperation were: capsular contracture (30.9%), cosmetic (30.9%), infection (5.1%) in the reconstruction cohort capsular contracture (44.3%), cosmetic (33.6%), and infection (4.8%) in the revision cohort.
The incidence of implant removal with replacement at 5 years post-implantation was 18.6% in the reconstruction cohort and in the revision cohort. The incidence of implant removal without replacement at 5 years post-implantation was 5.1% in the reconstruction cohort and 4.3% in the revision cohort.
The Kaplan-Meier cumulative rupture rates at 5 years were 1.3% in the reconstruction cohort and 1.5% in the revision cohort.
|
| Final Effect Findings |
For the reconstruction cohort, on a 1 (definitely dissatisfied) to 5 (definitely satisfied) scale, the average satisfaction level for patients and physicians was 4.3-4.4 at each follow-up timepoint. For the revision cohort, the average satisfaction level for patients and physicians was 4.4-4.5 at each follow-up timepoint.
|
| Study Strengths & Weaknesses |
A large number of patients were enrolled in the adjunct study. However, the study was originally designed to address the public health needs of reconstruction and revision patients before
device approval and to gather safety data regarding short-term post-implant complications under a limited clinical protocol without follow-up goals. The follow-up rates of the reconstruction cohort at 1, 3 and 5 years were 54.3%, 29.8%, 17.8%, respectively. The follow-up rates were slightly lower in the revision cohort, i.e., 47.9% at Year 1, 26.1% at Year 3, 15.7% at Year 5. The poor patient compliance provides limited meaningful interpretation of the available safety
results.
|
| Recommendations for Labeling Changes |
No. The Adjunct Study was designed to address the public health needs of reconstruction and revision patients before device approval. The follow-up rates of the reconstruction cohort and revision cohort were low for the duration of the study. Therefore, there is lack of valuable safety data from the study due to poor patient compliance.
|
