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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030053 / PAS005 |
| Date Original Protocol Accepted |
11/17/2006
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| Date Current Protocol Accepted |
11/17/2006
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| Study Name |
Core
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| Device Name |
MEMORYGEL SILICONE GEL -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 |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Core study is a 10-year prospective, open-label, multi-center cohort study to evaluate the safety and effectiveness of MemoryGel breast implants
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| Study Population |
The study populaiton is as per device indication. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast Augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the results of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
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| Sample Size |
1000 patients at up to 40 sites
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| Key Study Endpoints |
Safety endpoints include point prevalence on a per patient and per device basis of rates of occurrence of all adverse events and time to occurrence of the complication; Effectiveness endpoints include patient satisfaction measured by validated quality of life questionnaires and change in breast size measured by both bra and cup size and the chest/bust circumference.
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| Follow-up Visits and Length of Follow-up |
11 follow-up visits (6 months and annually 1-10 years after surgery) during 10 years of study
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| Interim or Final Data Summary |
| Interim Results |
A total of 1,008 female patients (including 552 Augmentation, 145 Revision-Augmentation, 251 Reconstruction, and 60 Revision-Reconstruction patients) were enrolled in the Core study. The overall follow-up rate was 64.4% at 7 years. The top 3 7-year Kaplan-Meier cumulative incidence rates of complications were any operation (19.3%), Baker III, IV capsular contracture (10.3%) and ecxplantation with or without replacement (7.2%) for augmentation patients; any operation (36.9 Baker III, IV capsular contracture (23.3%) and ecxplantation with or without replacement (20.1%) for revision-augmentation patients; any operation (36.8%), ecxplantation with or without replacement (19.8%) and Baker III, IV capsular contracture (14.0%) for reconstruction patients; any operation (38.9 Baker III, IV capsular contracture (29.4%) and ecxplantation with or without replacement (26.0%) for revision-reconstruction patients.
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| Actual Number of Patients Enrolled |
1,008
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| Actual Number of Sites Enrolled |
48
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| Patient Follow-up Rate |
62% at 10 years
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| Final Safety Findings |
For the Primary Augmentation cohort, the 10-year Kaplan-Meier estimated cumulative incidence rates for the key complications at the patient level were: capsular contracture III/IV, 12.1%; infection, 1.6%;
explantation with or without replacement, 11.6%; explantation with replacement with study device, 7.4%;
and any reoperation, 25.5%. The most frequently reported primary reasons for reoperation were capsular contracture II/III/IV (25.4% of reoperations) and breast mass (10.6% of reoperations).
For the Revision-Augmentation cohort, the rates were: capsular contracture III/IV, 24.4%; infection,
1.4%; explantation with or without replacement, 24.1%; explantation with replacement with study device,
13.6%; and any reoperation, 43.6%. The most frequently reported primary reason for reoperation was capsular contracture II/III/IV (30.4% of reoperations).
For the Primary Reconstruction cohort, the rates were: capsular contracture III/IV, 20.5%; infection,
6.2%; explantation with or without replacement, 33.4%; explantation with replacement with study device,
19.8%; and any reoperation, 49.0%. The most frequently reported primary reasons for reoperation were asymmetry (16.6% of reoperations), capsular contracture II/III/IV (14.0% of reoperations), rupture (12.7% of reoperations), and breast mass (10.8% of reoperations).
For the Revision-Reconstruction cohort, the rates were: capsular contracture III/IV, 36.9%; infection, 0%;
explantation with or without replacement, 37.8%; explantation with replacement with study device,
24.8%; and any reoperation, 50.7%. The most frequently reported primary reasons for reoperation were capsular contracture II/III/IV (23.4% of reoperations) and breast mass (12.8% of reoperations).
Overall, the most frequently reported reasons for explantation through 10 years were size change, capsular contracture II/III/IV, and rupture. Based on the MRI cohort, the overall Kaplan-Meier estimated cumulative rupture rates at 10 years were 27.9% and 18.5% for patients and implants, respectively
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| Final Effect Findings |
The overall mean changes in circumferential chest size were positive and statistically significant. The overall mean bra cup size increase from baseline across all follow-up visits was 1.8 cup sizes and was statistically significant. At the 10-year follow-up visit, overall 97.6% of patients indicated they would make the same decision to have breast implant surgery.
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| Study Strengths & Weaknesses |
One of the study strengths 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 10-year safety and effectiveness results reported in the Core
PAS final report.
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