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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070004 / PAS001 |
| Date Original Protocol Accepted |
03/09/2012
|
| Date Current Protocol Accepted |
05/29/2012
|
| Study Name |
Post-Approval PMA Cohorts Study (PACS)
|
| Device Name |
SIENTRA SILICONE GEL 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 |
The Post-approval PMA Cohorts Study (PACS) will continue to follow subjects from premarket cohorts for 10 years in order to assess the long-term clinical performance of the approved device. The PACS data are to be collected via annual physician follow-up evaluations and all patients in the study will have MRI at years 6, 8, and 10.
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| Study Population |
Women who received Sientra' silicone breast implants and were enrolled in the premarket Core Study and reconstruction cohorts of the Continued Access Study. The data obtained at baseline on each subject will be used as the control data for physical status, cancer history and status, rheumatologic history and status, medical history and status, and CTD history and status.
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| Sample Size |
A total of 1,788 subjects have been enrolled in Sientras PACS at 33 sites throughout the United States.
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| Key Study Endpoints |
The safety endpoints include local complications, implant rupture, connective tissue diseases (CTDs), CTD signs and symptoms, lactation complications, cancer and suicide. Effectiveness will be assessed based on quality of life (QOL) assessments and subject satisfaction.
|
| Follow-up Visits and Length of Follow-up |
10 years
Annually
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1,788
Primary augmentation: 1,116
Revision-augmentation: 363
Primary reconstruction: 225
Revision-reconstruction: 84
Number of subjects completed 10-year visit: 1,030
Primary Augmentation: 688 (66.8%)
Revision Augmentation: 192 (18.6%)
Primary Reconstruction: 118 (11.5%)
Revision Reconstruction: 32 (3.1%)
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| Actual Number of Sites Enrolled |
61
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| Patient Follow-up Rate |
At year 10, the overall follow-up rate for the PACS Study was 65%. Follow-up calculations were
based on the following formula: [(“Seen” (Number of Patients Completed Visit) /”Expected”
(Theoretically due – discontinued due to deaths & explants)].
The follow-up rates from year 1 to 10 for primary augmentation are 92%, 84%, 81%, 80%, 78%,
73%, 68%, 60%, 66%, and 67%, respectfully. For revision augmentation the rates are 89%, 85%,
80%, 80%, 76%, 73%, 67%, 57%, 65%, 62%, respectfully
|
| Final Safety Findings |
Deaths
There were 37 known deaths in the PACS study (10 primary augmentation, 4 revisionaugmentation,
15 primary reconstruction, and 9 revision-reconstruction subjects), which is
about 2% of the population. Most are due to cancers (breast, lung, or other cancers) or other
comorbidities, 9 were “unknown”; 7 are from the reconstruction or revision-reconstruction
cohorts, which may be related to either a recurrence or metastasis of their breast cancer.
Suicide
There was one “reported possible suicide” in the primary augmentation cohort.
Local Complications
Besides Baker Grade II capsular contracture, a “mild” event, the most common complication in
the primary augmentation, revision-augmentation and primary reconstruction cohorts was
Baker Grade III/IV capsular contracture (12.9%, 13.7% and 15.8%, respectively). In the revisionreconstruction
cohort, besides Baker Grade II capsular contracture, the most common
complication was asymmetry (16.9%), followed by Baker Grade III/IV capsular contracture
(14.3%).
Implant Rupture
The 10-year risk of rupture for the MRI cohort ranged between 6.8% to 16.5% and for the non-
MRI cohort between 3.5% and 6.6%. The overall risk of rupture at 10 years is 7.9%.
Connective Tissue Diseases (CTD) signs and symptoms
The frequency of each CTD Sign/Symptom stratified by Visit & Age Group are within 5% for the
primary augmentation cohort (max=4.6%) at year 10, and within 10% for the other cohorts
(max=8.3% Revision Reconstruction, max=6.0% Primary Reconstruction, 0.0% Revision
Reconstruction).
Lactation Complications/Pregnancy Difficulties
The incidences of post-operative pregnancy difficulties were 1.7%, 1.7%, 0.9% and 0.0%. The
incidences of post-operative lactation difficulties were 11.5%, 10.6%, 0.0% and 0.0% in the
primary augmentation, revision-augmentation, primary reconstruction and revisionreconstruction
cohorts.
Cancer
The Kaplan Meier risk for breast cancer is 0.6%, 1.6%, 2.9%, and 3.2% for the primary
augmentation cohort, the revision-augmentation cohort, the primary reconstruction cohort,
and the revision-reconstruction cohort, occurring anywhere from one to ten years after
surgery.
Reasons for Reoperation
In the primary-augmentation cohort, the most common reasons for reoperation were capsular
contracture (24.7%), style/size change (20.6%) and ptosis (10.7%). In the revision-augmentation
cohort, the most common reasons remain the same, with style/size change and capsular contracture (17.4% and 16.3%, respectively). In the primary reconstruction cohort, the most
common reasons were style/size change (20.2%) and asymmetry (16.1%). In the revisionreconstruction
cohort, the most common reasons remain the same with asymmetry (23.6%),
capsular contracture (21.8%) and style/size change (16.4%).
Reasons for Explantation/Removal
In the primary augmentation cohort, the most common reasons for explantation were
style/size change (49.1%) and capsular contracture (18.7%). In the revision-augmentation
cohort, the most common reasons were style/size change (43.8%) and capsular contracture
(11.1%). In the primary reconstruction cohort, the most common reasons were style/size
change (36.0%) and asymmetry (16.2%). In the revision-reconstruction cohort, the most
common reasons were style/size change (16.4%), asymmetry (23.6%), and capsular contracture
(21.8%).
Risk Factor Regression Analysis
For all four cohorts, Years of Implantation is associated with increased risk (p value <0.001) for
reoperation and explantation with or without replacement, and for Baker III/IV Capsular
Contracture, statistically significant. Device Surface and Placement were significant for capsular
contracture in primary augmentation, Device Surface was also significant for revision
reconstruction, and Participant’s Age was a risk factor for the revision augmentation cohort. In
|
| Final Effect Findings |
In terms of patient satisfaction at 10 years, overall more than 80% patients feel more feminine
and more attractive, and more than 74% feel better.
The Mean Cup Change (and standard deviation) was 1.6 +/- 7 and circumference increased
about 1-inch post-implant, 35.4 +/- 2.4 vs. 34.2 +/- 2.2. Paired t-test showed both statistically
significant improvements in terms of bra cup size and circumference.
There were no statistically significant changes in the SF-36 Subscale scores compared to the
general female population by the 10-year visit across all four cohorts.
The mean Rosenberg Self-Esteem scale scores and changes were within one point of each other
across all four cohorts, ranging from 25.7 +/- 4.55 to 26.4 +/- 2.91. Specifically, a score of 26.0 +/-
4.34 was observed in the primary augmentation cohort, 25.9 +- 3.95 in the revision
augmentation cohort, 25.7 +/- 4.55 in the primary reconstruction cohort, and 26.4 +/- 2.91 in the
revision reconstruction cohort.
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| Study Strengths & Weaknesses |
The PACS study assessed the continued follow-up of premarket cohorts. The participants were
followed annually for 10 years to assess the long-term clinical performance of the device with acceptable follow-up rates.
The PACS study is limited by its single arm design, i.e. only silicone is used across the four
indication cohorts. In addition, the smaller number of reconstruction and revisionreconstruction
cohort also limits the generalization of its results. Readers should be cautious in
interpreting the data and in making generalizations about the target population because each
of the four cohorts mentioned have a different patient profile, and with that, different levels of
risk.
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| Recommendations for Labeling Changes |
Labeling update is recommended to reflect the long-term safety and effectiveness results
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