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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Post-Approval PMA Cohorts Study (PACS)


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General
Study Status Progress Adequate
Application Number P070004 / PAS001
Date Current Protocol Accepted 05/29/2012
Study Name Post-Approval PMA Cohorts Study (PACS)
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 Design Description 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.
Study Population Description Women who received Sientra¿s 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.
Sample Size A total of 1,788 subjects have been enrolled in Sientra¿s PACS at 33 sites throughout the United States.
Data Collection 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

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%)
Actual Number of Sites Enrolled 61
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
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 f
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.
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.
Recommendations for Labeling Changes Labeling update is recommended to reflect the long-term safety and effectiveness results


Post-Approval PMA Cohorts Study (PACS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/07/2012 09/07/2012 On Time
one year report 03/09/2013 03/12/2013 Overdue/Received
two year report 03/09/2014 03/07/2014 On Time
three year report 03/09/2015 03/10/2015 Overdue/Received
four year report 03/08/2016 03/07/2016 On Time
five year report 03/08/2017 03/03/2017 On Time
Final Report 03/09/2018 03/08/2018 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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