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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Post-Approval Cont Access Study (PACAS)


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General
Application Number P070004 / PAS002
Current Plan Approved 05/29/2012
Study Name OSB Lead-Post-Approval Cont Access Study (PACAS)
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 Continued Access Study (CAS) was initiated under an FDA-approved investigational device exemption to provide supplemental data to the Core Clinical Study. The PACAS is to continue clinical follow-up of the primary augmentation and revision augmentation subjects previously enrolled in Sientra¿s CAS until each subject reaches her 5th year post-implantation.
Study Population Description Women who received Sientra¿s silicone breast implants and were enrolled in the premarket augmentation 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 2,497 subjects have been enrolled in Sientra¿s PACAS 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 5 years

Annually

Final Study Results
Number of Patients 2,524
Number of Sites 31
Follow-up Rate 48.5% for both primary and revision augmentation cohorts at Year 5
Safety Findings The Kaplan쳌]Meier risk rate of any complication at Year 5 was 34.8% in the primary augmentation cohort and 46.0% in the revision쳌]augmentation cohort.



The most commonly reported complications in the primary augmentation cohort were Baker Grade III/IV capsular contracture and nipple sensation changes (10.0% and 4.6%, respectively). In the revision쳌] augmentation cohort, the most commonly reported complications were Baker Grade III/ IV capsular contracture, implant malposition and nipple sensation changes (13.3%, 5.7% and 5.7% respectively).



The Kaplan쳌]Meier risk rate of reoperation was 20.2% in the primary augmentation cohort and 31.1% in the revision쳌]augmentation cohort.



The Kaplan쳌]Meier risk rate of implant explantation was 10.4% in the primary augmentation cohort and

16.3% in the revision쳌]augmentation cohort.



In the primary augmentation cohort there were four devices confirmed ruptured via explant and one device unconfirmed for a total of five reported ruptures through 5 years. In the revision쳌]augmentation cohort there was one device confirmed ruptured via explant and three devices with unconfirmed ruptures for a total of four reported ruptures through 5 years.



There were no unanticipated adverse device events among the study subjects.

Effect Findings In the primary augmentation cohort, 88.8% of patients increased their bra cup size by at least one cup,

79.2% increased by one to two cup sizes, while 9.5% increased by more than two cup sizes. Only 6.6% of the primary augmentation subjects achieved less than a one쳌]cup size increase.

Strengths & Weaknesses The Continued Access Study (CAS) was designed to provide supplemental safety and effectiveness data

for the premarket clinical study and to address the public health needs before device approval. It was conducted under the same protocol as the premarket clinical study. The subjects from the primary and revision reconstruction cohorts of the CAS were added to the premarket clinical study to support device approval and are now part of the Post쳌]approval PMA Cohort Study that will be followed for 10 years post쳌]implantation. The Post쳌]approval Continued Access Study (PACAS) only includes subjects from primary and revision쳌]augmentation cohorts of the CAS. The overall patient follow쳌]up rate of the PACAS was only 48.5% at Year 5. The low patient compliance significantly limited meaningful interpretation of the available safety results.

Label Changes No labeling change recommended at this time. The labeling will be updated based on the 5쳌]year clinical data from the Post쳌]approval PMA Cohort Study for the same device.


OSB Lead-Post-Approval Cont Access Study (PACAS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 03/09/2013 03/11/2013 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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