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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-Core


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General
Application Number P030053 / PAS005
Current Plan Approved 11/17/2006
Study Name OSB Lead-Core
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Core study is a 10-year prospective, open-label, multi-center cohort study to evaluate the safety and effectiveness of MemoryGel breast implants
Study Population Description 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.
Sample Size 1000 patients at up to 40 sites
Data Collection 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.
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
Final Study Results
Interim Safety Information 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.
Number of Patients 1,008
Number of Sites 48
Follow-up Rate 62% at 10 years
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

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.



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.

Label Changes The labeling will be updated based on the 10-year safety and effectiveness results reported in the Core

PAS final report.



OSB Lead-Core Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
CORE 1 year Study Report 11/17/2007 11/16/2007 On Time
CORE 2 Year Study Report 11/16/2008 11/17/2008 Overdue/Received
CORE 3 Year Study Report 12/11/2009 12/14/2009 Overdue/Received
CORE 4 Year Study Report 11/16/2010 11/16/2010 On Time
CORE 5 Year Study Report 11/16/2011 11/17/2011 On Time
CORE 6 Year Study Report - FINAL 11/13/2012 11/13/2012 On Time


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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