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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-Adjunct Study


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General
Application Number P030053 / PAS004
Current Plan Approved 11/17/2006
Study Name OSB Lead-Adjunct Study
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 Adjunct study is a 5-year study, in which patients will be followed at 1, 3, and 5 years postoperatively to assess satisfaction and occurrence of local complications.
Study Population Description The study population 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 number of study sites: 2,958; 12,811 reconstruction patients were implanted with 23,090 implants
Data Collection Safety endpoints include clinical complications such as infection, seroma, implant rupture and capsular contracture at 1 ,3, 5 years of follow-up and rheumatologic/immunologic symptoms and connective tissue disorders at 3, 5 years of follow-up
Follow-up Visits and Length of Follow-up 3 follow-up visits during 5 years of study (1, 3, 5 years post-implantation)
Final Study Results
Interim Safety Information A total of 136,609 patients implanted with MemoryGel breast implants for reconstruction and revision-reconstruction were enrolled in the Adjunct study. The overall patient follow-up rates at 1, 3 and 5 years were 35.7%, 24.0% and 16.0% respectively.
Number of Patients 147,585
Number of Sites 4,684
Follow-up Rate 44.0% at 1 year, 24.7% at 3 years, 13.8% at 5 years
Safety Findings The 3 most commonly reported complications using the Kaplan-Meier cumulative incidence estimates at

5 years were: asymmetry (18.6%), wrinkling (9.9%), and Capsular Contracture, Baker III/IV (8.3%) in the Reconstruction Cohort; asymmetry (23.7%), wrinkling (14.3%), and Capsular Contracture, Baker III/IV (11.7%) in the Revision-Reconstruction Cohort; wrinkling (12.3%), asymmetry (11.4%), and Capsular Contracture, Baker III/IV (9.2%) in the Revision- Augmentation Cohort.



The most common reasons by cohort for removal were: capsular contracture (36.4%), infection

(13.2%), and patient request for size and implant change (10.5%) in the Reconstruction Cohort;



capsular contracture (37.4%), leakage/rupture/ deflation (12.2%), and infection (11.5%) in the Revision-Reconstruction Cohort; capsular contracture (36.1%), leakage/rupture/ deflation (16.1%), and patient request for size and implant change (10.3%) in the Revision-Augmentation Cohort.



The Kaplan-Meier cumulative rupture rates at 5 years were: 1.8% in the Reconstruction Cohort; 3.6%

in the Revision-Reconstruction Cohort; 3.5% in the Revision-Augmentation Cohort.



Bilateral implantation, white, infra-mammary surgical approach and sub-glandular surgical approach showed a higher risk of rupture, and reconstruction, smooth surface implant, high profile implant, high education and sub-muscular surgical placement showed a lower risk of rupture.



Rheumatoid arthritis was the most common patient-reported rheumatic disease at 0.6%. Fibromyalgia and Raynaud's phenomenon were the most commonly reported rheumatic syndromes at 0.8% and 0.5% respectively.

Effect Findings N/A
Strengths & Weaknesses A large number of patients were enrolled in the adjunct study. However, the study was originally

designed to address the public health needs of reconstruction and revision patients before device approval and to gather safety data regarding short-term post-implant complications under a limited clinical protocol without follow-up goals. The overall patient follow-up rates at 1, 3 and 5 years in this final report were only 44.0%, 24.7% and 13.8% respectively. The poor patient compliance significantly limited meaningful interpretation of the available safety results.

Label Changes No


OSB Lead-Adjunct Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 11/16/2008 11/12/2008 On Time
3 year report 11/16/2009 11/12/2009 On Time
4 year report 11/16/2010 11/04/2010 On Time
5 year report 11/16/2011 11/04/2011 On Time
final report 11/02/2012 11/02/2012 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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