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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Core


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General
Study Status Completed
Application Number P020056 / PAS002
Date Current Protocol Accepted 11/17/2006
Study Name Core
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Interim or Final Data Summary
Actual Number of Patients Enrolled 715 patients including 455 primary augmentation, 147 revision-augmentation, 98 primary-reconstruction and 15 revision-reconstruction patients.
Actual Number of Sites Enrolled 23
Patient Follow-up Rate The follow-up rates for each cohort varied, but the overall rate was above 65% at Year 10. The follow-up rate was highest in the revision-reconstruction group and lowest in the revision-augmentation group. Specifically, the follow-up rate at Year 10 by cohorts were as follows; 66.8% in the augmentation cohort 63.8% in the revision-augmentation, 75.4% in the reconstruction and 80.0% in the revision-reconstruction cohort.
Final Safety Findings The most commonly reported complications for all cohorts include capsular contracture, breast pain, swelling, symmetry, wrinkling and implant malposition. The overall implant rupture rates by patient were 9.5% in the augmentation, 6.3% revision-augmentation, 27.2% in the reconstruction, and 6.7% in the revision-reconstruction cohort. The rate of any reoperation by 10 years post-implant was highest in the reconstruction cohort (71.5%), followed by revision cohorts (46.7% in the revision-reconstruction and 46.0% in the revision-augmentation cohorts), and lowest in the augmentation cohort (36.1%). The most frequently reported reason for reoperation varied with the indication. The most common primary reasons for reoperation were asymmetry, capsular contracture, device rupture, implant malposition, need for biopsy, patient request for style/size change and ptosis. Specifically for the revision-reconstruction patients, nipple complications were reported as the most common reason for reoperation. The incidence of breast implant removal by 10 years post-implant was highest in the reconstruction cohort (53.8%), followed by in the revision-augmentation cohort (32.4%), in the augmentation cohort (18.6%) and in the revision-reconstruction cohort (13.3%). The most common reasons for replacement/removal vary depending on the indication group. The most common reasons for implant replacement and removals are as follow: Asymmetry, capsular contracture, device rupture, implant malposition and patient request for style/size change.
Final Effect Findings Majority of the patients and physicians were satisfied with the surgical outcome. In the augmentation cohort, the patient and physician satisfaction was 93% and 94%, respectively, 84% and 83% in the augmentation revision cohort, 84% and 86% in the reconstruction cohort, 72% and 80% in the revision-reconstruction cohort
Study Strengths & Weaknesses One of the study strength 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
Recommendations for Labeling Changes The labeling will be updated based on the safety and effectiveness results reported in the final PAS report.


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 Report 11/16/2008 11/14/2008 On Time
CORE 3 year Report 11/16/2009 11/16/2009 On Time
CORE 4 year Report 11/16/2010 11/12/2010 On Time
CORE 5 year Report & Final Report 11/16/2011 08/26/2011 On Time
response to R43 RDEF & Final Report 03/17/2012 03/15/2012 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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