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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 Study

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Study Status Completed
Application Number P040046 / PAS001
Date Current Protocol Accepted 02/20/2013
Study Name Core Study
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
Interim or Final Data Summary
Actual Number of Patients Enrolled 941 patients including 492 primary augmentation, 156 revision- augmentation, 225 primary reconstruction and 68 revision-reconstruction.
Actual Number of Sites Enrolled 47
Patient Follow-up Rate The follow-up rate at 10 year was highest in the reconstruction group and lowest in the revision-augmentation group. Specifically, the follow-up rate at Year 10 by cohorts were as follows: 66% in the augmentation cohort, 55% in revision-augmentation, 81% in the reconstruction and 77% in the revision-reconstruction.
Final Safety Findings The most commonly reported complications vary by the indication group. The most commonly reported complications at 10 years by indication group are as follow: Augmentation cohort: Capsular contracture (9.2%), implant malposition (4.7%), breast pain (4.5%) and swelling (4.0%); Revision-augmentation cohort: Capsular contracture (11.9%), implant malposition (9.1%), asymmetry (6.9%) and breast pain (5.2%); Reconstruction cohort: Capsular contracture (14.5%), asymmetry (12.4%), breast pain (8.2%) and wrinkling/rippling (6.2%); Revision-reconstruction: Capsular contracture (26.8%), asymmetry (17.4%), wrinkling/rippling (12.8%) and infection (8.5%);

The overall implant rupture rates at 10 years by patient were 11.9% in the augmentation, 13.0% in the revision-augmentation, 8.5% in the reconstruction, and 9.7% in the revision-reconstruction cohorts.

The rate of any reoperation by 10 years post-implant was highest in the reconstruction cohort (54.6%), followed by revision cohorts (48.5% in the revision-reconstruction and 47.3% in the revision- augmentation cohorts), and lowest in the augmentation cohort (29.7%). 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, hematoma/seroma, infection, scarring and ptosis.

The incidence of breast implant removal by 10 years post-implant was highest in the revision- reconstruction cohort (42.4%), followed by reconstruction cohort (38.3%), revision-augmentation cohort (31.0%) and the augmentation cohort (19.6%). The most common reasons for replacement/removal
vary depending on the indication group. The most common reasons for implant replacement and removals are as follows: asymmetry, capsular contracture, device rupture, implant malposition and patient request for style/size change.
Final Effect Findings The majority of the patients and physicians were satisfied with the surgical outcome at 10 years. In the augmentation cohort, the patient and physician
satisfaction was 95% and 96%, respectively, 86% and 85% in the augmentation-revision cohort, 92% and
91% in the reconstruction cohort, 78% and 80% in the revision-reconstruction cohort.
Study Strengths & Weaknesses One of the study strengths is that the study was 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 Yes. The labeling will be updated based on the safety and effectiveness results reported in the final PAS report since these results will provide patients and physicians with long term data (10-years) on the performance of the device.

Core Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
final report 05/20/2013 05/15/2013 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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