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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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Adjunct


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General
Study Status Completed
Application Number P020056 / PAS004
Date Current Protocol Accepted 11/17/2006
Study Name Adjunct
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Interim or Final Data Summary
Actual Number of Patients Enrolled A total of 84, 329 patients were enrolled in the study; 45,055 in the reconstruction cohort and
39,274 in the revision cohort
Actual Number of Sites Enrolled 2,696 sites
Patient Follow-up Rate Reconstruction cohort: 54.3% at Year 1, 29.8% at Year 3, 17.8% at Year 5
Revision cohort: 47.9% at Year 1, 26.1% at Year 3, 15.7% at Year 5
Final Safety Findings The most commonly observed complications in the reconstruction and revision cohorts were capsular contracture, asymmetry, implant palpability/visibility, implant malposition and wrinkling. The cumulative 5-year risk rate for these complications in reconstruction and revision were as follows, respectively; capsular contracture (15.0%, 21.5%), asymmetry (11.1%, 10.6%),
implant palpability/visibility (7.1%, 11.5%), implant malposition (6.5%, 7.1%) and wrinkling (5.6%,
8.9%).

The rate of any reoperation at 5 years post-implantation was 34.4% in the reconstruction cohort and 30.1% in the revision cohort.

The most common reasons by cohort for reoperation were: capsular contracture (30.9%), cosmetic (30.9%), infection (5.1%) in the reconstruction cohort capsular contracture (44.3%), cosmetic (33.6%), and infection (4.8%) in the revision cohort.

The incidence of implant removal with replacement at 5 years post-implantation was 18.6% in the reconstruction cohort and in the revision cohort. The incidence of implant removal without replacement at 5 years post-implantation was 5.1% in the reconstruction cohort and 4.3% in the revision cohort.

The Kaplan-Meier cumulative rupture rates at 5 years were 1.3% in the reconstruction cohort and 1.5% in the revision cohort.
Final Effect Findings For the reconstruction cohort, on a 1 (definitely dissatisfied) to 5 (definitely satisfied) scale, the average satisfaction level for patients and physicians was 4.3-4.4 at each follow-up timepoint. For the revision cohort, the average satisfaction level for patients and physicians was 4.4-4.5 at each follow-up timepoint.
Study 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 follow-up rates of the reconstruction cohort at 1, 3 and 5 years were 54.3%, 29.8%, 17.8%, respectively. The follow-up rates were slightly lower in the revision cohort, i.e., 47.9% at Year 1, 26.1% at Year 3, 15.7% at Year 5. The poor patient compliance provides limited meaningful interpretation of the available safety
results.
Recommendations for Labeling Changes No. The Adjunct Study was designed to address the public health needs of reconstruction and revision patients before device approval. The follow-up rates of the reconstruction cohort and revision cohort were low for the duration of the study. Therefore, there is lack of valuable safety data from the study due to poor patient compliance.


Adjunct Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year adjunct study report 11/17/2007 11/16/2007 On Time
2007 Annual report 02/27/2008 02/27/2008 On Time
Annual PAS report 02/27/2008 02/27/2008 On Time
2 year report 11/16/2008 10/16/2008 On Time
3 year report 11/16/2009 11/12/2009 On Time
4 year report 11/16/2010 11/15/2010 On Time
5 year report 11/16/2011 11/04/2011 On Time
Final Report 02/17/2013 02/11/2013 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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