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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


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General
Application Number P020056 / PAS004
Current Plan Approved 11/17/2006
Study Name OSB Lead-Adjunct
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective study cohort to continue the follow-up of premarket cohort to evaluate the long term safety and effectiveness
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. Study includes women who received the device while undergoing reconstruction or revision between 1998 and November 17, 2006 are being followed through their 5th post-surgery year and evaluated at 1, 3, and 5 years to assess satisfaction and occurrence of local complications.
Sample Size Between study start in 1998 and device approval in November 2006, there were 43,384 reconstruction patients and 38,653 revision patients enrolled
Data Collection Primary objectives are to evaluated and estimate the rates of local complications (for example, capsular contracture, pain, implant rupture, seromas, and hematomas), and reoperations, and other longer term outcomes (connective tissue diseases, rheumatological signs and symptoms, neurological diseases, neurological signs and symptoms, specific health problems in the children born to women receiving Allergan Natrelle silicone gel filled breast implants, miscarriages and stillbirths, problems with lactation, cancer, and suicide through scheduled follow up visits. Other objectives include estimating the rate of rupture with mammography, potential interference of breast implant with timing of breast cancer diagnosis, and compliance with the recommended schedule for MRI screening for implant rupture.
Follow-up Visits and Length of Follow-up There are 3 scheduled follow up visits at 1, 3 and 5 years. Length of follow up is 5 years.
Final Study Results
Interim Safety Information 5 year reoperation rate is approximately 20% for each cohort of women. This may be important to monitor in the future.
Number of Patients A total of 84, 329 patients were enrolled in the study; 45,055 in the reconstruction cohort and

39,274 in the revision cohort

Number of Sites 2,696 sites
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

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.

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.
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.

Label 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.


OSB Lead-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
Annual PAS report 02/27/2008 02/27/2008 On Time
2007 Annual 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

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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