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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-Natrelle and 410 Combined Cohort


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General
Application Number P040046 / PAS003
Current Plan Approved 08/25/2016
Study Name OSB Lead-Natrelle and 410 Combined Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is designed to address postmarket questions for both Natrelle (P020056) and Natrelle 410 (P040046) silicone breast implants. The objectives of the study are to compare Round Responsive and Style 410 implants with saline implants or national norms in regard to long쳌]term safety (including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problem, effects on mammography, effects on satisfaction with breasts and psychosocial well쳌] being, and silicone subject compliance with magnetic resonance imaging (MRI) recommendations. This is a prospective observational study comparing targeted safety outcomes of subjects who elect to receive 1 or 2 Round Responsive implants or 1 or 2 Style 410 implants to national norms or those of a control group of women receiving saline breast implants.
Study Population Description Study Population

Subjects who have received Allergan silicone gel-filled breast implants or saline implants will be eligible to participate in the study.



INCLUSION:

Subjects must meet all of the following inclusion criteria at the time of surgery:

1) Female, age 18 years or older (age 22 or older for breast augmentation subjects)

2) Exhibit fluency and literacy in English or Spanish



EXCLUSION:

Subjects who meet any of the following criteria are not eligible for enrollment in the study:

1) Are transgender

2) If a saline implant subject, have a current or past unilateral or bilateral silicone gel-filled breast implant

3) Investigator decision that subject is not a suitable candidate for a long-term observational study



CONTINUATION (BIFS ARM ONLY):

Subjects are eligible to continue in the BIFS arm if they meet all of the following criteria:

1) Have complete baseline and years 1, 2, 3, and 4 follow-up questionnaires available (including the Satisfaction with Breasts and Psychosocial Well-Being modules of the BREAST-Q). Saline reconstruction and revision reconstruction do not need to have complete BREAST-Q questionnaires at baseline.

2) Meet all enrollment criteria, specifically the minimum age requirements for silicone implants (18 or older for reconstruction subjects and 22 or older for augmentation subjects), and were free of all target diseases at baseline

3) Are enrolled at a site that is selected in the cluster sampling to continue in the BIFS arm under Amendment 5.

Sample Size 2,000 subjects with Allergan Round Responsive silicone gel filled breast implants and 245 subjects with saline implants selected from the Breast Implant Follow-up Study (BIFS) cohorts, and 530 newly enrolled Style 410 highly cohesive silicone breast implants.



The BIFS continuation arm will be targeted to include 20 saline revision augmentation, 11 saline reconstruction, and 11 saline revision-reconstruction subjects. If the cluster sampling results in insufficient subjects from these groups, additional subjects (who would otherwise not qualify for the BIFS arm) will be selected from continuing sites at random to meet the targets.

Data Collection Adverse events (including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problem, effects on mammography, effects on satisfaction with breasts and psychosocial well쳌]being, and silicone subject compliance with MRI recommendations.
Follow-up Visits and Length of Follow-up 10 years.

Subject questionnaire will be collected annually. Office visits at Year 1, 4 and 10 for participants enrolled in the device group.


OSB Lead-Natrelle and 410 Combined Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/21/2013 08/20/2013 On Time
one year report 02/20/2014 02/18/2014 On Time
18 month report 08/27/2014 08/27/2014 On Time
two year report 02/20/2015 02/20/2015 On Time
6 month report (new study) 02/03/2016 02/03/2016 On Time
1 year report 08/03/2016 08/02/2016 On Time
18 month report 02/03/2017    
2 year report 08/03/2017    


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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