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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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Focus Group Study


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General
Study Status Completed
Application Number /
Requirement Number		 P040046 / PAS005
Date Original Protocol Accepted 02/20/2013
Date Current Protocol Accepted  
Study Name Focus Group Study
Device Name NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled A total of 45 subjects. (18 in the augmentation group, 17 in the reconstruction group and 10 in the revision group)
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings In general, both indication specific brochures were well received. Overall, participants found
the booklet easy to comprehend, saying it was organized in a logical way and written in language that was appropriate for the lay reader. As with the indication-specific brochure, the mini brochure was generally rated highly by focus group participants. The reconstruction groups rated it slightly lower than the augmentation groups, because they felt that it was aimed more to augmentation patients
Study Strengths & Weaknesses The focus group study is useful in exploring ideas and concepts through group interaction. However, the analysis is qualitative, it is difficult to generalize results from a small number of participants, and data analysis can be time consuming due to the open-ended nature of questions proposed for the focus group discussion
Recommendations for Labeling Changes No labeling change is recommended. The Focus Group Study was conducted to evaluate Patient Educational Brochures. No safety/effectiveness data of the sponsor¿s approved device were collected in the study. Allergan is considering the aesthetic comments related to photos, colors and font sizes for future labeling updates.


Focus Group Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 06/28/2013 06/28/2013 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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