f Post-Approval Studies (PAS) Database
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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		 P070004 / PAS005
Date Original Protocol Accepted 06/07/2012
Date Current Protocol Accepted 06/07/2012
Study Name Focus Group Study
Device Name SIENTRA SILICONE GEL 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
Detailed Study Protocol Parameters
Study Objectives Focus Group Study
Study Population Women interested in breast augmentation or reconstruction with Sientra Silicone Gel Breast Implants.
Sample Size Four focus groups with 8-10 participants in each group in Los Angeles, CA and Dallas, TX.
Key Study Endpoints Participants¿ answers to the questions regarding the effectiveness of patient labeling in communicating the risks and benefits of breast implant surgery.
Follow-up Visits and Length of Follow-up N/A
N/A
Interim or Final Data Summary
Actual Number of Patients Enrolled 37 (18 in the augmentation group and 19 in the reconstruction group)
Actual Number of Sites Enrolled 2
Patient Follow-up Rate n/a
Final Safety Findings In general, feedback from the four groups was positive and most participants found the

Brochures to be helpful and beneficial in making an informed decision about breast implant surgery. Sientra is proposing revisions to the current Patient Educational Brochures based on comments from the participants. Information will be added to the brochures to guide patients to appropriate resources. In addition, the clinical study results will be updated and data presentation will be restructured with the 5-year follow-up data from the Post-approval PMA Cohort Study
for Sientra¿s Silicone Gel Breast Implants.
Study Strengths & Weaknesses The focus group study is quick, usually inexpensive, and useful in exploring ideas and concepts through group interaction. However, the analysis is qualitative, it is difficult to generalize results if small, unrepresentative samples of participants are used, 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 was collected in the study.


Focus Group Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 03/07/2013 03/08/2013 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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