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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-Focus Group Study


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General
Application Number P070004 / PAS005
Current Plan Approved 06/07/2012
Study Name OSB Lead-Focus Group Study
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 Design Description Focus Group Study
Study Population Description 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.
Data Collection 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

Final Study Results
Number of Patients 37 (18 in the augmentation group and 19 in the reconstruction group)
Number of Sites 2
Follow-up Rate n/a
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.



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.
Label 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.


OSB Lead-Focus Group Study Schedule

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


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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