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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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Application Number P060028 / PAS005
Current Plan Approved 06/14/2013
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the Focus Group Study is to evaluate the patient informed decision brochure and ensure that the consumer information for Memory Shape Breast Implant meets patients and FDA¿s requirements.

The focus group will be conducted in person, rather than on the telephone with a moderator in the room.

Study Population Description Women who have had breast reconstruction or breast augmentation or currently considering breast implant revision. At least 20% of participants should be non-Caucasian. For augmentation groups, at least 50% of participants must be between ages 25 to 35 years old.
Sample Size Five in-person focus groups will be conducted (minimum eight respondents per conference): Augmentation

¿1 conference with women who have had breast augmentation

¿1 conference with women who have considered or are considering breast augmentation


¿1 conference with women who have had breast reconstruction

¿1 conference with women who have considered or are considering breast reconstruction


¿1 conference with women who currently have breast implants and are considering or may have considered revision surgery to replace one or both of their implants

Data Collection The study will employ two methods of data collection, focus groups and a self-administered survey, to capture both group-level and individual-level data.

A moderator will lead each group using discussion guide. Throughout the discussion, the moderator will pay attention to any unintended effects of the materials¿ content, particularly if respondents have any perceptions or beliefs that are inconsistent with the facts included in the patient educational material. Additionally, the moderator will probe for reactions to the sequencing of information, layout and format, and the effectiveness and clarity of data displays and other visual aids.

Respondents will also complete a self-administered survey designed to yield individual-level data on a number of critical questions. The survey will be designed to measure how well respondents¿ comprehended key information from the patient educational material, specifically what was learned in terms of the risks and benefits of receiving breast implants.

Follow-up Visits and Length of Follow-up There is no follow-up in the Focus Group Study

Final Study Results
Number of Patients 33 (18 in the augmentation group and 15 in the reconstruction group)
Number of Sites 7
Follow-up Rate N/A
Safety Findings Overall reactions to the patient educational materials are generally positive. Respondents in both the augmentation and reconstruction groups agree that the Patient Educational Brochure is relevant and clear. The study participants also offered suggestions for improving the materials.
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fs approved device was collected in the study.

OSB Lead-Focus Group Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final report 03/21/2014 03/14/2014 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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