In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
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
Reconstruction ¿1 conference with women who have had breast reconstruction ¿1 conference with women who have considered or are considering breast reconstruction Revision ¿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
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.
Followup Visits and Length of Followup
There is no follow-up in the Focus Group Study
Final Study Results
Actual Number of Patients Enrolled
33 (18 in the augmentation group and 15 in the reconstruction group)
Actual Number of Sites Enrolled
Patient Followup Rate
Final 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.
Study Strengths and 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 sponsorfs approved device was collected in the study.