|
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.
|