|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P030053 / PAS003 |
Date Original Protocol Accepted |
11/17/2006
|
Date Current Protocol Accepted |
11/17/2006
|
Study Name |
Informed Decision Process
|
Device Name |
MEMORYGEL SILICONE GEL -FILLED 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 |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The Informed Decision Process study is a random survey of physicians on an annual basis to determine the success of the informed decision process provided to woman who is seeking breast implants surgery
|
Study Population |
Each year, a random selection of 50 physicians are targeted for a survey to determine the success of the patient informed consent process.
|
Sample Size |
A total of 50 physicians surveyed each year
|
Key Study Endpoints |
Survey is administered to 50 physicians and asks questions on the level of understanding a patient has after consulting the Allergan patient planner.
|
Follow-up Visits and Length of Follow-up |
There are no follow up visits in this study
|
Interim or Final Data Summary |
Interim Results |
There is no interim device safety Information from this study
|
Actual Number of Patients Enrolled |
The Informed Decision Process consisted of yearly surveys. Each year a different sample was selected for the survey. These are the results for 2011 annual report.
54 surveys were returned. Per the condition of approval, the sponsor did administer the survey to a random selection of 50 physicians.
|
Actual Number of Sites Enrolled |
N/A
|
Patient Follow-up Rate |
N/A
|
Final Safety Findings |
N/A
|
Final Effect Findings |
The majority of respondents (94.2%) said the Informed Decision Brochure was of value in helping patients to understand the risks and benefits of implant surgery.
|
Study Strengths & Weaknesses |
The sample of physicians was chosen randomly, which is a strength of the study.
However, the observational, cross-sectional design of the study does not allow for any hypothesis testing. The results are descriptional only.
|
Recommendations for Labeling Changes |
Mentor has no current plans to change the Informed Decision Process based on the survey results.
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