At a national level of 15%, the reoperation rate following augmentation mammaplasty is too
high. We are conducting a survey to examine the pre-operative methods by which plastic
surgeons determine implant volume, size, shape and location; and to determine if the Mentor
"BodyLogic"TM System can successfully improve outcomes. We will evaluate how measurements
taken using "BodyLogic"TM influence choice of implant and whether there are any
re-operations, particularly for size change. We hypothesize that using this system will help
surgeons choose appropriate implants that will decrease the rate of reoperations, especially
for size change.
We are planning to survey 10 high volume plastic surgeons that perform at least 10 breast
augmentations a month and to collect data on at least 300 patients. The enrollment period
will be 3 months.
As part of this study, we are having the following steps performed:
1. Complete a 'general preference questionnaire', designed to document current
preoperative planning and assessment methods for breast augmentation.
2. For each study patient, a pre-operative "BodyLogic"TM worksheet will be completed.
Then, using the provided Implant Selection Booklet, the actual implant will be
selected. The surgeon will maintain a key of the patients, and will identify them to
the investigators only by subject number, and return these forms in provided stamped,
3. The patient returns at 1-3 months and 8-12 months for completion of the respective
"Body-Logic" post-operative worksheets for each visit and the surgeon will send us the
data in the provided envelopes periodically.
4. If during the course of the data collection, the surgeon has to re-operate on any
patient, he/she will fill the "re-operative form" and send it to us.
5. Finally, the surgeon will complete a post-study evaluation questionnaire to help us
understand how the "BodyLogic"TM System worked for him/her and how it could be
- Female (age > 22 years)
- Cosmetic Breast Augmentation only
- Primary breast augmentation
- Breast reconstruction
- Secondary breast augmentation
- <22 years of age