When the system is worn as directed - an average of 10 hours per day over a 10-week period - most women initially experience a doubling of breast volume, followed by a period of reduction in size as swelling diminishes. The increase in breast volume stabilizes with an increase of approximately 100cc or approximately one-cup size. 

The results of the clinical trial, which were presented to the U.S. Food & Drug Administration were as follows: 

NOTE: For the sake of clarity 100cc is roughly equivalent to 1 bra-cup size. 

Peak Growth.  Participants experienced an average volume increase of 161cc per breast at the conclusion of the 10-week period using the BRAVA System. (The range was 114-196cc depending on the individual wear pattern of the device.)

Relative-size Increase.  Depending on the initial size of the breasts, which ranged from 96cc to 282cc, there was an average increase in volume of 100% (range 29-300%) at the conclusion of the effective 10-week wear period. 

Final Growth.  After discontinuing use of the device, women experienced a reduction of breast size from their peak growth, leaving a final volume increase of 104cc (with a range of 34-158cc of growth). This represents approximately a 50% increase in breast from baseline. This correlates to an increase of approximately 1 bra-cup size for all subjects. 

The average difference between the change in chest circumference at the height of the nipple and at the inframammary fold (the crease under the breast) increased by 65% and stabilized on long-term follow-up. 

Satisfaction.  All women were satisfied with the results. Participants believed that their breasts had not only increased in volume but had also been lifted to some extent. All felt more comfortable with their body image and 100% indicated they would recommend the product to a friend. The before and after responses noted on the Satisfaction Questionnaire were highly significant for increased satisfaction in self-esteem. 

Conclusion.  After reviewing the system as a 510(k) Class II Medical Device, the U.S. Food and Drug Administration responded by allowing the sale of the BRAVA System. The system has met all FDA requirements, and the FDA has decided against regulating the system at this time. 

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