BRAVA

Description of Event or Problem

RPTR HAS MONITORED THE BRAVA BREAST ENHANCEMENT DEVICE ON 5 PTS. 2 REPORTED SOME ENHANCEMENT, 1 REPORTED NO CHANGE, 1 REPORTED AN ALLERGIC REACTION (REDNESS, ITCHING) ALL OVER THE UPPER HALF OF BODY AND ONE REPORTS ACTUAL SCARRING ON BREASTS FROM THE INTENDED "TISSUE EXPANSION" OF THE MACHINE. DEVICE IS USED EXTERNALLY USING A SUCTION APPARATUS WHICH IS PLACED OVER THE PT'S BREASTS. BRAVA, LLC, TELLS RPTR THAT THEY HAVE FDA APPROVAL FOR THE DEVICE, BUT THEY ARE BALKING ON REFUNDING ANY MONEY TO THE INJURED PT. RPTR HAS DISCONTINUED USE AND PROMOTION OF THE DEVICES.