Clinical outcomes (MACE).
breast band or fixture, damages
EVENTS
MACE denotes Major Adverse Cardiovascular Events.There were 7 device defects occurred during the treatment period (6 in the LIPUS group and 1 in the placebo group), which were immediately repaired. All of the device defects were damage of breast band or fixture which fix the probe with breast band. In this trial, there were no serious health damages related to the LIPUS therapy.