Articles

Safety was assessed by looking at rates of complications for all subjects and MRI data on a limited cohort of patients to evaluate asymptomatic device rupture. Effectiveness was assessed by the examination of breast dimensions, patient satisfaction and Quality of Life measures. The study enrolled 494 patients undergoing breast augmentation with 987 devices, 221 patients undergoing breast reconstruction with 361 devices and 226 patients undergoing implant revision with 432 devices.
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