Establishment Labs Holdings Inc. announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants. This approval covers both primary and revision breast augmentation procedures in the United States.
This marks a transformative moment for breast aesthetics in the U.S., as Motiva implants are the first new breast implant PMA approved by the FDA since 2013. The company's CEO, Juan José Chacón-Quirós, highlighted that this approval brings a choice of highly differentiated technology backed by rigorous scientific and clinical research to the market.
Clinical data from the Motiva U.S. IDE Study demonstrated low complication rates, with less than one percent for capsular contracture and rupture in the primary augmentation cohort at three years. The Motiva SmoothSilk surface is designed for enhanced biocompatibility and low inflammation, while the Ergonomix device adapts its shape to body position, offering a natural feel.
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