FDA approves Motiva SmoothSilk implants for breast augmentation; first new PMA since 2013

ESTABLISHMENT LABS HOLDINGS INC.

FDA approval for Motiva SmoothSilk Ergonomix and Round implants in primary and revision breast augmentation.
Three-year clinical trial data: capsular contracture 0.5%, rupture 0.6%, infection 0.9% in primary augmentation cohort.
First new breast implant PMA approved by FDA since 2013; nearly 4 million Motiva devices already delivered in 85+ countries.
CEO Juan José Chacón-Quirós calls approval transformative for U.S. breast aesthetics, citing differentiated technology.
Study conducted at 32 U.S. and 3 European centers; patient compliance at 92.4% at 3-year endpoint.

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