Yes, Motiva Implants®* are FDA approved with less than 1% device related-complications¹.
Reference:
1. Glicksman C, Wolfe A, McGuire P. The study of the safety and effectiveness of Motiva SmoothSilk silicone gel-filled breast implants in patients undergoing primary and revisional breast augmentation: 5-year clinical data. Aesthet Surg J. 2025;(sjaf245). doi:10.1093/asj/sjaf245
Disclaimer:
*Motiva SmoothSilk® Round and Motiva SmoothSilk Ergonomix® implants have received Premarket Approval (PMA) from the Food and Drug Administration (FDA) for Augmentation Indication, and are commercially available in the US.
Motiva Implants® for Reconstruction Indication are not yet commercially available in the US and are undergoing clinical investigation pursuant to FDA regulations for investigational medical devices.