Establishment Labs makes silicone gel breast implants under the Motiva Implants brand, used for breast augmentation, revision augmentation, and breast reconstruction. Motiva implants are differentiated by a proprietary smooth shell surface, gravity-sensitive fill technology, and embedded RFID microtransponders for device traceability. The company received FDA PMA approval in September 2024 — the first new breast implant approval since 2013 — and began U.S. commercial sales in October 2024. Motiva implants are sold in over 100 countries, through a direct sales force in the U.S., Brazil, Argentina, and key European markets, and through exclusive third-party distributors elsewhere. Revenue is recognized when the device is implanted. Beyond the core implant, Establishment Labs offers the Motiva Flora Tissue Expander (the only MRI-compatible tissue expander on the market), Preservé (a minimally invasive augmentation procedure priced at roughly 2x a standard augmentation), and Mia Femtech (a narrow-indication procedure targeting women who would not otherwise consider traditional augmentation). Manufacturing is done entirely in-house at two Costa Rica facilities with capacity exceeding 1 million implants per year. The U.S. commands the highest ASPs — more than 2x the blended international rate — making it the highest-margin geography, and management expects U.S. revenue to grow from roughly 22% of total sales toward 30%+ in 2026. Key growth priorities include deepening U.S. penetration, expanding into U.S. breast reconstruction, and scaling the minimally invasive product portfolio.