Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced on Monday that it has submitted Motiva breast implants to the U.S. Food and Drug Administration (FDA) for approval in primary and revision breast reconstruction procedures. The move underscores the company’s commitment to expanding its presence in the reconstructive surgery market.
The submission is backed by data from the Motiva U.S. Investigational Device Exemption (IDE) Study, which included 274 post-mastectomy reconstruction patients. Of these, 220 patients underwent primary reconstruction while 54 received revision procedures, providing comprehensive clinical evidence of the implants’ safety and effectiveness.
Motiva SmoothSilk Round and Motiva Ergonomix implants are highlighted by Establishment Labs as representing state-of-the-art innovation in plastic and reconstructive surgery. The company emphasizes that these products are designed to deliver natural aesthetics while addressing the unique needs of reconstruction patients.
Motiva implants previously received FDA approval for breast augmentation in September 2024. Since that approval, more than 60,000 Motiva implants have been sold across the United States, demonstrating strong market adoption and growing consumer confidence in the brand.
In addition to implants, Establishment Labs’ Motiva Flora tissue expander was cleared for use in the U.S. in 2023. The device is now employed in over 200 cancer centers nationwide, helping breast cancer survivors rebuild breast tissue following mastectomy.
Shares of Establishment Labs closed Friday’s trading session at $76.45, up 1.06%. Analysts note that the company’s expansion into breast reconstruction could provide a significant growth driver, building on its existing success in the cosmetic breast implant market.
