NEW YORK, N.Y. — Establishment Labs Holdings Inc. said it has submitted Motiva implants to the U.S. Food and Drug Administration for approval for use in primary and revision breast reconstruction, expanding the potential use of the products beyond breast augmentation.
The company said Motiva implants were previously approved by the FDA for breast augmentation on September 27, 2024, and the new submission seeks to extend that approval to reconstruction procedures, including post-mastectomy patients.
“Expanding our FDA approval from breast augmentation to reconstruction is an important step forward for women’s health,” said Jeff Ehrhardt, senior vice president and general manager of North America for Establishment Labs. “Breast reconstruction has seen little innovation for more than a decade, despite these patients often needing improved and more advanced technology. This milestone brings us closer to offering the benefits of Motiva to women after mastectomy, providing the same proven technology that has seen rapid adoption in breast augmentation.”
The Motiva U.S. IDE Study was conducted at 17 centers in the United States and one center in Western Europe and included 274 post-mastectomy reconstruction patients, including 220 primary and 54 revision cases. According to the company, the study evaluated Motiva SmoothSilk Round and Ergonomix implants, which feature a patented SmoothSilk surface designed to enhance biocompatibility and reduce inflammation.
The Motiva SmoothSilk Ergonomix implant is designed to adapt and move in a way intended to mimic natural breast tissue, maintaining a round shape when lying down and a teardrop shape when standing. The Motiva SmoothSilk Round implant is designed to provide increased upper breast fullness while maintaining a consistent round form regardless of body position. Since FDA approval for breast augmentation in 2024, the company said more than 60,000 Motiva implants have been sold in the United States.
“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” said Mark Clemens, M.D., MBA, FACS, professor of plastic surgery at The University of Texas MD Anderson Cancer Center. “While surgical techniques have advanced significantly, innovation in reconstructive devices has been more gradual, making technologies that address real clinical limitations especially important. In my experience, the ability to safely image patients with MRI during the expansion process and to improve precision during radiation planning has made MRI-conditional tissue expanders, like Motiva Flora, a valuable addition to reconstructive care. The availability of a reconstruction indication for Motiva implants expands our options further, allowing surgeons to thoughtfully incorporate device characteristics such as unique surface design and clinical performance data into individualized reconstructive planning.”
The company also noted that the Motiva Flora tissue expander, which was cleared for use in the United States in 2023, is currently used at more than 200 cancer centers for breast reconstruction following breast cancer. Flora is the only regulatory-approved tissue expander with an integrated radio-frequency port that is MRI conditional.
