December 29, 2025 — Leads & Copy —Establishment Labs Holdings Inc. (NASDAQ: ESTA) has submitted its Motiva® implants to the U.S. Food and Drug Administration (FDA) for approval in primary and revision breast reconstruction.
The FDA previously approved the products for breast augmentation on September 27, 2024.
Jeff Ehrhardt, Senior Vice President and General Manager of North America at Establishment Labs, stated that expanding the FDA approval to breast reconstruction is an important advancement for women’s health.
Ehrhardt noted the lack of innovation in breast reconstruction over the past decade and emphasized the need for improved technology for patients. He believes this submission brings the company closer to offering Motiva’s benefits to women after mastectomy, utilizing the same technology that has seen rapid adoption in breast augmentation.
The Motiva U.S. IDE Study, conducted at 17 centers in the U.S. and one center in Western Europe, included 274 post-mastectomy reconstruction patients, consisting of 220 primary and 54 revision patients.
Motiva® SmoothSilk® Round and Ergonomix® Implants feature the patented SmoothSilk® surface, designed for enhanced biocompatibility and to promote low inflammation. The Motiva® SmoothSilk Ergonomix® device adapts, reacts, feels, and moves like natural breast tissue. Its shape adapts as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. The Motiva® SmoothSilk® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position.
Since approval for breast augmentation in 2024, more than 60,000 Motiva implants have been sold in the United States.
Dr. Mark Clemens, MD, MBA, FACS, and Professor of Plastic Surgery at The University of Texas MD Anderson Cancer Center, noted that successful breast reconstruction depends on aligning surgical technique with appropriate tools.
Clemens added that innovation in reconstructive devices has been more gradual, making technologies that address real clinical limitations especially important. He stated that the ability to safely image patients with MRI and improve precision during radiation planning has made MRI-conditional tissue expanders, like Motiva Flora, a valuable addition to reconstructive care. Clemens believes that the availability of a reconstruction indication for Motiva implants expands options, allowing surgeons to incorporate device characteristics such as unique surface design and clinical performance data into individualized reconstructive planning.
The Motiva Flora® tissue expander, cleared for use in the United States in 2023, is used at over 200 cancer centers for breast reconstruction following breast cancer. It is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional.
Establishment Labs Holdings Inc. is a global medical device company focused on women’s health and wellness in breast aesthetics and reconstruction. The company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 90 countries. Since 2010, over four million Motiva® devices have been delivered to plastic and reconstructive surgeons.
The company’s minimally invasive platform includes Mia Femtech® and Preservé®. GEM® is a next-generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB-approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer. Zensor™ is an RFID technology platform used to safely identify implantable devices, and includes the company’s first biosensor Zenº™, currently part of an IRB-approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications and over 100 scientific and clinical studies and publications.
Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820.
Jeff Ehrhardt, Senior Vice President and Establishment Labs’ General Manager of North America.
Source: Establishment Labs
