NEW YORK, December 29, 2025–(BUSINESS WIRE)–Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, primarily in breast aesthetics and reconstruction, today announced that it has submitted Motiva® implants for US Food and Drug Administration (FDA) approval in primary and revision breast reconstruction. The products were previously approved by the FDA for use in breast augmentation on September 27, 2024.
“Extending 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 Establishment Labs North America. “Breast reconstruction has seen little innovation for more than a decade, despite the fact that these patients often require improved and more advanced technology. This milestone brings us closer to bringing the benefits of Motiva to post-mastectomy women by providing the same proven technology that has seen rapid adoption in breast augmentation.”
The Motiva US IDE study was conducted at 17 centers in the US and one center in Western Europe and included 274 reconstruction patients after mastectomy, including 220 primary and 54 revision patients. Motivation® SmoothSilk® Round and Ergonomix® Implants represent the latest technology in plastic surgery. These devices feature the patented SmoothSilk® surface, designed for enhanced biocompatibility and scientifically proven to promote low inflammation. The motive® SmoothSilk Ergonomix® The device is the world’s first breast implant to incorporate the science of ergonomics, as it is designed to adapt, react, feel and move like natural breast tissue. Motivation® SmoothSilk® Ergonomix® The implants are unique in the implant market in that their shape can adjust as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing. The motive® SmoothSilk® Round implants provide increased fullness and softness of the upper breast while maintaining a round full shape regardless of their position. Since approval for breast augmentation in 2024, more than 60,000 Motiva implants have been sold in the United States.
“Successful breast reconstruction depends on aligning the surgical technique with the proper tools,” said Mark Clemens, MD, MBA, FACS and Professor of Plastic Surgery at The University of Texas MD Anderson Cancer Center. “While surgical techniques have advanced significantly, innovation in reconstructive devices is more incremental, 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 improve accuracy during radiation planning has made conditional tissue expanders such as Motiva Flora a valuable addition to reconstructive treatment. It further expands our options, allowing surgeons to carefully incorporate device features such as unique surface design and clinical performance data into personalized reconstructive design.”
Motiva Flora® The tissue expander was approved for use in the United States in 2023 and is used in more than 200 cancer centers to reconstruct the breast after breast cancer. Flora is the only regulatory approved extender in the world with an integrated port that uses RF technology that is conditional MRI.
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical device company dedicated to improving the health and wellness of women in breast aesthetics and reconstruction through the power of science, engineering and technology. The Company offers a portfolio of breast health, breast aesthetics and breast reconstruction solutions in more than 90 countries. With more than four million Motiva® devices delivered to plastic and reconstructive surgeons since 2010, the Company’s products have set a new standard for patient safety and satisfaction. The company’s minimally invasive platform consists of Mia Femtech®a unique minimally invasive breast harmonizing experience, and Preservé®a breast tissue preserving and minimally invasive technology for breast augmentation, augmentation revision and mastopexy augmentation. JEWEL® is a minimally invasive next-generation system for gluteal ergonomic modeling that is currently in IRB-approved pivotal study. Motiva Flora® The tissue expander is used to improve outcomes in breast reconstruction after breast cancer and is the only regulatory approved expander in the world with an integrated port that uses radio frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to securely identify implantable devices outside the body and includes the company’s first Zenº™ biosensor, currently part of an IRB-approved pivotal study to measure breast core temperature. These solutions are supported by more than 200 patent applications in 20 separate patent families worldwide and more than 100 scientific and clinical studies and publications in peer-reviewed journals. Establishment Labs manufactures in two facilities in Costa Rica in compliance with all applicable regulatory standards in accordance with ISO13485:2016 and FDA 21 CFR 820. Visit our website for additional information at www.establishmentlabs.com.
Forward-looking statements
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