A New Era for Breast Reconstruction? Motiva Seeks FDA Approval

NEW YORK, NY – December 29, 2025 – Establishment Labs Holdings Inc. has formally submitted its Motiva implants to the U.S. Food and Drug Administration (FDA) for use in breast reconstruction, a move that could significantly alter the landscape for post-mastectomy patients. The submission, announced today, seeks approval for both primary and revision reconstruction surgeries, building on the device's successful U.S. launch for breast augmentation in September 2024.

For more than a decade, the field of breast reconstruction has seen only gradual advancements, leaving a critical patient population with limited options. Establishment Labs aims to change that by introducing technology that has already seen rapid adoption in the aesthetics market, with over 60,000 Motiva implants sold in the U.S. since their initial approval. This expansion represents a pivotal step toward providing what the company calls a more advanced, patient-centric solution for women recovering from breast cancer.

“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.”

A Leap in Technology for Post-Mastectomy Care

At the heart of the submission are Motiva's state-of-the-art implants, which feature several key innovations designed to address common complications and improve aesthetic outcomes. The devices feature a patented SmoothSilk surface, a unique nano-textured shell engineered for enhanced biocompatibility. Clinical data has shown this surface promotes low inflammation, which can significantly reduce the risk of common complications like capsular contracture—the painful hardening of scar tissue around the implant that is a leading cause for revision surgery. Notably, the company reports zero confirmed cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare cancer linked to certain textured implants, with its SmoothSilk devices globally.

Further setting Motiva apart is its Ergonomix implant, the first of its kind to embody the science of ergonomics. Filled with a proprietary soft silicone gel, it is designed to adapt to the body’s movements, maintaining a round shape when a person is lying down and shifting to a natural teardrop shape when standing. This dynamic quality aims to mimic the look, feel, and movement of natural breast tissue, a crucial factor for patient satisfaction and psychological well-being after a mastectomy.

The U.S. clinical trial data submitted to the FDA included 274 post-mastectomy reconstruction patients, providing a specific evidence base for this vulnerable population.

Addressing Critical Gaps in the Patient Journey

The potential impact of Motiva extends beyond the implant itself. The company’s ecosystem includes the Motiva Flora tissue expander, which was cleared for U.S. use in 2023 and is already utilized in over 200 cancer centers. Tissue expanders are used in the initial stage of reconstruction to stretch the skin and muscle to create a pocket for the permanent implant. Traditionally, these devices contain a metallic port for saline injections, which interferes with magnetic resonance imaging (MRI).

Flora’s design is a significant step forward, as it is the only regulatory-approved expander in the world with an integrated, non-magnetic port that is MRI conditional. This allows patients to undergo necessary MRI scans for cancer surveillance without the risk of device-related complications or image distortion, a major advancement in patient safety and peace of mind during the reconstruction process.

“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” said Dr. Mark Clemens, a Professor of Plastic Surgery at The University of Texas MD Anderson Cancer Center, in the company's announcement. “While surgical techniques have advanced significantly, innovation in reconstructive devices has been more gradual. 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.”

A Strategic Move in a Multi-Billion Dollar Market

Establishment Labs' push into reconstruction is a calculated strategic expansion into a substantial and growing market. The global breast reconstruction market is projected to reach nearly $5 billion by 2030, driven by increasing breast cancer rates and a growing awareness of reconstructive options. The U.S. market is dominated by established giants like Mentor (a Johnson & Johnson company) and Allergan (part of AbbVie), but there is a clear appetite for innovation.

This is evidenced by the FDA's recent approval of Mentor's larger-sized implants for reconstruction in December 2024, which addressed a long-standing unmet need. The regulatory environment, while stringent, appears open to new technologies that can demonstrate clear patient benefits. The FDA has also recently increased its safety requirements, mandating boxed warnings and patient decision checklists for all breast implants to ensure informed consent.

For Establishment Labs, this submission is a critical step toward capturing a larger market share and achieving profitability. The company's stock has surged over 66% in the past year, and analysts have set optimistic price targets, with some projecting the company could capture 20% of the U.S. market by the end of 2025. With worldwide revenues climbing 33.8% in the third quarter of 2025 to $53.8 million and a stated goal of becoming cash-flow positive, a successful entry into the reconstruction market could be a powerful catalyst for financial growth. If approved, Motiva's advanced features could position it as a premium option for the hundreds of thousands of women who undergo mastectomies each year, potentially redefining the standard of care.