Motiva Implants: A New Hope for Breast Reconstruction Patients

NEW YORK, NY – December 29, 2025 – Establishment Labs Holdings Inc. has taken a significant step toward transforming breast reconstruction for women in the United States, announcing its submission to the U.S. Food and Drug Administration (FDA) for the use of its Motiva implants in primary and revision reconstruction procedures. The move follows the company's successful entry into the U.S. market with an FDA approval for breast augmentation in September 2024, and it signals a major push into a clinical area that medical experts say has been starved for innovation.

For countless women who undergo a mastectomy as part of their cancer treatment, breast reconstruction is a critical component of their physical and psychological recovery. This submission could pave the way for a new generation of implant technology, offering features designed to improve safety, aesthetics, and overall quality of life for this specific patient population.

A New Frontier in Post-Mastectomy Care

For more than a decade, the technology available for implant-based breast reconstruction has seen only incremental changes, leaving both surgeons and patients desiring more advanced options. Establishment Labs aims to fill this void with its Motiva line, which has already seen rapid adoption in the augmentation market, with over 60,000 units sold in the U.S. since its 2024 approval.

"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 Establishment Labs’ General Manager of North America, in the company's announcement. He noted that reconstruction patients often have more complex needs and could benefit significantly from more advanced technology.

The sentiment is echoed by leading medical professionals in the field. Reconstructive surgery has evolved, but the tools have not always kept pace. Aligning advanced surgical techniques with equally advanced devices is crucial for optimizing patient outcomes.

“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” commented Mark Clemens, MD, a 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.”

Dr. Clemens also highlighted the value of related innovations, like the company's MRI-conditional tissue expanders, which improve the precision of radiation planning and allow for safer imaging during the expansion process. The potential approval of Motiva implants for reconstruction would further expand surgeons' ability to create individualized treatment plans based on specific device characteristics and clinical performance data.

The Technology Behind Motiva's Promise

At the heart of Establishment Labs' submission are two key innovations: the SmoothSilk® surface and the Ergonomix® implant design. These features differentiate Motiva from many existing products and directly address long-standing concerns in breast implant surgery.

The patented SmoothSilk® is a unique, biocompatible surface designed to minimize inflammation and the body's foreign-body response. This is critical for reducing the risk of complications like capsular contracture—the formation of hard scar tissue around the implant, which is a leading cause for revision surgery. Global data from over four million Motiva devices delivered since 2010 suggests low rates of this complication. Furthermore, in an era of heightened concern over Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare cancer linked primarily to older, macro-textured implants, Motiva's surface is positioned as a safer alternative, with zero confirmed cases of BIA-ALCL reported globally.

The Motiva SmoothSilk Ergonomix® implant introduces a dynamic quality not seen in many conventional devices. It embodies the science of ergonomics, designed to adapt its shape to the body's position. The implant is round when a woman is lying down but assumes a more natural, teardrop shape when she is standing, mimicking the movement of natural breast tissue. This addresses a key patient desire for a result that not only looks natural but also feels and moves naturally.

This technology is part of a broader ecosystem the company has built for reconstruction. In 2023, it received clearance for its Motiva Flora® tissue expander, now used in over 200 U.S. cancer centers. The Flora is the only regulatory-approved expander in the world that is MRI-conditional with an integrated port, a significant safety and convenience feature for patients requiring ongoing MRI surveillance post-mastectomy.

Navigating a High-Stakes Regulatory Pathway

Breast implants are designated as Class III medical devices by the FDA, the highest-risk category, subjecting them to the most rigorous regulatory review process, known as Premarket Approval (PMA). The submission by Establishment Labs is based on its U.S. Investigational Device Exemption (IDE) study, which enrolled 274 post-mastectomy patients, including those undergoing both primary and revision reconstruction, across 18 medical centers.

The FDA's review will be meticulous, scrutinizing the clinical data for safety and effectiveness specifically within this patient group. While the agency has a target review clock of 180 days, the total time from submission to a final decision for complex devices like breast implants often extends to a year or more, as the process can involve requests for additional information and consultations with external advisory panels.

Although the prior FDA approval for augmentation provides a strong foundation of safety data, the reconstruction indication is considered distinct. Reconstruction patients often have compromised tissue from mastectomy and potential radiation therapy, presenting different clinical challenges. A dedicated approval for this use case would validate the technology's performance and safety for this specific, and often more vulnerable, population.

Shaking Up a Concentrated Market

An approval for reconstruction would position Establishment Labs to disrupt a U.S. market historically dominated by a few major players, namely Mentor (a Johnson & Johnson company) and Allergan Aesthetics (an AbbVie company). By entering this medically necessary and less elective segment, the company would unlock a substantial new revenue stream and solidify its standing as a comprehensive player in breast health.

The potential market is significant, valued at over $500 million annually in the U.S. and growing. Establishment Labs' strategy appears to be one of differentiation through technology, offering solutions that directly address the unmet needs of surgeons and patients. The rapid uptake of Motiva for augmentation suggests a strong appetite in the U.S. for new options that promise better safety profiles and more natural aesthetic outcomes.

For Establishment Labs, a publicly traded company (NASDAQ: ESTA), a favorable FDA decision would be a major catalyst, likely boosting investor confidence and validating its long-term growth strategy. The submission marks a pivotal moment, not just for the company, but for the future of breast reconstruction. The FDA's decision will now be a focal point for surgeons, patients, and investors alike, potentially heralding a new standard in post-mastectomy care.