Establishment Labs Holdings Inc. has submitted its Motiva implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA). The agency previously greenlighted the products for use in breast augmentation on Sept. 27, 2024.

“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. “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 patients.

Motiva SmoothSilk Round and Ergonomix Implants represent state-of-the-art innovation in plastic surgery. These devices feature the patented SmoothSilk surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation. The Motiva SmoothSilk Ergonomix device is billed as the world’s first breast implant that embodies ergonomics, as it is designed to adapt, react, feel, and move like natural breast tissue. Motiva SmoothSilk Ergonomix implants are unique to the implant market, as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up, according to Establishment Labs. 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.

“Successful breast reconstruction depends on aligning surgical technique with appropriate tools,” stated Mark Clemens, M.D., 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 FDA cleared Establishment Labs’ Motiva Flora tissue expander in 2023; the product is used in more than 200 cancer centers for breast reconstruction after breast cancer. Flora reportedly is the world’s only regulatory-approved expander with an integrated port using radio-frequency technology that is MRI conditional.

Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The company offers solutions for breast health, breast aesthetics, and breast reconstruction in more than 90 countries. With over 4 million Motiva devices delivered to plastic and reconstructive surgeons since 2010, the firm’s products have helped created a new standard for safety and patient satisfaction, Establishment Labs bigwigs claim. The company’s minimally invasive platform consists of Mia Femtech, a minimally invasive experience for breast harmonization, and Preservé, a breast tissue preserving and minimally invasive technology for breast augmentation, revision augmentation and mastopexy augmentation. 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 after breast cancer. Zensor is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zen, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by more than 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820.