Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global leader in women’s health and breast aesthetics, announced today that it has submitted its Motiva® breast implants for U.S. Food and Drug Administration (FDA) approval for primary and revision breast reconstruction. The implants were previously cleared for breast augmentation in the U.S. in September 2024.
“Expanding our FDA approval from breast augmentation to reconstruction is a significant step forward for women’s health,” said Jeff Ehrhardt, Senior Vice President and General Manager of North America at Establishment Labs. “For more than a decade, breast reconstruction has seen limited innovation, even though patients often require advanced technology. This milestone brings us closer to offering the proven benefits of Motiva to women after mastectomy.”
The Motiva U.S. Investigational Device Exemption (IDE) study involved 274 post-mastectomy patients across 17 U.S. centers and one Western European center, including 220 primary and 54 revision reconstruction patients. Motiva® SmoothSilk® Round and Ergonomix® implants incorporate patented SmoothSilk® surfaces designed for enhanced biocompatibility and low inflammation.
Notably, the Motiva® SmoothSilk® Ergonomix® implants are the first in the world to integrate ergonomic design, adapting to body movements—maintaining a round shape when lying down and a teardrop shape when standing. The SmoothSilk® Round implants provide consistent upper breast fullness and softness in all positions. Since FDA approval for augmentation in 2024, more than 60,000 Motiva implants have been sold in the United States.
“Successful breast reconstruction relies on pairing surgical technique with the right devices,” said Mark Clemens, MD, MBA, FACS, Professor of Plastic Surgery at MD Anderson Cancer Center. “Innovations that address clinical limitations, such as MRI-conditional tissue expanders like Motiva Flora, improve outcomes and precision in radiation planning. FDA approval for reconstruction indications with Motiva implants further expands options for individualized patient care.”
The Motiva Flora® tissue expander, cleared in the U.S. in 2023, is used in over 200 cancer centers for post-mastectomy reconstruction. It is the only expander globally with an integrated radio-frequency port that is MRI conditional.
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical device company advancing women’s health through innovative breast aesthetics and reconstruction technologies. Operating in over 90 countries, the company has delivered more than four million Motiva® devices since 2010. Its portfolio includes minimally invasive platforms such as Mia Femtech®, Preservé®, GEM®, and the Motiva Flora® tissue expander.
Forward-Looking Statements
This press release contains forward-looking statements, including anticipated regulatory approvals, commercialization plans, and product adoption. Actual results may differ due to risks including regulatory challenges, market adoption, competition, and operational factors. Investors are cautioned not to place undue reliance on these statements.
