Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company focused on enhancing women’s health, has received U.S. FDA approval for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in both primary and revision breast augmentation.
“Today’s approval marks a new era in U.S. breast aesthetics,” said Juan José Chacón-Quirós, Founder and CEO. “Motiva implants offer highly differentiated technology, grounded in rigorous scientific research, allowing women to achieve their aesthetic goals without compromise. We are fully committed to bringing this transformative technology to the U.S.”
Motiva® SmoothSilk® Round and Ergonomix® implants represent cutting-edge innovation in plastic surgery, featuring the patented SmoothSilk® surface designed for enhanced biocompatibility with low inflammation. The Ergonomix® implant is the first of its kind, adapting to the body’s movement, maintaining a round shape when lying down and a teardrop shape when standing. The SmoothSilk® Round implants provide increased upper breast fullness while maintaining their round form in any position.
“The Motiva U.S. IDE Study, the most rigorous breast implant clinical trial under FDA guidelines, demonstrated that Motiva implants are not only safe and effective but also deliver exceptional results,” said Dr. Caroline A. Glicksman, a board-certified plastic surgeon and Medical Director of the Motiva study. “With less than one percent rates of capsular contracture and rupture, these implants will be a welcomed innovation in the U.S. market.”
The study, conducted at 32 centers in the U.S. and three in Western Europe, showed impressive outcomes, with 92.4% patient compliance at three years post-implantation. The risk rates for complications were remarkably low, with capsular contracture at 0.5% and rupture at 0.6%.
“There has been a lack of innovation in the U.S. breast implant market for over a decade,” added Dr. M. Bradley Calobrace, a study investigator. “Motiva implants, with their low inflammatory surface and next-generation viscoelastic design, will revolutionize breast augmentation, offering safer and more aesthetically pleasing results.”
Since 2010, nearly four million Motiva® devices have been used in over 85 countries. The company’s innovations are backed by over 200 patent applications and supported by more than 100 clinical studies and peer-reviewed publications. The FDA approval of Motiva® implants is the first new breast implant PMA approval since 2013.
Dr. Kamakshi R. Zeidler, a board-certified plastic surgeon and member of Establishment Labs Femtech Advisory Board, emphasized, “Motiva is the first implant truly designed for women’s lifestyles, offering a natural feel and movement. The low complication rates seen in the clinical trial make this a groundbreaking option for women in the U.S.”
About Establishment Labs
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through science, engineering, and technology. The company’s Femtech solutions, including the Motiva® breast implants and the Mia Femtech™ experience, set a new standard for safety and patient satisfaction in over 85 countries. Establishment Labs operates two manufacturing facilities in Costa Rica, adhering to the highest regulatory standards.
