Establishment Labs Celebrates 10 Years of Motiva Safety Data

• Findings Show Less Than 1% Device Related Complications
  
  
• Nearly 1.3 Million Implants Placed Worldwide

SANTA BARBARA, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, is today announcing its latest clinical data demonstrating 10 years of outstanding safety outcomes reported in women who have received the Company’s Motiva silicone breast implants.

At today’s virtual symposium “Motiva: A Decade of Contributions to Women’s Health,” the Company will present 10-year post-market surveillance data demonstrating an unmatched device-related complication rate of less than 1% for the key safety endpoints of capsular contracture and implant rupture, with nearly 1.3 million breast implants placed worldwide outside of the United States. These rates are consistent with data reported in the Company’s patient registry of more than 145,000 patients, as well as studies reported in peer-reviewed publications.¹ There have been no cases of BIA-ALCL reported with Motiva Implants.

Also at the symposium, plastic surgeons with extensive global experience using the Company’s Motiva Implants will discuss their own results. “In 428 primary and revision breast augmentations over the last six years, the complication rate for my patients receiving Motiva is 0.3%,” said Dr. Giovanni Botti, an independent plastic surgeon and clinical Professor of Plastic Surgery at the University of Padua, and author of the medical text Aesthetic Mammaplasties. “Importantly, my patients see more natural results in terms of softness, comfort and ergonomy with their Motiva Ergonomix implants.”

“These 10-year findings are another validation of the rigorous science and engineering behind the strong safety profile of our Motiva Implants,” said Juan José Chacón-Quirós, Chief Executive Officer of Establishment Labs. “The placement of nearly 1.3 million Motiva Implants in over 80 countries, along with positive real-world data sets, implant registries and independent publications, are evidence of the high degree of confidence plastic surgeons and patients have in Motiva. Establishment Labs has an unwavering commitment to women’s health and well-being, and I want to thank each of our employees who remain united in our vision to transform this industry through science and innovation.”