Establishment Labs Holdings Inc., a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced publication of its 2025 Post-Market Surveillance (PMS) Report. The report is being released ahead of the annual meeting of the American Society of Plastic Surgeons held October 9-12 in New Orleans.
“Publishing our PMS report every year since the launch of Motiva in 2010 shows our dedication to accountability and transparency,” said Peter Caldini, Establishment Labs Chief Executive Officer. “No other company in our industry publishes this level of information on an annual basis, and I would encourage them to do so. What is most important is the consistency of our post-market surveillance data across diverse sources, all of which show less than 1% device-related complications with Motiva implants leading to reoperations. These results are the basis for our continued success worldwide, our strong start in the United States since FDA approval, and our confidence in our 2025 financial guidance and strong growth in 2026.”
Establishment Labs’ Post-Market Surveillance Report is published each year and includes data on the real-world performance of Motiva implants. The report includes a comprehensive review of outcomes with Motiva implants from peer-reviewed publications, global registries, the company’s warranty and claims data, and studies supporting regulatory approvals, including data from the US FDA study. The PMS report has been released annually since the commercial launch of Motiva implants in 2010. Establishment Labs’ PMS Report can be found on the company’s website: https://establishmentlabs.com/science-based-innovation/pms-report/.
“The consistency of outcomes over fifteen years, across all regions of the world, and from many different sources is not a coincidence, it is the result of purpose-driven design,” added Roberto de Mezerville, Chief Technology Officer at Establishment Labs. “Our technologies were engineered to perform better by incorporating the latest advancements in science and technology, and the data continues to validate that we’ve established a new benchmark in the industry. Notably, the performance remains consistent regardless of placement technique, subglandular or submuscular, and incision site. Today there are more than two million women worldwide with Motiva, and we expect an approximate 400,000 to join them next year. We are not just shaping the future of this industry, we are redefining what women can expect from science, design, and innovation with minimally invasive and tissue-preserving technologies.”
