Establishment Labs Statement in Response to ANSM Decision to Ban Macrotextured and Polyurethane Breast Implants in France
Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health in breast surgery. Women are at the center of everything we do at Establishment Labs and it is our mission to protect their health by offering safe solutions in breast aesthetics and reconstruction. Based on those principles, a decade ago we began conducting research in conjunction with a risk analysis of breast implant safety, ultimately deciding never to manufacture macrotextured breast implants.
As a result, Motiva Implants® have not been affected by today’s decision from Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) to ban macrotextured and polyurethane breast implants.
Motiva Implants® are clearly differentiated from any other available traditional breast implants. Our SmoothSilk®/SilkSurface® shell is classified in the smooth category according to ISO-14607:2018 “Non-active surgical implants – Mammary implants – Particular requirements”, Annex H, Test for surface characteristics, which we had confirmed by independent testing conducted by Laboratoire National de Métrologie et d’Essais (LNE), a renowned third-party laboratory based in France.
We offer the most comprehensive portfolio of advanced smooth implants, which incorporates our proprietary SmoothSilk®/SilkSurface® nanosurface technology, which has been designed to minimize inflammation and maximize biocompatibility. This is one of just many safety features that we have built into our Motiva Implants® to improve patient safety and aesthetic outcomes.
Our entire portfolio of Motiva Implants® remains available in France and across more than 70 countries worldwide.
For additional information about our advanced product portfolio and breast implant safety features, please visit motiva.health.
Read our complete position statement on breast implant safety here.
*Motiva Implants® are not available for sale in US and Canada.