Establishment Labs Statement in Response to ANSM Decision to Ban Macrotextured and Polyurethane Breast Implants in France

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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.

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This information is intended solely for the use of healthcare professionals. A healthcare professional must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Motiva® does not dispense medical advice and recommends that healthcare professionals be trained in the use of any particular product before using it in a procedure or surgery. A healthcare professional must always refer to the package insert, product label and/or instructions for use before using any Motiva® product. The information presented is intended to demonstrate particular products, as well as the breadth of Motiva® product offerings. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your local representative if you have questions about the availability of specific products in your area. Motiva® products that are CE marked are marked according to the applicable EU Regulations and Directives.