Establishment Labs Statement Regarding TGA’s Regulatory Actions in Australia

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Establishment Labs Statement Regarding TGA’s Regulatory Actions in Australia

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.

On September 26, 2019, the Therapeutic Goods Administration (TGA) in Australia confirmed that Motiva Implants® will not be affected by their investigations and the subsequent REGULATORY ACTION ANNOUNCED in relation to breast implants and breast tissue expanders sold in Australia. As part of the new TGA requirements, Establishment Labs will provide additional information to practitioners and consumers in Australia and report of adverse event for all of our breast implant and tissue expander devices sold globally.

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. TGA’s recent announcement is further affirmation of Motiva’s differentiation.

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® remain available in Australia and across more than 75 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.