April 4, 2019

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.

 

Establishment Labs was founded to improve safety and aesthetic outcomes in breast surgery. With this as our mission, we have been diligently researching breast implant surfaces and the immune system response for more than a decade. This has included building a body of scientific evidence that shows that macrotextured surfaces can potentially trigger, in susceptible hosts, inflammatory conditions through a cascade of elements. While our research investigates numerous aspects of breast implant surfaces, our understanding is that chronic inflammation is a core contributor to re-operations for patients with certain types of textured implants and is a potential contributing factor for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Motiva Implants® were designed to reduce the body’s inflammatory reactions and we believe have demonstrated a superior safety profile with almost nine years in the market.

Our mission is embodied in our commitment to patients, the safety profile of our products, and our continued work to ensure Motiva Implants® exceed the safety standards required by regulatory bodies around the world. A study performed by the Langer Lab at MIT indicated that our proprietary SmoothSilk®/SilkSurface® implant surface technology attracts fewer inflammatory cells than a traditional smooth surface, and it is this unique surface that is responsible for lower complication rates in breast surgery. Motiva SmoothSilk®/SilkSurface® implants are categorized as a smooth implant surface per the applicable international standard ISO-14607:2018. Our commitment to patient safety extends from avoiding high risk, but uncommon events such as BIA-ALCL, to also reducing complication rates that lead to reoperations for more common, low risk adverse events like capsular contracture.

Since bringing our products to market in 2010, we have maintained a strict post-market surveillance Quality Management System database, which has shown no reported cases to date of BIA-ALCL related to Motiva Implants®. With our post-market surveillance in place, more than half a million implants have been placed in the market. Motiva Implants® are produced at two manufacturing sites compliant with ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program.

Our scientific efforts are at the very heart of what we do here at Establishment Labs. We are actively studying implant biocompatibility and sponsoring independent medical and scientific research to advance and improve outcomes in women’s health. One of our greatest strengths is that our scientific understanding of biocompatibility is incorporated into the design of all our products. This is our answer to the very questions the industry and its consumers are now facing.

Regulatory Licensing Documentation:

Establishment Labs recommends following best medical practices and surgeon’s instructions on monitoring breast implants. Patients are encouraged to contact their health care provider if any changes are noticed.