ESTA Position Statement on Breast Implant Safety

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:

• CE Mark Certification of Sterile Silicone Breast Implants Motiva Implant Matrix
• CE Mark Certification of Motiva Implants^® Anatomical TrueFixation^TM, Sterile Silicone Breast Implants
• MDSAP Certification

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.

*Motiva Implants^® are not available for sale in US and Canada.