News – Establishment Labs

Establishment Labs Statement Regarding TGA’s Regulatory Actions in Australia

Posted on 13 12月, 2020 (13 12月, 2020) by Carolina Cerdas

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 […]

Establishment Labs Statement in Response to TGA’s Breast Implant Review related to Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Posted on 13 12月, 2020 (13 12月, 2020) by Carolina Cerdas

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, the Therapeutic Goods Administration (TGA) in Australia has confirmed that supply of Motiva Implants® will not be affected by their INVESTIGATIONS. Motiva Implants® are clearly differentiated from any other available traditional breast implants. Our […]

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

Posted on 13 12月, 2020 (13 12月, 2020) by Carolina Cerdas

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 […]

Marrying Clinical Data with Science: Our Approach to Next-Generation Breast Implants

Posted on 12 12月, 2020 (15 12月, 2020) by Carolina Cerdas

While silicone breast implants have been around since the 1960s, they’ve experienced little technological evolution in the past three decades until the 2010s. Meanwhile, women around the world face INCREASING NEWS COVERAGE of breast implant-related side effects – most of which have been linked to one particular implant surface – the macrotextured kind. But despite mounting evidence that macrotextured implants potentially trigger inflammatory conditions in patients, leading implant manufacturers CONTINUE TO MANUFACTURE, MARKET, AND SELL 4TH AND 5TH GENERATION IMPLANTS that haven’t significantly changed since the 1980s. Such conditions can range from common, low-risk capsular contracture (which is when the natural tissue capsule formed around an implant hardens and contracts) to a form of […]

5 Decades & 5 Generations of Breast Implant Evolution – Disrupted by Motiva^®

Posted on 3 12月, 2020 (15 12月, 2020) by Carolina Cerdas

Since their inception in the mid-60s, surgery with silicone gel breast implants has consistently been one of the most commonly performed cosmetic procedures in the world – and yet, the devices have seen relatively little evolution by their most prominent manufacturers in the last 50 years. 1st Generation While breast implants have existed since the late 19th century, they weren’t made of silicone or saline until the 1960s. Previously used materials have included ivory, glass, ox cartilage, ground rubber, and polyester. Injections with raw, liquid silicone were received by an estimated 50,000 women before surgeons and manufacturers realized that the silicone needed to be housed in barrier shells to keep […]

ESTA Position Statement on Breast Implant Safety

Posted on 3 12月, 2020 (15 12月, 2020) by Carolina Cerdas

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 […]