{"id":6182,"date":"2020-12-13T23:08:39","date_gmt":"2020-12-14T04:08:39","guid":{"rendered":"https:\/\/establishmentlabs.com\/?p=6182"},"modified":"2020-12-13T23:09:07","modified_gmt":"2020-12-14T04:09:07","slug":"establishment-labs-statement-regarding-tgas-regulatory-actions-in-australia","status":"publish","type":"post","link":"https:\/\/www.establishmentlabs.com\/es\/news\/establishment-labs-statement-regarding-tgas-regulatory-actions-in-australia\/","title":{"rendered":"Establishment Labs Statement Regarding TGA\u2019s Regulatory Actions in Australia"},"content":{"rendered":"
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Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women\u2019s 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.<\/p>

On September 26, 2019, the Therapeutic Goods Administration (TGA) in Australia confirmed that Motiva Implants\u00ae<\/sup>\u00a0will not be affected by their investigations and the subsequent\u00a0REGULATORY ACTION ANNOUNCED<\/a>\u00a0in 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.<\/p>

Motiva Implants\u00ae<\/sup>\u00a0are clearly differentiated from any other available traditional breast implants. Our SmoothSilk\u00ae<\/sup>\u00a0\/ SilkSurface\u00ae<\/sup>\u00a0shell is classified in the smooth category according to\u00a0ISO-14607:2018<\/a>\u00a0\u201cNon-active surgical implants \u2013 Mammary implants \u2013 Particular requirements\u201d, Annex H, Test for surface characteristics, which we had confirmed by independent testing conducted by Laboratoire National de M\u00e9trologie et d\u2019Essais (LNE), a renowned third-party laboratory based in France. TGA\u2019s recent announcement is further affirmation of Motiva\u2019s differentiation.<\/p>

We offer the most comprehensive portfolio of advanced smooth implants, which incorporates our proprietary SmoothSilk\u00ae<\/sup>\u00a0\/ SilkSurface\u00ae<\/sup>\u00a0nanosurface 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\u00ae<\/sup>\u00a0to improve patient safety and aesthetic outcomes.<\/p>

Our entire portfolio of Motiva Implants\u00ae<\/sup>\u00a0remain available in Australia and across more than 75 countries worldwide.<\/p>

For additional information about our advanced product portfolio and breast implant safety features, please visit:\u00a0MOTIVA.HEALTH<\/a><\/p>

Read our complete position statement on breast implant safety\u00a0HERE<\/a>.<\/p><\/div>

*Motiva Implants\u00ae<\/sup>\u00a0are not available for sale in US and Canada.<\/em><\/p><\/div><\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women\u2019s 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 […]<\/p>\n

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