Establishment Labs Holdings Inc.

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The investigation focuses on Establishment Labs’ repeated claims that its breast implants are safer than those of its competitors due to “rigorous science” and “clinical data.”

On Oct. 19, 2022 Establishment Labs’ claims came into question, when analyst Hindenburg Research published a scathing report entitled “Establishment Labs: A Financially Stretched Silicon Safety Charade.”  Hindenburg accuses the company about misleading investors about safety claims, concluding in part:  (1) “almost all key safety studies touted by the company have undisclosed or under-disclosed conflicts of interest;” (2) “Australian and French authorities expressed concerns with the company’s data with Australian regulators calling the company’s main safety data ‘observational uncontrolled studies;'” (3) “[t]he advisor Establishment just hired to support its U.S. launch was sued by the SEC in 2018 for fraudulently lying then destroying records that concealed regulatory and safety issues with breast implants;” and (4) “records show Establishment ships products to entities formerly owned by the CEO and his family, raising questions of conflicts of interest.”

In response, the price of Establishment Labs shares closed sharply lower on Oct. 19, wiping out more than $100 million of shareholder value.