The Medical Device Single Audit Program, or “MDSAP,” attempts to provide rapid certification for medical device manufacturers operating in multiple countries. The program, supported by the US Food & Drug Administration, is controversial in that it does not rely on subsequent surveillance audits. MDSAP participant companies can deviate wildly from requirements once they obtain the certification, without any oversight. In the US, MDSAP has been seen as a “pay to play” scheme that risks the health of the public.<\/p>\n
The MDSAP status of Establishment Labs would support this theory. According to a report<\/a> published by the forensic financial research firm Hindenburg Research, Establishment Labs and the Motiva implant line present a serious risk to patients who receive the implants. That report highlights key concerns over Establishment Labs and its founder, Juan Jos\u00e9 Chac\u00f3n-Quir\u00f3s, noting that the company has “has incurred losses every year as a public company, accumulating a $249.4 million deficit<\/em>.”<\/p>\n Chac\u00f3n-Quir\u00f3s has publicly boasted on social media that he invented the Motiva implant line after developing the products in a pizza oven in his garage<\/a>.<\/p>\n The Hindenburg Research then goes on to claim that Motiva’s “QID” tracking capabilities were achieved by inserting pet-grade RFID trackers<\/a> into the implants:<\/p>\n Establishment claims to have pioneered innovations like its \u201cQid\u201d chip technology, a scannable RFID chip embedded inside its implants used by doctors to obtain serial numbers and other basic information about the implant. The RFID chips were originally intended for pets. Establishment bought the technology from a company that reportedly \u201cimproperly marketed its implanted microchip for medical uses\u201d before failing after cancer concerns about the chip were revealed by the media.<\/p><\/blockquote>\n![\"\"](\"https:\/\/www.oxebridge.com\/emma\/wp-content\/uploads\/2022\/10\/breastpizza.jpg\")
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