Category Archives: Medical Devices

FOI application to view TGA “compliance notice sent with educational material” for complaint AC-KD45638R/2018 (Paingone)

This Freedom of Information (FOI) application reveals that the TGA summarised a detailed complaint alleging numerous specific breaches of the Therapeutic Goods Advertising Code 2015 by sending one sentence to the advertisers, “The complaint alleges the advertisement may be misleading … Continue reading

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Ear Candles: the outcome of TGA complaint AC-5TMWIYHC/2018

Ear candling is a widely promoted alternative medical practice that involves inserting and lighting a hollow candle in the ear canal. It is claimed that candling creates a vacuum that removes wax and that it can also relieve ear ache, … Continue reading

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Complaints to the TGA by Monash SPHPM Summer Vacation Scholarship students

Lucy Romanoff investigated the illegal promotion and supply of body-building supplements in Australia. This problem was highlighted by the ABC earlier this year, but no action has been taken by the TGA about the products mentioned. One ingredient mentioned by … Continue reading

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A global investigation into medical device harm

The International Consortium of Investigative Journalists (ICIJ) latest investigation: The Implant Files. Everything you need to know about, “The Implant Files” Medical Devices Harm Patients Worldwide As Governments Fail On Safety Medtech Giant Pushes Boundaries As Casualties Mount And Sales … Continue reading

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Consequences of TGA failure to act on complaints about illegal products

Therapeutic goods must be entered by the sponsor in the Australian Register of Therapeutic Goods (ARTG)  before they can be legally sold. The purpose is to ensure consumers have some protection against potentially dangerous or fraudulent goods &/or misleading and … Continue reading

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TGA fails to act on the promotion and sale of unapproved therapeutic goods

Products not regulated by the TGA represent, “a serious risk” says the regulator in, “Buying medicines and medical devices“. “These items have a high chance of being counterfeit, containing the wrong amount of active ingredient, being contaminated with toxic chemicals, … Continue reading

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Letter to The Age 5/9/18: Spotlight on regulators (published)

Your editorial (2/9) says the government should have a more rigorous process to protect consumers from ineffective treatments and products. There are government regulators that are meant to do this job but they are weak and ineffective. The Australian Health … Continue reading

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Non-transparent outcome of TGA complaint: Sawyer Extractor™ Pump for Snake Bite, AC-22VHXCSG/2018

Screen shot 03/09/2018 and 8/11/2019 https://www.survivalsuppliesaustralia.com.au/products/sawyer-extractor-kit.php N.B. Finally taken down from this site on 26/11/2018 after publicity on ABC Background Briefing (around 34 minutes in) BUT, still available 27/11/2018 at https://www.amazon.com.au/Sawyer-Products-B4-Extractor-Pump/dp/B000AU9PEC Finally removed 12/12/2018 On 30/07/ 2018 I submitted that … Continue reading

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TGA new complaint system: compliance notices ineffective

Two outcomes (of 16) TGA complaints have now been received. AC-E7JS15BB/2018, submitted 3/8/18,  Brand Developers Australia Pty Ltd – Pain Erazor https://www.youtube.com/watch?v=ye6s7qB-4Gc&feature=youtu.be “Pain Erazor” (ATG no: 276939) won a 2017 Choice “Shonky” award, was the subject of a scathing N.Z. Consumer review, … Continue reading

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