Breast Implant Illness Australia BIIA | Medical and health

Breast Implant Illness Australia BIIA

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14.01.2022 Debunking fact from the fiction, Pink Hope Community teamed up with Dr Samriti Sood, a Sydney-based Specialist Oncoplastic Breast Surgeon, to discuss the topic of Breast Implant Illness. https://youtu.be/MXItJ4ajqWg

12.01.2022 https://www.marieclaire.com.au/breast-implant-illness

11.01.2022 **If you have breast implants or know someone who has you need to read this** For those who have been following my breast implant journey, I have been talking a...bout the action the TGA in Australia (Therapeutic Goods Administration) has taken against some breast implant manufacturers due to ongoing concerns about their safety. As part of their original regulatory action in September last year, they made the decision to suspend some companies from being able to supply breast implants in Australia. This was to give the manufacturers an opportunity to address the concerns that were raised. The company’s had until the 24th of October 2020 to provide submissions to the TGA to demonstrate the safety and performance of the implants and to show they had taken steps to remove the grounds for suspending their device. The manufacturers were required to provide samples for laboratory analysis and documentation about their manufacturing processes, risk management strategies, clinical evidence, and biological safety assessments. Why were they originally suspended? Well, for each implant, the TGA assesses the manufacturer's documentation against the following guidelines: Evidence of implantation assessments (e.g. did not result in swelling or persistent inflammation in the body) Evidence of reproductive toxicity (e.g. did not result in harm to reproductive organs or fertility or affect offspring) Evidence of carcinogenicity (e.g. did not cause cancer) Evidence for immunotoxicology testing (e.g. did not harm, or elicit an altered response from, the body's immune system) The TGA identified a number of deficiencies in the evidence submitted by sponsors and manufacturers to demonstrate an acceptable level of safety and quality of the materials used and/or the long term effects of the implants in the body. Specifically, the TGA was concerned that there was insufficient evidence to demonstrate compliance with ISO 10993:2018 biological evaluation of medical devices. (the guidelines above) When I tell you why your mind will be blown. The following safety and performance concerns were identified in just one of the company’s reports. Absence of carcinogenicity testing Absence of immunotoxicology testing Absence of implantation assessment Absence of reproductive toxicity testing. This means that they could not provide any evidence that they even underwent testing for these. Let alone actually passing the testing under these guidelines. Let me be clear here. This means they could not prove to the TGA that their breast implants: did not cause cancer, did not harm, or elicit an altered response from, the body's immune system, did not result in swelling or persistent inflammation in the body, or did not result in harm to reproductive organs or fertility or affect offspring) SERIOUSLY? How have these been available for years in the market and been placed into women’s bodies without them meeting these strict health guidelines?????? Why has it taken the TGA to investigate for action to be taken here? The other company listed had an absence of evidence relating to the risk of chronic-active tissue response, reproductive toxicity and carcinogenicity Insufficient evidence of immunotoxicology testing Insufficient evidence relating to biodegradation. Further to these concerns, the claimed benefits of the highly textured surface of the device was not supported by the manufacturer's evidence. As a result, the TGA has cancelled their registration from the Australian Register of Therapeutic Goods (ARTG), effective 27 October 2020. This means that they can no longer supply breast implants to Australians. I looked and couldn't find anything about this in the media? Why wasn’t this in the news? Yes, it is public knowledge on the TGA website but I had to dig around to find this information. PLEASE be informed. PLEASE share this information far and wide with any woman you know that has or is considering breast implants. Please remember that these companies do not have your health in mind, they are only interested in making money. This is evident in the fact that they lied about completing laboratory testing to ensure that their products were safe to put into women’s bodies. Do your own research and make sure you weigh up the risks vs the benefits of having implants. And ask yourself if it is worth risking your health for the perception of enhanced beauty.

02.01.2022 Do you suffer from any of these? https://www.breastimplantillness.com/