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Wednesday 28 November 2018

Medical Implants harm patients. Health Regulators fail to protect patients. Yet why is it that 'investigative journalists' refuse to admit the same applies to Pharmaceutical Drugs and Vaccines?

Perhaps investigative journalism is not entirely moribund! An International Consortium of Investigative Journalists from 58 media organisations around the world, including the BBC, the Guardian, and the British Medical Journal, has investigated the safety of a wide variety of medical implants and discovered that many thousands (more accurately many millions) have been fitted with inadequately tested, unsafe and faulty implants that cause patients severe pain, suffering, and death.


Are the journalists correct? As far as implants are concerned it would appear that they are. Even the UK's Royal College of Surgeons wants the law to be changed to keep patients safe. Their statement can be found on their website. These are the people who select the implants, and implant them into us, and they accept that there is a serious problem.

The investigation revealed some shocking stories about heart pacemakers, rods to correct spinal problems, artificial knees and hips.
  • implants to support and shape the spinal cord that have cracked and disintegrated
  • replacement knee and hip joins that are sold to hospitals without proper or adequate testing
  • implants that have never been tested on humans, but tested on baboons, or dead pigs!
  • contraceptive implants that cause serious internal damage and bleeding
  • implanted defibrillators that 'misfired'
  • vaginal mesh implants for incontinence that have never been tested, and which caused severe abdominal pain
  • breast implants that have caused cancer. The Daily Mail article recalled the 50,000 British women who had PIP implants, and in 2011 were warned they were a cancer risk
  • hernia mesh which, amongst other things, stopped one of Britain’s top athletes from competing for years.
The Guardian article has given these figures about the scale of the problem

               "In the UK alone, regulators received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018. A third of the incidents had serious repercussions for the patient, and 1,004 resulted in death."

The situation is no better in the USA.

               "In the US, the Food and Drug Administration (FDA) has collected 5.4 million 'adverse event' reports over the past decade, some from manufacturers reporting problems in other parts of the world. These included 1.7 million reports of injuries and almost 83,000 deaths. Nearly 500,000 mentioned an explant - surgery to remove a device."

BBC Panorama, in a programme broadcast on 26th November 2018, focused on the story of Maureen (it is written up here). She was the first UK patient to be fitted with a 'Nanostim' pacemaker. A traditional pacemaker has leads from a battery to the heart that delivers the electrical pulse, but the cables can break. The Nanostim was the first lead-less pacemaker to sit independently inside the heart. But the battery failed within 3 years, and surgeons then discovered that they could not remove it. So she now has a traditional pacemaker, with the useless Nanostim remaining inside her heart. The BBC said Maureen was not alone, that a number of batteries have failed, and parts have fallen off inside patients.

The Nanostim pacemaker was withdrawn, but not before it had killed at least two people died, and another ninety incidents recorded of serious patient harm.

And it remains true that there was only one clinical study before Nanostim was approved for use on the public, paid for by the company, and it followed just 33 patients for just 90 days.

So why have surgeons fitted millions of faulty medical implants into their patients? They may want a law change now, but they fitted them, and it is their patients who are now suffering, some in chronic pain, others at risk of serious disease, and many of them dying.

The investigation points its finger at what is described as a 'lax' system of regulation in Europe (it is no different America, and throughout the world). We are told that Europe does not have a governmental body that checks medical devices before they are put into patients. Instead a series of companies, called 'notified bodies', issue CE marks - the same mark of approval given to devices like toasters and kettles. Apparently there are 58 of them in Europe, and approval by any one of them means a product can be used anywhere in Europe. The report says that companies 'shop around' these so-called safety organisations - until finally one of them agrees to approve the product.

The Nanostim heart pacemaker, for instance, was turned down by safety bodies in Germany because of a lack of evidence. Yet it was approved by the British Standards Institute in the UK, and thereafter approved everywhere!

It also states that health regulators, like the European Medicines Agency, and MHRA in the UK are failing in their duty to protect patients, that they seem keener to support manufacturers, and their profitability, than their main duty - to protect patients from harm. The report raises concerns about the level of scrutiny medical devices undergo both before and after they go on the market, and whether regulators detect and act upon negative findings quickly enough.

The report also criticises the secrecy and lack of transparency in which all this is being done. It claims that even surgeons, who implant the devices, do not always see the evidence upon which a device has been approved for safety and effectiveness. Even when the BBC Panorama programme asked questions of HMRA,  the UK regulator, the spokesman was reluctant to answer - because of issues of 'confidentiality'. There were no doubt many other reasons for not being straightforward with the public, but he said that he was "bound by confidentiality when it comes to some of the actions that we've taken around individual devices".

And drug regulators are routinely allowed to get away with this failure to protect patients with a wide variety of platitudes. Indeed, the platitudes are usually supported, even by these 'investigative journalists', who seem always eager to 'pull their punches' whenever they can. For instance the BBC told us the the implant industry "says that it has transformed millions of lives for the better". Maybe, but the figures also show clearly that they have transformed the lives of millions of other people for the worse.

I have not written much on medical implants before. Yet much of what this investigation has revealed is similar, if not exactly the same, as what happens in the dubious world of pharmaceutical drugs and vaccines. Although the evidence of this investigation is damning about medical implant manufactures, it failed completely to recognise that the same can be said of the pharmaceutical industry, and the drug patients are routinely given. For instance, the BBC had this to say about the problem.

               "And it’s all because medical devices don’t undergo the same checks as drugs before they’re given out widely to patients."

Really! Regular readers of this blog will know that this is nonsense, the sort of nonsense regularly committed by our 'public service' broadcaster which will have nothing to do with any criticism of the drugs industry! The history of pharmaceutical drugs and vaccines is IDENTICAL to what is being described here. I have outlined the gross problems and failures of drug regulation here, in chapter 14 of my ebook, "The Failure of Conventional Medicine".

The criticism of the testing and regulation of medical implants is no different to the criticism of the testing and regulation of pharmaceutical drugs and vaccines. It is the same system.

The only difference, perhaps, is that the implant industry is smaller, individual manufacturers are smaller, and so less influential, less powerful. They do not support, fund and control the mainstream media.

So anyone who is disturbed about what this investigation has revealed should now consider further. If medical implants are dangerous to human health, how much more dangerous are pharmaceutical drugs? If we wish to avail ourselves of a medicine that "first does no harm" we must look not just at medical implants, but all the drugs and vaccines that are also causing patient harm.