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.

AND YET THEY IMPLY THAT THE SAME DOES NOT APPLY TO PHARMACEUTICAL DRUGS AND VACCINES!

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.

THE REGULATION OF MEDICAL IMPLANTS
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.

Is the conventional medical establishment content to support a system of regulation that insist on patients playing a game of Russian Roulette?

YET HAVE WE NOT HEARD ALL THIS BEFORE?

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.

Breast Implantation; where is the Medical Honesty?

What can we learn from this, the latest scandel arising within the world of ConMed? The issue of breast implantation has hit the headlines following news that French-made PIP implants were made with 'industrial' rather than 'medical' quality silicone, and that they rupture more easily than they should.

The main lesson, perhaps, is that it is difficult for patients to obtain the truth, or even full information, from the ConMed Establishment, and the governments and mainstream media who appear slavishly to support it.

The initial reaction of the UK government was that 'there was no problem'. Is there any more typical response to a medical scandal? Whenever there has been evidence that a Big Pharma drug, or a conventional medical procedure, might be dangerous, this is almost invariably the first response. "There is no evidence". "People should not be alarmed".

Within a matter of days, the UK government had changed its tone. Instead of a 1% failure rate, they had to admit that the failure rate was closer to 7-8%. It would appear that government was prepared to pour balm over health problems - even when it was not in possession of the full facts!

Indeed, there seems always to be a point at which the game of 'Russian Roulette' with our health becomes too dangerous - even for Government! As long as drugs, medical procedures, implants, etc., cause damage or death to just a small number, this appears to be acceptable. Beyond that point, however, they are forced to ask questions, slowly, tentatively, of course, whilst more 'reviews' are held!

Yet, this is perhaps nothing compared to the information given to the women who sought, and accepted these breast implants. Most of those who have spoken to the media tell a similar story - they were told that the silicone implants were safe, and rarely if ever ruptured. In the main, this procedure is carried out in private, for profit, clinics, who, of course, have a vested interest in providing women with such re-assurance. Whether these clinics are going to be as willing to accept responsibility now so many of these implants have, indeed, ruptured remains to be seen.

So was the information given to women honest? Did the clinics know that this manufacturer was not using medical-grade silicone? Probably not, as the French company selling them would have realised they would not have sold many had they done so. It was not in their interests to tell the clinics. So why did they use industrial-grade silicone? Was there no medical-grade silicone available? Or was it just because it was cheaper to do so, and so boosted company profits?

Anyway, it seems clear that private, for profit, health interests have dominated these medical procedures. The question is, has honest, full, transparent information for patients suffered as a result? There seems to be little doubt about this.

Moreover, there is little difference between this situation, and the ongoing sale of all ConMed drugs, and other medical procedures - as they are promoted by the National Health Service, and supported by Governments of all colours. In these health care matters, we, as patients, are dealing with enormously important, immensely influential, and frighteningly powerful private interests. And it would appear that profit is of central, over-riding importance. Our health, too often, appears to be a secondary consideration - regardless of whether we deal with private clinics, or the NHS, or indeed rely on Government and its agencies to tell us the truth about conventional medicine.

So perhaps the main lesson to be learnt is that we all have to be weary about what we are told about conventional medicine; that we need to question whether the information given to us is full, open and honest: or whether we are listening to the vested interests of a powerful medical establishment.