I warned about the dangers of metal hips 15 YEARS ago: A whistleblower reveals the real scandal over danger joints
02:49 GMT, 20 March 2012
The horrifying revelations about the dangers of metal-on-metal hip implants may have come as a shock to the thousands who have them.
Sadly, the news didn’t come as a surprise to me.
As someone who designs medical devices, I worked with the company contracted to develop and manufacture one of the first of these hip resurfacing devices.
What’s shocked me is that this scandal has taken so long to be exposed.
Some studies are linking metal-on-metal replacements with bladder cancer. Certainly, they have a far higher failure rate than other types of replacement hips
With a metal-on-metal replacement, the top of the bone and the socket it goes into are replaced or resurfaced in metal.
The first replacements were carried out at the start of the new millennium and were hailed as providing better mobility than the old — but safe and long-lasting — metal on plastic replacements.
Fifteen years ago, I and a number of other colleagues were vociferous in our criticism of the new design.
I am not patting myself on the back. An averagely bright teenager knows that running metal against metal will cause friction, and sooner or later friction causes wear.
This wear results in debris, tiny particulates which, in a car engine, for example, will filter to the bottom and lie in the sump waiting to be drained out.
There is no sump in the human body — just highly delicate tissues and organs, a complex vascular system and lungs, in which metal debris could cause untold damage.
The Medicines and Healthcare Products Regulatory Agency, the safety watchdog, has talked about toxins from the particulates causing inflammation in the body.
Some studies are linking metal-on-metal replacements with bladder cancer. Certainly, they have a far higher failure rate than other types of replacement hips.
Those who warned against metal-on-metal included people like me who worked on the prototypes as well as engineers and designers who had heard about the development and were concerned.
But no one listened to us.
With a metal-on-metal replacement, the top of the bone and the socket it goes into are replaced or resurfaced in metal
Indeed, when several of us pointed out this basic design flaw to the company I worked with, we were told the surgeon who’d come up with the idea — and who was working with the company to produce and endorse this replacement system — knew better than we did.
The attitude that the surgeons know best has become endemic in our industry.
‘Designed by surgeons for surgeons’ seems to be a slogan that every medical device company wants to trumpet on their new products, without stopping to consider just how ludicrous this is.
Certainly surgeons may spot a need for a medical advance or even come up with a rough concept of how this may work.
But unless they happen to also have an engineering or design degree alongside their medical and surgical skills, allowing them to act as if they are design experts is — as we can see now — a dangerous path to take.
Unfortunately, instead of enlightening them regarding their limitations, the medical devices companies have been all too ready and willing to foster this illusion.
This is not to do with cost. It is no more expensive to hire an engineer than a surgeon. It is simply that there is nothing a medical device company likes better than to get a surgeon on board to ‘advise’ on a product.
As a result, virtually every surgical device in the past ten years has got surgeon approval or design input.
Most vitally, it also gives companies a gateway into that magic world of NHS buyers, who in turn rely heavily on the recommendations of those same surgeons when they spend our millions on medical products.
The medical world, particularly within individual specialities such as orthopaedics, is a small place.
The medical device companies know only too well that if one surgeon turns their back on a product, their colleagues may well follow suit, and all those millions of pounds spent designing and producing will have gone to waste.
But if a surgeon endorses it — well, the sky’s the limit. It is common knowledge within the industry that items costing just a few pounds to produce are sold to the NHS with profit margins as high as 2,000 or 3,000 per cent above the manufacturing cost.
The argument is that the high prices are necessary to recover the design and development costs, the on-going assessment of the product, surgeon training and possibly royalty payments to the surgeon who ‘assisted’ with the design concept.
No wonder then that surgeons are so powerful — and that many of them are becoming very rich.
No longer content to earn a five-figure salary from the NHS, then doubling that with private work, a surgeon involved with a medical device manufacturer can be paid handsomely for that, too.
One surgeon in the North-East told me quite openly that he earned well over 100,000 per year in device royalties alone.
No doubt the device he worked on, will, on his recommendation, be in regular use in his NHS operating theatres.
Even more blatant is the recent development of surgeons forming companies to buy medical devices and instrumentation direct from the manufacturers, often based overseas, at discounted prices and then encouraging their hospitals to buy from them at an inflated price.
And all on the pretext that because they are surgeons they somehow provide a more authoritative endorsement of the products they are selling.
In any other profession this would be seen at the very least as a conflict of interest.
No one is saying that surgeons or, indeed, any doctor should not be allowed to come up with ideas for improving patient care. Of course, they are the ones at the front line, who see the need for a new device or a better product.
But then they should step away, leave the design to experts who have had years of training in design and engineering to actually create, test and produce the device.
In short, surgeons should stick to being surgeons.
I’m not saying this because I want to protect my profession. I’m saying it because I genuinely believe it is unsafe to allow untrained people so much power and responsibility in producing devices that can have a huge impact on people’s health.
Maybe the NHS bureaucrats will wake up and realise what is going on under their nose and do something about it. But I’m not holding my breath.
Interview by Isla Whitcroft.