There was an inevitability about it, and now the band wagon is rolling, it seems everyone from esteemed journal The Lancet to daily newspapers such as The Guardian are jumping on it. The case being made in such as this item, an interview with Lancet editor Dr Richard Horton on BBC Radio 4’s Today Programme, is that the reluctance of private healthcare providers to replace PIP implants with a “safer” alternative provides a vision of a future. The NHS is apparently going to give way to a private sector which is all too willing to walk away from its responsibilities, with the upshot that we see the recurrence of this lack of patient care far more frequently than would be the case at present.
Let’s examine this giant non sequitur, which effectively states that because it’s the private sector, it’s ungovernable when it comes to seeking recourse in the event of clinical device-related “problems”? Is this really the case? Indeed is this really the burning issue? Surely the starting point is to understand what’s gone wrong in the PIP case, bring in measures to minimise recurrence and agree who’s responsible for incurring the cost when an approved device goes wrong again in the future? And that depends on circumstances which stand a good chance of being subtley different every time. It could be the approver if they didn’t act correctly, or the device maker if they acted fraudulently or suffered unforeseen product problems (of which more later), or the clinician if they acted inappropriately (for which they’re insured) or the provider of the service who one could argue does hold a bit of the can as the ultimate “retailer” of the service. It could of course be “the system” which may have allowed just enough loopholes to exist for the determined fraudster to get to market. All of this gets much more tricky when the perpetrator of the crime disappears of course.
Firstly lets ponder the competent authority, the MHRA, which was alerted about the PIP situation (according to The Guardian) in 2008 when “surgeons had begun publicly reporting their own anxieties about these prostheses”. Should MHRA have acted based on information available at the time, when none of the other competent authorities in Europe were doing so? The article supports its case by quoting the concerns of one surgeon who noted; “That a high cohesive gel implant could have suffered such a massive failure only three years after implantation is very worrying.”
It’s true that some surgeons expressed concern about the implants early and even shock that their colleagues continued to use them. Yet many plastic surgeons were apparently writing reports to support the quality of PIP implants.
What was MHRA supposed to do? Obviously, exactly what it did will come out at some point and it will indeed be something of an indictment if the answer is truly nothing. The agency, in a statement issued on Wednesday this week claims it investigated adverse incidents and continually monitored the safety of these implant.
Let’s take a look closer to home for a minute. PIP implants were cheap, they were not FDA approved (in fact no silicone implants were allowed to be sold in USA between 1992 and 2006 because of generic concerns about silicone, concerns which had been allayed by 2006 based on historical implant data), were suffering daily negative press and a fuzz of information and misinformation even then. Yet the surgeon population and healthcare provider population continued to use them because presumably “they must be OK or the MHRA would have stepped in.”
Remember this is not Chewing Gum or Training Shoes, this is surgery, populated by people with big brains and, in the interest of their patients, among the most cautious characters you could meet when it comes to product and technique selection. Yet we’re asked to believe that they and the companies apparently dictating what products they used chose to wait for a government agency to tell them of their concerns while they implanted 40,000 of these things? The argument that MHRA should have spotted this and acted when clinicians at the very front line, sitting across from their patients, were happy to continue using the products just doesn’t stack up because it’s not at all black and white, except perhaps in retrospect. Indeed the MHRA is no different to other countries’ competent authorities in allowing the situation to endure, so don’t lets throw too many stones its way just yet.
So now, should the private sector show a hint of mea culpa? Providers shouldn’t have the temerity to hide behind the fact that the government agency continued to permit use of the product. Ultimately the government agency may not be able to duck the issue if it transpires that they allowed the product to remain on the market in the face of clear and oft reported problems. However when Mr Lansley says the private sector has a moral responsibility to replace these implants, he has to be at least partly right. Actually they probably know this, because in a TV interview this week, the boss of one of them argued that the reality was that he couldn’t afford to replace them rather than that he disagreed with the “moral” point. Other providers have agreed to do the work, which suggests again a healthily pragmatic and moral thought process.
Measures to prevent recurrence
From MHRA’s release of this week, Professor Sir Bruce Keogh, NHS Medical Director stated that; “The safety of people who decide to have cosmetic surgery or a cosmetic intervention is my sole aim. The vast majority of practitioners in the cosmetic industry are professional and well skilled – but I’m concerned that the sector as a whole does not have the systems for monitoring the results for patients and alerting us to possible problems. I will work with the industry to improve regulation and governance and increase consumer confidence.”
So it seems that the implant and failure data was anything but complete and this is borne out by the fact that failure rate information from different countries was so variable. So, somewhere on the “to do” list must be data collection.
Back to UK’s MHRA again, don’t forget this is not the organisation that allowed the product onto the market (albeit that it had the ability to enforce its withdrawal). Competent authorities exist in all European member states and sit atop the Notified Bodies who themselves implement the EU Medical Devices Directive. In this case the MHRA would have had zero involvement in the approval process or any subsequent auditing activity. In fact the Notified Body in question was esteemed German organisation TUV Rheinland, a company who does not have a reputation for being a walk in the park.
Questions need to be asked and are being asked, not so much about Notified Body actions, more about regulatory controls, like the ease with which PIP could covered its tracks because, as is always the case in the EU, they knew when their Notified Body audits were scheduled. There are no FDA style spot checks this side of the pond (yet).
Medical Devices Industry body Eucomed has also published its proposed changes which point, among other measures to use of “only the best” Notified Bodies.
Could it happen again?
So it’s all a giant mess, with lots of finger pointing, lots to resolve and not just who pays. But does it spell out a vision of the future? Well, according to Lancet editor Richard Horton it does. He ignores the fact that if we choose to use “zero risk” devices by allowing no more new products to be approved(assuming all current products work perfectly), we would stop future life-saving or life-enhancing developments in their tracks. Surely he doesn’t really want that.
Like night follows day, occasional product problems are a highly regrettable inevitability and mostly will not result in shuttered windows and rich ex-bosses sunning themselves at their villas, but huge costs incurred by the likes of DePuy as they act with massive moral responsibility and put right the ASR hip disaster.
Dr Porter mixes up what looks like fraudulent activity in one French company with what is certainly not a fraudulent activity in many others, disasters for which they are picking up the tab. He suggests that Health secretary Andrew Lansley has no power and is left “pleading with the private sector” providers to fulfil their duty of care. Statutorily that’s probably correct of course. The private sector stuck cheap implants in because they were CE marked, which is the point at which their responsibility for problems outwith any warranty provision ends. You can make your own mind up about whether there was enough doubt being cast on the cheap PIPs for the private sector to reassess their buying decisions (and with it their “moral responsibility”).
Is it really an NHS vs Private Sector issue?
Are we honestly suggesting that the recent problems associated with all-metal hips, implantable defibrillators and heart valves to name those quoted by Dr Horton are the same as PIP and wouldn’t happen in the NHS? They DID happen in the NHS and in all cases the devices were also approved by perhaps the world’s toughest regulatory body, the FDA. Bad stuff does happen and unless the perpetrator goes bust or vanishes, the perpetrator picks up the bill regardless of provider status. If they can’t/won’t then the provider is next in line and their case for not carrying any part of the can is strengthened if they made good calls in good faith. Imagine for example if they used cheap instruments from the world’s burgeoning “garage industry” instrument makers (which may well be CE marked because it’s such a simple process for certain categories of device) and an instrument breaks inside someone, do they have responsibility for corrective measures? Of course they do. A CE mark is not a guarantee of perfection. Are things any less likely to be put right than they would be in the NHS? No, because the “dreaded” market forces would pretty soon ensure that the world knew all about the bargain basement provider and their lack of judgement and care.
So we need to learn, we need to iron out loopholes, not least for the self-interest of the medical devices industry, and we need the regulatory process to be examined, reformed and probably toughened. We frequently hear experts referring to European patients as “guinea pigs” for devices ultimately intended for US sale, countered by other experts from USA worrying that US patients are being denied new technologies because of regulatory barriers. Somewhere in the middle lies a good solution.
Regulatory changes are already in the pipeline of course. But to suggest that even if we do these things the private sector will remain some uncontrolled cowboy, chucking devices at surgeons and saying go ahead, put them in patients, without a care to their quality or duty of aftercare, is to miss the point and smells of politicking. Indeed if anyone is more likely to be tempted to use the cheapest devices right now it’s probably the NHS who, despite being the paragon of all things medical has the global reputation for being one of the slowest adopters of modern, patient-benefitting technology in the developed world. The suggestion that the NHS may be slightly more likely to fix problems than the private sector should really be a moot point.
I think if I were the proprietor of a private healthcare provider I might take offence at a lot of the invective and I might consider the alternative strategy, which is that the best way to attract customers is to offer a good product, not just a cheap product. Harley Medical Group and its ilk might heed that thought, because punters do after all have a choice about where they go to have their bodies modified and might consider the way customers are looked after right now as a decision-making factor in the future.
Then there’s the implant manufacturers. Imagine the favourable press if you were the one to cut your prices in half in order to help save the private sector some cash right now.