September 22, 2021

I, Science

The science magazine of Imperial College

Beauty clearly doesn’t come cheap. In order to “get their PIPs out”, in the words of one Harley Street protester last weekend, an estimated £150m will need to be found in the UK alone. So, with the country’s largest cosmetic surgery group claiming that this is a price it just can’t afford to pay, I’ve decided to take a closer look at who should be footing the bill.

There’s been a lot of talk of morals flying around in this debate recently. Two weeks ago, Health Secretary Andrew Lansley served a ferocious shot at the private health sector, telling clinics it was their “moral duty” to offer free implant removal to concerned customers, whatever the cost. Not to be outplayed, Mel Braham, Chairman of The Harley Medical Group, returned a solid volley, arguing that it was the government who needed to accept “moral responsibility” for the debacle in light of the failure of its health regulatory agency, the MHRA, to, um, well, regulate.

Love-fifteen and a gentle round of applause, perhaps. It was, after all, the MHRA that failed to spot that industrial-grade silicon fillets were being injected into 40,000 of its citizens. But if private clinics, such as The Harley Medical Group, which performed 14,000 PIP procedures, won’t pay, then who will? Maybe more to the point, who should pay and who can? The question is a complex one, so like the scientist (and accountant) that I am, I’ll consider the options one at a time and hope that a sensible answer emerges somewhere in the process.

First, the easy question: who should pay? Who’s the most to blame for the PIP fiasco? Certainly not the British taxpayer, right?! Jean-Claude Mas, ex-PIP owner, is the obvious candidate, but he’s inconveniently on the run. His company has also now legally ceased to exist in a way that Monsieur Mas is probably wishing he could imitate, so it seems we’ll have to look further afield in our quest for a financially liquid culprit.

PIP’s unfortunate end-users are the most obvious victims of the saga. But, playing devil’s advocate, as regular readers will know I am wont to do, they did voluntarily have the procedure knowing at least some of the potential risks, generally for cosmetic reasons. They also chose PIP over other available brands, and not necessarily because it was the safest option – PIP implants were the cheapest out there, and clearly, with hindsight, for good reason.

But, let’s be honest, blaming the patients just feels wrong, so perhaps it’s best to move swiftly on.

The private clinics are currently taking much of the flak, but, arguably, they’re the least culpable, at least when it comes to the original procedures. They were using implants emblazoned with a genuine CE mark, and none of this debate centres on any claimed misconduct by the clinics or surgeons themselves. Unhappily for the clinics, their insurers have tended to agree that their clients weren’t to blame, and are therefore refusing to pay out.

Which brings us to Europe’s regulatory agencies; in the UK, the MHRA. And this seems like a pretty promising line of attack. As discussed in Part 1, the European regulatory environment for high risk medical devices is undeniably slack, and tighter governance may well have caught the problem much earlier. But agencies like the MHRA are shoehorned into following current legislation as set by the EC and passed by each national parliament, which in the UK consists of officials elected by, hang on a minute, the British taxpayer. Oh dear.

Maybe a different approach will give us a more satisfactory scapegoat. So, who stood to benefit from the implant procedures in the first place? Surely whoever makes the gain should take the pain?

Again, PIP and Monsieur Mas spring to mind, particularly given the healthy margins up for grabs once all that expensive medical-grade silicon had been done away with. The private clinics also took a healthy cut of the profits, and would be in the awkward (if profitable) position of benefitting twice if, say, patients were to pay for their own removal and replacement procedures.

But – and, again, I’m aware that I’m taking a pretty contentious position here – it is arguable that, when all goes well, the people benefitting most from cosmetic surgery are the patients themselves. For the most part, excluding NHS patients who were generally undergoing reconstruction, these women were willing to undergo a painful and risky procedure for the sake of bigger breasts. They were also willing to pay an average of £3500-£5000, often on credit, for the privilege, so the surgery was obviously seen as valuable by the women who had it. Contentious or not, we need to consider this when looking at the issue of liability. (I would have been a pretty unpopular figure on Harley Street last weekend.)

But, in reality, many of these women simply can’t afford to pay. So let’s look at who can.

The clinics are clearly the ones currently under the cosh, particularly The Harley Medical Group, the most impacted private provider. But with 14,000 unhappy customers, a bucket-load of bad PR and potentially the loss of its primary revenue stream, the financial hit could prove untenable. While the company has now confirmed it will remove and in some cases provide replacement for confirmed ruptures, they maintain that they are unable to remove implants for all concerned patients, arguing that “The Harley Medical Group does not have enough hospitals, surgeons and staff to manage this alone”. This may well be true. In normal circumstances the Group generates a large proportion of its profits from the 4,000 breast enlargement procedures it performs every year, meaning it could take a whopping three and a half cash-strapped years to clear the backlog.

Which brings us back to the taxpayer. The NHS constitution states that it will provide “a comprehensive service, available to all”, while also promising the “best value for taxpayers’ money and the most effective, fair and sustainable use of finite resources”. Given that there is still no evidence that non-ruptured PIP implants pose a health risk, removal of implants simply because a patient is worried about them, as Mr Lansley has currently set out, doesn’t seem to represent value for money. There are also serious ethical considerations when potentially lifesaving drugs are regularly rejected for NHS use on the basis of cost. Finally, the news that NHS Wales will be paying for both removal and replacement for private patients, in contrast with the rest of the NHS, adds an additional layer of farce as we all try to work out what on earth postcode has to do with the ethical distribution of finite healthcare resources.

Whether we are patients, taxpayers, shareholders or medical professionals, we have all been victims of a crime committed by Jean-Claude Mas and PIP. As such, there are no easy answers when it comes to settling up. Maybe we all need to take the hit. But it would be counter-productive to expect the private sector to pay more than its fair share. The Harley Medical Group didn’t break any rules in using PIP implants, and if they are to be forced into administration through moral one-upmanship and a failure by the government to recognise their own role in this mess, the vacuum they leave will be quickly filled. And their replacement, like PIP, may not be so law-abiding.

Image: London24