Abstract
The authors of the invited articles in this issue of Clinical Risk were given a broad remit to enable them to explore ‘clinical risk’ as it applies to their practice, expertise and healthcare system in relation to aesthetic surgery. Like it or not, we live in a ‘globalized’ world in which patients have endless information easily available via the Internet, broadcast and printed media, as well as from advertising in all its forms. In addition, travel is easier now than ever before and few countries are ‘out of bounds’, and patients who can afford cosmetic surgery, can afford to travel. Cosmetic surgery and treatments are not covered by any healthcare, or insurance, system in the world but consumer demand for cosmetic procedures has increased dramatically over the last 20 years, slowing only as the ‘crunch’ started in 2007. As a direct result, market forces have been allowed to work with even less regulation than in the financial markets.
The attitude of the public has changed based on easy access to consumer credit. The consumer must have the latest product as soon as it comes out, and they believe that ‘new is better’. There is also the expectation of a perfect result every time with no risk and no adverse outcomes, and there is the attitude that someone must be to blame, and must make recompense, if they occur. We have reached a stage where public expectation, driven by media hype and, dare one say, professional greed, has brought us to a ‘perfect storm’ in the cosmetic surgical market. It is against this backdrop that these articles should be read.
It is paramount that every person, organization and regulator involved in the cosmetic surgery industry strenuously protects the patient. If we do not do that there will be a backlash, just as there has been in the banking industry. This is not protectionism but common sense. The world needs bankers more than cosmetic surgeons.
The role of the medical profession
Over the last decade increasing numbers of medical and non-medical practitioners have been drawn into the market because it is seen to be highly profitable. We are now seeing a generation of surgeons who want to train purely to perform cosmetic surgery, rather than being attracted to performing reconstructive surgery. There has also been a massive increase in ‘marketing’, including discount vouchers, 2-for-1 offers and holidays with surgery! In no other area of medicine is there such an unregulated mess. What is worse is that national governments would not allow it to happen in other areas of medicine. Imagine a ‘2-for-1’ advert for general surgery? That way lies madness!
It seems as if the doctor's first duty to protect their patients has been forgotten by many in the cosmetic surgery market. The General Medical Council (GMC) of the UK enshrined that duty as the overriding principal of Medicine, and it has been set out in the Hippocratic Oath for millennia. The article by Mr Slack 1 sets out the current regulatory framework in the UK. Adam Searle, a past President of the British Association of Aesthetic Surgery, suggested that the metaphorical ‘crock of gold’ on the consultation desk between the patient and practitioner could change both sides' approach to the outcome of the intended treatment. The medical profession must not fall into this trap. If we have to sell anything, we should sell our advice, not procedures. If we cannot self-regulate, then, like the financial institutions, regulation will eventually be imposed. With the ‘crunch’, competition for what remains of the market will be fierce and, in an unregulated market, the outlook is poor for all involved. The medical profession has to get itself in order but, unfortunately, it may be too late due to ‘globalization’.
The role of the media
‘He who lives by the sword, shall perish by the sword.’ Matthew 1.26:52
Some in this industry have tried to ‘harness’ the media to project to the public what can done and how good they are. But there lies a fundamental misconception, in that the media cannot be ‘harnessed’. Ask any ‘personality’ who has used the media for publicity and they would agree. At the first slip of the veil of respectability, the media expose the individual's failings, particularly in the UK. Some doctors, who have courted the media, have fallen foul of it in the end. Some have been ‘struck off’ the Medical Register, and some have ‘retired’. The article by Mr Boyd, 2 a partner in Carter-Ruck, the famous English libel lawyers, shows how, and why, those in the cosmetic sector may fall foul, rightly or wrongly, of disgruntled patients, colleagues, families and the press.
A recent online article by a writer for a British national newspaper illustrates the impact of the media. The author tells how she had injections of semi-permanent filler to her face ‘on a whim’ and ended up mutilated. The author writes regularly on cosmetic issues and admitted her decision was primarily based on advertisements. She now regrets her decision. To her credit, she does not name the doctor. This case illustrates that advertising can be a powerful tool but is often misused in the cosmetic surgery industry and misinterpreted by those it is aimed at. The ‘media’ also have a responsibility to inform and not to sensationalize. The paper by Dr Fogli 3 explains that, in France, advertising is not allowed in any area of medicine, and cosmetic procedures cannot be advertised by third-party organizations, but he does point out that adverts originating outside France continue to be problematic. Perhaps, like tobacco, there should be a Europe-wide ban on advertising all cosmetic ‘surgical’ procedures, including on search engines.
Similarly, the cosmetic surgery industry should not sell procedures directly to patients. New products, such as barbed thread facelifts and fibroblast culture for facial lines have come onto the market with great publicity and media interest, only to disappear rapidly when it became clear that they have a high complication rate and/or low efficacy, leaving behind disgruntled patients and doctors. I have read in the press of ‘unscrupulous doctors’ using these procedures. On the contrary, usually, the doctors have used the procedures in good faith after appropriate training but there is a fundamental problem in the UK, which is best illustrated by the group of products termed ‘dermal fillers’. In the USA, there are only a handful of fillers with FDA approval (mostly for moderate to severe facial lines in HIV patients with lipodystrophy), whereas in the UK there are over 100 on the market. Why the difference? In the USA, the products undergo testing as a ‘drug’, but in the UK they are tested as a ‘device’ and so only have to pass ‘CE’ mark requirements, which relate to standards of production, not of efficacy. Drug testing is lengthy and expensive but CE marking is not. That is why substances can be injected, which are perfectly legal, but do not need to be licensed for efficacy or safety. The fault here lies with the EEC, and it is a major area in which the public and the profession need to be protected, because both can only judge a new product on the company's marketing information. It seems logical that biomedical firms in Europe should have to test their products as rigorously as any new drug and, to that end, the EEC should adopt FDA-like testing for implantable devices. This would remove many of the problems at a stroke. ‘New’ is definitely not necessarily ‘better’ in this market. ‘Permanent’ and ‘semi-permanent’ fillers all come with a greater incidence of complications, which may not be correctable. ‘If it sounds too good to be true, it usually is!’ applies just as much to cosmetic products as to the financial markets. ‘Quackery’ was outlawed in medicine over a century ago, but it is in danger of returning in the cosmetic surgery industry. One only has to look in women's magazines to read unsubstantiated claims for procedures and treatments. The plight of the journalist and her filler-ravished face can work to the benefit of the public, and the profession, if it helps to expose and correct this Europe-wide problem. The Consumer's Association (Which) and professional bodies, such as BAAPS, are actively campaigning to change this situation, and if the media join in the cause by being more sceptical and realistic about what can be achieved, hopefully the public will take note.
The role of the patient
All cosmetic treatments are medical interventions, and every medical intervention has a complication and failure rate. Consequently, there are no ‘consumers’ or ‘clients’, but only ‘patients’ and they must take responsibility for making informed decisions about their care and for how they exercise their choice. Dr Bradbury's article 4 suggests ways to maximize the success of any procedure and how to minimize the risk of ending with a dissatisfied patient.
The media and both published and broadcast ‘marketing’ have wittingly or unwittingly given the public the impression that cosmetic surgery procedures are quick fixes and carry no risk of downtime or complications. Nothing could be further from the truth and it defies common sense to think otherwise. This effect is perhaps best illustrated by the increase in ‘surgical tourism’, a decision made, it seems, based almost entirely on cost. The patients who choose to go abroad seem to believe that their surgeon is as qualified as a UK-trained surgeon and that the facility where they will have the procedure is as well regulated as one in the UK is by the Care Quality Commission. Dr Nahai's paper 5 discusses this situation from an international perspective.
There is increased medical risk as well. The most common misinformation given to surgical tourists is about risks, including postoperative recovery. For example, a patient from the west of England died from DVT following a facelift abroad.
The public are aware of the risk of deep vein thrombosis (DVT) after a flight and also after surgical procedures. This risk can be reduced by taking aspirin for antithrombotic prophylaxis, but aspirin increases the risk of perioperative bleeding in cosmetic surgical procedures, so patients in the UK are usually asked to stop before major cosmetic surgery because a haematoma may need a return to theatre, and lead to other complications. If the patient is abroad, the care of those complications will extend well beyond the end of the ‘holiday’. Occasionally, a blood transfusion might be required in these circumstances. Would any one want a blood transfusion in a country with a published HIV rate of 25% such as South Africa?
Complication rates should be as low as possible, but how can the patient be sure they are being told the truth about the risks, and what will happen if they develop a complication? At the minor end of the spectrum, 1 in 25 of the population will form a ‘bad’ scar, no matter how well the wound is stitched, and it will take a minimum of four months to settle, by which time, the patient will be long gone! The surgeon is practically working risk-free, because the patient will never go back for follow-up or revision, will not be able to take legal action or use the media to expose bad practice.
Role of the general practitioner (GP)
In the UK, the GP remains the filter for entering secondary care. They often now refer generically rather than to a named surgeon or physician, with the aim of getting the patient into secondary care under a target time. As a consequence, the GP may not know who is ‘good’ locally. Coupled with this, patients often report that their GP would not support their request for cosmetic surgery, no matter how well-founded, and may give the patient the impression that they are wasting the GP's time. The GMC rightly continues to insist that the GP is informed of any proposed treatment. If the patient bypasses the GP and goes directly to a surgeon (as many do), and the surgeon does not inform the GP, the surgeon has sole responsibility for all aftercare (e.g. a DVT, infection or myocardial infarct). The message to both surgeon and patient is clear: ‘Always inform the GP! They are there to protect both of you.’
Reduction of clinical risk in cosmetic surgery
It is fundamentally important that any doctor or healthcare professional working in this market must act in the patient's best interest and within their sphere of training and competence. They must also behave responsibly, with integrity and probity. All surgical work is subject to audit in the UK. If a surgeon was going to have an operation, they would want to know how many procedures, and with what complication rate, the surgeon they are consulting has done. So why not do the same with your own patients? A good maxim, which may sound familiar, is ‘Do unto others as you would have done to you’. Not withstanding, there has to be regulatory framework and the French Government have taken bold action. It is agreed in the profession that more needs to be done internationally to both regulate and educate. All providers of care (doctors, non-medics, institutions and facilities) involved must be subject to regular inspection and revalidation. Mr Khoo's paper 6 looks at the way forward chosen in the UK.
The patient has to pay for cosmetic treatments and, if they develop a complication, they may have to pay to have it corrected. That would annoy anyone and often leads to legal action. An insurance product should soon be available in the UK, which will cover the patient for such an eventuality. It should help to protect both patient and surgeon, and it will also allow a third party to know the claims history of practitioners. It is logical that a surgeon with a poor claims history will be removed from cover and any patient would be foolish to have them touch them. The new policy may not reduce clinical risk, but it should help reduce the sequelae of complications for all concerned. Currently, medical malpractice insurance, which all surgeons performing these procedures in the UK must hold, covers any surgeon, no matter how bad their claims history, training and expertise. Mr Grover's paper 7 looks at this aspect of the industry.
Perhaps the single most important factor in reducing clinical risk in cosmetic surgery is the motive for performing any procedure must never be financial gain, so I suggest we get our act together as an industry as we are in grave danger of biting the hand that feeds us.