COSMETIC CHANGES AHEAD
Partly as a consequence of last year’s PIP breast implant scandal, Professor Sir Bruce Keogh, the NHS Medical Director was asked by the government to look at whether the cosmetic surgery industry needed to be more effectively regulated. On announcing this review, Sir Bruce explained ‘I am concerned that too many people do not realise how serious cosmetic surgery is and do not consider the lifelong implications – and potential complications it can have’. The resulting Keogh report is due for publication next month, and in anticipation of the recommendations for change, the purpose of this article is to examine what some of the current difficulties with the provision of cosmetic surgery are and what could be done to improve the industry and the average patient’s experience.
Cosmetic surgery is defined by the Department of Health as ‘Operations or other procedures that revise or change the appearance, colour, texture, structure, or position of bodily features to achieve what patients perceive to be more desirable’. In their consultations with Sir Bruce, organisation such as BAAPS (the British Association of Aesthetic Plastic Surgeons) have identified difficulties in the industry at every stage of the treatment process from the manner in which patients are persuaded to have treatment in the first place to the quality of aftercare.
(1) Advertising & Consent
Sir Bruce’s first remit was to look at how best to ensure that people considering such interventions are given the information, advice, and time for reflection needed to make an informed choice.
Advertising practices and commercial hard selling of cosmetic surgery have become more and more aggressive in recent years. People are influenced and encouraged by the media and celebrities to consider treatment as a means to improve their confidence and self-image. Often the vulnerable (e.g. the young, the recently divorced) are preyed on and gimmicks such as 2 for 1 offers are used as an economic inducement.
BAAPS and other organisations are calling for drastic change including an outright ban on cosmetic surgery advertising or at least the outlawing of some particularly controversial practices such as time limited offers, BOGOF, and ‘refer a friend’ packages.
Mr Harrison is all for change but takes a nuanced approach because of the practicalities of enforcement:-
BAAPS’ principal desire to ban all advertising of cosmetic surgery is entirely desirable. In the 1960s and 1970s surgeons were threatened with being struck off by the GMC. The latter is no longer so, and for example, if one is invited to comment on a patient’s treatment in a newspaper or on television, it can be described as legitimate educational comment, not advertising, but the effect is similar. If one person advertises, it stimulates his competitors to do the same. Attempts by BAAPS in years gone by to outlaw the advertising as practised by the commercial clinics failed miserably and cost it and its members a substantial amount of money which they are still paying off in high subscriptions. In conclusion I have no doubt that it would be a very desirable concept to stop advertising cosmetic surgery but in the present climate I rather doubt it would be truly practical.
As the law currently stands, there are published minimum standards set out in the Care Standards Act 2000. This requires for example that treatment providers explain the risk factors associated with individual procedures and that patients are guided through a selection of different treatment options prior to surgery. However there is no requirement to provide the patient with any written information or for the treatment provider to obtain a relevant medical history from the Claimant’s GP. Also, and perhaps more controversially there is no requirement that the initial consultation to discuss the procedure beforehand (including the risks and likely outcome) is with the surgeon who will administer the treatment or even with a medical professional. This means that in some clinics, the patient’s ‘consent’ is being obtained by a nurse or a salesperson.
Good practice during the initial consultation should be the surgeon themself meeting the patient, explaining the procedure and making a handwritten consultation note of what was said, including an explanation of the specific complications of the procedure in question (this might be bleeding, haematoma, infection, wound breakdown, delayed healing, skin damage, unfavourable scarring, asymmetry, the need for further surgical adjustment and even nipple necrosis and gangrene in some extreme examples). Good practice is for the surgeon to give the patient some written information about the procedure, usually a pro forma consultation form with all the relevant potential complications highlighted as well as leaflets and patient information sheets giving perhaps more generic advice about types of cosmetic surgery (i.e. breast, facial, or abdominal).
Again, BAAPS and other relevant organisations have made recommendations to Sir Bruce about what sort of changes they would like to see at the consent process stage. These include:-
• Requiring that the initial consultation is with the surgeon who will administer the treatment
• Banning free consultations for cosmetic surgery so that people don’t feel obliged to go through with surgical responses
• Requiring that the initial consultation is at least 30 minutes long and requiring a two-stage written consent for surgery so people would have time to reflect and ‘cool off’ before making a decision
• Providing better information for patients, including photos of expected bruising and scarring and more detail on the risks associated with surgery
• A standardised consent process supported by a standardised form
• Consideration of the need for patients to be referred to a clinical psychologist before going ahead with treatment (if necessary)
Certainly if these reforms were adopted, the patient would surely benefit as it would be more likely that in each and every case he would be making a fully informed decision about the treatment and the surgeon would know that the patient had full capacity to make that decision.
Mr Harrison agrees, although again stresses that any approach taken must be pragmatic enough to work in every day clinical practice:-
‘It is best practice to explain complications very carefully. In a busy practice, to write out all the complications in longhand is time-consuming, and if a patient wishes to discuss correcting various parts of their anatomy with all complications included it can cause long delays in the waiting room. Essentially most have proformas with most of the recognised complications at least as topic headings, to signify that these complications have been properly discussed. They are usually signed by the patient and the surgeon, and dated. Patients commonly forget about the various complications that have been described, so these proformas protect both parties. Similarly, photographs are taken both pre- and post-operatively, as again the patient often forgets their pre-operative appearance. Patients are always asked to provide their GP’s name and address so that a letter can be sent to them. In cosmetic surgery many patients don’t like their general practitioners to know that they are having this sort of surgery, as they are fearful of censure. Consent forms are always signed on the day of operation by the operating surgeon in every reputable hospital. Patients also often sign a private consent form for the practice notes. One feature of the consultation process where the surgeon has to tread carefully is providing the possible patient with images of what they are going to look like. Computer photographs morphed to, for example, reduce the sze of a nose, augment a chin, smooth out a face as expected in a facelift, is ill-advised, particularly if a print-out is provided to the patient. Unfortunately surgery is not like a computer. The response of a human body is completely different and subcutaneous scarring often takes many months to settle. Similarly, showing pre- and post-operative photographs of other patients does not mean that a certain individual is going to respond in a similar manner. It is human nature that a surgeon will show his good results, but it does not mean that another individual will respond similarly. The surgeon also needs to be wary of certain groups in plastic surgery, for example, the male multiple rhinoplasty, where essentially the individual may be unsatisfiable. In my experience, most competent surgeons probably over-state the complications, rather than the reverse’.
From a legal perspective, it would make it far simpler for a patient to successfully sue a surgeon who failed to warn him of the risks of the procedure and performed it without his informed consent. In very basic terms, the legal test for clinical negligence (known as the Bolam test) is that the treatment complained of cannot be endorsed by a responsible body of medical opinion within that given field of practice. So if in the future there were a standardised consent process which the surgeon in question had not followed, then it would be easier for the patient to demonstrate that no responsible body of cosmetic surgeons would have done as the surgeon had done and a breach of duty might be established in law.
(2) The Surgeon and the Surgery
Also within the remit of Sir Bruce’s investigation is how best to assure patients and consumers that the people who carry out procedures have the skills to do so
Many people assume that cosmetic surgery is not really medicine at all and that it is relatively simple compared to orthodox forms of surgical treatment. However this is not true as Clive Orton the former of president of BAAPS has stated ‘In fact most cosmetic surgery operations are extremely complex and require a high degree of anatomical knowledge and surgical skill as well as aesthetic appreciation”.
Surgical practice in the UK is currently regulated by the General Medical Council (GMC) and practicing surgeons should be enrolled on its specialist register. However, some concessions are made for private surgeons who have been practising since before April 2002 so that by satisfying certain criteria, these doctors can practice without the need to be on the specialist register.
Mr Harrison commented as follows:-
‘Most trainees in the field of plastic surgery will have been through most of the cosmetic procedures, but there are specialties within plastic surgery such as oculo-plastic, oromaxillo-facial, ear nose and throat and dermatology, many of whom have relatively scant experience in the cosmetic field and who like to move into a more lucrative field.’
During his investigation, Sir Bruce came across some respondents who felt that the existing plastics surgery register did not offer guarantees of good practice, and that doctors not on the specialist register were still able to routinely offer patients a safe, effective, and appropriate service in a primary care or non-specialist setting. Indeed the majority of respondents approached by Sir Bruce felt there needed to be a change in the training, revalidation and accreditation of professionals to prevent them from operating outside of their area of expertise. This is because the current system allows those with medical training but no experience in cosmetic interventions to conduct procedures in which specialist training should be required.
On the subject of complications in plastic surgery, Mr Harrison gives the surgeon’s perspective:-
‘Complications can occur in the very best of hands, and the surgeon who says he has no complications is simply untruthful. Perhaps the most relevant factor about choosing a quality surgeon is not so much that he gets you into trouble, as that he knows how to get you out of trouble when it occurrs. The surgeon is also dependent on the honesty of the patient. Smoking causes necrosis of skin and delayed healing. It is highly addictive, and many state that they have stopped when, of course, they have not. Some use Aspirin when they have been asked not to, some self-harm and some hide medical conditions. The managers of good private hospitals are usually very understanding in regard to particularly immediate complications such as haematomas after a facelift, or extra nights in hospital due to uncontrolled vomiting. Late (arguably subjective) complications such as dissatisfaction with the shape of a nose or further enlargement of silicone breasts despite the fact that most observers would consider them entirely satisfactory, are more contentious issues where some compromise has to be accepted.
Another area of concern is whether there was sufficient scope for patients who do experience sub-standard treatment to seek financial redress when things go wrong. This can be particularly problematic where foreign surgeons operate in clinics in the UK but don’t have medical liability insurance to pay compensation and costs to enable wronged patients to claim in negligence.
Mr Harrison said:-
Choosing a foreign surgeon to operate upon you, particularly in advertising clinics, should be a decision to be taken with care. Most good surgeons in their own country do not need to travel abroad. Many European exams are entry exams, not exit, and, for example, Italy provides training to a considerable number of surgeons who have little chance of ever finding employment in their own country. The insurance cover of foreign surgeons needs to be questioned. Many are inadequate relative to the UK insurance societies, and if seriously threatened, the individual would return to their own country where it would be difficult to sue them. Many of these surgeons have not been through the rigours of the NHS selection committees, which do attempt to stop individuals who are clearly unsuited to surgery and therefore the patient has little concept of his skills profile. Complications can be a great deal more difficult to correct than if the surgery has been carried out correctly in the primary instance.
Again from a legal perspective, it stands to reason that it would be easier for a patient to demonstrate that no responsible body of cosmetic surgeons would have planned or executed an operation in the manner complained of if the profession only included those practitioners who had the necessary training, qualifications, and experience because the Bolam test relies on a minimum quality standard being observed and enforced across the board. Certainly everybody Sir Bruce has consulted with to date believes that private providers or cosmetic interventions should at least meet the quality and safety standards expected of the NHS.
Good news for patients is that all EU based medical professionals practising in the UK will soon be required to have insurance or other arrangements ‘appropriate to the nature and extent of the risk’ in place by October 2013 as part of the implementation of the EU Patients’ Rights in Cross Border Healthcare Directive.
This can be problematic. Unlike the NHS, it can be contractually unclear whether or not a cosmetic surgeon at a private clinic is responsible for dealing with poor surgical outcomes and indeed who will be financially liable for the correction of any complications. There is currently no clear legal requirement to place a duty on clinics or surgeons to provide aftercare where a patient is harmed as an unexpected consequence of a procedure and the majority of bodies asked by Sir Bruce felt that there should be a specific duty of care on the practitioner to provide this to the patient.
Indeed the practical reality faced by the patient can be that the clinic does not have a high dependency unit on site or even a fully equipped theatre to deal with an emergency that arises after the patient has been discharged home following surgery. This means that the patient ends up being ‘bounced’ to the NHS, often through a local Accident & Emergency department.
The quality of aftercare is not an insignificant factor and indeed it can play a crucial role in maximising the aesthetic result which the patient is seeking. Sadly poor results are often the result of poor aftercare, even after the best and most skilfully performed cosmetic surgery.
On the subject of aftercare, Mr Harrison commented as follows:-
‘Patients must be seen by either the surgeon or a qualified deputy the following day. Mitigating circumstances can always occur ,but this should be the expected norm. Nursing care of the patient is an integral part of the surgical experience. From the surgical aspect it has altered in respect that the Sister is no longer the reliable path to surgical orders, as her duties have have moved towards administration, and the nurse in charge of the patient may not have English as their first language. Comprehension of post-operative procedures can be misinterpreted.
The protection and well-being of patients in the 1960s and 1970s was much more robust from the aspects of surgery, nursing and advertising. It was possibly more expensive, but the patient was well-protected. Advertising clinics have made cosmetic surgery more available to the less well-off, but brought with it a stream of complications. Sir Bruce Keogh has the unenviable task of trying to reverse the clock in an age of consumer demand. Unfortunately as with the horse meat scandal, people will continually seek the cheapest offer, and then are surprised to find that it is horse, not Aberdeen Angus’.
We don’t yet know what Sir Bruce’s recommendations to the government will be although some of the issues touched on in this article are likely to be included. However the bigger question is whether the government will act by introducing new regulations in the light of those recommendations or permit the status quo to continue for another 5 or 6 years until the next scare.
We have been here before. There was a review in 2005 under the then chief medical officer, Sir Liam Donaldson which concluded by recommending statutory regulaion of Botox injections, dermal fillers, and laser treatments but the department of health did not accept the need for change and these products were allowed to continue being marketed in the UK in the same way as any other consumer product.
We shall wait and see whether things will be different this time….