Sadly, it usually takes a tragedy or a scandal before Governments take action in the healthcare sphere for the protection of patients and the public. The Thalidomide tragedy, the deaths of children at Bristol Royal Infirmary, and the murders by Harold Shipman all resulted in major changes to the law and the regulation of healthcare professionals. The public scandal involving Poly Implant Prothese (PIP) silicone breast implants has shone a spotlight onto cosmetic surgery and other cosmetic interventions in general.
The Secretary of State for Health has asked Sir Bruce Keogh, the NHS Medical Director, to convene a panel of experts to look at what can be done to improve the safety of patients. The panel will look at cosmetic surgery such as breast augmentation; and noncosmetic interventions such as injectable dermal fillers. The panel will consider a wide range of issues such as regulation and clinical governance, information and consent, and recording outcomes. Sir Bruce's review will not extend to clinically indicated interventions such as reconstructive surgery for a breast cancer patient following mastectomy.
Fitness to Practise cases and the Courts
In view of the elective nature of the types of surgery and interventions covered by the review, commercial considerations will on occasions influence decisions and behaviour both of practitioners and patients. Plainly, some patients will be vulnerable. The possible need for further regulation raised by the PIP implant scandal, is reinforced by recent cases that have come before the GMC's Fitness to Practise Committee.
- In December 2011, Dr Phanuel Dartey was erased from the Medical Register because, amongst other things he operated on a patient's labia majora, and failed to ensure that she understood and accepted the specific risks and complications. Dr Dartey had also forged evidence of membership of a medical defence organisation, and was practising without insurance.
- In June this year, the GMC's Fitness to Practise Committee found Dr Aamer Khan's fitness to practise was found to be impaired because, amongst other things, he unreasonably induced a patient to accept surgery by agreeing to undertake financially discounted cosmetic surgery; did not record relevant documentary information in the preoperative clinical assessment ; did not ensure that the times of administration of the patient's sedative medicine and vital signs were monitored and recorded; did not record relevant information in the operation note and failed to provide adequate post-operative clinical care.
Recent High Court cases have also brought the possible need for further regulation to the fore. The case of Dr David Waghorn illustrates how regulation is currently carried out by the Care Quality Commission. Independent hospitals must be registered with the Care Quality Commission. In March 2010, inspectors from the CQC made an unannounced visit to the Berkeley Clinic in London. They found Dr Waghorn in a basement room, performing liposuction under local anaesthetic on a female patient. Dr Waghorn was working without assistance and, at the time of the inspectors' arrival, the procedure had taken 4 hours and was not complete. Dr Waghorn did not know the patient's name, and no medical records for the patient were ever found. Dr Waghorn was convicted of failing to register the premises with the CQC, and was fined £2500. Dr Waghorn appealed to the High Court against his conviction, arguing that the premises did not require registration because he did not own the Berkeley Clinic. His appeal was dismissed in June this year. Pending a fitness to practise hearing, the GMC's fitness to practise committee imposed conditions on Dr Waghorn's registration that prevent him from carrying out any cosmetic surgical work or aesthetic procedures, including liposuction.
Practitioners who are in breach of their duty of care to patients may, of course, also be sued. In the 2011 case of Penny Johnson v Mr Le Roux Fourie, the High Court awarded damages of over £6m, including compensation for loss of past and future earnings, to a high earner who, when 42 years of age, consulted the defendant, a plastic surgeon, about minor plastic surgery to her nose and dark circles under her eyes. In the event the defendant proposed more radical plastic surgery involving a replacement of pre-existing breast implants, and a facelift with further surgery to the forehead and eyes. The surgery was carried out negligently, and had serious consequences both physical and psychological. It caused permanent damage to the claimant's right facial nerve, resulting in an abnormal spontaneous facial movement, known as jactitation, which presents as an abnormal grimace, and is exacerbated by fatigue or stress. As a result of the surgery to her breasts, her left breast was higher than the right, and was an odd shape with unsightly lumpy scarring. The physical injuries resulted in a prolonged adjustment disorder with features of anxiety and depression.
Being able to sue practitioners can provide patients with a financial remedy after the event, but statutory regulation and fitness to practise measures are mainly intended to prevent instances of sub-standard treatment occurring.
The Keogh Review
In announcing the Keogh review, the Department of Health noted that a medical practitioner does not have to be a surgeon to carry out cosmetic surgery unsupervised outside the NHS, and that in any event there is no section of the Specialist Register that refers to cosmetic practice. The GMC's guidance "Good Medical Practice" makes it clear that doctors are expected to practise only in the clinical fields in which they are competent, but competence is currently self-assessed and cases will only be dealt with by the relevant healthcare regulator if a complaint is made. Moreover, cases will only be investigated if there is likely to be a finding that a practitioner's fitness to practise is impaired.
Specific procedures the Keogh panel will look at include breast enlargement; the use of dermal fillers to plump up wrinkles, deal with scarring and augment the lips; chemical peel to improve the appearance of the skin, laser hair removal, and the administration of botulinum toxin. In common with other cosmetic procedures, botulinum toxin can be injected by anyone acting in accordance with the direction of an appropriate practitioner. While this may be a doctor, nurse, dentist or pharmacist, all of whom will be required to follow the professional standards appropriate to their respective professions, the product need not be administered by a member of any healthcare profession. One of the most difficult issues for the Keogh panel to address concerns the cosmetic procedures which can legally be carried out by people with no recognised qualification.
Not only can some cosmetic procedures be legally carried out by people with no recognised qualification, but non-surgical cosmetic interventions, including the injection of subcutaneous substances, can be delivered in non-healthcare settings which do not require the premises to be registered with the CQC. For example, beauticians or hairdressers administer dermal fillers or laser hair removal. Some have diplomas, but they may have received no training in relevant cosmetic treatments. They may belong to a relevant trade organisation, but such organisations are not regulated, for example by the Council for Healthcare Regulatory Excellence (soon to be renamed as the Professional Standards Authority for Health and Social Care).
The Keogh panel will additionally look at
- how patients give informed consent for procedures;
- the appropriateness of information available to them, including the way in which the advertising of cosmetic procedures is regulated;
- whether all providers should be required to have adequate indemnity arrangements in place;
- whether there should be a formal "cooling-off" period between consultation and surgery
- prescribing; and
- the regulation of products
Medical Revalidation
The Department of Health's background paper for the Keogh review attaches significant importance to the forthcoming requirement for revalidation, even though ministers have not yet given final approval to the process. The purpose of revalidation is to assure patients and the public that practitioners are up to date and fit to practise. Ministers have not yet given final approval for the details, but doctors will be subject to periodic checks on their competence in all the fields in which they practise, both in the NHS and privately. Revalidation will probably include a requirement for annual feedback from patients and colleagues, as well as evidence of continuing professional development, and reviews of complaints and relevant information about clinical outcomes.
What Recommendations might be Expected?
In many areas of healthcare, professional self-regulation is no longer the norm. It seems likely that the recommendations of the Keogh panel will continue this trend, because a higher priority will be placed on protecting patients and the public than protecting the interests of providers, especially where there is a risk that practitioners will be motivated by commercial considerations.
The Minister for Health, Earl Howe, has already carried out a review of the actions of the MHRA and the Department of Health in relation to PIP silicone breast implants, and has recommended that Sir Bruce should examine ways of promoting a stronger culture of clinical governance, clinical audit and reporting in cosmetic surgery. This is likely to result in requirements for incident reporting, and reviewing outcome data by individual surgeons and other providers to become the norm.
It seems likely that the Keogh panel will recommend that some treatments should be carried out only by medical practitioners and, in some cases, by specialists who are included in a new section for cosmetic surgery in the Specialist Register.
In the case of procedures that are not covered by specific healthcare laws, health and safety at work legislation or consumer protection laws may apply. However, these laws were not designed specifically to protect patients who undergo cosmetic surgery or interventions; and enforcement is not in the hands of bodies with healthcare expertise, such as the CQC or MHRA. Primarily, enforcement is the responsibility of trading standards officers employed by local authorities. Most London councils exercise licensing powers over cosmetic clinics, and require compliance with a code of conduct, covering access to expert advice, staffing, maintaining a register, safety, qualification and maintenance of equipment. It would not be surprising to find that the Keogh panel recommends wider use of such powers.
It is apparent from recent Fitness to Practise cases and from the Waghorn case that record keeping in the case of cosmetic procedures is not always adequate. It is likely that the requirements for record keeping will be spelled out, and that the scope will be widened. This may require revised good practice guidance from the General Medical Council and the General Dental Council. Through CQC registration, which will be extended over time across healthcare professions, a legal requirement to provide aftercare to patients may also be imposed.
The Department of Health suggests that revalidation will play a role in improving patient protection. Doctors will be legally obliged to have clinical indemnity from October 2013, and doctors who work outside their competence may find it difficult to obtain indemnity cover or practising rights in a private hospital.. However, revalidation is new to the medical profession, so achieving the desired level of governance and patient protection through a system that is untested may be expecting too much, at least in the short term. Moreover, it seems undesirable to leave insurers and hospitals to police the competence of clinicians. Doing so, would not eliminate the risk that doctors may practise while uninsured or that an insurer or medical defence organisation may decline to cover a claim, thus removing the financial protection patients are entitled to expect. If anything, as one recent Fitness to Practise case has shown, a requirement for insurance will not necessarily prevent unscrupulous practitioners from forging insurance documentation. These rare cases may be the very ones in which patients most need protection – uninsured practitioners are not likely to be able to meet a £6m compensation claim from their personal resources.
The Keogh panel will consider whether non-healthcare professionals should be required to audit their processes and take part in clinical audit. It is difficult to see how such activity could be regulated. In any event, there is a more fundamental problem because there is no way of knowing whether beauticians who deliver cosmetic interventions like fillers, Botox®, laser treatments or chemical peels, have the appropriate skills to deliver them, and there is no system for monitoring performance.
Summary
Public and press interest in the PIP scandal make it inevitable that the law will be strengthened to protect patients who undergo cosmetic surgery and other treatments. However, it is far from certain that increased regulation will provide protection when surgery or treatment is provided by an unscrupulous or unqualified practitioner.
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