The origins of plastic surgery, a medical speciality concerned with the correction or restoration of form and function, can be traced back to 800BC when reconstructive surgery techniques were being carried out in India (MSN Encarta (2008) ‘plastic Surgery’). Incredibly developments in this field have taken place over the centuries, including the development of facial surgery during World Wars I and II. The advancement of treatment’s together with the increasingly accessible world of social media/Kardashian culture has meant that aesthetic plastic surgery – where the end goal is, in its simplest form, the enhancement of appearance through surgical and medical techniques – is a commonplace occurrence and not simply the reserve of the rich and famous. Nine out of ten cosmetic procedures in the UK are now non-surgical, such as botulinum toxin (Botox), dermal fillers and laser hair removal. The numbers undertaking such procedures are constantly increasing and are worth 75% of the market in total. Treatments can be so easy to come by that they can now be done during a lunch hour during the workday. With such rapid changed occurring to the world of (non – surgical) cosmetic procedure, what difficulties have arisen in regulating this industry?
Cosmetic interventions and protection: the review
An independent review (the review) of cosmetic surgery led by Professor Sir Bruce Keogh, the then NHS medical director, was commissioned by the government following the PIP breast implant scandal (review of the regulation of cosmetic intervention: The review, published in April 2013, shockingly found that there was next to no regulation for non-surgical procedures, despite the fact that they account for 90% of cosmetic procedures undertaken in the UK. The simplest of errors can cause extreme problems for consumers/patients; by way of example, if Botox is not caried out properly, this can result in droopy eyelids, muscle weakness, vision problems, or trouble speaking, swallowing, or breathing.
Sir Keogh said:
At the heart of this report is the person who chooses to have a cosmetic procedure. We have heard terrible reports about people who have trusted a cosmetic practitioner to help them, but when things have gone wrong, they have been left high and dry with no help. These people have not had the safety net that those using the NHS have. This needs to change. We would like to see everyone who chooses to have any cosmetic procedure better protected. We would like to see people who carry out procedure trained to a high standard. We would like the public to feel confident they are going to be well looked after and, if things go wrong, that they will be supported. And ultimately, if someone needs to stop in on the side of patients, we think there should be an ombudsman to do that.
The main actions that the review group said would contribute to a successful and safe cosmetic surgery industry included:
- Ensuring all practitioners are properly qualified for all the procedures they offer;
- Providers being obliged to ensure that people are aware of the implications and risks of procedure and that they have adequate time to consider this information before agreeing to treatment;
- An advertising code of conduct to be developed and compliance to be mandatory for all practitioners;
- Insurance products developed to protect patients in the event of product failure or provider insolvency;
- Making all dermal fillers prescription only; and
- An ombudsman to oversee all private healthcare including cosmetic procedures.
Non-surgical interventions: key recommendations and responses
Below is a list of some, not all, of the review’s recommendations relating to non-surgical interventions and the governments responses to those recommendations:
- Treatment to be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures.
- Non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualifier clinical professional.
- Government response: legalisation to be looked at to underpin the above recommendations.
- Development of appropriate accredited qualifications for providers of non-surgical interventions.
- Training should include an understanding of safe premises and responsibility involved.
- Government response: to work with professional and regulatory bodies to ensure that codes of practice and strengthened for responsible professional. (The General Medical Council (GMC’S) guidance in ‘Good medical practice’ and on ‘Consent: patients and doctors making decisions together’ already required this: GMC to ensure that the issue is fully covered in the ethical framework for cosmetic surgery.
- All practitioners to be registered centrally.
- Unannounced inspections of manufactures of class III and IIb medical devices to ensure production is compliant with the regulations. Reports to be made public where possible.
- Government response: risk – based audits were the most appropriate of inspections – unannounced audits were being addressed in the revision of the medical devices EU directives.
- Responsible information, resolution and redress, including prohibition of certain advertising practices, such as financial inducements and time-limited deals.
- Government response: GMC to lead on developing a code.
- All organisations providing cosmetic surgery should have a doctor on the board as medical director who is professionally accountable for all work carried out by the provide organisation and for its procedures, practices, and wider activity.
- Government response: under the current regulations each provider had to have a responsible officer, a senior doctor who must demonstrate that they have systems in place to ensure that all doctors engaged in cosmetic surgery are providing high standards of care. They also have statutory responsibility to ensure that all doctors employed by or contracting with the organisation are competent and fit to undertake the duties they are being given.
- Parliamentary and Health service Ombudsman to also cover the whole private healthcare sector, including cosmetic procedures.
- All individuals performing cosmetic procedures to have adequate professional indemnity cover.
So, what happens next?
Clearly the government accepted that more needed to be done to regulate the cosmetic surgery industry and one of the keyways in which they anticipated that this would be done was through joint regulations with the GMC and other professional bodies. Having assessed the revies ad response and following numerous discussions and meetings on the issue, the GMC published their ‘guidance for doctors who offer cosmetic interventions’ which came into effect on 1 June 2016.
They key aims of the guidance are to make sure that doctors:
- Are appropriately trained and experienced to practice safely;
- Work with each individual patient to make sure their expectations about the outcomes that can be achieved for them are realistic;
- Follow current guidelines or protocols for safe, effective provisions of cosmetic interventions;
- Consider the psychological needs of their patients; and
- Do not allow any financial or commercial interests in a particular intervention, or an organisation providing cosmetic interventions, to adversely affect standards of good patient care.
The guidance make plain that in order to maintain a licence t practise, the practitioner must demonstrate, through the revalidation process, that they work in line with the principles and values set out in the guidance. Serious or persistent failure to follow the guidance would put the registration at risk. The GMC was not the only body which made various recommendations and provided key regulations following the revies and government response:
- ‘Professional Standards for cosmetic surgery’, Royal College of Surgeons (2016)
- ‘qualifications requirements for delivery of cosmetic procedures’ and ‘report on implementation of qualifications requirements for cosmetic procedures’, NHS Health Education England (2015)
The guidance from the GMC also recommends that doctors refer to other sources for complete regulatory guidance and codes of practice, including:
- The British Association of Aesthetic Plastic Surgeons.
- The British Association of Plastic Reconstructive and Aesthetic surgeons
- ‘Marketing of cosmetic interventions’, Committee of advertising practice (2013)
It is unsurprising that one of the key points repeatedly emphasised within the guidance is the need to ensure that the patient provides informed consent. Following the landmark case of Montgomery v Lanarkshire Health Board (2015) the previous year, taken together with the PIP scandal a few years before that, the guidance espoused (as the GMC had been doing for several years in any event despite the lack of any doctrine of informed consent In English law until that time) that a more cooperative approach in the consultation room was required and that patient autonomy was key, in a safe environment with trained and competent practitioners on hand.
Despite the governments response to the review stating that legislation was being looked into to legally regulate the cosmetic surgery industry, this has not yet resulted in any bill successfully going through Parliament, some four years on. The Cosmetic Surgery (Standards of Practice) Bill 2016-17 had its first reading on 19 October 2016 in the House of Commons. The bills aims was to make provision about the training, qualifications and certification of medical practitioners and conducting cosmetic surgery proceeded; to establish a code of practice for the provision of information to patients on the options and risks in relation to such procedures: to make provision about permissible treatments; and for connected purposes. The Bill was expected to have its second reading debate on Friday 12 May 2017, but as general election was called, Parliament was dissolved, and no further action had subsequently been taken.
Botched cosmetic surgery today: the safety nets and the pitfalls.
Cosmetic treatment undertaken by medically trained professionals both via the NHS and privately should now be more controlled. As noted above, the guidance from professional bodies is more succinct than pre-review and sets out various codes of practices that should be adhered to by medical professionals carrying out cosmetic treatment. Nonetheless, I is noteworthy that ‘cosmetic surgery ‘is not yet recognised as a regulated branch of medicine by the GMC.
Both in tort and under contract, breaches of duty by medical professionals carrying out cosmetic intervention can now more clearly be demonstrated if there has been failure to follow, for example, GMC guidance as to safety procedures. However, Sarah Marsh recently reported in the Guardian (‘Botched cosmetic surgery: law change urged as complaints treble’, www.legallease.co.uk/botched) that despite the review and subsequent response, the number of problems related to treatment such as lip fillers and Botox has almost trebled, jumping from 378 in 2016 to 931 within 12 month. The highest number of complaints were about dermal fillers, and a large proportion of all complaints were related to practitioners found via social media. The nub of the problem appears to be that data allegedly shows 83% of procedures were administered by non-medics. Clearly there is still an issue with rogue practitioners. This is likely to remain the case unless the government takes a stronger hold of the legal regulation of the cosmetic surgery industry and those permitted to carry out cosmetic treatment.
Social media continues to place extreme and unfair pressure on the consumer as to aesthetics. Even with better controls as to advertising now in place, the caustic celebrity culture and its portrayal of quick beauty has resulted in greater demand, and a consequent increase in supply, of cosmetic intervention.
Albeit the GMC and other professional bodies continue to do a commendable job in trying to provide guidance and training to all medical practitioners as regards this area of intervention, the same cannot be said as to the regulation of non-medics. Without formal legal regulations and/or legalisation in place for an ever-increasing industry, access to cosmetic intervention will become even easier and complaints will undoubtedly continue to rise, with marginal redress for victims of poor and inadequate treatment save for pursuing a matter to litigation via allegations of negligence and/or breach of contract. However, cosmetic procedure has been under a significant spotlight these last few years and change has slowly started.
Change needs to continue as per the review and response in the years to come. The present may not be looking so good, but the future may look better.
If you wish to speak to a Solicitor regarding a claim arising out of beauty treatment please contact Grace Newbold, Solicitor on 0114 2678780 or email [email protected]