PI Brief Update

FREE BOOK CHAPTER: What is Cosmetic Surgery? (From 'A Practical Guide to Cosmetic Surgery Claims' by Dr Victoria Handley)

19/07/17. Cosmetic surgery is where a person chooses to have an operation or invasive medical procedure, to change their physical appearance for cosmetic rather than medical reasons. We refer to cosmetic surgery as any intervention, procedure or treatment carried out with the primary objective of changing an aspect of a patient’s physical appearance. This includes surgical and non-surgical procedures, both invasive and non-invasive. Non-surgical procedures such as Botox or dermal fillers, typically used to relax or fill crease lines, do not involve surgery but there are still risks attached.

Cosmetic surgery is rarely available on the NHS unless there is an overriding physical or psychological reason. The majority therefore have surgery carried out privately. The NHS will not help if it goes wrong unless there is a serious complication which means that emergency or life-saving treatment is necessary.

If we consider the most heavily regulated surgical invasive procedures and understand the burdens on the treatment provider, documents they must have and disclose and consent; we can apply the same principles to all cosmetic treatments. The cause of action for a cosmetic surgery claim can arise via legislation (Consumer Protection Act) or common law negligence.

The Patient vs Profit

The cosmetic surgery industry is worth approximately £3.6 billion. It has expanded at such a rate that regulation is glaringly inadequate. Competition for clients is high. To attract new patients the marketing strategies of cosmetic surgery clinics and doctors are slick and persuasive. Botulinum toxins and hyaluronic acid fillers account for the majority of non-surgical cosmetic procedures. The aim of cosmetic surgery clinics is to have a strong relationship with the clients so they will keep coming back, often every 3-4 months and so will their friends. Word of mouth is a good way to establish the practice and quality training will keep them coming back. Referrals bring loyal clients and the foundation of trust with successful treatments means long term clients.

Having surgery is a big decision and its’ based on a dissatisfaction with appearance. Surgical cosmetic procedures are on the increase both in number and type. It is possible to cosmetically alter the majority of your body. Certain procedures are one off whilst others (implants) will need to be removed and replaced in time. The procedures are however expensive. Many clients take out loans or pay on credit cards.

Websites and social media platforms allow clinics to market directly to their key audience. People considering surgery want as much information as they can get and recommendations or good feedback is key. Clinics attract patients by writing educational materials, feature articles, advertorial in newspapers or magazines, books and blogs sharing experiences. Many are written by allegedly ‘ex-patients’ making recommendations about the care they received. Online forums discuss issues emotively and offer solutions, special offers and vouchers. Clinics are persuasive ‘they only offer safe treatments that deliver results’, the ‘guarantee scheme’ helps build trust. They only ever work with the ‘industry’s best doctors, surgeons or nurses’. They ‘continually invest in technology which combined with the superior skill of the doctors, delivers the best results’. They ‘care about their patients and their satisfaction’. They state that ‘patient safety is a priority’. Best of all ‘as seen on TV’. For a patient considering surgery, all boxes are ticked.

Aggressive marketing and ruthless sales tactics of some unscrupulous companies mean that it is very difficult for patients to find independent, trustworthy information to inform them as to what an operation would entail. Undergoing cosmetic surgery is a big decision. A patient should never feel rushed or pressured into getting surgery by a third party. They should not be pressed to proceed because of special offers which are time limited, discounts or two for one deals. Surgery should not be offered as a prize. Marketing must be factual, clear and not misleading.

The decision by a clinic or doctor to operate and accept a patient as a customer should be considered carefully. In some situations it is clear that the patient should not have the desired procedure. This is not patient autonomy being overruled by defensive medicine. There is an increasing trend towards multiple surgeries which carry additional risks. It may seem attractive to the patient to have one procedure to fix all. It may seem attractive to the surgeon to be paid for carrying out multiple surgeries in one sitting. Nevertheless, the combined risk factors, level of monitoring needed during and post-surgery and the inherent driver to have so many procedures done at the same time should sound alarm bells. A surgeon should politely decline but the fear that the patient will take the considerable sum of money elsewhere often overrules good sense.

Seeking a psychological profile of the patient before cosmetic procedures are carried out seems like a good way of determining the right patient for the right procedure. But, how much can we really know about the psychological issues related to individuals? Who is suitably qualified to carry out the psychological profiling and what indeed is the overall correct outcome if someone displays psychological issues? Various studies have taken place in the US and Canada which have shown that there is a slightly higher risk (just over twice that found in the general population) of suicide among women with breast implants. Quite why is unknown. In contrast to women in the general population, women with implants have significantly lower body mass indices, greater likelihoods of cigarette smoking, more induced abortions and fewer live births, lower educational levels and more screenings for breast disease. Is this more reflective of who they are rather than a link between suicide and implants? Should this influence the choice of procedure at all?

Whilst psychological profiling can identify issues, what is expected to happen with the data? There may be a clear reason identified to say no to further procedures. Identifying and classifying body dysmorphia (BDD) for instance, is not the role of a cosmetic surgeon. BDD occurs in 1% of the general population. If an individual has a pre-occupation with an imagined defect in appearance, isn’t that the subjective nature of cosmetic surgery procedures in any event? A client may be dissatisfied with their appearance and seek treatment. A surgeon may think the client looks fine. At what point is the surgeon wrong to undergo treatment if it is what the client wants after considering the risks and complications? Equally, the patient who has seen several surgeons because they have failed to produce the desired result: are they ever going to find the desired result? Does it exist and can additional surgery with additional scarring seek to achieve it?

It is an interesting discussion and it is raised to highlight the argument that psychological profiling can have. Many clinics have a questionnaire completed by nurses setting out the reasons for seeking surgery. They are likely to encounter increasing numbers of patients who are seeking cosmetic surgery and who have psychological issues or psychiatric comorbidities. Being alert to specific psychiatric disorders will enhance proper diagnosis and one may expect cosmetic surgeons not to undertake treatments. Quite how they are to deliver their diagnosis of psychological illness when they are not qualified to do so is interesting.

The chances of a patient encountering poor quality products, poor quality treatment, and poor quality aftercare is surprisingly high – and for non-surgical procedures, there is no guarantee of redress. Treatments carried out which are non-surgical have less regulation. Doctors are regulated by the General Medical Council but individuals have no such professional duty.

Regulation

Thought has been given to restricting cosmetic interventions carried out by doctors, nurses, and others, who are not appropriately qualified or indemnified to do so. There is a need to help patients find redress when things go wrong. The Department of Health’s report into the Review of Regulation of Cosmetic Interventions was asked to review regulation in the cosmetic interventions sector following the PIP implant scandal which exposed ‘woeful lapses in product quality, aftercare and record keeping’. It also drew attention to widespread use of ‘misleading advertising, inappropriate marketing and unsafe practices right across the sector’. It recommended:

• A register of everyone who performs surgical or non-surgical cosmetic interventions

• Classifying dermal fillers as a prescription only medical device

• Ensuring all practitioners are properly qualified for all the procedures they offer

• All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures

• A ban on special financial offers for surgery

• An advertising code of conduct with mandatory compliance for practitioners

• Compulsory professional indemnity in case things go wrong

• An ombudsman to oversee all private healthcare, including cosmetic procedures, to help those who have been treated poorly.

The Cosmetic Surgery (Minimum Standards Bill) 2012-2013 was drafted to establish minimum standards for the practice of cosmetic surgery, including non-surgical procedures. The Bill was designed to set up an Implant registry, establish the Cosmetic Surgery Regulatory and Standards Authority, seek the prohibition of advertising cosmetic surgery and cosmetic intervention procedures, clarify offences and identify non-surgical cosmetic intervention procedures. In 2013 it failed to complete its passage through Parliament before the end of the session which means the Bill will make no further progress.

According to the Review of Regulation of Cosmetic Interventions, the current regulatory framework places ‘no restrictions on who may perform nonsurgical cosmetic procedures. No qualifications are required to carry out these procedures and, in the absence of accredited training courses, anyone can set up a training course purporting to offer a qualification. There are a number of self-accredited training organisations but none are regulated’.

The Royal College of Surgeons guidance, Professional Standards for Cosmetic Practice, stated that ‘only licensed doctors, registered dentists and registered nurses should provide any cosmetic treatments (including laser treatments and injectable cosmetic treatments)’. However, there is no legislation that will make indemnity or insurance for all practitioners become obligatory.

When things go wrong and you are instructed by a client who has undertaken a cosmetic procedure which they are unhappy with it is important to identify who the Defendant is and how they may be regulated.

Check that the hospital or clinic is registered with the Care Quality Commission (CQC). If they are not registered they may be practising illegally and their insurance may not cover them or the patient if something goes wrong. By law a clinic or hospital must register with the CQC if they offer:

• Cosmetic surgery involving instruments or equipment being inserted into the body (including implants)

• Laser lipolysis (such as Smart Lipo)

• Refractive eye surgery or lens implant surgery

They do not regulate:

• Subcutaneous muscle relaxing injections for improving appearance such as Botox

• Dermal fillers

• Chemical peels

• Laser and intense pulse light treatments like hair removal or skin rejuvenation

• Procedures that do not involve cutting or inserting instruments or equipment into the body

Check the inspection reports from the CQC to ascertain prior concerns for the clinic or hospital. There may be prior concerns highlighted which are prudent to the case at hand.

BAPRAS & BAAPS

Check whether the surgeon is a full and accredited member of BAPRAS (British Association of Plastic Reconstructive and Aesthetic Surgeons) or BAAPS The British Association of Aesthetic Plastic Surgeons.

Failing to become a member of recognised organisations or listing a different specialism to that undertaken in the patient’s case can be indicative of the type of defendant that you are dealing with. There is no requirement to be registered but patients would be wise to only undertake surgery from a doctor registered with these associations as a starting point.

General Medical Council

Check the General Medical Council register. There are about 245,000 doctors on the UK medical register. Doctors who provide cosmetic surgery independently in the private sector only need to be registered as a doctor. They do not have to be listed as a specialist surgeon on the GMC’s specialist register.

The GMC ensures that for every doctor who joins the register there are no concerns about behaviour, health or performance that could prevent them from doing their job. Once a doctor is on the register there are a series of checks called ‘revalidation’ that occur once every five years. Revalidation is the process whereby doctors are required to demonstrate that they are up to date and fit to practice in accordance with their professional standards. They must collect information about their practice including feedback from patients, have an annual appraisal based on the guidance ‘Good Medical Practice’ and reflect and consider improvements that they could make. Revalidation makes sure that every licensed doctor has an annual appraisal.

If a doctor poses an ongoing risk, they can have their practice restricted or suspended (whilst they retrain say). On occasion, a doctor is not allowed back to work because their conduct was so serious. They can be removed from the register or ‘struck off’.

Some doctors fly into the UK to perform cosmetic surgery. They are not registered with the GMC. Some clinics fly patients out of the country to undergo cosmetic procedures. In both instances, the patient is not afforded the protection that they would get in the UK.

The GMC published ‘Guidance for Doctors who offer Cosmetic Interventions’ in April 2016 which incorporated principles from existing guidance but went further. It set a higher standard to address the specific safety issues and ethical concerns of the cosmetic sector following the recommendations of Sir Bruce Keogh’s Review of the Regulation of Cosmetic Interventions. It is prudent to read the guidance and use it when reviewing medical records, instructing experts to comment on adherence to professional duties, reviewing witness statements and drafting Part 18 questions.

Throughout the guidance, the terms ‘you must’ and ‘you should’ are used. ‘You must’ is used for an overriding duty or principle. ‘You should’ is used when providing an explanation of how a doctor will meet the overriding duty. It is also used where the duty or principle will not apply in all situations or circumstances, or where there are factors outside a doctor’s control that affect whether or how they can follow the guidance. Thus, all documents in the case can be checked against the overriding duty to ensure compliance with the professional standards. Any omission will strengthen the patients case.

The Royal College of Surgeons has also produced guidance on the professional standards, skills and experience needed to carry out cosmetic interventions (Professional Standards for Cosmetic Surgery (2016)). Taking the recommendations of the review by the Department of Health into the regulation of cosmetic interventions following the publication of Professional Standards for Cosmetic Practice (RCS, 2013), the Royal College of Surgeons and the Cosmetic Surgery Interspecialty Committee (CSIC) developed a certification scheme. The aim was to provide evidence of competences (including professional behaviours, clinical skills, knowledge and experience in defined areas of cosmetic surgery. The guidance addressed key areas of risk identified for cosmetic surgery including ‘communication, consent, professional behaviours and dealing with a psychologically vulnerable patient’. Space does not permit the full reproduction of this important document. You are encouraged to read it and keep it to hand for every communication and review of your file. Your expert should refer to the standards when considering the medical notes and consent documents.

Cosmetic surgery is often advertised online and by email. The marketing tactics put pressure on the recipient to sign a contract to avail of a deal. Promotional tactics should not be used to encourage people to make an ill-considered decision but nevertheless they do. The patient should be advised about any financial or commercial interests that could be seen to affect the doctor’s advice. The purchase of goods and services over the internet, by telephone or by email order are generally subject to consumer protection regulations. On 13 June 2014, the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 replaced the Consumer Protection (Distance Selling) Regulations 2000 and Cancellation of Contracts made in a Consumer's Home or Place of Work etc Regulations 2008. The regulations set out pre-contractual information that should be provided to a consumer, depending on whether the contract is made on or off premises eg: main characteristics of the goods or services, identity of trader, total price including tax.

The Committee of Advertising Practice has developed guidance on the advertising and Marketing of Cosmetic Interventions.

Check also:

Qualification Requirements for Delivery of Cosmetic Procedures and Report on Implementation of Qualification Requirements for Cosmetic Procedures both by NHS Health Education England.

The Private Healthcare Information Network (PHIN) provides a search function to ‘compare different hospitals. It is independent and not for profit and works with organisations across the UK including NHS, care quality regulators, government information sources, the medical profession and independent hospitals’. All providers of private healthcare in the UK, including most NHS hospitals, are required by law to submit data to PHIN.

Specific Regulation of Procedures

• Botulinum toxin is regulated as a prescription medicine but it can then be used by a non-health professional.

• Breast implants are regulated as a medical device and must be performed by a qualified doctor.

• Chemical peels are regulated under General Product Safety Directive only if sold direct to a consumer. Anyone in the clinic can administer it.

• Dermal fillers are regulated as devices only if they have an explicit medical purpose. As most don’t they can be used by anyone in the clinic to administer to a patient.

• Laser treatment equipment is regulated as a medical device but again it can be used by anyone in the clinic to administer to a patient.

• Intense pulsed light is not regulated as a device and again can be used by anyone.

If your client has undergone a non-surgical procedure, then ask questions of the practitioner to determine whether they have the required skill and expertise to undertake the procedure successfully and safely. What training and accreditation process have they undertaken to identify and manage complications of treatment? The curriculum and training should be disclosed and reviewed.

Statutory Duty of Candour

Independent care providers registered with the CQC are subject to a statutory duty of candour. It is defined in the Robert Francis Report as “The volunteering of all relevant information to persons who have or may have been harmed by the provisions of services, whether or not the information has been requested and whether or not a complaint or a report about that provision has been made” (Francis chaired a public inquiry into how poor care at Mid Staffordshire Foundation Trust was allowed to happen in the period between January 2005 and March 2009, and why none of the organisations responsible for regulating or managing the trust spotted problems sooner. His recommendations following the inquiry are known as the ‘Francis Report’).

This statutory duty sits alongside existing contractual and ethical duties of candour. Doctors have had a professional duty of candour for many years. In its core guidance for Good Medical Practice (2013) para 55, the GMC says:

“You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should:

1. Put matters right (if that is possible)
   
   

2. Offer an apology
   
   

3. Explain fully and promptly what has happened and the likely short-term and long-term effects”.

The intention of the regulation is to ensure that providers are open and transparent with people who use services and other ‘relevant persons’ (people acting lawfully on their behalf) in relation to care and treatment. It sets out the basic requirements that providers must follow when things go wrong with care and treatment, including, ‘informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong’. It applies to registered persons when they are carrying out a regulated activity. As such the CQC can prosecute for a breach of parts 20(2)(a) and 20(3) of the Regulation and can prosecute without first serving a Warning Notice. There are other regulatory actions available to the CQC including ‘a summary conviction for a fine not exceeding £2,500’. Where an organisation’s clinical governance procedures for reporting and investigating incidents are followed, it is rare for a patient safety incident to be overlooked. In any event, doctors must always follow their ethical duty, irrespective of whether the statutory duty applies.

It is worthy of note that the NHS does not limit the private work undertaken by their surgeons. It is worth checking to see if there are any NHS issues. If the doctor is suspended from practice in the NHS, he or she can still do private work unless the GMC has placed a restriction on his/her licence. If there is a partial restriction they can only do certain procedures.

From a tactical point of view – know your defendant. Find out what work he or she does and how often. How often is the private work carried out? Do they work weekends? Could the surgeon have been too tired? When was the date of surgery? Did they work weekends or evenings in the run up to the surgery? Did they operate with back to back surgeries? How accurately can they recall your patient and the conversations and why?

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