Consent, complications and fat-freezing

Linda Evangelista’s lawsuit against Zeltiq Aesthetics has raised questions surrounding the safety of fat-freezing procedures and how clinicians can protect themselves against similar claims

Following supermodel Linda Evangelista’s claims of having developed paradoxical adipose hyperplasia as a result of treatment with Allergan’s CoolSculpting device, the British Association of Aesthetic Plastic Surgeons (BAAPS) released new data from its audit of fat-freezing treatments in the UK. BAAPS’ Audit of Complications looked into complications from fat-freezing treatments requiring surgery that presented to its member surgeons between 2018 and 2020.

According to the data, 7% of BAAPS members reported having to deal with serious complications, with 21 patients requiring surgery over the three-year period. Despite undergoing surgery to attempt correction, all 21 patients were left with some permanent deformity or scarring which was not present before undergoing the fat-freezing treatment. Of these patients, nine required liposuction, eight required an abdominoplasty and four required surgery for skin necrosis, as the original fat-freezing treatment had caused skin in the abdomen to die, needing surgical removal and reconstruction of the abdomen.

In a press release, BAAPS said it believes the root cause of these findings is largely to do with irresponsible marketing of nonsurgical treatments that are often sold on the back of celebrity endorsements, overshadowing the “benefits versus risks” thought process for patients. BAAPS also said it believes that “non-surgical treatments are often released onto the market with less long-term follow-up than comparative surgical operations.” Marc Pacifico, vice president of the organisation, said, “Celebrity culture has clouded people’s judgment by making them blind to the risk of complications, a phenomenon that has been exploited by manufacturers and clinics in pursuit of sales over safety.”

In light of this, BAAPS has produced a Code of Candour for Celebrity Marketing. It reads as follows: 1. Just like on Instagram, a celebrity endorsement must say that it is a paid promotion either by payment itself or an inducement such as free treatment. 2. The celebrity must also say if they had other treatments which may have contributed to the overall result (i.e.) statement saying whether they had alternative treatments or clearly denying that they did not so readers can see that the proposed treatment was entirely responsible for the result being promoted. 3. A clear before and after so the public can see what result the celebrity actually achieved. Often, they just show a picture of a celebrity who frankly always looked good, so who knows whether the treatment was responsible or actually made any difference at all? Many before-and-afters have completely different lighting, designed to enhance and flatter the “after” photograph – lighting should be standardised and comparable for before-and-after photos.

In a press conference held on 30 September during which the audit and Code of Candour were announced, BAAPS president Mary O’Brien commented: “It’s really important that we understand some of the principles behind non-surgical treatments, that they’re not without risks, that marketing glamorises treatments. And, if complications do occur, that they don’t just cause physical scars, they cause emotional scars too. That’s the reasoning behind our Code of Candour.”

LEGAL VIEW

Lawyer Matthew Trinder explains the legalities around informed consent and clinical negligence claims

Practitioners in aesthetic medicine are perhaps more susceptible to compensation claims alleging lack of informed consent, where patients can easily say the treatment was not essential and they would not have agreed to it at all had they been advised properly of the risks, benefits and alternatives. Consent cases are very common, even where the procedure itself may have been carried out with all appropriate skill and care. The patient may say even non-negligent complications would have been avoided had they not undergone the procedure at all following adequate counselling. In some cases, under English law, it may not even matter if the patient cannot say whether they would have gone ahead or not.

The CoolSculpting matter is currently before the courts, but Evangelista is understood to be alleging that she wasn’t educated about the potential risk before signing up for CoolSculpting. In cases like this it is not uncommon for the claim to be brought against the manufacturer of the device or product (in this case, Zeltiq Aesthetics, a subsidiary of Allergan) as opposed to the individual practitioner or clinic who performed the treatment.

However, practitioners and clinics should not draw any false comfort that they will not be in the firing line if they do not take steps to mitigate their risk in these situations.

WHAT ACTUALLY IS “INFORMED CONSENT”?

Since 2015 the legal standard for consent in the UK is called the Montgomery test, named after a case in the Supreme Court. Briefly, a doctor is under a legal duty to take reasonable care to ensure that the patient is aware of any material risk involved in the recommended treatment and of any reasonable alternative or variant in the treatment.

A material risk is something which in the circumstances of the particular case, either:

•A reasonable person in the patient’s position would be likely to attach significance to the risk; or

• The doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.

Hence, the answer to this test is specific to the patient and no longer determined by a body of responsible practitioners. While it is not necessary to warn of every academic or hypothetical risk, it can be very difficult for a practitioner to know where to draw the line.

There are only two limited exceptions to the Montgomery test which are unlikely to apply for practitioners of aesthetic medicine. First, a doctor is entitled to withhold information if they reasonably consider that its disclosure would be seriously detrimental to the patient’s health; and second, where emergency treatment is required for a patient who is unconscious or otherwise unable to make a decision.

It is not uncommon to see the manufacturer, clinic and practitioner all named as defendants to the same claim and these may be very expensive to defend in England, where the patient will be entitled to recover their own legal costs from the losing party (often several times higher than the value of the claim itself), but a successful defendant is often expected to bear its own costs of successfully defending a claim. Hence, a little prevention is certainly better than cure.

PROPER PROCESSES

To comply with the law, before providing any treatment, a doctor has to engage in a dialogue with the patient about the nature of all material risks, the effect which the risk would have upon that patient if it materialises, the importance to the patient of the benefits of the proposed treatment, as well as any alternatives or variants available.

In addition to the opportunity for asking questions, patients should have sufficient time to consider whether to proceed or not, perhaps after going away to think, carrying out research, speaking with friends or family or getting a second opinion. It is no longer about risk percentages or what a reasonable practitioner would deem it necessary to mention.

As ever, clear notes must be kept contemporaneously –a “consent” tick-box is not enough, and pro-forma consent forms where the patient is just asked to sign at the bottom may have limited value, especially where only provided a short time before the treatment begins, or where the process was delegated to a junior member of the team without the experience to answer questions. The presence of a chaperone (who also signs the written consent) can help save a practitioner from a consent claim. This can also be very helpful where a patient is vulnerable, has mental health issues or unrealistic expectations. Refusing treatment or referring some patients for a second opinion and/or psychological care may be the best decision in some cases, though depending on the treatment, ethical practitioners would unlikely go ahead with the procedure in a case like this anyway.

Warnings about material risks to treatments displayed on a clinic or practitioner’s website can be a powerful source of evidence in defending a claim, especially where patients self-refer through the website (via a contact form, for example) and the warnings can be embedded in the process. Information leaflets can also be a useful adjunct to the consent process, but patients will often forget them later or will deny that these leaflets were provided at all; and you may be unable to locate the correct version if a claim is brought several years later.

There are now several interesting digital consent aids on the market that are worth exploring, such as Vault by Eido Healthcare. More technology including AI will undoubtedly play a greater role in the future, but for now these aids should be seen as augmentation and not a substitute.

PROTECTING YOURSELF

All indemnity/insurance options are not alike, and a specialist broker is a good idea. “Medmal” (medical malpractice) insurance policies will also have a variety of different terms including financial caps per claim or in the aggregate, exclusions, or else reporting requirements that can result in claims being “bounced”. Some will specify that they do not cover treatment on celebrities or sportspersons at all. A traditional medical defence organisation does not provide a contract of insurance that is enforceable in the usual way and are not subject to a regulator or the Financial Ombudsman; they are effectively members’ organisations providing discretionary cover. There are pros and cons of different forms of cover.

Clinics relying on their practitioners to have their own indemnity/insurance are taking a huge gamble. Where the practitioner or clinic does not have indemnity/ insurance cover, or for some reason they are not covered by their indemnity/ insurance provider, the patient will look for another pathway to compensation and often another defendant with insurance cover or deeper pockets. This may not seem fair to whoever is left in the frame. I have seen numerous cases whereby the practitioner did the treatment as a favour for a “friend” and was very surprised to hear that they can still be sued – the old legal maxim “no good turn goes unpunished” is worth keeping in mind. Fortunately though, most consent claims can be avoided by common sense augmented by good clinical governance and risk management.

MATTHEW TRINDER

Matthew Trinder is a partner at law firm Browne Jacobson, where he heads up the firm’s medmal insurance offering. He specialises in clinical negligence matters and has particular expertise in aesthetic medicine and cosmetic surgery. Contact him: matthew.trinder@ brownejacobson.com

PRACTITIONER VIEW

Aesthetic Medicine editorial board member Dr Raj Thethi on properly performing the consent process in clinic

Since the news hit about Linda Evangelista’s alleged PAH (paradoxical adipose hyperplasia) from CoolSculpting treatment, we have been getting a lot of questions from patients regarding this specific complication in clinic.

PAH is a rare but reported adverse effect of cryolipolysis. In 2014 it had a reported rate of incidence of 0.0051% of the over 650,000 CoolSculpting procedures performed worldwide since it entered the market. 1 However, a recent multicentre evaluation from Canada that looked at 8,658 treatment cycles in 2,114 patients found a higher incidence rate of between 0.05% and 0.39%. 2

PAH causes a gradual enlargement of the treated area. It occurs when the stimulus (the freezing of fat cells) activates a reactionary process in the fatty tissue that thickens and expands the fat cells rather than breaking them down and allowing the body to process and remove them. PAH is only known to occur following a cryolipolysis treatment.

Frustratingly, it may not become apparent until sometimes six months post-procedure, with patients complaining that they are getting bigger in the exact shape of the applicator. No single unifying risk factor has been identified, though the phenomenon seems to be more common in male patients undergoing cryolipolysis.

With knowledge of Linda Evangelista’s incredibly unfortunate complication now in the public domain, we as practitioners must make sure that we are following every step to make sure our patients know about all the possible complications that can occur; even from the simplest of treatments.

Complications will happen to every practitioner performing a procedure; it is not a question of skill, but basic probability.

If a practitioner claims to not have complications, only one of three possible statements can be true: 1. The practitioner in question is not doing enough procedures, which is an issue of experience 2. The practitioner is lying which is an issue of probity 3. The practitioner is having complications but does not recognise them as such. This is the most dangerous instance and surrounds the issue of competence and insight. The Dunning-Kruger effect may be to blame for this lack of recognition; a type of cognitive bias in which people believe that they are smarter and more capable than they really are.

DUTY CALLS

Given that all practitioners will inevitably stumble across complications, it is our duty as medical professionals to make sure that our patients have a robust process of informed consent before we embark on any physical treatment. “Consent” is a term that is thrown around quite a bit, but we must recognise that consent comes in many different forms. It is the permission given before any medical examination, test or procedure. This can range from simple verbal consent to examine a face during a consultation, to formal written consent to perform an invasive procedure. We must, however, understand that consent itself is not the signature at the end of the form, nor is it the patient’s name written in block capitals and dated; rather, consent is the process.

Medico-legally, valid consent is based on three premises; consent must be voluntary, informed and the patient making the decision must have able capacity to do so. This is no different in aesthetics and nor should it be. Consent is often overlooked and simplified by practitioners but it is important that we take the process very seriously. We must take time in our consultations to actively engage in the patient’s understanding of the procedure and what is involved; the different treatment steps, expected outcomes and at what point they could be achieved. Of course, part of the consent process must also cover the potential for complications and their respective risks. It is important to also talk about the difference between absolute and relative risk with these complications, as patients may sometimes struggle to comprehend the gravitas of certain complications if they are not phrased in an appropriate manner for the patient to understand.

CRYSTAL CLEAR

Making sure that we give all of the possible treatment options – including doing nothing – is incredibly important after the Montgomery ruling. The Montgomery case showed that as practitioners we must discuss absolutely all potential possibilities of treatment for a certain condition and then let the patient come to an informed decision. This also would include treatments that you may not perform within your practice. The potential alternative treatments outside the realms of your practice and competency would also need to be discussed with the patient indefinitely.

Here, we can take the potential example of fat-reduction treatments. The following are examples and by no means an exhaustive list – there are a whole range of different treatment modalities and options available. These can start at simple things such as cellulite-targeting skincare products for the body and physical massage which can help to stimulate the local lymphatic drainage and reduce the appearance of cellulite on the skin’s surface. Next, there are potential energy-based devices including ultrasound cavitation, laser-based and radiofrequencybased treatments that can help to reduce the composition and extent of fatty adipose tissue. These could be further divided into invasive forms of energy-based device or non-invasive forms that purely treat from the skin surface. We then have injectable treatments including certain types of mesotherapy and also treatments based around deoxycholic acid as well as new collagenases entering the market. The next step is potentially minimally invasive treatments such as liposuction or internal based radio-frequency such as InMode’s Bodytite, as well as potential aspiration of fatty tissue. And finally, we’ve got full surgical procedures involving physical excision of adipose tissue as well as the surrounding skin.

Even if you personally perform only a handful of these potential procedures, you have a moral, ethical and legal duty to make sure you provide the patient with all the possible alternatives before you embark on any treatment. If, once all the options have been discussed, the patient is still interested, it is down to the practitioner to make sure that the patient is suitably prepped for the procedure, that the timescales are adequate and most importantly, all of the potential complications and risks have been discussed and understood by the patient.

Parts of the informed consent process and helping to establish capacity mean that you have to make sure the patient fully understands all of the information that has been given to them, is able to repeat that information back to you in a logical sequence, is able to further show you their reasoning as to why they want a certain procedure, and is able to make a rational decision based on the information given to them and on solely their own abilities to make decisions. If all of these steps cannot be performed then it cannot be classed as legally-informed consent and thus, the procedure should not be commenced in any way. In such cases further council should be sought. It is very rare that in our line of work we have patients who would be treated without capacity by proxy through lasting power-of-attorney or mental health advocates.

COOLING OFF

The GMC’s guidelines for cosmetic doctors make a very clear point that the patient should be offered a cooling-off period if appropriate for the procedure. On some level this is down to judgement of yourself and the patient, but common sense must always prevail. If the procedure you are offering is relatively quick, has minimal discomfort and relatively low risk, there is no need for a cooling-off period if the patient is happy to proceed.

If I use the example of the injections of botulinum toxin, we regularly have patients who are seen, consulted and treated on the same day. I can perform this treatment on the same day as a doctor as I have the ability to hold stock. This is most likely the case for most of the patients who are potentially considering botulinum toxin type A actions. However, we occasionally do get very anxious patients who would like more time to think over their options and make sure that the particular treatment is the right one for them. We should never force or coerce anyone into a decision and hence, in such cases having a cooling-off period would be a sensible idea. This must be taken on a case-by-case basis.

Written and signed consent is important as the final adjunct to the consent process but it is purely that; an adjunct. From my previous time working in surgery, I know that many surgeons get patients to initial next to each paragraph of the text in the written consent form to show they’ve read and understood the information. Making sure the form is signed and dated with the patient’s name printed clearly is really important. It’s also important to make sure that if you are doing an ongoing treatment with multiple sessions required, that consent has been reviewed, any questions answered and the physical and mental health of the patient is deemed to still be the same before the start of each session. Written consent must be obtained again, too. This is most definitely a portion of the content process that is often overlooked by practitioners as they believe once a signature has been obtained, it will still hold power for any further treatments. Unfortunately, it may not.

DR RAJ THETHI

Dr Raj Thethi is founder of Yorkshire Skin Centre in Leeds. He graduated from Leeds University Medical School and completed his surgical training in the Yorkshire Deanery. He has also completed a Level 7 accredited course in Aesthetic Medicine, is a Member of the Royal College of Surgeons (Edinburgh) and is a trainer for Teoxane.