References

General Medical Council. Guidance for doctors who offer cosmetic interventions. 2016. https://tinyurl.com/45myrmfe (accessed 11 October 2021)

Ho D, Jagdeo J. A systematic review of paradoxical adipose hyperplasia (PAH) post-cryolipolysis. J Drugs Dermatol. 2017; 16:(1)62-67

Stroumza N, Gauthier N, Senet P, Moguelet P, Nail Barthelemy R, Atlan M. Paradoxical adipose hypertrophy (PAH) after cryolipolysis. Aesthet Surg J. 2018; 38:(4)411-417

The importance of informed consent

02 November 2021
Volume 10 · Issue 9

The recent and highly publicised case of the unsuccessful fat freezing procedure undergone by model Linda Evangelista has generated a great deal of attention within the profession and in the general media. Media sources have outlined several facts surrounding the case, including the lack of informed consent and the financial claim the patient is pursuing through litigation. It is beyond the scope of this editorial to make any judgement or criticism or draw any conclusion about the circumstances leading to the ongoing litigation. However, the relevant claims seem to stem from Evangelista undergoing a fat freezing procedure without being consented appropriately.

Fat freezing is a minimally invasive procedure and an alternative to more aggressive fat removal procedures, such as liposuction. Complications related to fat freezing techniques include minor, localised and reversible complications, such as erythema, pain and oedema. More serious complications involve paradoxical adipose hyperplasia (PAH), which is an unwanted tissue hypertrophy.

The reported incidence of complications varies in studies. Earlier data suggests a rate of 0.0032% (Ho and Jagdeo, 2017). However, more recently, an incidence rate of 1% was identified (Stromza et al, 2018). This wide variation in incidence can be a source of confusion. This is particularly true when some reports contradict others. Additionally, some figures have been provided by the industry and raise the obvious question of bias. However, there is a consensus about the rise of this incidence, either because it was initially underdiagnosed or practitioners are now more aware of it. It is also possible that the reported figures underrepresent the reality. This could be due to lack of regulation that allows many non-medical people to have access to these devices with little to no knowledge of PAH and how to assess patients for it. Furthermore, if not educated to the fact that this is a recognised complication, patients may feel embarrassed to report an increase in fat (Ho and Jagdeo, 2017).

PAH is generated by a minimally invasive procedure and the only treatment available to correct it is an invasive procedure, such as liposuction or other surgical modalities. The latter is what the patient avoided by requesting fat freezing. This amplifies the problem, particularly if the patient has not been made aware when consented.

Consent must provide the patient with the knowledge and information to make an informed choice, and risks must not be trivialised. Indeed, in this case, the risk of PAH should have been discussed, along with the therapeutic options to deal with potential complication. Verbal and written consent are the basics and fundamentals of care that must take place, along with a cooling off period (General Medical Council, 2016).

The combination of a minimally invasive procedure with a relatively low risk may lead to complacency when consenting, as there might be an unconscious belief that these two parameters protect us from substantial or life-threatening complications. While PAH is not a life-threatening condition, it can have devastating consequences for the patient that are significant in terms of the psychological effect. The Evangelista case is a striking reminder about the absolute necessity of informed consent. At this stage, it would be inappropriate to speculate about the lack of consent, as claimed by the press. However, it should provide a stark wake-up call to ensure that we always adhere to our professional code.

Considering the patient reaction regarding her appearance and her claim about the fact she was not made aware of the complication, together with the substantial financial claim, we must reflect that, perhaps, it is not enough to merely explain the procedure and enumerate the potential complications. It is wise to lay down the therapeutic alternative, should a particular complication take place. This is particularly relevant when the method of dealing with a complication is potentially what the patient was initially trying to avoid.