BEYOND THE CONSENT FORM

Expert witness Jen Vittanuova considers what truly informed consent looks like

Informed consent in aesthetic medicine must go beyond signatures and standardised forms from the manufacturer. This article explores the realities of consent through the lens of clinical experience and medico legal casework, highlighting how poor communication and inadequate documentation frequently lead to patient complaints and legal challenges. Drawing on current legal standards; including the Montgomery ruling, and regulatory requirements around prescription only medicines, it offers a practical, patient centred framework for aesthetic practitioners. The article encourages early consultation, personalised discussion, proper documentation, and clear boundaries around treatment decisions. In doing so, it reframes consent as a clinical safeguard, not just a legal formality.

It’s the phrase I hear most often in aesthetic negligence cases: “But the patient signed the consent form.”

And yet, in nearly every case I’ve reviewed, the signed form alone was not enough to establish valid consent. Because informed consent in aesthetic medicine is not just a formality, it’s a structured, patient specific process. A process that must be clinically reasoned, ethically sound, and legally defensible.

As both a nurse prescriber and expert witness, I’ve seen how consent, when poorly approached, becomes the weakest link in a practitioner’s defence. Often, it isn’t the treatment outcome that’s in question, but the adequacy of the consent process itself. In this article, I aim to highlight what truly informed consent looks like in modern aesthetic practice, and why simply “getting a signature” isn’t enough.

BEYOND MONTGOMERY: THE CONSENT CONVERSATION

The legal standard for informed consent was redefined by the Supreme Court in Montgomery v Lanarkshire Health Board [2015],1 which emphasised that patients must be informed of material risks, not just those considered statistically significant, but those that might reasonably matter to the individual patient.

In aesthetics, where procedures are elective and the outcomes subjective, understanding what matters to each patient is vital. One person’s acceptable risk may be another’s dealbreaker. “Bruising,” for example, may seem routine to us, but for a patient with their son’s wedding in three days, it becomes a significant consideration.

Yet despite this, I frequently see consent forms and clinical notes that reflect a generic, templated approach. Risks are listed, forms are signed, and patients are treated, without any documented evidence of an individualised conversation. In medico-legal terms, that’s a red flag.

WHERE CONSENT FALLS SHORT IN AESTHETIC CASES

In my expert witness work, the following themes repeatedly emerge when consent is challenged:

• Consent was obtained immediately before treatment, with no time for reflection

• There is no documentation of alternative treatments or the option to decline

• No cooling off period was offered or discussed

• Consent was obtained by reception/admin staff, not the treating clinician or prescriber, and often by email alone

• The patient’s understanding or specific concerns were not explored or recorded.

While any one of these issues may not be sufficient to establish negligence, collectively they create a pattern that undermines the integrity of the consent process. A signed form means very little in the absence of clear, contemporaneous records showing that the discussion took place and was understood.

KNOW WHEN NOT TO TREAT

While most aesthetic patients have capacity, clinicians must remain alert to red flags, especially when a patient appears distressed, indecisive, or overly focused on perceived flaws. In cases of suspected Body Dysmorphic Disorder, it may be clinically and ethically appropriate to defer treatment. Knowing when not to proceed is a mark of good practice, and a well-documented refusal can be just as defensible as any signed consent form.

MAKING CONSENT CLINICALLY ROBUST

Improving the consent process doesn’t require more paperwork, it requires more reflection and record-keeping. Practical steps to ensure consent is valid and defensible include:

• Initiate consent early: Ideally at a separate consultation from the treatment itself

• Tailor the discussion: Explore what matters most to the individual patient, their goals, concerns, and expectations

• Offer cooling-off periods: Especially for first-time or prescription-only treatments

• Discuss alternatives: Including the option of no treatment at all

• Document everything: Use the patient’s own words where possible. Note your clinical reasoning, not just the procedure.

For prescription-only medicines (POMs) such as botulinum toxin, this separation isn’t just best practice, it is often a legal and regulatory necessity. In most aesthetic settings, a Patient Specific Direction (PSD) is required2 when the medicine is being administered by someone other than the prescriber. This means a face to face consultation must take place with a prescriber, who then issues a prescription and PSD before the medicine can be ordered or given.

Where the prescriber is also the person delivering the treatment, a PSD is not required, but appropriate documentation, rationale, and compliance with prescribing standards still apply.

It’s also important to note that the rules around holding stock, issuing prescriptions, and delegation vary across professions (doctor, nurse, dentist) and differ between England, Scotland, Northern Ireland and Wales. Practitioners must ensure they are following current guidance relevant to their professional role and location.3

Example:

“Patient concerned about bruising due to upcoming event. Discussed risks and downtime. Offered alternative of delaying treatment, patient opted to proceed after consideration.”

This kind of documentation demonstrates shared decision making, risk disclosure, and patient led care, all of which stand up far more strongly than a generic, manufacturers form.

MANAGING EXPECTATIONS, AND WHEN NOT TO TREAT

A significant proportion of aesthetic complaints are driven not by technical error, but by mismatched expectations. Patients expected more volume, less downtime, or faster results. Managing this begins at the consent stage.

Use visual aids, timeframes, and realistic language. Avoid promising perfection or guaranteeing outcomes. Set parameters early, “You may need two or three sessions to achieve that result”, and document them.

And remember: you are not obligated to treat everyone. If a patient is pressuring you, has unrealistic goals, or displays concerning psychological traits, declining treatment is not only appropriate, it’s good clinical practice.

In several of the strongest legal defences I’ve reviewed, the clinician had declined to treat and carefully documented why. That record alone can be your greatest protection.

FINAL THOUGHTS

True informed consent is a clinical process, not a clerical task. It is the culmination of ethical practice, professional judgement, and clear communication. It protects patients, but it also protects you.

A robust consent process isn’t about covering yourself after the fact. It’s about clarity before you even pick up a needle. Ask yourself:

• Would my notes support me if challenged?

• Have I explored what really matters to this patient?

• Do I know when to say no?

Because when things go wrong, and sometimes they do, it won’t be the form that defends you. It will be the thought, time, and care you put into what happened before the form was ever signed.

JEN VITTANUOVA

Jen Vittanuova is an experienced nurse prescriber, clinic owner, clinical trainer, expert witness, and key opinion leader for the JCCP with over 25 years in cosmetic surgery and medical aesthetics. She has owned and operated her own clinics for over 15 years and previously ran a successful clinic in Dubai. Vittanuova specialises in clinical risk and the legal frameworks underpinning safe aesthetic practice. As a national speaker and educator, she is known for her accessible and no-nonsense approach to compliance, consent, and documentation. Through her platform Legally Aesthetic, Vittanuova provides training and consultancy to help practitioners elevate standards while protecting their patients, and themselves.