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The Critical Importance of Written Information on Iron Extravasation and the Montgomery Consent Principle


Scott Harding-Lister, Director at Apex Health Associates

Mattew Fowler, Senior Expert at Apex Health Associates

Mr Harding-Lister and Mr Fowler are both medico-legal experts providing opinions regarding iron infusions and in particular, iron extravasation injuries.

In the realm of healthcare, the concept of informed consent is not merely a procedural formality; it is a fundamental patient right, underscored by the landmark Montgomery v Lanarkshire Health Board (2015) ruling. This pivotal judgement reshaped the understanding of informed consent within the UK and beyond, emphasising that healthcare providers/practitioners must ensure patients are aware of any material risks involved in a proposed treatment, as well as alternatives.

The case of iron extravasation, a potential risk associated with iron infusions, is a prime example where the Montgomery ruling's principles are critically applied.

The exact numbers of patients suffering an iron extravasation are unclear. The literature provides a wide range of possible numbers of patients that suffer this type of injury. We have recently made a Freedom of Information request to all of the NHS Trusts within the United Kingdom. To date we have responses indicating that 63% of responding Trusts have a specific leaflet regarding iron extravasation.

Understanding the Montgomery Ruling

The Montgomery decision marked a departure from the traditional "doctor knows best" approach, advocating instead for a patient-centred model of care. According to this ruling, patients must be given sufficient information to make informed decisions about their healthcare, including the disclosure of any significant risks and the existence of any reasonable alternative treatments. The judgement highlights the importance of considering the patient's perspective—what they would consider significant within their personal context.

Why Written Information Matters in the Light of Montgomery

Of course, the health care practitioner and patient conversation about the proposed treatment is paramount in which the patient can explore issues, options, and concerns with their care provider. The health care provider can provide information and identify any issues, risks and present reasonable treatment options for that individual.

In addition to this, providing patients with detailed written information about iron infusion treatments and the risk of iron extravasation becomes not just beneficial but imperative for several reasons:

  • Enhanced Patient Autonomy: Montgomery emphasises respecting patients' autonomy and their right to decide upon their medical treatment once adequately informed. Written materials ensure that patients have access to all the relevant information needed to make an informed choice, reflecting this ethos.

  • Risk Communication: The ruling underscores the necessity of discussing material risks, which in the context of iron infusions includes extravasation. Written documents serve as a comprehensive resource for patients to understand these risks fully.

  • Bolstering the Consent Conversation: Verbal discussions about consent are crucial but can be augmented by written information, ensuring patients can revisit the specifics of their treatment and risks at any time, facilitating a more informed and considered decision-making process.

  • Legal and Ethical Compliance: Providing written information alongside verbal discussions ensures healthcare providers meet the standards set by Montgomery for informed consent, demonstrating a commitment to ethical practice and patient care.

What Should Be Included?

In our opinion, there is no right or wrong answer to what should be included as it will be dependent on the treating clinicians and the patient population. However, any written information is like to cover:

  1. Contact/Clinician Details: Contact details should be given for a clinician who is able to provide clarification and answer any questions that the patient may have before their treatment. This clinician needs to have the clinical knowledge and expertise to assist the patient in providing detailed information during the consent process.

  2. Procedure and Alternatives: Clear description of the iron infusion process, its benefits, and any reasonable alternatives. We imagine this to be a lengthy description, in clear language.

  3. Risks and Side Effects: Including the risk of iron extravasation, its symptoms, and how it is managed.

  4. Aftercare and Emergency Contacts: Instructions for aftercare and whom to contact in emergencies, ensuring ongoing support.


The Montgomery ruling has irrevocably changed the landscape of patient consent, placing the patient's right to information at the forefront of medical care. In providing written information about treatments like iron infusions and the associated risks such as iron extravasation, healthcare providers not only adhere to the legal and ethical mandates set forth by Montgomery but also honour the spirit of patient-centred care. This approach fosters trust, enhances patient autonomy, and ensures that decisions about healthcare are made in a truly informed context.


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