Failures of informed consent and the impact on women’s health

  • 8th March 2023

Sex and gender bias in health and social care results in poor outcomes for patients and has a negative impact on safety during care and treatment. For the last two International Women’s Days, Patient Safety Learning has highlighted patient safety concerns on this topic, considering the broader risk to safety posed by this bias and the impact on outcomes and safety of women being historically underrepresented in clinical trials and medication research.[1] [2]

The theme of this year’s International Women’s Day is #EmbraceEquity. In support of this aim, there are seven different missions which have been identified to help forge a gender-equal world, including one focused specifically on health:

“To assist women to be in a position of power to make informed decisions about their health”.[3]

This year we will focus on this mission, considering the relationship between women’s health, informed consent and patient safety. We will first set out what we mean by informed consent, before discussing how failures in consent can have a negative impact on women’s health. Then we will consider the UK Women’s Health Strategy in relation to these issues, and discuss what is needed to improve patient safety.

Informed consent

The NHS defines informed consent as:

“… the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead.”[4]

This is often broken down into the acronym BRAN (Benefits, Risks, Alternatives and doing Nothing).[5] The landmark UK Supreme Court judgment Montgomery v Lanarkshire Health Board case in 2015 reaffirmed this principle in law, setting out the legal duty of doctors to disclose information to patients about risks.[6]

However, despite this legal obligation, far too often we see cases of avoidable patient harm where there has been failure of informed consent. Although this is an issue that can impact any patient, this is often particularly notable in health conditions and areas of care that predominantly affect women. In this blog, we will look at three areas where failures of informed consent have patient safety implications for women:

  • receiving information about benefits and risks
  • being told about alternative treatments and options, and
  • the impact on patients after failures of informed consent.

Receiving information about benefits and risks

To provide informed consent, patients need to be made aware of the benefits and risks of a procedure or treatment before deciding whether to proceed.

The Independent Medicines and Medical Devices Safety (IMMDS) review highlighted this as a recurring point of concern in medical interventions predominantly affecting women. This Review examined how the healthcare system responded to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants, uncovering a truly shocking degree of avoidable harm over a period of decades.[7]

Let’s look at the case of sodium valproate; an epilepsy treatment that is potentially harmful to the developing fetus and can lead to physical deformities and learning difficulties in children if taken when the woman is pregnant - a condition known as Fetal Valproate Syndrome. The IMMDS Review highlighted that many pregnant women who were taking sodium valproate as an epilepsy treatment did so without knowing that this could harm their unborn child.

What is particularly concerning in this example is that it is not a historic problem. Despite national attention on the findings of this Review and the serious harm caused, there are still women taking sodium valproate during pregnancy today who are not aware of the associated risks. This has been identified as one of the three top priorities areas of work for Dr Henrietta Hughes, the new Patient Safety Commissioner for England.[8]

Information and alternative treatments and options

Having choices, and the opportunity to discuss different options, is an important part of informed consent. When considering healthcare treatment patients often find themselves reliant on healthcare professionals to tell them about the full range of options.

An example of where having this choice may not always be the case, and can be detrimental to women’s health, is hysteroscopy. Hysteroscopy is a procedure used as a diagnostic tool which involves a long, thin tube being passed through the vagina and cervix, into the womb, often with little or no anaesthesia. While some women do not find the procedure painful, many experience severely painful and traumatic hysteroscopies, raising significant patient safety concerns.[9]

One key issue commonly highlighted is that women are not always being told of the possibility of severe pain or are not being offered the full range of pain management options available to them for a hysteroscopy. Many are just told to expect mild period-like cramping and to take simple analgesics, such as paracetamol, beforehand.[10] [11] Patient feedback suggests that approaches to this across the country are not consistent. Some women receive no information about pain management options, while others are able to discuss various options including a general anaesthetic. At Patient Safety Learning we have recently highlighted the need for improvements in this area, calling for an independent review of these services, including the application of informed consent.[12]

There are also concerns that the choices offered to women may vary depending on their race. Last year the organisation Five X More published a survey into Black women’s experiences of maternity services in the UK which raised serious concerns about inconsistences in how Black and Black mixed women were approached compared to white women or their own family members who were white. Examples it highlighted included:

"... some women felt that they were not always provided with the opportunity to make informed decisions (“I didn’t request pethidine yet I was given it”); that they were pressured into making decisions about treatment (“…I found the attitude for an induction to be very forceful”); that procedures were performed without consent (“…She said she wanted to see how dilated I was, but also carried out a cervical stretch without my prior knowledge or permission), and that medication was administered, sometimes by junior or student members of staff without permission”.[13]

Impact after failures of informed consent

As well as the concerns and issues around lack of informed consent at the time of care and treatment, it can also have long-reaching consequences afterwards for the patient.

An example of this is women who have been harmed by surgical mesh. As noted in the IMMDS Review, many women reported a failure of informed consent:

“… they never knew they had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh”.[14]

Many women harmed by mesh have been forced to live with a constant reminder of this lack of consent and abuse of trust, as they deal with significant health problems and difficulties in accessing mesh removal through the NHS.[15] [16] [17] It is hard to overstate the emotional and psychological impact this can have on a patient. These experiences serve to significantly undermine trust in healthcare and healthcare professionals.

Returning to the example of hysteroscopy procedures, in sharing their experiences with us on the hub many women spoke about ongoing feelings of violation following experiences of severe pain. These feelings of violation are often exacerbated by the fact that they were not informed of the risk of severe pain beforehand. Most shockingly perhaps, there are cases where women asked for the procedure to be stopped due to the level of pain and their wishes were not followed.[18]

This raises serious questions around how patients are responded to when actively withdrawing their consent.

In some cases the associated trauma has translated into a reluctance to attend other important appointments such as cervical smear tests, potentially compromising their long-term health. This dangerous knock-on effect has also been raised by women who experienced painful contraceptive device (IUD) procedures, and again did not feel adequately informed beforehand.[19]

Influence of paternalistic, sexist, and misogynist attitudes

Absence of informed consent is not an issue that solely affects women. However, as we have shown, there are many examples of consent issues that relate to care and treatment predominantly affecting women.

Failures of informed consent are driven by a range of factors, including a lack of training, extremely busy working environments and communication difficulties. However, in the cases discussed here where informed consent has failed, many of those women affected have spoken about this being interwoven with concerns about paternalistic, sexist and misogynistic treatment.

There is now a wealth of evidence around this issue, and more broadly about a massive gender health gap which impacts on women’s care and treatment in a range of ways, from the point of diagnosis through to treatment and aftercare.[20] [21] Far too often women still find themselves met with defensive and unresponsive attitudes from the healthcare system and can often feel belittled, dismissed and patronised.[22]

Women’s Health Strategy

The gender health gap is becoming widely acknowledged and last year the UK Government published a new Women’s Health Strategy for England seeking to close this gap.

One area this Strategy identifies is the need for improvements in informed consent and shared decision-making to support women to make informed decisions about their health and care. It also refers to ongoing work by the Royal College of Obstetricians and Gynaecologists to develop new consent guidance for nine gynaecological procedures.

The Strategy includes a six-point long term plan for making a transformational change in women’s healthcare, and tying into the #EmbraceEquity theme of this year’s International Women’s Day one of these points is:

“Ensuring women’s voices are heard – tackling taboos and stigmas, ensuring women are listened to by healthcare professionals, and increasing representation of women at all levels of the health and care system.”[23]

The ambition behind this strategy is welcome, as is the Government’s decision to appoint a new Women’s Health Ambassador, Dame Lesley Regan, to drive system-level changes to close the gender health gap.[24] However, whether these good intentions will be translated into real progress and improvements in women’s health is yet to be seen.

In talking about implementing changes, the Women’s Health Strategy notes the wide and varied range of stakeholders that will need to be involved in this effort and states that the Government ‘will develop a delivery plan for the commitments set out in this strategy’. However, there is currently no timetable for this or indication of what resources may be allocated to support this work.

Improving informed consent

Patient Safety Learning believes that plans to improve informed consent need to be a core part of the Government’s delivery plan for its Women’s Health Strategy.

The Strategy refers to the increased use of patient decision aids and conversation aids to support informed consent, including a series of digital tools called iDecide to better support informed decision-making in labour.[25] While such tools are important, they need to form part of a wider programme of work to create meaningful change. The IMMDS Review highlighted some important points around this, which we believe should inform the Government’s approach in this area:

  • Greater thought needs to be given to help patients better understand risk.
  • Information around consent should be shared in way that is clear and meaningful.
  • Talking to, or hearing from, others who have experienced the same intervention with or without complications could be hugely beneficial and should be considered as part of the informed consent process.
  • Patient decision aids should be validated, standardised for each procedure and be jointly developed with patients, reflecting their experiences and outcomes.

Commenting on this issue, Patient Safety Learning’s Chief Executive Helen Hughes said:

“All too often, female patients are not given the information needed to make a truly informed decision about their own health. Not only is it unlawful, but it can lead to long-lasting physical and psychological harm. Through its Women’s Health Strategy, the Government has an opportunity to significantly improve informed consent across the NHS, ensuring patients receive consistent access to all the information and options they need in relation to their care. But these changes cannot take place in isolation, they must also form part of a wider change in approach to tackle the persistence of paternalistic attitudes that treat women as passive participants in their care.”

Work around informed consent in the Women’s Health Strategy, and this broader culture change, will need to be accompanied with clear leadership, delivery plans and effective resourcing if we are to move towards a safer healthcare system for women.

Share your views

We would love to hear your thoughts and feedback on the content of this blog. To leave your comments below, please sign up to the hub. If you would like to share your experiences and insights on any of the issues raised, you can also get in touch with the Patient Safety Learning team at [email protected].

Related reading

For International Women’s Day 2023 we have picked out 7 resources to highlight, and evidence, some of the key patient safety issues concerning women’s health equity in our latest Top Picks article.


[1] Patient Safety Learning, Dangerous exclusions: The risk to patient safety of sex and gender bias, 8 March 2021.

[2] Patient Safety Learning, Medicines, research and female hormones: a dangerous knowledge gap, 8 March 2022.

[3] International Women’s Day, 2023 Theme, Last Accessed 27 February 2023.

[4] NHS England, Consent to treatment, Last Accessed 27 February 2023.

[5] Julie Smith, Informed consent: what is it?, 21 December 2020.

[6] UK Supreme Court, Montgomery v Lanarkshire Health Board, 2015.

[7] The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020.

[8] Patient Safety Commissioner for England, Patient Safety Commissioner: 100 Days Report, 2 February 2023.

[9] Patient Safety Learning, Hysteroscopy: 6 calls for action to prevent avoidable harm, 1 March 2023.

[10] Campaign Against Painful Hysteroscopy, CAPH Survey Results – Hysteroscopy Action, Last accessed 27 February 2023.

[11] Patient Safety Learning’s the hub, Community Forum, Painful Hysteroscopy, Last accessed 1 March 2023.

[12] Patient Safety Learning, Hysteroscopy: 6 calls for action to prevent avoidable harm, 1 March 2023.

[13] Five X More, The Black Maternity Experiences Survey: A Nationwide Study of Black Women’s Experiences of Maternity Services in the United Kingdom, 24 May 2022.

[14] The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020.

[15] Kath Sansom, ‘Mesh removal surgery is a postcode lotter’ – patients harmed by surgical mesh need accessible, consistent treatment, 2 December 2021.

[16] Anonymous, “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery, 1 May 2022.

[17] Patient Safety Learning and Sling the Mesh, Specialist mesh centres are failing to offer adequate support to women harmed by mesh, 25 August 2022.

[18] Patient Safety Learning, Hysteroscopy: 6 calls for action to prevent avoidable harm, 1 March 2023.

[19] Sophie, Medical trauma from IUD fitting: it’s not just five minutes of pain for five years of gain, 10 January 2022.

[20] Sarah Graham, Rebel Bodies: A guide to the gender health gap revolution, 5 January 2023.

[21] Caroline Criado Perez, Invisible Women: Exposes data bias in a world designed for men, 5 March 2020.

[22] Sarah Graham, Gender bias: A threat to women’s health, 4 August 2020.

[23] Department of Health and Social Care, Women’s Health Strategy for England, 30 August 2022.

[24] Department of Health and Social Care, Dame Lesley Regan appointed Women’s Health Ambassador, 17 June 2022.

[25] iDecide, iDecide: Your birth, your decisions, Last Accessed 2 March 2023.



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