Woman’s mesh consent form was changed after signing – how can patients be better protected?

Summary

Yvette Greenway-Mansfield experienced complications relating to the vaginal mesh that was used to treat a uterine prolapse. Those complications were not listed on the consent form she signed. Fortunately, she kept her copy and was able to prove this. Yvette has recently been awarded £1 million because it was found that her form had been doctored after she had signed it.  

Her successful medical negligence claim was also based on the fact that alternative treatment options were not considered when they should have been. These alternatives came with fewer risks, and it was agreed that they would actually have been more suitable in her case. 

In this blog, I reflect on the levels of harm caused to the patient and how digital consent forms could help protect others. 

Content

“I felt utterly vindicated. If I hadn’t kept that documentation, I could be standing in court, being subjected to a grilling, being made out to be a liar. It breaks my heart for women who have to go through that.” Yvette Greenway-Mansfield.

When I read about Yvette’s experience, I was stunned. Anyone who follows healthcare news, and especially readers of the hub, will be familiar with the vaginal mesh scandal and the horrors experienced by so many women. Yvette is one of these women. But what stopped me in my tracks was that not only did she have to endure debilitating physical pain, she then had to prove that she had not been warned of those complications. Standing her ground when a trusted healthcare professional had doctored her consent form must not have been easy. If she had not kept that copy, she would most likely have been perceived to be lying, confused or ignorant, or possibly all three.

It is often assumed that patients don’t read the information given to them about their care. This is why the healthcare professional in question, I assume, must have hoped they would get away with falsifying her consent form. Not only does it show a flagrant disregard for integrity and decency, but it is also an extraordinary act of disrespect towards the victim.

It also raises the question of whether this happens more frequently but cannot always be proved if the victim is unable to produce their copy. One way to avoid this is to make sure everyone is offered a digital version of their consent form – something the NHS is moving, albeit slowly, towards. A paper trail (preferably digital) evidencing the information patients have been given and the forms they have signed is achievable in this day and age and something all healthcare providers should be aiming for.

The implications of this story are far reaching:

• Yvette’s trust in her healthcare team was completely destroyed.
• She was harmed by a treatment that was later deemed unnecessary.
• She had her consent form altered without her knowledge.
• She finally had the mesh removed following a private referral.
• To this day, she has to live with urinary and faecal incontinence and chronic pain.

How can we expect someone who has been through all of that to trust the healthcare system? If and when she experiences health problems in the future, who will she turn to? I cannot speak on her behalf, but I suspect she will be reluctant to engage with the NHS.

Cases like Yvette’s are, fortunately, few and far between. However, it is important that healthcare professionals and organisations learn from them and take steps to ensure they do not and cannot happen ever again.

I am passionate about patient need and expectation when it comes to informed consent. My team and I work with clinical consultants to create patient information about surgical procedures, so this story really hit a nerve. Digital consent forms can ensure that everyone has a record of the information sent to the patient and, if they go ahead, the consent form for that procedure. That way there is simply no option or opportunity for anyone to change or lose it. I hope to see the option of digital consent being rolled out across all healthcare organisations in the UK in the very near future.  

Related reading:

• Woman who suffered complications from vaginal mesh implant awarded at least £1m
• What does pelvic mesh do and why are women suing over it? – explainer
• The difficulty of medical negligence cases and why financial redress from the Government is so important for mesh victims
• Using digital pre-op information to support informed consent (by Julie Smith)
• Accessible patient information: a key element of informed consent (by Julie Smith)
• Informed consent: what is it?
• When will the Government take responsibility and meet the needs of all mesh patients? A blog by Paula Goss
• Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh
• First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review (8 July 2020)

Share your thoughts

What did you think about the issues raised in Julie's blog? Have you ever had to sign a consent form in healthcare for yourself or on behalf of someone else? How was the process? Did you feel well informed to make a decision? Could anything be done to improve the consent process? 

Perhaps you're a healthcare professional who can share good practice or some of the challenges that might exist in making sure everyone is able to make an informed decision before undergoing medical treatment or surgery. 

Please comment below (sign up first for free) or get in touch with us at content@pslhub.org to tell us more.

About the Author

Julie is the Content Director at EIDO Healthcare. She oversees a library of leaflets used to support patients in making informed decisions about their care, with a focus on medical procedures and operations. Julie and her team are trained in Plain English, risk communication, easy-read information, translation processes and more.

Julie is a healthcare editor by background and previously worked at MA Healthcare as Editorial Director, overseeing 25 healthcare journals. She was also the Editor for a number of journals while at MA Healthcare, including the British Journal of Nursing and British Journal of Community Nursing. She is a member of the PIF TICK steering group and a Trustee and Board Member of the Lindsay Leg Club Foundation.