Consent
12. Mrs E says the Trust did not give her the opportunity to make an informed consent decision about the operation change in February 2024. She says had she had time to properly consider it she would have opted to wait. The Trust agreed the approach to the operation needed to change as they could not source the pyro-carbon ball but maintain she did provide consent, and that they provided appropriate information to allow informed consent.
13. We will therefore consider whether adequate information and time to consider was provided to allow informed consent in light of the need for change of approach ahead of the surgery.
14. The Royal College of Surgeons ‘Consent: Supported decision-making: A guide to good practice’ (November 2018) (RCS consent guidelines) and the RCS ‘Good Surgical Practice: A guide to good practice’ (2014) (the RCS Good Surgical Practice guidelines) advise the Trust to make sure the patient provides consent after understanding appropriate and sufficient information.
15. According to RCS Consent guidelines, informed consent requires the surgeon to be satisfied the patient has received and understood appropriate and sufficient information. We understand this can vary between each treatment and the information should be given objectively and side by side (pros, cons and risks) including the option of no treatment.
16. Moreover, the Trust needs to allow sufficient time to the patient to. The length of time may vary as this will depend on factors like the patient’s understanding and the complexity of the treatment and its risks. Lastly, the consent process should be documented prior to the procedure once the patient has agreed to it.
17. The dispute in this case is whether Mrs E’s was given the opportunity to make an informed consent in February 2024, when the Trust proposed to do a different surgery than the one, she agreed to in December 2023.
18. We have looked at this case history of the consent process to understand what happened. Our understanding is the consent process began in December 2023 and ended in February 2024 when she had the surgery.
19. Mrs E suffered from osteoarthritis on her left shoulder. In December 2023, she had a consultation, and we can see there was a discussion about her condition and the treatment options. The Trust explained she had the option do nothing or decide on a shoulder replacement.
20. For shoulder replacement they provided her with three surgical options. Option one, was pyro-carbon hemiarthroplasty (replacing just the ball), option two was an acromioclavicular joint excision (replacing the ball and socket) and option three was a reverse shoulder replacement. According to the advice we received, those are appropriate options for her condition.
21. The records show the Trust explained all three surgical options would be under general anaesthetic and gave recovery timeframes. It also explained the risks, their risk rates and document that the shared decision was to undergo surgical option one (to replace just the ball). We note no consent form was signed for surgical option one but there is no dispute this was agreed. The surgery was set for February 2024.
22. From the December 2023 consultation notes, we can see the Trust provided information about the various treatment options, including the option not to undergo surgery, risks and risk rates and planned the surgery in a future time to allow the patient time to consider the options. The consultation notes the risk as 12% systemic complications (cardiac, respiratory and urological, and 6% risk of regional problems (fracture, nerve and vessel damage, dislocation, infection, haematoma and stiffness).
23. In February 2024, the day of the surgery, according to Mrs E she arrived around 7.30am in the morning at the hospital expecting to undergo the surgery she agreed to. According to Mrs E, around 10am the Trust informed her they could not source the pyro-carbon ball for her agreed surgery. The Trust proposed to perform surgery option two (to replace both the ball and socket) of the shoulder joint instead. Mrs E advised she agreed to it but never signed a consent for this and was taken to theatre around 12.30pm. We note there is a signed consent form for surgical option number two (replace the ball and socket).
24. Looking at the consent form, it lists the potential risks and benefits of the proposed surgical option number two. These are pain, infection, bleeding, scar, nerve/blood vessel/tendon damage, stiffness, loosening, dislocation, need for further surgery and systemic complications.
25. According to our adviser, completing a consent form on the day of the surgery is not in line with the RCS Good Surgical Practice. This is because the patient needs to have sufficient time to make an informed decision. That is generally considered not to be the same day as the information being shared with them. We therefore considered what information Mrs E would have had available to her at this time as she had previously had all options explained and the approach to be taken was essentially the same.
26. Our orthopaedic adviser also explained the risks are similar for both surgical options (one and two). He also explained the surgical approach for both surgeries is the same. Our understanding is this is because, the subscapularis muscle/tendon needs to be cut in order to access the shoulder joint in both surgeries. It is then repaired and secured back in its place. We note however, there is a known risk of the subscapularis muscle/tendon being damaged or loosen which will require further surgery.
27. Our adviser also explained she needed to be aware that a plastic socket would be used which can become loose or wear out, failure rates, and lifespan of the implant of surgical option two compared to surgical option one.
28. Although the risks and benefits are documented on the consent form there is no other documentation to show what kind of information was given to Mrs E in February 2024. However, we note all surgical options, and their potential risks were discussed in December 2023, and the risks were also documented on the consent from February 2024. As such, we are satisfied she had appropriate information shared with her earlier on.
29. However, we also appreciate this was a change in which approach would be taken, and she would still require some time to consider the change in position. The guidelines do not specify how long that needs to be, but our understanding is this is on a case-by-case basis as in cases of emergency surgery the patient may not have the luxury of time compared to other types of surgery.
30. Mrs E advised she was informed the surgery she initially consented to could not take place around 10am and was taken to theatre around 12.30pm. Therefore, this gives a 2.5-hour window in which the discussions for the new surgery could have taken place. The consent form does not have any time stamps therefore we don’t know what time these were discussed or the form signed.
31. In our view in February 2024, there was no reason for an urgent or emergency surgery therefore, time was not a pressing issue in this case. We appreciate, being told the surgery she agreed to was not going to go ahead on the day it was supposed to take place would cause some frustration. As such, we are also conscious that a decision to proceed quickly may be considered advantageous.
32. Considering the RCS Consent guideline point 4.8m which explains the length of time may vary as this will depend on factors like the patient’s understanding and the complexity of the treatment and its risks. Along with the absence of any documentation about any discussions and information provided on the day of the surgery. It is difficult to say whether enough time was given to Mrs E to decide about the change of surgery in February 2024.
33. Moreover, according to RCS Consent guidelines point 2.3, the patient needs to be made aware of their options, including the no treatment option. Whilst we can see she was made aware of this as an option in December 2023, we cannot see any documentation about this mentioned as an option in February 2024. We also appreciate Mrs E says she felt rushed and pressured into making a decision on the change in procedure on the day. Without any further information documented we are unable to say adequate time was given for her to make the decision. We do note she was aware she had the right to refuse treatment and in essence withdraw her consent any time before the surgery. We appreciate she might feel she did not want to cancel the surgery on the day and wait to be rescheduled on a different date sometime in the future.
34. Overall, we are satisfied the Trust provided adequate information about the surgical options and their risks. However, we have seen an indication of a failing in the consent process following the change from surgical option one to surgical option two in February 2024. Specifically, the lack of documentation about any discussions on the day of the surgery (February 2024). Because of the lack of documentation, we cannot say if adequate time was not given to Mrs E to decide on the surgery. However, we do note there is a signed consent form which outlines the risks and benefits and that built on previous discussions about risks and benefits.
35. Accordingly, we cannot say the consent process was in line with guidelines and we find a failing in that. But we can say appropriate information about risks and benefits had been previously available to her. We discuss the impact of this below.
Installed the wrong size pyro-carbon head and ball
36. Mrs E says the Trust installed the wrong size pyro-carbon head and ball. The Trust maintained the humeral heal (ball) and the glenoid (socket) were measured during the surgery and the appropriate size replacement was used.
37. We could not find any specific guidelines about this and therefore we have relied on our adviser to come to our view.
38. Our adviser indicated this would come down to clinical expertise and considering the patient. They explained that without the post-operative X-rays, it is not easy to establish whether the incorrect size of the ball and socket component was fit. However, from the surgery notes, it appears both the ball and socket were measured before the actual part was fitted. They also note a size small trial was used before the real component was fitted.
39. Our adviser explained the patient’s humeral head was removed and measured to be 46mm low profile head. This was trialled during the surgery and found to allow the desired movement and therefore, the same size real component was fitted.
40. Our understanding is the decision on the correct size to be fitted is decided during the operation based on the anatomy and the needs of the patient. We could not find any reference to any agreed size prior to the operation.
41. Considering the available records and the advice we received, we are satisfied the Trust measured and tested the component before it was fitted to the patient which was an appropriate approach. Therefore, we have not identified any indications of failings.
Impact
42. We saw an indication of a failing in the lack of documentation regarding discussions about the surgery. We note there is a signed consent form for the surgery. This shows the basic information was shared with her about risks. Whilst it would have been helpful to have more documented information about the nature of the discussion that supported that, as a minimum we can see that she was given information on both December 2023 and February 2024.
43. We have considered what would have happened if she had been given more time to consider her options. We cannot say whether she would have gone ahead with the procedure she had on this occasion. She says she would not. We do not doubt her statement of this but also appreciate this is likely to be coloured by her experience post operatively which was negative. We have considered whether the failings are linked to the impact.
44. Mrs E says because of the failings, she suffered great distress and since the operation she has been in constant pain and discomfort. She is unable to lift her left arm above 45 degrees and has pain in her neck, arms and hands as well as her sleep, which impacts her day-to-day life. She also says that she needed to undergo a shoulder replacement surgery to correct the damage.
45. According to our adviser the surgical approach is the same for both surgical options (one and two). This is because both require cutting the subscapularis tendon which sits in front of the joint. This tendon is cut to access the joint and later repaired in its position. Therefore, the risks are the same for these surgical options.
46. We can see Mrs E developed problems postoperatively and was reviewed on 16 July 2024. She was advised her humeral head was sitting anteriorly (was not in place), and this was likely due to a failure of the subscapularis tendon. The Trust explained the most common reason for the failure of the replacement is the failure of the rotator cuff (a group of four muscles and their tendons that surround the shoulder joint). Our adviser explained the risk of the tendon failing (after repair) is a known risk for all these surgical options.
47. Mrs E had a total replacement surgery in December 2024. Looking at the records from this surgery, we can see a pseudo-capsule was found around the joint and the surgeon attempted to release and mobilise the subscapularis but found degenerate, retraced poor quality tissue. Our adviser explained this means the subscapularis had torn after it was repaired in February 2024, and this is a known risk for both surgical options (one and two) and was recorded on the consent form.
48. Whilst we appreciate the failing in the lack of documentation about discussions in February 2024, there is a signed consent form which explains the known risks. Moreover, the surgery method is the same for the shoulder surgery options she given and the common risk for all of them is the failure of the scapularis muscle/tendon. Therefore, on the balance of probabilities, it is likely she would suffer the same impact even if there was no change in surgery. Similarly, whilst, with hindsight, she maintains she would not have gone ahead we can see she agreed to those risks when considering the first procedure. As such we are unable to take the view that events would have been different if she had been given more time and information.
49. Whilst we appreciate this was a very difficult time for Mrs E, we cannot link the impact she experienced to the failing identified.