East and North Hertfordshire Teaching NHS Trust

4. Mr O complains about the treatment and care he received from the Trusts radiologist in June 2023, when he underwent an elective coil embolisation to treat his varicocele. He complains the Trust did not fully inform him about the potential risks of this procedure. He also raises concerns about the radiologist not performing the surgery correctly.

5. Mr O says since the procedure he has lived in debilitating and disabling pain. This affected his ability to walk, exercise, have sexual relations and carry out everyday tasks. Mr O says the procedure has caused him psychological trauma.

6. Mr O says he had to pay for the coil to be removed privately. This involved removing the gonadal vein itself.

7. In bringing this complaint to us Mr O seeks accountability, service improvements and compensation.

8. In 2022 Mr O was experiencing worsening testicular pain on the left side, especially after exercise and physical exertion. Mr O’s GP referred him to the Trust. The Trust performed a scan of Mr O’s scrotum and examined him. Following this the Trust diagnosed a varicocele. A varicocele is a swollen and enlarged vein in the scrotum.

9. On 28 June 2023 Mr O attended the Trust for coil embolisation of his varicocele. This is a minimally invasive, non-surgical procedure where coils are used to block the enlarged veins to relieve pain and improve fertility.

10. Following the procedure, Mr O began to experience debilitating pain where the coils had been inserted.

11. On 4 July Mr O returned to the Trust’s emergency department (ED) reporting pain from the operation. Mr O told ED staff he was informed the pain should resolve in two days. Mr O explained he had sharp pain in his left groin and constant pain in his testicle and abdomen since the procedure. The ED staff detected no abnormalities. They provided Mr O with pain relief and antibiotics, before they discharged him and referred him back to urology for a follow up ultrasound.

12. Mr O returned on 5 and 22 July to ED reporting the same issue. Mr O requested the Trust remove the coil. The Trust explained how this would not be possible. Mr O enquired about the removal of the entire vein. The Trust were also unwilling to perform this request.

13. Mr O’s pain continued until he had the vein and coils removed at a private hospital.

16. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications of failings. We will explain the reasons for our decision in detail below.

Informed of the procedure’s risks

17. Mr O complains the Trust did not adequately inform him of the risks of coil emobolisation. He told us the Trust assured him the procedure had a short recovery time and would not have any impact on his sexual functioning. He said the Trust did not inform him the procedure can cause permanent damage or chronic pain.

18. The Trust’s response said the surgeon had fully consented Mr O in line the guidelines from the British Association of Urological Surgeons (BAUS) and the British Society of Interventional Radiology (BSIR). The Trust explained Mr O’s symptoms are not recognised complications of this procedure.

19. Our adviser explained that the Trust acted in line with common practice when communicating the procedural risks to Mr O prior to his embolisation. They said that the consent form Mr O signed included all the known and understood risks of this procedure, including pain.

20. the BSIR published information sheet on varicocele embolisation, explains that some patients may experience mild discomfort in the loin or scrotum afterwards which rarely lasts more than a few days.

21. The CIRSE standards for varicocele embolisation summarise potential complications as ‘epididymo-orchitis, epididymitis (2%), Pampiniform thrombophlebitis (2-15%), post-embolisation syndrome (0.8-14%)’. Our adviser suggested that each of these potential complications could cause pain but that the document states that symptoms from these complications last up to ten days in the majority of cases.

22. The BAUS published information sheet describes risk of pain around puncture site which can sometimes worsen in the days after the procedure and back pain for 48 to 72 hours after the procedure.

23. Given the above literature and general lack of evidence suggesting chronic, severe or debilitating pain is a common problem, our adviser explained the Trust’s consent form adequately recognised the potential risks of Mr O’s procedure in line with standard practice.

24. We appreciate how difficult this experience must have been for Mr O and do not underestimate the impact it had on his life. We equally appreciate how frustrating it must have been for a typically straight forward and voluntary procedure to have had such an adverse effect on him.

25. Whilst pain and discomfort after varicocele embolisation may be common, our adviser states this is generally mild and will resolve within two weeks. Our adviser recognises pain was included as a complication in the procedure consent form but that details of any discussion regarding pain cannot be considered.

26. Our adviser explained that the nature, persistency and severity of pain that Mr O experienced were very rare and not well described in the literature or standard of practice. Therefore, there is no evidence to suggest a deviation from standard of practice in this instance. As a result of this, we will not be taking this complaint any further.

The procedure

27. Mr O told us about his concerns that he suffered such significant complications because of a failing in how the procedure was completed.

28. The Trust’s response did not acknowledge any failings in how the procedure was carried out.

29. Our adviser considered how Mr O’s procedure was performed. Having seen the varicocele embolisation imaging provided by the Trust and the removed gonadal vein images provided by Mr O, they determined the procedure was performed appropriately and followed common practice.

30. The images show an injection was made into the gonadal vein and coils deployed within it. Our adviser stated there was no evidence of any complications during the procedure, including no evidence of contrast extravasation. This is a complication that can cause pain and discomfort when the contrast dye injected during the procedure leaks outside the intended blood vessel.

31. Coils were used as embolisation material in this case. Our adviser did suggest there is no guidance or enough scientific evidence on which embolisation material is better in varicocele embolisation, something the CIRSE Standards of Practice does acknowledge.

32. Our adviser considered the position by which the Trust had inserted the coil into Mr O’s vein, they suggested one of the coils was deployed close to but not below the level of the left inguinal ligament (a ligament in the groin). They stated this is common practice of varicocele embolisation, as it is traditionally believed that coils below the inguinal ligament are more commonly felt by patients and can cause discomfort.

33. The adviser said one of the coils was deployed close to but still at a safe distance from the left renal vein (a blood vessel that carries blood from the left kidney). The adviser recognised this position was chosen to also block a smaller collateral vein running parallel to and joining the main left gonadal vein (a blood vessel that carries blood from the testes) at this level. They said this was an appropriate coil position.

34. The number and length of coils in between were well spaced out and not packed too tightly within the vein. Our adviser explained it is commonly believed that tightly packed coils could cause more symptoms after embolisation. However, there is no specific guidance on how many coils should be deployed within the gonadal vein for varicocele embolisation.

35. We appreciate Mr O’s concerns about how the procedure was performed given the significant pain he experienced in the time that followed the embolisation. We hope our consideration of his complaint can help to reassure him the Trust performed the procedure as would be expected and we have seen no indication his complications were due to failings in the surgery. We do not underestimate how challenging this experience must have been for Mr O and how it may be disappointing to still be unaware of the cause of his pain symptoms.

36. We have found the Trust performed the coil embolisation appropriately and in line with common practice. As such, we will not be taking this complaint any further.

1. We have carefully considered Mr O’s complaint about the Trust. We are sorry to hear about the very difficult time Mr O has clearly experienced. We would like to thank Mr O for sharing the details of his concerns, as we know this may have been distressing for him.

2. Having considered Mr O’s complaint, we have seen the Trust acted in line with standard practice when informing Mr O about the potential risks of his coil embolisation procedure and how its radiologists performed it.

3. We recognise Mr O has concerns about the Trust’s actions and what happened caused him significant pain and distress. We do not underestimate how difficult it must have been. We hope our later explanations clearly explain our conclusions on this matter.