Failure to remove infected mesh
25. Mr B complains that during his mesh removal surgery in May 2022, the Trust failed to remove all of the mesh, resulting in his wound not healing for 18 months.
26. In its complaint response, the Trust said it could not identify any errors in the surgery.
27. Due to Mr B’s hernia repair wound not healing and the pain he was experiencing, the Trust decided to perform a mesh removal surgery in May 2022.
28. After this surgery, Mr B’s wound did not heal properly, and he was under the review of vascular and a tissue viability nurse. In August 2023, he underwent further surgery where it is noted there was suspected retained mesh from the previous surgery. The surgeon performed an excision of the wound and his wound healed after this surgery.
29. The surgical case report says infection is a relatively rare complication of inguinal hernial mesh repair and was less than 1% in some studies. It says a mesh removal is the best chance of curing the infection, but it is not without its own complications.
30. The BHS guidance states one adverse event of a hernia repair surgery is chronic post operative pain due to the mesh being infected, and a mesh removal surgery is an option to consider treating this when antibiotics do not work.
31. Our colorectal adviser said mesh infection from a hernia repair surgery is rare. Hernia mesh works by embedding into the tissue surrounding it, with tissue growing through and around the mesh. Our colorectal adviser said due to this, performing a mesh removal is a complicated procedure requiring expert skill to avoid damaging the surrounding tissue.
32. Our colorectal adviser reviewed the operation notes from May 2022 and confirmed the surgeon followed the correct procedure and said the notes suggest due care was taken to minimise damage to the surrounding structures. The note says the mesh was removed entirely. Our colorectal adviser said there was no indication the surgeon could see any mesh left inside by the end of the operation.
33. In his second operation to remove mesh in August 2023, the surgeon removed and marked a piece of tissue to be studied under a microscope to check if it had any mesh fibres.
34. Our colorectal adviser said this suggests there was no visible mesh left behind in May 2022, but there were possibly microscopic fibres of mesh embedded into the surrounding tissue which would not be visible to the human eye. Our colorectal adviser did not see any evidence of surgical error by the Trust in May 2022.
35. The surgical guidance say surgeons should carry out surgical procedures in a timely, safe and competent manner and ensure they follow current clinical guidelines in their field.
36. As we have not seen evidence of surgical error, we found the surgeon acted in line with the surgical guidance by providing the appropriate surgical treatment in a safe and competent manner in May 2022.
37. We found the surgery in May 2022 was carried out appropriately. We do recognise that, based on the surgical notes in August 2023, there may have been some retained mesh. However, as it is likely this was microscopic, we did not find this meant that the surgery in May 2022 was conducted inappropriately.
38. We have found the surgeon followed the correct surgical technique in line with the surgical guidance, and we have not found any failings with the surgery.
Failure to diagnose and treat his mesh removal wound for 18 months
39. Mr B complains about the Trust’s failure to identify the cause of his infection in a timely manner.
40. After Mr B’s mesh removal surgery in May 2022, his wound did not heal. He spent 18 months with recurrent wound infections, he had to have a wound vacuum pack (a vacuum pump used to promote wound healing), wound debridement (removal of infected tissue), and antibiotics, in the Trust’s attempt to treat his recurrent wound infections.
41. Between September 2022 and November 2022, Mr B was being treated by the tissue viability nurse.
42. In October 2022, he was prescribed steroids for management of possible pyoderma gangrenosum. In March 2023, the Trust decided to close his wound following him being treated with a vacuum pack. In June 2023, the Trust confirmed he did not have pyoderma gangrenosum.
43. In August 2023, due to Mr B’s wound not healing, the Trust decided to undergo a further operation, where there was suspected retained mesh found.
44. Our colorectal adviser said the Trust were treating Mr B with the presumption that all mesh had been removed in May 2022, and it was expected that the wound would eventually heal without further surgery.
45. They also said a wound is usually considered chronic if it is not healing after three months.
46. The NICE surgical site guidance says when a surgical site infection is suspected by the presence of cellulitis, either by new infection or an infection caused by treatment failure, give the patient an antibiotic that covers the likely causative organisms.
47. After Mr B’s surgery in May 2022, the Trust treated his wound infection with antibiotics, as well as dressing changes every two days. This is in line with the above NICE guidance for treating an infected wound.
48. The NICE surgical site guidance says to use a specialist wound care service to manage surgical wounds.
49. Between June 2022 and July 2022, Mr B’s wound deteriorated. The Trust referred him to the vascular department under the care of a tissue viability nurse, which is in line with the NICE surgical site guidance.
50. In September 2022, Mr B was treated in hospital with debridement, and with a wound vacuum pack. This then changed to wound packing.
51. In October 2022, the tissue viability nurse requested a dermatology review, suspecting pyoderma gangrenosum. The dermatologist prescribed steroids for the possible treatment of pyoderma gangrenosum.
52. The notes suggest his groin wound was well controlled and was healing well, with the tissue viability nurse saying there was no evidence of infection. In October 2022, the Trust performed an MRI to look for any signs of residual mesh, but no residual mesh was noted.
53. As Mr B’s wound was significantly improving and there was no evidence of residual mesh in the MRI, the Trust proposed a 3 month follow up and discharged him.
54. Our colorectal adviser said this was appropriate given there was improvement. They said if the wound is healing slowly, it would be appropriate to persist with conservative measures. They said reopening the wound would be a careful clinical decision, given there is no guarantee that further surgery will improve the wound, and it would undo any progress the wound has made at healing.
55. The GMC guidance say in providing good clinical care, a clinician must provide effective treatments based on the best available evidence.
56. We found the Trust acted in line with this by relying on the evidence it had at the time that Mr B’s wound was healing slowly, and a possibility of pyoderma gangrenosum, and deciding to monitor the wound.
57. Mr B’s wound began bleeding, and he was admitted to hospital again in March 2023. Dermatology considered the wound consistent with pyoderma gangrenosum and continued steroid treatment.
58. According to the BAD advice, pyoderma gangrenosum can develop in a surgical wound which causes an ulcer, with the edge of the ulcer looking purple. It says there is unfortunately no single test for pyoderma gangrenosum which is why patients remain under follow up care by dermatology, as Mr B did.
59. In June 2023, following another round of steroid treatment not working, the Trust ruled out pyoderma gangrenosum.
60. The NICE chronic wound guidance recommends using dressings containing silver to be used when symptoms of infection are present in the wound. In June 2023, the Trust treated Mr B with Aquacel (a dressing containing silver), in line with this guidance.
61. His wound was noted to be improving, with no smell and healthy granulation tissue (new tissue developing in the wound bed). On this basis, the Trust felt further surgery was not appropriate and to review him again in six weeks.
62. By the end of July 2023, Mr B’s wound showed signs of worsening. He had bleeding and an offensive smell. He was admitted to hospital, and the Trust decided to reopen the wound.
63. Our colorectal adviser said a decision and timing of reoperation is complex and unique to the clinical progress of the patient. In this case, Mr B’s wound had periods of significant healing, and his wound was consistent with pyoderma gangrenosum, and it was appropriate to follow the advice from dermatology first.
64. The GMC guidance says a clinician should promptly provide or arrange suitable advice, investigations or treatment where necessary. It also said they should refer a patient to another practitioner when this serves the patient’s needs.
65. We have found the Trust appropriately investigated Mr B’s wound and referred him to relevant practitioners in line with the GMC guidance. The Trust carried out an MRI to check for suspected mesh and considered other possible causes for his wound not healing well by involving dermatology.
66. The decision to reopen the wound is a complex clinical decision, and there is no timeframe set out by guidance on when to do this. The Trust felt all the mesh had been removed, so it did not have a reason to reopen the wound earlier. We also recognise Mr B’s wound showed signs of significant healing during this 18-month period, and it was reasonable for the Trust to allow the wound to continue healing.
67. We are very sorry Mr B suffered with an open wound for such a long time. We recognise this is a long period, and why he questioned if his surgery should have been done sooner. We have not seen any evidence of an unnecessary delay, and we think the Trust arranged for suitable investigations into why his wound was not healing. We have not found a failing in this aspect of the complaint.
Failure to treat the infection in his testicles
68. Mr B complains the Trust failed to appropriately treat the infection in his testicles. He says the Trust waited too long, and as a result he had to get his testicle removed, and it also spread to his other testicle.
69. In its complaint response, the Trust said there has likely been some nerve damage that has affected his bladder, which is a known risk of surgery.
70. After Mr B’s mesh removal surgery in May 2022, he was unable to pass urine and was referred to urology. He had a suprapubic catheter put in place.
71. In June 2022, Mr B was admitted to the Trust complaining of right testicular pain. The Trust performed a urine dip which was positive for blood and leucocytes (infection in the urinary tract). The Trust suspected epididymo-orchitis ((inflammation of the testicle, usually due to infection). He was prescribed antibiotics and improved in hospital. He was discharged with antibiotics and pain relief to continue at home.
72. In September 2022, while in hospital for his groin wound, he complained of testicular pain. The Trust performed a testicular and scrotal ultrasound which showed a small cyst, and inflammation of the scrotal skin. The Trust suspected he had epididymo-orchitis.
73. The Trust arranged him for follow up as an outpatient under urology to monitor his catheter and epididymo-orchitis.
74. In May 2023, The Trust performed a urodynamic procedure (tests to assess how well the bladder functions). This indicated he had an atonic bladder (a condition where the bladder muscles cannot contract fully, leading to difficulties in urination).
75. In June 2023, he had a right scrotal abscess and had a surgical procedure to remove this.
76. Urology wanted to perform sacral nerve stimulation (an implant sending electrical impulses to treat his bladder), but until his mesh removal wound healed, this was not possible.
77. In August 2023, while in hospital to treat his wound, he developed right testicular pain and was discharged with antibiotics for right epididymo-orchitis.
78. In September 2023, he complained of testicular swelling and pain. The notes say on examination it looked fine, but urology requested an ultrasound of the testicle.
79. He had an ultrasound of his testicles in September 2023 and October 2023, which showed no signs of acute epididymo-orchitis. He was discharged.
80. In late October 2023, he had a follow up review with urology. They identified he had a very tender right scrotum and noted that despite multiple courses of treatment he kept having recurrent testicular pain and recurrent inflammation and infection.
81. The Trust decided an epididymectomy (a surgery to remove the duct behind the testicle) would be the next option to prevent recurrent infections going forward. The Trust advised there was a possibility of an orchidectomy (surgery to remove a testicle) as a risk of this surgery.
82. In January 2024, the Trust operated on Mr B. The consultant was unable to remove the epididymis due to thickened tissue between the testis and the epididymis. The consultant performed an orchidectomy instead, discussing this with Mr B during the procedure, as he was under spinal anaesthetic and kept awake.
83. Following his right orchidectomy, he remained under urology care and suffered with further recurrent infections in his left testicle. To date, he remains under the care of urology to treat his epididymo-orchitis in his left testicle.
84. The surgical case report says mesh removal can sometimes cause injury to the testicles, but an infection leading to an orchidectomy is a rare complication.
85. Our urology adviser said Mr B’s clinical presentation was unusual. They said epididymo-orchitis is a common condition, but the recurrent and persistent nature of his symptoms, along with his chronic and unhealing groin wound, made this unusual.
86. The BASHH guidance says acute epididymo-orchitis is a condition resulting from either infectious or non-infectious disease, commonly spreading from either sexually transmitted diseases or the urinary diseases from the bladder.
87. The EUS guidance recommends an ultrasound as the gold standard for evaluating scrotal disease. It says conservative treatment including antibiotics, anti-inflammatory agents, and pain medication should be used before considering surgical treatment.
88. The BASHH guidance recommend antibiotic treatment for acute epididymo-orchitis. It says in 80% of cases, swelling and tenderness should completely resolve within three months of antibiotic treatment. If there is little improvement, further investigation or surgical assessment can be considered.
89. In line with the BASH guidance and the EUS guidance, the Trust performed an ultrasound, and Mr B was treated with antibiotics and pain relief, which temporarily improved his epididymo-orchitis.
90. Our urology adviser said the Trust investigated Mr B and treated him with antibiotics as set out by the above guidance. They also said given he developed scrotal symptoms shortly after the mesh removal operation, a chronic wound infection could explain his symptoms, and it was appropriate to wait for this to be treated first.
91. The GMC guidance says in providing clinical care, a clinician must prescribe drugs or treatment, including repeat prescriptions, only when they have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serves the patient’s needs.
92. Our urology adviser said there is not enough evidence comparing surgical treatment, and an orchidectomy is not standard treatment for epididymo-orchitis. They said the source of the recurrent infections was not clear, and it was appropriate for the Trust to wait for the groin wound to heal and treat him conservatively with antibiotics first. They said an orchidectomy was appropriately only offered as a last resort, as it is not supported as standard treatment for epididymo-orchitis.
93. We have found the Trust acted in line with the GMC guidance by only offering an orchidectomy when it was satisfied it had attempted all other possible treatments first. There are currently no national guidelines covering an orchidectomy as treatment for epididymo-orchitis, and our urology adviser said surgery is considered the last option.
94. We have not found a failing with how the Trust treated Mr B’s epididymo-orchitis. We are sorry Mr B suffered in pain. Recurrent infection is rare, and antibiotic treatment is the standard treatment for epididymo-orchitis. An orchidectomy is not standard treatment and it was appropriate for the Trust to not consider this option earlier. We do not consider this a failing by the Trust.
STD testing and misdiagnosis of gonorrhoea, and a referral to psychiatry
95. Mr B complains that in October 2024, during the Trust’s investigation into his left epididymo-orchitis, it inappropriately performed repeated STD (sexually transmitted disease) testing and referred him to psychiatry.
96. He said the Trust was aware he was not sexually active, so he was put through painful STD testing unnecessarily. He said the Trust suspecting he had as Munchausen syndrome (now known as factitious disorder, where one deliberately makes themselves ill to gain attention) was inappropriate given his complex medical history.
97. In October 2023 and June 2024, Mr B advised the Trust he was not sexually active as it was severely painful.
98. In October 2024, Mr B was admitted to hospital with left testicular pain. He confirmed he was not in a relationship, and he had not been sexually active in the last 3 months.
99. In October 2024, urology made a referral to microbiology, as Mr B’s scrotum was not improving and it suspected cellulitis (a bacterial skin infection).
100. Microbiology advised in males under 35 years old, the most common bacterial cause of epididymo-orchitis are chlamydia and gonorrhoea. They requested further STD tests be undertaken and then to refer him back to microbiology.
101. The EUS guidance says in patients with epididymo-orchitis, STDs should be screened for all patients with a sexual history or signs of urethritis suggesting STDS.
102. The BASHH guidance says a sexually transmitted cause for epididymo-orchitis should always be excluded during investigations.
103. Our urology adviser said STD screening was appropriate, as STDs can be present undiagnosed for a significant time, and it is recommended by guidance to rule this out. They said his recurrent infection was unusual, and the Trust carried out appropriate investigations into this, including STD testing.
104. Mr B also complains the Trust misdiagnosed him with gonorrhoea in October 2024. We reviewed his records, and we have not seen evidence of a positive test for gonorrhoea or of a diagnosis of gonorrhoea being made during his admission. The records also confirm he had a negative test result. We have not found the Trust misdiagnosed him with gonorrhoea.
105. We have found no failing by the Trust in performing STD screening in October 2024. We recognise Mr B feels this was unnecessary. Unfortunately, due to his recurrent infections, it was appropriate and in line with the above guidance for the Trust to rule out this common cause for testicular infection.
106. In late October 2024, Mr B’s ultrasound was normal, suggesting cellulitis on the testicular skin. His blood tests were worsening, with a high white blood cell count, and high c-reactive protein, which suggests inflammation and infection despite antibiotic treatment. He also had increasing symptoms of pain. The Trust referred him to psychiatry to consider a psychological cause for his new symptoms.
107. He was reviewed by psychiatry, who did not find he had health anxiety, or factitious disorder. They suggested he may have chronic pain.
108. Our urology adviser said due to the chronic and recurrent nature of Mr B’s symptoms, and his struggle with wound healing, despite being otherwise fit, it was appropriate to consider if there was a psychological cause for this.
109. The GMC guidance says a clinician must promptly provide or arrange suitable advice, investigations or treatment where necessary.
110. We have found the Trust acted in line with the GMC guidance by arranging a psychiatry review. The Trust explored all other causes for Mr B’s recurrent infection prior to obtaining a psychiatry review. This review formed one part of the Trust’s investigation into Mr B’s symptoms, and it did not lead to a diagnosis. We do not consider this a failing.
111. We are sorry Mr B was upset by the additional STD testing and referral to psychiatry. We do understand how distressing this must have been given how unwell he was. We think the Trust’s investigations were appropriate in the absence of a clear explanation for his symptoms to try to find the cause of his recurrent infections. We do not consider these investigations a failing by the Trust.
112. We are very sorry to hear how Mr B has struggled with complications since his surgery in 2021, and we recognise the life changing impact this has had. We understand how distressing this experience has been for him throughout, and why he brought his complaint to us. We have not found that anything has gone wrong in his care, and we are not upholding his complaint. This decision does not take away from the impact he has experienced.