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| ORIGINAL ARTICLE |
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| Year : 2019 | Volume
: 2
| Issue : 3 | Page : 105-113 |
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Medico-legal implications in hernia surgery
Reinhard Bittner
Department of Hospital Surgery, Sechenov University, Moscow, Russia; Department of Surgery, Marienhospital Stuttgart, Stuttgart, Germany
| Date of Submission | 14-Jul-2019 |
| Date of Acceptance | 15-Jul-2019 |
| Date of Web Publication | 30-Aug-2019 |
Correspondence Address:
Dr. Reinhard Bittner
Supperstr. 19, 70565 Stuttgart
 Source of Support: None, Conflict of Interest: None  | 4 |
DOI: 10.4103/ijawhs.ijawhs_27_19
AIM: Litigation is always a severe burden for every surgeon who is involved. The study aims to show the most important reasons for an allegation and how to prevent a lawsuit.
METHODS: Based on the own experience as a medical advisor, ten medico-legal cases are analyzed and a systematic overview of the corresponding literature is given.
RESULTS: Allegation for malpractice is not very frequent; in hernia surgery, <1% of the patients are involved. Furthermore, only in 20%–40% of these cases, the decision is in favor of the claimant. However, every case is associated with compensation ranging from roughly between $19,000 and $8,000,000. Totally the author had to perform 10 reports in legal cases for the court: In three cases, compensation had been refused, because informed consent had correctly been done, and the operative situs was clearly documented, and in the third case, the preoperative diagnostics and the operative performance had been according to the medical standard. The claim was successful in three patients because of technical failure, in two cases because of wrong indication, and in two cases because of delayed reoperation.
DISCUSSION: There are five key features in the prevention of a lawsuit in surgery: (1) “informed consent:” Take the time, use a standard form, show pictures and make handwritten notes to explain in detail the indication for surgery, the technical performance of the planned intervention, and the steps of aftercare; (2) “technical performance” of the operation should follow the generally accepted medical standard. Deep knowledge of anatomy is an indispensable precondition of perfect operation; (3) a “delay in timely response” to a complication is not excusable; (4) “careful documentation” of all steps of the treatment may possibly avoid a legal case; and (5) “establishing an empathic relationship” between the surgeon and the patient and his/her relatives as well is essential for avoiding an accusation.
CONCLUSION: Medico-legal implications in hernia surgery are rare, but a severe burden for every surgeon concerned and may be associated with damage to the reputation of the surgeon and high costs. The best ways of preventing such a disaster are the correct indications and operative performance according to the current medical standard and empathic aftercare.
Keywords: Complications, endoscopic hernia repair, hernia repair, inguinal hernia repair, laparoscopic hernia repair, lawsuits, litigation, malpractice, medico-legal aspects
How to cite this article:
Bittner R. Medico-legal implications in hernia surgery. Int J Abdom Wall Hernia Surg 2019;2:105-13 |
| Introduction | |  |
Complications during and after surgical interventions may happen; however, in most of the cases, they are not caused by malpractice. On the other hand, malpractice does not inevitably lead to a litigation case. Some patients who are not satisfied with their surgical treatment claim for compensation of their suffering due to complicated course. Fortunately, in many cases, these claims are not justified, but the differentiation between a complication which can happen and a treatment failure may be difficult. Anyway, a litigation case is always a severe burden for a surgeon who is accused.
The aim of the present study is to analyze several legal cases, to advise how to avoid this burden, and to review the literature accordingly.
| Methods | | |
The study is based on the experience of the author as a Medical Advisor for the Court and the Conciliation and Compensation Commission of the German Medical Association in ten cases of patient claims. For review of the literature, a PubMed research was done using the following research terms: “litigation AND hernia repair,” “malpractice AND hernia repair,” “litigation AND laparoscopic hernia repair,” “litigation AND open hernia repair,” “malpractice AND laparoscopic hernia repair,” “malpractice AND open hernia repair,” “mishaps AND hernia repair,” and “mistakes AND hernia repair.”
Using these search terms, a total of 280 hits were found; however, due to double mentioning, non-English language, or not related to the topic of this study, only 32 publications seemed to be useful.
| Results | | |
Case reports
Case
A 49-year-old male patient was admitted in the department for general and visceral surgery for repair of a right-sided scrotal inguinal hernia. The surgical approach was by transabdominal preperitoneal patch plasty (TAPP). After establishing the pneumoperitoneum and the first laparoscopic view to the groin, the diagnosis “scrotal hernia” could be confirmed. Furthermore, the operating surgeon found extensive adhesions between the large hernia sac and the omentum, respectively, the small bowel. After introducing the working trocars, an operator describes in his report a meticulous detachment of all these adhesions. A lesion to the bowel did not happen according to this report. During the following days, the patient complained of some unusual severe pain in the region of the right lower abdomen and of the flank. Therefore, he was kept in the hospital for observation. At the 3rd day, after the operation, because of increasing right-sided pain, a urologist was consulted who recommended a computed tomographic (CT) scan. In the CT scan, an inflammatory mass in the right lower abdomen/flank was suspected. Despite increasing signs of sepsis not before 2 more days later, the patient was reoperated: intraoperatively, two lesions to the small bowel and fecal peritonitis were found. During the operation, resuscitation because of a septic shock was necessary. A hemicolectomy was done and the abdominal cavity was lavaged. One day later, the patient died.
Take home message
- An adhesiolysis of some hernia content from the hernia sac is unnecessary and carries the risk of an injury to the hernia content. In the case you find severe adhesions between the hernia content and the peritoneum, it is advisable not to try adhesiolysis, but start the operation as usual, dissect the preperitoneal space, expose the hernia ring, incise the ring and reduce the sac inclusive the hernia content “en bloc”.
- In case of unusual pain, do not wait such a long time, do a relaparoscopy, and you will find the reason and can repair in time and avoid a septic course. A relaparoscopy is not a severe burden for the patient, you can use the old openings, and you can do it even in the bed of the patient on the intensive care unit. However, the real severe mistake, in this case, was that the urologist found in the CT scan suspicion of an abscess formation, but the surgeon operated not before 2 days later. In the litigation process, the surgeon was found guilty and had to pay compensation to the relatives of the patient. Reason for being guilty was delay in treatment of the complication.
Case
A 46-year-old male patient was admitted in the hospital because of a bilateral inguinal hernia. He was treated by TAPP. The meshes were fixed by fibrin glue. Operation and early postoperative course were uncomplicated. However, 8 days later, a recurrence was detected on the right side. Re-TAPP was done. Intraoperatively, a direct recurrence was found because of dislocation of the mesh toward the right lateral compartment. Removal of the primary implanted mesh was not possible; therefore, the surgeon implanted a second mesh; however, this time, he fixed the mesh with tacks. At the evening after the operation and the next day, the patient suffered from urinary retention and gross hematuria. He was treated with a Foley catheter for 24 h. After ceasing of the hematuria, the catheter was removed, and the patient dismissed at home. Three months later, when the patient was jogging the hematuria recurred. Now, he visited a urologist. The urologist performed a cystoscopy which showed a foreign body penetrating the wall of the urinary bladder [Figure 1]. In the following operation, the urologist resected that part of the bladder containing the foreign body. The pathologic-histologic investigation of the specimen revealed a section of the wall of the urinary bladder, in which parts of a mesh with metallic tacks were incorporated. The postoperative course was uncomplicated, but the patient claimed for compensation. The Court accepted his claim.
Take home message
Use of glue is an excellent technique for mesh fixation; however, for a sustainable success, a complete dissection of the groin is required starting at the spina iliaca anterior superior (Spina iliaca ant. sup.) and ending about 1–2 cm beyond the symphysis at the contralateral side. In the case of bilateral hernia, there should be an overlapping of both meshes in the midline. Pubic bone and rectus muscle must be clearly exposed; only in this case, the mesh can safely be fixed to these structures even with tacks. In his operating report, the surgeon does not describe the view neither of the mesh which was implanted on the contralateral side nor the view of the midline constituting by the rectus muscle and the symphysis. We concluded the technical failure of the surgeon, i.e., the surgeon had missed the right plane and fixed the mesh to the urinary bladder.
Case
A 53-year-old male patient was admitted in a surgical unit because of an umbilical and an epigastric Hernia. Intraoperatively, the surgeon cut the bridge between the two hernia openings. This resulted in a fascial defect in the midline of 5–6 cm. Although the surgeon describes a very thin fascia and a concomitant rectus diastasis, he closed the defect by suture according to Mayo. Already 2 months later, a large recurrence was observed and the patient was reoperated. This time a mesh was implanted; however, the size of the mesh was not documented. One year later, a third operation because of a second recurrence was performed. Intraoperatively, a defect of 2.2 cm × 1.3 cm was detected and again closed with a mesh. According to the report of the Medical Advisor of the Compensation Commission of the German Medical Association, the patients claim for compensation was justified.
Take home message
According to multiple comparative studies and the data from registries, it is recommended to implant a mesh in primary ventral hernias except in cases the umbilical hernia is very small (diameter < 1–2 cm) and occurs within the midline of a dense linea alba of a quite normal stabile abdominal wall. Furthermore, one study could demonstrate a very high recurrence rate in patients presenting with a hernia in the midline and a concomitant rectus diastasis, but the implanted mesh was not large enough to stabilize the whole midline.[1] The surgeon was convicted to pay compensation because his performance was not adequate to the clinical standard at that time.
Case
A 63-year-old female patient was submitted to the hospital because of a recurrence nearly 2 years after open sublay repair of an incisional ventral hernia in the midline. By ultrasound, a hernia defect of 3.5 cm × 4 cm was described. A laparoscopic repair using the IPOM technique was planned. Intraoperatively, extensive adhesions were found which had to be detached from the abdominal wall inclusive of the hernia defect for implantation of the onlay mesh. During adhesiolysis, two lesions to the transverse colon had to be overstitched what according to the operation report could be done safely. The immediate postoperative course was uneventful; however, already the next day, the patient complained of severe abdominal pain and nausea which persisted for the following days. Not at least due to the demanding of the relatives of the patient, a reoperation was done not before the 3rd postoperative day. During the interval between the operation and the reoperation, no description of an investigation of the abdomen can be found in the medical record. During the first reoperation, two openings of the small bowel (ileum) were found and a severe fecal peritonitis was also found. A resection of the part of the injured ileum and a lavage of the abdominal cavity were done. Again, the postoperative course was complicated; no control of the septic process was possible despite a total of 18 revisional operations. Remarkable eight surgeons were involved and 12 of the reoperation were done during emergency time. At the end, the patient died 53 days after the primary operation. The Medical Advisor agreed to the claim of the relatives and requested compensation, because an adequate postoperative care had not been provided by the surgeon.
Take home message
Injuries to the bowel during an adhesiolysis may happen; every surgeon has to be aware of this complication. However, this complication becomes a litigation case, if the surgeon does not react adequately according to the medical standard. Keep in mind, all aberrations from normal postoperative course must be carefully documented, and the reoperation has to be in time. Revisional operations are the most difficult in surgery; they must be done by the most experienced surgeon during the prime operation time and not during duty time by the surgeon on call.
Case
A 43-year-old male patient was admitted because of a painful right-sided recurrent inguinal hernia after an open repair (Lichtenstein) 4 years ago. The surgeon performed a laparoscopic reoperation (TAPP). Intraoperatively, he found very dense adhesions between the vas deferens and the hernia sac. During parietalization of the hernia sac and taking down these adhesions, the Ascalenia spermatica was damaged. When attempting to control the bleeding, a thermic lesion to the vas did happen. Apart from that, the further operation ran uncomplicated. Immediately, after the operation, the patient was informed of the complication which had happened. Moreover, a urologist was consulted. The urologist found a swollen right scrotum, but the testis showed still some perfusion. Two months later, ultrasound showed homogeneous parenchyma with normal perfusion of both of the testes. Nevertheless, the patient claimed for compensation.
Take home message
Damage to the testicular vessels is a well-known complication in inguinal hernia repair and may result in painful orchitis and atrophy of the testes in the latter course. Therefore, it is extremely important to get preoperatively the informed consent of the patient, document the clinical evidence, and talk to the patient postoperatively. The surgeon had done all these requirements; moreover, the testes recovered completely. The claim of the patient was refused.
Case
During a postoperative routine check after an orthopedic operation of his shoulder, a 55-year-old male patient complained of some numbness at the lateral/proximal part of the skin of the right thigh when remaining in an upright position for a longer time. The patient was transferred to a general surgeon who diagnosed a “17-mm” inguinal hernia by ultrasound. Furthermore, corresponding to the complaints of the patient, he suspected a meralgia paresthetica and admitted the patient to a hospital for hernia repair. A Lichtenstein repair was performed but unfortunately not by the surgeon who had admitted the patient. Intraoperatively, no hernia sac was found but lipoma at atypical location. Lipoma was removed, and because of the complaints, a neurectomy of the N. ileo-inguinalis (ilioinguinal nerve) was performed. Postoperatively, the patient reported not only persistent numbness at the thigh but now also in the inguinal region. He complained of problems when shaving this region and during sexual activities.
Take home message
Meralgia paresthetica was described for the first time by Bernhardt in 1895[2] and is caused exclusively by a compression of the nervus cutaneous femoris lateralis (N. cut. fem. lat) [Figure 2] when perforating the muscles of the abdominal wall. Maybe, the operating surgeon was not well informed, and therefore, he had mismatched the nerves. Without deep knowledge of the course of the nerves and their manifold variations, a safe inguinal hernia repair is not possible neither openly nor laparoscopically.[3] Furthermore, keep in mind, do not operate on a patient presenting with a small hernia but complaining about unusual severe pain (>visual analog score [VAS] 3) or about pain located to an atypical region. The decision of the Medical Advisor is that the surgeon had to pay compensation because of not indicated hernia operation with resection of the N. ileo-inguinalis.
Case
A 50-year-old male patient was operated on because of a bilateral inguinal hernia. The operative technique was TAPP. The peritoneal incision was closed by running sutures. Operation and early postoperative course were uncomplicated. However, 19 days later, the patient was readmitted as an emergency case. The diagnostics showed an incomplete small bowel ileus. Immediately after admission and finishing the diagnostics, the patient was reoperated by open approach. Intraoperatively, incarceration of a loop of the small bowel into a small defect in the peritoneal suture line was found. The bowel was reduced and recovered rapidly. The defect in the suture line was closed by suture again. The postoperative course was uneventful.
Take home message
In the literature, there are many cases reported presenting with ileus due to incarceration of small bowel into a defect within the insufficiently closed peritoneal suture line. A defect size of 1 cm is enough to cause this life-threatening complication. A carefully done tight closure best by running suture without any gap is essential to avoid this mishap. Fortunately, the surgeon had photo-documented the groin after peritoneal suture showing a tight closure; therefore, the claim of the patient for compensation was refused. Keep in mind, careful documentation of all treatment data is the best way to avoid a lawsuit.
Case
A 37-year-old male patient visited an orthopedic surgeon because of pain in the right groin which had been persisting for >6 months. As clinically no significant pathology was found, the orthopedic specialist ordered an MRT which showed “a hernia defect with protrusion of fatty tissue into the inguinal canal.” According to this MRT finding, the patient was submitted to a general surgeon who performed a laparoscopic hernia repair (TAPP). Intraoperatively, a very small right-sided indirect hernia was found. The implanted light-weight mesh was fixed by absorbable tacks. The day after the operation, the patient was dismissed at home without any complaints; however, a few days later, the pain occurred again. Because of this pain, the patient visited, for several times, his surgeon who gave advice and injected a local anesthetic to the groin. Unfortunately, the surgeon did not document his findings and respective treatment. Moreover, he did not charge any money and confessed to the patient that using tacks in his case had been a mistake. Not at least because of the surgeons' confession of some “failure,” the patient was encouraged to claim for compensation. A total of 14 visits to various kinds of specialists followed, inclusively a second MRT which showed an unchanged finding in the groin. A recurrence was diagnosed. In the end, about 10 months after the primary operation, a second surgical intervention because of pain and suspected recurrence was performed with the attempt to remove the mesh. Remarkably, only some parts of the mesh could be removed, but it was a Shouldice operation added. Postoperatively, the complaints persisted.
Take home message
Obviously, the patient complaint of pain in the groin; however, he had no significant hernia, if any, then a very small one which could not be detected clinically. In such cases, MRT may be helpful especially for the detection of other pathologies; however, for diagnosis of a hernia, except the incarcerated, a dynamic MRT must be performed, “dynamic” means during rest and during Valsalva maneuver like it is usually done in ultrasound. The operation was performed according to the medical standard at that time. In the postoperative period, the surgeon did medical care without charging and accused himself in front of the patient not to have used the best fixation technique in the first operation. Keep in mind: (1) Do not operate on a patient complaining about pain in the groin but without proof of a significant hernia; (2) MRT is only helpful when it is performed as a dynamic MRT; (3) always tell honestly the facts to the patients and express your compassion with the patients suffering, but do not accuse yourself or do treatment without documentation or charging. When doing in this way, you may induce a feeling in the patient that something had gone wrong. Because the surgeon had relied on the firm diagnosis of the radiologist, he could not be accused of malpractice and the claim of the patient for compensation was refused.
Case
A 50-year-old male patient was operated laparoscopically (TAPP) because of a right-sided indirect inguinal hernia. The mesh was fixed with clips, and further, the peritoneum was closed with clips. The operation was uncomplicated; however, immediately after the operation, the patient complained about pain in the region of the lateral/proximal part of the thigh. Despite pain management, no improvement was observed; therefore, 3 days after the primary operation, a laparoscopic revision was done. During this operation, the lateral part of the mesh and eight clips were removed. Nevertheless, the pain persisted. After multiple consultations of experts, a ½ year later, he was operated again by a neurosurgeon. An open approach to the preperitoneal space was chosen. Intraoperatively, the neurosurgeon found a clip sticking to the N. cut. fem. lat. The clip was removed as well as parts of the nerve damaged by the clip. After the operation, the condition of the patient improved, but some complaints persisted.
Take home message
In open inguinal hernia repair, most of the risks for an injury are the N. ileo-inguinalis, the nervus hypogastricus and the nervus genitofemoralis (N. genitofemoralis). In laparoscopic inguinal hernia repair, most of the risks are the N. cut. fem. lat. [Figure 2] and N. genito-femoralis. All surgeons who are doing hernia repair must be familiar with the location of these nerves and the multiple variations in their course. Moreover, every surgeon must be familiar with the skin areas the sensitivity is provided by these nerves. Without any doubts, the skin of the lateral part of the thigh is provided by the N. cut. fem. lat. Therefore, in the first revisional operation, the surgeon should have searched for this nerve to identify the reason for the pain and treat the patient accordingly. As the neurosurgeon did not find any mesh in that region he found the nerve, it is suspected that the nerve was damaged when closing the peritoneum by clips near the Spina iliaca ant. sup. and not due to the fixation of the mesh. The partial removal of the mesh inclusive of the eight clips had been unnecessary. The Medical Advisor decided that the surgeon had to pay compensation. Keep in mind, deep knowledge of the anatomy of the groin is an indispensable precondition for uncomplicated operation.
Case
An 81-year-old male patient visited an orthopedic surgeon because of pain in the right groin. He submitted the patient to a well-known hospital for hernia repair; however, the consulted surgeon did not find any hernia. Twelve days later, the patient visited another hospital because of persisting pain. In this hospital, the surgeon diagnosed clinically and by ultrasound an inguinal hernia and performed a laparoscopic repair (TAPP). Intraoperatively, the surgeon reported a right-sided indirect hernia, grade II (defect size <3 cm), according to the EHS classification. In the operation report, there is no hernia sac described, but a cord lipoma only. The lipoma was removed and a 10 cm × 15 cm mesh without fixation implanted. The operation run uncomplicated, but the pain remained and occasionally even increased and reached a VAS of 8–9. He visited the surgeon who had operated on him several times; however, neither clinically nor by ultrasound and dynamic MRT, a recurrence or another cause for the pain was found. The MRT was repeated several days later in another setting. Again, a recurrent hernia could not be confirmed; however, in both investigations, degenerative changes of the hip joint and some liquid within the capsule of the joint were found. Nevertheless, 3 weeks after the first operation, the patient was reoperated in another hospital with the intention to remove the mesh by open approach. However, the surgeon was not able to remove the mesh; instead, incomprehensibly, he implanted a second mesh because of suspicion of a recurrence.
Take home message
This case shows several mistakes which can be done in hernia surgery. The patient complained of pain in the groin, but it was difficult to prove a significant hernia. It is generally accepted that preoperative pain is the most important risk factor for postoperative chronic pain.[4] Furthermore, the small hernia (defect size <1.5 cm [EHS I] and <3 cm [EHS II]) is a significant risk factor as well.[5] Therefore, a comprehensive diagnostic is necessary to exclude other reasons for pain before a hernia repair is performed. In addition, it is important to know that in hernia patients, pain scores higher than VAS 3 are highly suspicious for another disease. However, in patients who quite clear present with a hernia in combination with unusual severe pain, besides hernia repair, search for other causes for pain and special psychologic assistance is necessary. Again keep in mind, do not do a hernia repair in patients having no hernia (difficult to diagnose) or a small hernia only but presenting with unusual severe pain.
Litigation cases in hernia repair in Germany
In 2018, in the German hospitals and in medical praxis outside the hospitals, a total of 19.5 million patients were treated. Of this number, 5972 alleged malpractice cases (0.03%) were settled; however, only in 1499 cases (25%), compensation was accepted. In most of these cases, the patients recovered completely, but in 482 patients (0.0024%), the damage was minor or moderate permanent, and in only 127 cases (0.00065%), the damage was severe and permanent. Eighty-eight patients (0.00044%) died because of malpractice. Mostly, orthopedic/trauma patients were affected (2092 cases), 816 patients treated in general surgery, and 684 cases in internal medicine. In total, since 2014, the claims were decreasing by 11% from 12,053 in that year down to 10,839 in 2018.[6] In hernia surgery, the data are quite similar; in 23.2% of claims, compensation was accepted. The Conciliation and Compensation Commission found malpractice in only 0.007% of the cases. The Commission decided that in four cases, the operative technique were not adequate to the current medical standard; in three cases, the indication for surgery was wrong, in 2 cases a foreign body was left in the wound; and in one patient, there was insufficient postoperative care. In the region around Stuttgart in 2006, there were six claims registered: three in open and three in laparoscopic hernia repair. In laparoscopic repair, the reasons for claim were twice small bowel lesions, and in one patient with bilateral hernia, only one side was operated on. In open surgery, the reasons were in two cases of atrophy of testes and one case with chronic pain. Interestingly, only the patient with the bilateral hernia received compensation.
Litigation cases – Review of the literature
In general, the review of the literature shows similar results like in Germany, but there are also some national peculiarities. Of the 32 publications mentioned above, only 19 presented precise data regarding litigation or informed consent practice. Interestingly, nearly half of the papers, namely seven,[7] came from the UK, three from the USA, two from Sweden, two from Finland, and each from Germany, France, Nigeria, and Singapore.
Comparable to Germany, the overall frequency of litigation is low. A recent publication from the UK analyzed the cases of the Westlaw database, which were registered between 1991 and 2016. Forty-six cases met the selection criteria and were included for the review. The most frequent legal argument was improper performance (n = 35, 76%), followed by failure of informed consent (n = 14, 30%). The most common complications were nerve/chronic pain (n = 20, 45%) and testicular damage (n = 10, 23%). Successful litigation after inguinal hernia surgery was relatively infrequent – only 21.7% – with an additional 10.9% resulting in settlement awards.[8]
An earlier paper analyzed the data from the NHS Litigation Authority about all claims made between 1995 and 2009. In total, 398 claims were made. Of these, 209 cases had been settled, of which 144 (46.6%) were in favor of the claimant to a cost of 7.35 million GBP/12 million USD/7.93 million Euros. Testicular injury and chronic pain featured in 40% of all claims. Visceral injuries and injuries requiring corrective procedures were the only predictors of a successful claim (P = 0.015 and P= 0.002, respectively). Claims associated with visceral and vascular injuries were more likely to occur in laparoscopic than in open repairs. Sexual dysfunction and chronic pain resulted in the highest average payouts of 85,467 GBP/140,565 USD/92,177 Euros and 81,288 GBP/133,693 USD/87,674 Euros, respectively. In detail, in 76.8%, the reason for claim was some kind of intraoperative error; in 17.6% delay in recognition of the complication; in 14.4%, substandard in postoperative care; and in 13.1%, not sufficiently done inform consent.[7] Another study from the NHS Litigation Authority, which covered 2002–2007, revealed a total of 223 claims following inguinal hernia repair.[9] Out of the 159 cases which were closed at the time of that analysis most frequently the patients claimed because of ischemic orchitis in 35 cases (22%). In 21 cases (13.2%), the reason was visceral injury; in 19 cases (12%), operative failure; and in 17 cases (10.6%), infection. Successful litigation was in 64 cases (40%). Interestingly, 13 patients based their claim exclusively on “failure to be warned on the potential complications of the procedure.” Consequentially, there are five papers from the UK,[10],[11],[12],[13],[14] one paper each from Germany,[15] one from the USA,[16] and one from Singapore[17] dealing with the problem how to improve informed consent and documentation. Hard to believe, but the study from Germany in 55 patients showed in a reevaluation questionnaire after informed consent had been performed that 45.3% of the patients could not even recall a single mentioned complication and only 18.2% were able to mention two or more complications. A similar result was reported by the study from the UK; Uzzaman et al.[10] have published. A recall in 86 patients revealed that only two patients (2.3%) had been aware of developing chronic pain and only ten patients (11.5%) realized the potential for testicular problems. However, in another study, it is reported that the consenting surgeons had recorded the risk for bleeding and infection in 100% of the patients, but serious complications such as chronic pain, testicular complications, and visceral injuries were poorly accounted in only 14%, 45.3%, and 52.1%, respectively. Moreover, special emphasis is necessary when consenting elderly patients. Chia et al.[17] showed that 26.7% of elderly patients (>65 years) claimed that they did not understand the indication for surgery. In summary, informed consent is a key feature in perioperative management; therefore, there is an urgent need for standardized forms to achieve consistency and effectiveness of the consenting practice. In countries already using such kind of forms, it is advisable for better understanding of the patients to add some pictures and some handwritten comments.
In Finland, the situation is in some way different because the Finnish National Patient Insurance Center handles financial compensation for patients' injuries without proof of malpractice. During the study years (2003–2010), 25,738 ventral hernia operations were performed, and 127 claims from the whole country were reported to the Patient Insurance Centre. The overall rate of claims was 4.9/1000 hernia procedures. For primary hernias(16,243 operations), 41 claims (0.25%) were reported. The most common complication was infection (n = 28, 68%) followed by pain and hernia recurrence (n = 6, 15% in both). In incisional hernioplasties (9495 operations), 86 claims (0.9%) were registered. The most common complication reported was infection (n = 42, 49%) followed by hernia recurrence in 25 cases (29%) and bowel lesion in 24 cases (28%). Major complications (n = 15, 17%) consisted mainly of bowel lesions in laparoscopic operations. There were significantly more claims after laparoscopic than open hernioplasties (P = 0.001).[18] A second study from Finland investigated the database during the same period for urologic complications which had resulted in 62 claims (0.07%) (from 335 litigations) of 92 000 inguinal hernia repairs.[19] The distribution of claimed urological complications consisted of 34 (55%) testicular injuries, ten (16%) bladder perforations, and seven (11.3%) massive scrotal hemorrhage.
In Sweden, all alleged cases of malpractice are regulated by the Swedish National Patient Insurance Company (LÖF). Between 2010 and 2015, 290 cases (0.85%) out of a total of approximately 34,000 cases with repair of a ventral hernia were identified.[20] Interestingly, 57 cases (20%) were related to anesthetic mishaps, a problem which was also pointed out by an author from Nigeria.[21] A total of 207 claims were related to surgical complications. In total, 116 litigations (40%) were compensated. Out of the surgical claims, 24.4% were due to infection, 16.4% due to poor cosmesis, 15.4% recurrence, and 12.5% pain, and in 12.1%, the claim was caused by an inadvertent enterotomy.[20] Another study from Sweden analyzed litigation claims related to groin hernia repair.[22] The authors used the Swedish Hernia Registry (2008–2010) and found 130 claims (0.26%) out of a total of 48,574 cases with repair of groin hernias, 26 cases (20%) dealt with bleeding, and 7 (5.4%) with intestinal injury. Eighty cases (62%) presenting with complications had been considered malpractice.
In a study from the USA,[23] 460 malpractice claims against general surgeons which were closed between 2003 or 2004 were analyzed by the American College of Surgeons. Surgeon reviewers identified deficiencies in care that fell below accepted standards more often before and after operations than during them. These deficiencies were often the result of a failure to recognize surgical injuries, and many of these deficiencies were preventable. The quality of surgical care was satisfactorily met in 36% of cases. The most frequent events leading to claims included delayed diagnosis, failure to diagnose, failure to order diagnostic tests, technical misadventure, delayed treatment, and failure to treat. Another study from the USA[24] did a retrospective analysis of 44 published cases from 25 states of the US. The causes for claim were as follows: 16% failure to obtain informed consent, 16% retained foreign body, 11% death, and 9% infection. The Court ruled in favor of the plaintiff 27% suits with compensation ranging from roughly between $19,000 and $ 8,000,000.
A very recently published paper present factual data on the medico-legal aspects of medico-legal claims after abdominal wall surgery in France.[25] In total, 180 claims (123 open and 57 laparoscopic surgery) were analyzed and mainly heard by the Conciliation and Compensation Commission (CCI) (82 patients) and the High Court (79 patients). The incidents motivating patient complaints after groin hernia surgery (n = 85) were chronic pain (31.7%), infection (28.2%), and testicular damage (8.5%). Seven patients (8.2%) died as a result of this surgery (including one fetus). Claims after ventral hernia repair (n = 95) were motivated by infections (48.4%) and postoperative peritonitis or bowel obstruction (12.6%). Nine patients (9.5%) died following these ventral hernia repairs. Surgical error was identified in 59 of the 168 cases analyzed (35.1%) and compensated; 44% of recognized faults were surgical site infections, 27% linked to delay in reoperation, and 20% were related to the operating room environment.
| Discussion | | |
A lawsuit because of alleged malpractice is always a severe burden for the surgeon, not only because of possible financial implication but also because of danger of loss of reputation. In total, according to the situation in Germany and according to the review of the literature, the frequency of recognized malpractice is far below 1%; however, one case might be enough to ruin the whole career of a surgeon. Therefore, for a young surgeon, it is of essential importance to be familiar with the reasons for an accusation and to learn how to prevent such a disaster which may destroy the future as a surgeon. Most frequently, there are five fields the surgeon may fail (1) related to the indication; (2) informed consent; (3) preoperative preparation; (4) operative performance; and (5) postoperative care.
Ad 1: Five of the cases, the author as Medical Advisor was confronted with, were related to the indication. It is an absolute must, not to operate on patients having severe pain but only a small or even no hernia.[5] If there is a need for a CT scan or MRT, both of these diagnostics must be done as dynamic investigation. Basically, the indication for surgery must be according to the current medical standard, or if provided according to generally accepted guidelines. Ad 2: “Informed consent” is a key feature, even a special standardized form is often not sufficient, especially in elderly patients. Take the time, show pictures, and make handwritten notes to explain in detail the indication for surgery, the technical performance of the planned intervention, and the steps of aftercare. Ad 3: Besides the usual preparation for surgery, mark the side the intervention is planned. This is important even in laparoendoscopic treatment. Ad 4: The technical performance of the operation should follow the generally accepted medical standard. In three of the cases reported above, the failure of the surgeon led to a severe complication. A complication does not inevitably lead to a lawsuit if the patient had given his consent; however, if there is an inadequate reaction of the surgeon or the surgeon is not familiar with the nerve anatomy like in two of the cases described above, the complication may become a legal case. Deep knowledge of anatomy is a second key feature of perfect operation. Ad 5: In two of the cases described above, a fatal result was reported due to an inadequate delay of the re-operation. A delay in timely response to a complication is a third key feature and is not excusable. It is important to keep in mind that to do a reoperation is not to esteem as a real defeat but shows responsible treatment. Furthermore, with the possibility of diagnostic laparoscopy, this kind of reintervention is not a severe burden for the patient but can give precise information about the intra-abdominal situation.
As case 7 showed, the careful documentation of all steps of the treatment is the fourth key feature for avoiding a legal case. Last but not the least, the fifth key feature for the prevention of a medico-legal implication is to establish an empathic relationship between the surgeon and the patient. This is especially important in the presence of a complication. The complication as well as the needed reactions should be explained to the patient and also to his relatives very frankly and in a friendly way without any accusation of anyone or anything what unfortunately the surgeon in case 8 had done. It is of paramount importance that the surgeon must not convey to the patient a feeling that he is hiding something.
| Conclusion | | |
To avoid or at least to reduce medico-legal implications, it seems to be necessary to develop a specific error management culture.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
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