Originally published December 2012
Hernia repair is a common and valuable surgical procedure. However, as with any surgery, there are risks for both the patients and physicians involved.
To help physicians manage their medico-legal risks, the CMPA reviewed its legal and medical regulatory authority (College) cases from 2007 to 2011 that involved patients presenting with inguinal, ventral, and umbilical hernias. The study identified 121 closed cases, the majority of which involved general surgeons.
Most hernias were repaired using an open approach, and many were repaired with mesh. The most common complications with inguinal hernia repairs were testicular atrophy, nerve injuries, infection, and chronic pain. Complications with ventral hernia repairs included infection, small bowel injury, and recurrence. Infection was the most common complication with umbilical hernia repairs.
The majority of the 80 legal actions had favourable outcomes for the physicians involved, however many cases were settled because peer expert support could not be obtained for the care in question. Of the 41 College cases, the majority had favourable outcomes for the physicians involved. The Colleges did, however, express concern in many cases. The most common allegations in both the legal and College cases were lack of informed consent, injury during surgery, and inadequate assessment of post-operative complications.
The most common pre-operative problem was failure to document the consent discussion, which included the surgical risks of scarring, chronic pain, and recurrence. Other consent-related problems included insufficient attempts to ascertain whether the patient understood the consent explanation, and unauthorized procedures performed when there were non-emergency intra-operative findings. Less common were delays in diagnosis of incarcerated hernias.
Case example: Documentation of the consent discussion
Prior to surgery, a general surgeon discussed the risks and benefits of an incisional hernia repair and abdominoplasty with an obese, 55-year-old woman with a large recurrent incisional hernia and pannus. During surgery, the surgeon found multiple fascial defects along the lower midline incision up to the level of the umbilicus. At the end of the difficult operation a mesh was placed and the wound was closed.
Post-operatively, the surgeon saw the patient regularly for several months and it was during this time that she developed a wound infection and hernia recurrence. The surgeon advised her that a repeat surgery was too risky. The patient complained to the College, alleging the surgeon failed to obtain informed consent and did not provide adequate follow-up care. She was also dissatisfied with the appearance of her abdomen.
The College concluded that the surgeon's care met the clinical standard, and the complications were known risks of the surgery. The College did, however, recommend that the surgeon document the consent discussion in more detail including what went into the decision-making process, in accordance with its consent to treatment policy.
Case example: Delay in diagnosing a hernia
A 55-year-old morbidly obese male was being followed monthly by his family physician for a back injury. Two days prior to a routine scheduled visit, the patient developed fever, abdominal pain, vomiting, and diarrhea.
The patient said these symptoms were communicated to the family physician at the time of the scheduled visit, however neither these symptoms nor a relevant physical examination were noted in the patient's medical record. The relevant entry dealt only with the back complaints. Twenty-four hours later the patient presented to an emergency department with hypotension and respiratory failure. Physical examination was difficult, but when his abdominal panniculus was displaced, a large non-reducible right inguinal hernia was discovered. The patient was taken to the operating room where the ischemic bowel was resected. He underwent a lengthy recovery.
One year later the patient initiated a legal action alleging negligence on the part of the family physician for failing to detect the incarcerated hernia. Expert support for the physician's care could not be found. Additionally, the physician altered his medical records after receiving notification of the lawsuit. The matter was deemed indefensible and the CMPA paid a settlement to the patient on behalf of the family physician.
The most frequent intra-operative problems identified were injuries to the bowel, blood vessels, or nerves. Although most injuries were recognized as inherent risks of the procedure, in some cases the surgeon's technique, inexperience, or misidentification of anatomy were contributing factors.
Wrong-sided surgery also occurred and was often associated with surgical safety processes that were inadequate, non-existent, or not complied with by the operating room team. The next case demonstrates what might happen when these processes are not followed.
Case example: Wrong-sided surgery
A 35-year-old immigrant male was referred to a general surgeon for treatment of a large symptomatic left inguinal hernia.
At the time of the initial consultation, the patient was accompanied by his spouse who acted as a translator. Surgery was suggested and agreed to. A booking and consent form were completed and signed; both indicated incorrectly that the surgery was to be on the right side of the body. Just prior to the surgery, a pre-op nurse noted the side was incorrect and contacted the surgeon. Without the benefit of a translator or physical examination, the surgeon asked the patient to identify the side of the hernia. The patient pointed to the right (incorrect) side and the surgeon marked that side with an "X" using indelible ink. A time out did not occur prior to the surgery. A right-sided exploration was performed in which a small direct hernia was repaired. The wrong-side surgical error was identified shortly after the surgery; disclosure and an apology was made to the patient. In subsequent discussions, it emerged the patient thought the "X" marking indicated the side not to operate on. As the matter was considered indefensible, the patient received a settlement paid by the CMPA on behalf of the member surgeon and by the hospital on behalf of the hospital staff.
Comprehensive surgical safety checklists were not generally in use when wrong-sided surgery cases occurred, such as the one described. The CMPA article "Safe surgery: Closing the gap with the surgical safety checklist," explains that by fostering a patient safety mindset and encouraging team communication, use of a surgical safety checklist could decrease the risk of surgical complications.
Issues identified in the post-operative period included delays in diagnosing and inadequate management of post-operative complications, most often wound infections. In one case, a College counselled the physician to have a higher threshold of suspicion for infection in patients with associated co-morbidities such as diabetes.
Communication was also a problem. Clear discharge instructions were not provided to patients, including information about who would be providing follow-up care and the symptoms and signs that would require immediate assessment and treatment. As shown in the following example, in some cases physicians were criticized for failing to communicate with other physicians and healthcare professionals.
Case example: Inadequate communication and follow-up care
Two days following discharge after an uneventful laparoscopic ventral hernia repair with mesh, a 62-year-old female attended her follow-up appointment.
The surgeon noted the surgical wounds were healing well with no signs of infection. As the patient lived several hours away, a return appointment was made for two months later. Two weeks later, the patient was hospitalized locally and treated for a seroma. Attempts by the treating physician to contact the surgeon were unsuccessful. The patient also sent several faxes and left phone messages with the surgeon that went unanswered. The surgeon assumed the patient was being managed locally and did not involve himself in the care. The patient ultimately required treatment by another surgeon for wound infection.
Six months later, the patient arranged to see the original surgeon who was willing to assume wound care if the patient remained in the city. Since the patient preferred to be treated in her own hometown, the surgeon transferred the care to the local surgeon.
A complaint to the College alleged inadequate follow-up care by the original operating surgeon. The College concluded the surgeon should have handled his communications more efficiently and in a timely way, and specifically the patient should have been made clearly aware of who was responsible for her care.
The CMPA articles "Informed discharge" and "Walk-in clinics: Unique challenges to quality of care, medical-legal risk," reinforce the need to educate patients to recognize the signs and symptoms that should alert them to seek further medical attention, as well as the importance of arranging appropriate follow-up care.
Risk management considerations
Based on the opinions of peer experts who reviewed the clinical care in these cases, the following suggestions for managing risks associated with hernia repairs (and other surgical procedures) may help to prevent adverse events (accidents in Québec) and mitigate medico-legal risk.
- A thorough examination should be performed on patients who present with undifferentiated abdominal pain.
- An informed consent discussion should include the proposed surgical procedure, the anticipated outcome, significant risks and complications, and available alternatives. Timely and complete documentation of the consent discussion can later serve as confirmation that the patient was appropriately informed.
- After verifying the patient's identity, the planned procedure, and the site, consent should be confirmed with the patient or patient's representative, the medical record should be reviewed, and the site should be marked when indicated. Some surgeons initial the correct site ("operate through your initials") rather than relying on other marks that may be misinterpreted.
- Prior to discharge, the patient should be properly informed about clinical symptoms and signs of potential complications that indicate the need for assessment.
- The patient should be made aware of the need for follow-up visits and how these arrangements will be made.