by Olga Maystruk, Designer and Brand Strategist, and
Susie Edwards, Risk Management Representative
Presentation
On June 25, a 35-year-old man came to an emergency department (ED) reporting right lower abdominal pain following exercise. The patient had a history of hypothyroidism and gastric sleeve surgery.
Physician action
The ED physician saw the patient and ordered an unenhanced CT scan of the abdomen and pelvis; no pathology was observed. The ED physician suspected an inguinal hernia and referred the patient to General Surgeon A for a same day follow up. During the visit, General Surgeon A observed reducible inguinal hernias bilaterally.
On June 27, General Surgeon A surgically repaired the bilateral hernias with mesh via a laparoscopic incision. The treating anesthesiologist administered two postoperative bilateral transversus abdominis plane (TAP) blocks with ultrasound guidance.
Following surgery, the patient reported numbness and weakness in his right leg and left thigh. He was seen by a neurologist who ordered nerve conduction velocity (NCV) and electromyography (EMG) tests. After observing signs of femoral neuropathy, the neurologist ordered an MRI.
The scans revealed acute L5-S1 central disk herniation with inferior annular tear and moderate central canal stenosis. Additionally, an MRI of the pelvis with and without contrast revealed edema and enhancement of the right femoral nerve and some of the extending branches. The neurologist also observed enhancing loculated fluid, consistent with inflammation associated with inguinal hernia, along the anterior abdominal wall extending into both inguinal regions.
On July 15, General Surgeon A took the patient back to surgery to remove the mesh from the right inguinal area. He also referred the patient to a neurosurgeon.
On September 15, the patient saw the neurosurgeon and discussed a nerve repair procedure.
On November 10, the neurologist performed another NCV, EMG, and MRI and observed that a substantial right femoral nerve dysfunction still existed. A week later, a neurography MRI was performed that revealed tethering of the femoral nerve and atrophy of the anterior compartment muscles in the right thigh.
On December 5, the patient was evaluated by a plastic surgeon who recommended a femoral nerve graft using bilateral sural nerves harvested from the patient’s legs.
Two months later, General Surgeon B took the patient to surgery, exposed the pelvis and inguinal area, and removed some remaining mesh. The plastic surgeon then performed the nerve anastomoses. General Surgeon B performed the closure.
The patient was discharged nine weeks later, after starting physical and occupational therapy.
The patient still reports weakness, sensation insensitivity, and pain. He is taking pregabalin, oxycodone, acetaminophen, and topiramate.
Allegations
A lawsuit was filed against General Surgeon A and the anesthesiologist alleging the following:
- failure to obtain adequate informed consent;
- improper performance of the hernia repair;
- inappropriate order of a TAP block;
- failure to obtain an informed consent for the TAP block;
- failure to assess postoperative complications; and
- failure to perform an adequate mesh removal procedure (during July 15 surgery).
Legal implications
Consulting physicians who reviewed the case for the defense were critical of General Surgeon A’s informed consent discussion, as the patient was not told about potential complications or alternative treatments. While acknowledging that complications often occur during surgery, these consultants found General Surgeon A’s hernia repair performance deviated from the standard of care. However, they did note that the follow-up care was timely and appropriate.
One of the experts also stated that the patient may have an ambulatory disability and neuropathic pain for the foreseeable future. This may be difficult for the defense to overcome.
The plaintiff’s attorney consulted with the plastic surgeon in this case who reported that during surgery repair, he discovered “clear evidence” that the femoral nerve had been completely transected during the initial surgery performed by General Surgeon A.
A general surgeon who consulted with the plaintiff’s attorney believed that General Surgeon A was negligent in his performance of the laparoscopic hernia repair. He also stated that injury to the right femoral nerve could not have occurred during this procedure unless the surgeon was negligent.
Disposition
The case was settled on behalf of General Surgeon A. The outcome of the case against the anesthesiologist is unknown.
Risk management considerations
An effective surgical informed consent process enables the patient to make rational, independent decisions. This is a critical part of surgical patient care. Studies have demonstrated that the average patient has an inadequate comprehension of the issues related to surgical procedures. Ideally, the informed consent discussions are held well in advance of the procedure, so patients have time to consider the risks, benefits and alternatives. 1,3
According to the Journal of the American College of Surgeons, surgical patients who participate in longer informed consent discussions before an operation (15 to 30 minutes in length) have a better understanding of the proposed operation. In addition, researchers found that asking the patient to “repeat back” their understanding of the procedure enhanced patient comprehension of informed consent issues. 1
Medical ethics, common law, and, in many states, codified statutory law mandate the informed consent process. Physicians would be prudent to be knowledgeable in these topics as they relate to their practice and location. 2
The most important step in the informed consent process is to have a frank and open dialogue with patients. This provides an opportunity for physicians to establish rapport and engage patients in making decisions about their own care. 3
The discussion should emphasize the physician-patient relationship in the decision-making process and include the following information:
- differential diagnosis;
- description and purpose of proposed treatment;
- benefits and expected outcome of proposed treatment;
- risks associated with treatment;
- alternatives to treatment (including risks and benefits); and
- consequences of no treatment. 3
Document the education process in the patient’s chart. In some states, medical board rules require documentation of patient and family education in the medical record. Check your state board rules regarding medical record documentation to ensure compliance.
Examples of educational materials that may be used during the informed consent process include pamphlets, videos, handouts, and pre/post-treatment instructions. These can help patients make an informed decision. They may also help patients remember what they have consented to should they have any questions before the procedure or develop complications following the procedure. 3
Some additional informed consent considerations include the following.
- Use descriptive, non-medical terms to ensure patients understand complicated procedures. Use key repetitive phrases, and then ask patients to repeat what you have said. Draw diagrams if necessary. 3
- If the patient refuses to follow your recommendations after an informed consent discussion, document their refusal or any noncompliance. You may wish to consider having them sign an informed refusal of care document. 3
- Anesthesiologists and radiologists should not rely on the primary or attending physician to handle the informed consent process on their behalf. It is a mistake to assume the primary physician has adequately addressed the risks associated with the intended anesthesia or radiological procedure. The only person truly qualified to respond to a patient's questions is the physician who will perform the procedure. 3
- Informed consent is not limited to surgical, invasive, or diagnostic procedures. Written consent should also be obtained for prescribing medications that involve potentially significant complications or side effects. 3
Resources
- American College of Surgeons. Study Finds Patients Benefit from Discussion of Operations. July 10, 2010. Available at https://www.facs.org/media/press-releases/jacs/informedconsent0710. Accessed on October 15, 2020.
- Patrick TJ, Carson GV, Allen MC, et. al. Medical Informed Consent: General Considerations for Physicians. Mayo Clinic Proceedings. Volume 83, Issue 3. March 1, 2008. Mayo Clinic. Available at https://www.mayoclinicproceedings.org/article/S0025-6196(11)60864-1/fulltext. Accessed October 15, 2020.
- Texas Medical Association. Informed Consent: A Process of Communication. September 5, 2013. Available at https://www.texmed.org/template.aspx?id=1745. Accessed October 15, 2020.
Olga Maystruk can be reached at olga-maystruk@tmlt.org.
Susie Edwards can be reached at susie-edwards@tmlt.org.
