Delayed response to surgical complications leads to adverse outcomes.
A 48-year-old gravida 2, para 2 presented to her physician complaining of menorrhagia and increased cramping during the previous 18 months. The initial progress notes document that the patient tried various oral contraceptives over the next 5 years without improvement. An endometrial biopsy revealed fragments of inactive endometrial glands and stroma in a hemorrhagic background. Laboratory evaluation showed normal thyroid stimulating hormone (TSH) and decreased hemoglobin and hematocrit, at 8.9 g/dL and 26.4%, respectively.
The physician recommended an endometrial ablation and a tubal ligation. There was a reasonable written informed consent, although no discussion of hormonal intrauterine systems (IUS) was documented in her chart.
The patient underwent a laparoscopic Filshie clip application. A hysteroscopy and dilation prior to the ablation had revealed a small polyp, and subsequent pathology revealed a benign, weakly proliferative to atrophic endometrium. Initial attempts to perform the endometrial ablation with a bipolar electrosurgical global ablation device revealed a narrow endometrial fundal width (2.5 cm). The device was removed and reinserted, subsequently failing the uterine integrity test, suggesting uterine perforation. The procedure was discontinued, with no apparent complications.
Two months later, a physician at an outpatient surgery center performed a hysteroscopic electrosurgical endometrial resection and ablation with monopolar electrosurgery, using sorbitol for distension. The procedure took 50 minutes, and the physician documented a fluid deficit of 2000-2500 mL. The nurses’ notes reflect the use of 5000 mL of sorbitol with a deficit of 2800 mL. A sodium level of 131 mEq/L was obtained at the end of the procedure. Furosemide was given in the operating room. In recovery, the patient at first had normal respiration, oxygen saturation, blood pressure, and pulse. But approximately 2.5 hours later, she was having difficulty breathing and experiencing abdominal distension and pain, which she rated as 10 out of 10. She was therefore transferred to the center’s affiliated hospital with a diagnosis of electrolyte imbalance after hysteroscopy. One and a half hours after transfer, computed tomography (CT) revealed free air throughout the patient’s abdomen and within her pelvis and a surgical defect in her anterior right uterine wall. She was given morphine and meperidine, but her pain did not subside, and she was admitted for observation.
Early the next morning, the nurses tried to have the patient stand, at which point she became dizzy and nauseous. The patient returned to bed and the symptoms slowly subsided. However, she complained of increasing pain. Upon evaluating the patient that morning, the physician documented that abdominal distension had improved and that she continued to have decreased, but improved, bowel sounds. The patient’s pain was documented as being 6 out of 10. The physician notes stated, “Computed tomography (CT) scan of the abdomen and pelvic shows free fluid in the abdomen, no evidence of blood or other abnormalities.” Assessment at this time was still an endometrial ablation complicated by fluid shift and pain. The plan was to increase her diet and discharge her in the afternoon.
At 4:40 PM on postoperative day 1, the pathologist notified the surgeon that the endometrial ablation showed smooth muscle fragments consistent with benign leiomyomas, with probable small-bowel mucosa and muscular wall identified. Two hours later, the gynecologist documented that the patient had a tender abdomen, with no rebound or guarding. The progress notes documented the pathology results and a plan to consult a general surgeon and proceed to surgery.
That evening, the surgeon carried out an exploratory laparotomy, evacuated peritonitis, and performed a partial small-bowel resection, primary anastomosis with a stapling device, and an incidental appendectomy. Pathology revealed a 1-cm small-bowel perforation and an appendix with periappendicitis. Cultures obtained during surgery included a heavy growth of Klebsiella, moderate growth of Haemophilus, and light growth of Streptococcus. Broad spectrum antibiotic therapy had begun prior to surgery and continued postoperatively. The patient improved dramatically and was discharged 3 days after the exploratory laparotomy.
Approximately 3 months after the original surgical procedures, the patient presented to another hospital with acute abdominal pain. A CT scan revealed fluid in the abdomen and a probable small-bowel obstruction. The patient underwent an exploratory laparotomy, which found an acute small-bowel obstruction secondary to a confined perforation and perianastomotic abscess. The patient then underwent a partial small-bowel resection and right hemicolectomy. She recovered uneventfully and was discharged 6 days after this procedure.
Nevertheless, she continued to complain of persistent menorrhagia, chronic abdominal and pelvic pain, and bowel incontinence. She was no longer able to work and was separated from her husband.
The patient sued the physician for negligence during the performance of the endometrial ablation that subsequently required multiple operations and hospitalizations and resulted in loss of earnings, loss of consortium, and significant pain and suffering. She sued the original general surgeon for negligent management of the initial bowel injury, claiming that a primary anastomosis without concomitant diversion was below the standard of care. She also sued the hospital for improperly granting privileges to the gynecologist and sued both the radiologist and pathologist for improper communication of abnormal findings to the gynecologist.
After discovery, the radiologist was dismissed from the suit because communication of critical findings to the gynecologist, documentation of communication method (phone), and time of communication had been clearly indicated in the CT report. The pathologist was also dismissed because the phone communication of abnormal results had been clearly documented in the pathology interpretation and report.
The general surgeon likewise was dismissed when, at deposition, the plaintiff’s expert conceded that primary anastomosis without diversion is within the standard of care and an acceptable alternative surgical approach. The defense expert testified that the subsequent anastomotic leak is a recognized complication from anastomosis, which had been properly managed when discovered 3 months after primary anastomosis.
The hospital elected to settle the suit before trial because its medical staff office could not produce documentation about the gynecologist’s training in or experience performing endometrial ablation, either with bipolar or hysteroscopic electrosurgical devices, or about the gynecologist’s privilege to perform endometrial ablations.
At trial, plaintiff expert testified that management with the global electrosurgical ablation device at the initial procedure, when a perforation was suspected, had been appropriate. However, the expert expressed criticism on 3 issues. First, there was no documentation to show that the option of a levonorgestrel intrauterine system (IUS) had been discussed or offered, even though an IUS is as effective as endometrial ablation at controlling abnormal uterine bleeding and can be inserted in the office without anesthesia or surgical risk. Second, fluid management at the second procedure fell below the standard of care. There were discrepancies in the documented fluid deficit, which ranged from 2000 to 2800 mL. Regardless, the deficit placed the patient at risk for fluid overload and hyponatremia. Having noticed that her electrolytes were normal, the gynecologist should have entertained the idea that fluid had been lost via a uterine perforation. Third, although transfer and admission to the hospital were appropriate, the gynecologist failed to respond to or appropriately document the free air identified on the CT scan, most concerning for a bowel perforation. The gynecologist did not acknowledge the finding of free air nor express concern about bowel perforation. Broad-spectrum antibiotics should have been promptly administered and the patient referred to a general surgeon for immediate exploration. The delay in treatment resulted in a higher risk of infection, subsequent breakdown of the anastomosis, a walled-off abscess, and a small-bowel obstruction. The multiple bowel resections led to the patient’s bowel incontinence and persistent pain.
The defense expert testified that endometrial ablation is an accepted treatment for heavy menstrual bleeding. Perforation is a recognized complication of both global ablation devices and hysteroscopic electrosurgical endometrial ablation. Although there was a significant fluid deficit during the hysteroscopic procedure, the patient did not show any symptoms of fluid overload and there were no objective findings to that effect. The delay in performing the exploratory laparotomy was not significant and, when notified of the pathology results, the gynecologist immediately obtained a general surgery consult and the patient underwent exploratory laparotomy, with appropriate surgical management. Furthermore, at that point, the surgeon became the primary physician caring for the patient.
After 6 hours of deliberation, the jury returned a plaintiff’s verdict, awarding $1.5 million. Post-verdict polling of the jury revealed that 2 facts had weighed heavily in its decision:
Informed consent is the process of counseling patients about treatment and management options. The informed consent document merely memorializes the discussion. Each state and jurisdiction has its own requirements for documenting such discussions, and some only require that R/B/A (risks, benefits, and alternatives) be discussed. However, it is recommended that informed consent should document a discussion of the planned procedure or treatment, the alternatives to such treatment, including doing nothing, and the substantial complications related to the planned procedure or treatment. Electronic records allow the development of smart phrases that include these items, minimizing the time required for full documentation of these discussions. In this case, no discussion about the option of a levonorgestrel IUS, which has similar treatment outcomes to endometrial ablation without the surgical risks, was documented.