The Doctor’s Advocate | Third Quarter 2022
An Ounce of Prevention

Mitigating the Legal Risks of Urinary Tract Injury Following Gynecologic Surgery

Pamela Willis, BSN, JD, Senior Patient Safety Risk Manager, The Doctors Company

The case presented in this article highlights the importance of expanding the informed consent process for gynecologic surgeries to include the increased risks of injuries to surrounding tissues. Augmenting the informed consent process for high-risk patients is critical.

Case Scenario

A 41-year-old woman underwent a routine laparoscopic hysterectomy secondary to uterine fibroids. The patient had a history of two prior cesarean sections and a laparoscopic myomectomy. No complications were noted during the laparoscopic hysterectomy, and the patient was sent home to recover per routine protocols.

Four days later, the patient presented to an emergency room with severe abdominal pain. A CT scan ruled out any postsurgical abnormalities. The patient reported no blood in her urine or urine leakage, but she had pain with urination. She was given an antibiotic prescription for a urinary tract infection and released.

On day seven, the patient saw her surgeon postoperatively and continued to complain of dysuria, urgency, frequency, and a pressure sensation in her bladder. The patient stated that she called the office several times prior to the visit to complain of these symptoms but did not receive a call back. During the visit, the antibiotic was switched per urine culture results, and the patient was deemed to be recovering normally from the surgical procedure.

At two weeks post-op, the patient was grocery shopping when she noted urinary incontinence. The following week the patient went to see a urologist on her own. The urologist diagnosed a vesicovaginal fistula (VVF), which was repaired surgically two weeks later. The patient continued with a catheter for eight weeks postprocedure.

In the months following the fistula repair, the patient developed dyspareunia and continued to complain of a pressure feeling in the bladder, with urgency and frequency of urination. Ultrasound studies at that time showed that the bladder was functioning properly.

The patient brought a lawsuit against her surgeon for negligence in the performance of her laparoscopic hysterectomy. She alleged that the fistula had been created during that procedure and had been overlooked by the surgeon. Additionally, she alleged that because the surgeon did not have VVF as a differential diagnosis, identification of the fistula was delayed, causing further harm and distress.

While the defense had strong medical expert support, the jury sympathized with the patient and her longstanding issues with incontinence, painful intercourse, and bladder discomfort. They awarded the plaintiff monetary damages.

Risk Management Discussion

A recent review of gynecologic surgery claims with a focus on those involving urinary tract fistulas reveals the importance of expanding the scope of the informed consent conversation prior to surgery.

Because it is likely that the patient has never heard of bladder fistulas, making only a cursory mention of them as a known complication could conflict with true informed consent and shared decision making. Typical consent phrasing such as “possible damage to bowel or bladder” may not be viewed as informative enough for the patient to fully understand and consent to her procedure. A patient may be better prepared to consent if she is given a brief description of fistulas and their accompanying consequences.

Frequently in courtroom examination, a patient will be asked, “If you had known the complications you were going to experience, would you still have consented to the procedure?” Of course, this question, asked in hindsight, is not a true and accurate depiction of how the patient felt at the time she consented. Nonetheless the question is often permitted in court and is used frequently in malpractice litigation.

True informed consent is not just a signature on a document; it is a process involving clear communication between the patient and provider so that the patient can make informed decisions based on realistic expectations.

While it is not possible to anticipate or discuss every potential surgical risk with the patient, a cursory discussion about fistulas and their potential complications is an opportunity to bring patient expectations more into alignment with potential risk outcomes. Because litigation often results from unmet patient expectations, take any opportunity to adjust those expectations.

Although the incidence of VVF is relatively low (between 0.02 and 0.22 percent¹), the risks are higher when the patient has had a prior C-section or pelvic surgery, as in the case presented. In addition, patients who experience genitourinary injury during a hysterectomy are 10 times more likely to pursue legal action than those who don’t experience urologic injury.²

In the case scenario, the patient’s emotional state was a motivating factor toward litigation. The jury gave great weight to the noneconomic damages that the patient had experienced. Noneconomic damages—such as emotional distress, physical pain and suffering, loss of enjoyment of life, and damage to spousal relations/relationships—are recognized as important damages that deserve remuneration. In many states, these types of damages have no statutory cap on the dollar amount and can result in sizable verdicts and settlements. Patient participation in shared decision making with acknowledgment of the risks can influence how a jury considers noneconomic damages.

If a patient is unable to understand what a VVF might entail, she may not be considered informed enough to consent to the gynecological surgery she is contemplating. Learn more about informed consent by reading our article “Informed Consent: Substance and Signature.”

Routine Bladder Testing

Performing routine bladder testing on patients following all gynecologic procedures may also mitigate risk. Although this is not currently agreed on as the standard of care,³ some surgeons prefer to complete each case this way.

One problem with relying on this method of mitigation, however, is that some injuries to the bladder do not manifest immediately. For example, a thermal injury that thins the tissue may not allow leakage until the tissue breaks down a bit further.

Cystoscopy in the immediate postoperative period may give false assurance that the bladder has been uninterrupted, and the patient may still undergo a delayed fistula. Patients who undergo bladder testing following their procedures could also benefit from knowing that a fistula may still develop despite a favorable outcome to their bladder testing.

Perhaps more important than routine testing is heightened awareness and post-op vigilance, especially for patients at higher risk of a complication like VVF. Documenting concerns and actions taken can ultimately be helpful should there be litigation.

Informed Consent Documentation

Our sample document, “Basic Elements of an Informed Consent,” offers suggestions on creating a form to document patient understanding of specific risks.

Consider adding language to the basic informed consent stating that gynecological procedures may result in bladder injuries that may not manifest immediately in the postoperative period and that a fistula (a hole or opening in the bladder) may develop on rare occasions. You may also consider documenting in the preoperative note that the patient understands this risk.

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