Did vaginal hysterectomy result in iatrogenic injuries?

Facts

A 50-year-old woman presented to Dr. A on 10/20/2011 at a nonparty hospital clinic with a complaint of pelvic pressure from fibroid growth. She testified that her grandmother, mother, and sister all died from uterine cancer and that she was advised by her mother’s physician to undergo a hysterectomy to decrease her risk of the disease. Following a lengthy discussion on the different ways in which he could perform the surgery, it was agreed that Dr. A would do a vaginal hysterectomy with conversion to abdominal hysterectomy as needed.

The woman was admitted on 12/29/2011 with a preoperative diagnosis of symptomatic fibroid uterus. A consent form was signed authorizing Dr. A to perform a diagnostic laparoscopy, cystoscopy, possible laparoscopy-assisted vaginal hysterectomy with removal of tube and ovaries, possible total vaginal hysterectomy, and possible laparotomy.

Dr. A, assisted by resident Dr. B, performed a cystoscopy, diagnostic laparoscopy, total vaginal hysterectomy, right salpingectomy, and uterosacral ligament colpopexy. During cystoscopy, brisk blue jets of urine were seen from each of the ureteral orifices. Following removal of the cystoscope and insertion of the laparoscope, Dr. A noted that the uterus was markedly enlarged and distorted due to the fibroid. He reported no significant adhesions from a prior cesarean delivery via vertical incision that were deemed to impact a vaginal hysterectomy.    

Before completing the procedure, Dr. C, a nonparty urologist was consulted and he stented the right ureter. According to his separate Operative Report, with the stent in place, IV methylene blue was given and seen coming out of the left ureteral orifice and out of the stent on the right side. Subsequently, the vaginal cuff was closed and vaginal packing was placed. Under Complications, a right ureteral injury was listed. The patient was transferred to the Recovery Room in stable condition with an indwelling Foley catheter and later to the floor in stable condition.

On 12/30/11 at 10:30 a.m., Dr. B reported that the patient was not yet out of bed but was feeling well. She complained of wetness, more when moving, laughing or coughing. Upon examination, it was noted that the catheter was in place and draining clear urine. No vaginal bleeding was seen when the packing was removed, but mild-moderate clear, odorless fluid was leaking from the vagina. The patient was ordered to be out of bed and advanced to a regular diet.

On 12/31/11, the patient was feeling well and her catheter was removed. She complained of vaginal leaking of mild-to-moderate clear fluid. The next day she complained of more intense leaking of clear/pinkish fluid from her vagina. The vaginal packing was removed and was described as moist and slightly blood-tinged. The patient also complained that she was leaking urine. The resident discussed the case with Urology and Dr. A, who commented that urinary incontinence was to be expected to some degree. The patient was discharged with instructions to follow up with Dr. A in 2 weeks and with Dr. C in 1 week.

The patient presented to the ED on 1/5/12, complaining of bed-wetting and right flank pain x2 days and moderate intermittent urinary incontinence x1 day. It was noted that the patient had spoken with a urologist, who instructed her to come into the office, but she did not want to wait as she was experiencing leg pain. A Foley catheter was placed and she was admitted to the gynecology service for possible ureteral injury. A computed tomography (CT) scan of the abdomen and pelvis with contrast showed bilateral distal ureteral leaks with associated fluid collections, a right ureteral leak in communication with the vagina, and possible pyelonephritis of the right kidney. The patient was advised that she was to be readmitted for operative repair.

On 1/7/2012, Dr. C performed a cystoscopy, speculum examination, and bilateral retrograde pyelogram and placed a left ureteral stent. The postoperative diagnoses were listed as urinary incontinence and ureterovaginal fistula. The Operating Room record noted that Dr. A was present during this procedure.

Dr. A examined the patient postoperatively, noting that she was feeling well and there had been no leaking since the surgery. Laparoscopic repair of the right ureteral injury was recommended, possibly on 1/9 or 1/10, but the procedure was subsequently put on hold.
Dr. A testified that repair was cancelled because the patient did so well immediately after the 1/7 surgery that spontaneous healing of the right ureter was anticipated. On 1/10/2012, the patient was discharged with a leg bag, prescription for ciprofloxacin, and instructions to call Dr. C for a follow-up appointment in 1 week.

The woman again presented to defendant hospital on 2/6/2012, arriving via ambulance. She reported that following the removal of 2 stents from her bladder 2 days earlier, she had been experiencing urinary leakage. Urinalysis showed large blood, positive nitrites, and large leukocyte esterase. A urine culture grew Escherichia coli. Ciprofloxacin was given for a urinary tract infection. She was admitted under the care of Dr. C with diagnoses of persistent postoperative fistula, genital tract fistula, depressive disorder, and urethral stricture.

Two days later, Dr. C performed a cystoscopy and placed a right ureteral stent. According to the Operative Report, Dr. C encountered difficulty in passing the wire into the right ureteral orifice but a 6-Fr 24-cm right ureteral stent was inserted. Following the procedure, the patient’s Foley was discontinued and a drainage bag was placed. She was discharged home with prescriptions for acetaminophen/oxycodone and ciprofloxacin and advised to follow up with Dr. C.

At a postoperative visit with Dr. A. on 2/23/2012 , the plaintiff’s cuff was well healed and no leakage was noted. Dr. A also noted that the patient was to follow up with Urology regarding the stent.

On 4/12/2012, the plaintiff presented to the ED with complaints of constant right flank pain x2 days that was 10/10 on the pain scale. She reported that her right stent was removed 3 days earlier and she was now experiencing increasing involuntary leakage of urine. The patient was admitted under the care of Dr. C with a diagnosis of urinary incontinence for pre-op labs and CT abdomen/pelvis with IV contrast.

On 4/13/2012, a CT of the abdomen and pelvis revealed new moderate right hydronephrosis and hydroureter, “despite the presence of ureteral stent, which might be occluded.” The most distal segment of the right ureter, measuring 1.5 cm, could not be visualized, possibly due to a stricture.

There was also evidence of right pyelonephritis; the left kidney and ureter were unremarkable. No urine extravasation was seen. Later that day, the patient was discharged home with instructions to follow up with Dr. C.

On 5/9/2012, the plaintiff presented to defendant hospital with complaints of right-sided kidney pain x3 weeks, measuring 10/10 on the pain scale. It was noted that she was taking oxycodone 3x/day for the pain. The patient was readmitted under the care of Dr. C with a diagnosis of urinary calculus and a secondary diagnosis of stricture/kinking of the ureter. Dr. C performed a right ureteral reimplantation for a right ureteral stricture. Dr. C’s operative report indicated that once the right ureter was identified, “there appeared to be a very dense inflammatory process in the distal right ureter.” The ureter was freed very carefully. Nevertheless, “despite very minimal manipulation, the ureter looked ischemic in this area and easily tore.” The patient was discharged on 5/14/2012 with a catheter and leg bag, and instructions to follow up with Dr. C in 2 weeks.

On 5/17/2012, the patient presented to Dr. A’s office for an emergency visit. She complained of leaking from the abdominal incision and pain from the urinary catheter. Dr. A noted that the patient was tearful and stated that she was going to her social worker later that day for admission secondary to depression. The woman also demanded that the urinary catheter be taken out or she would pull it out herself. Although Dr. A advised the patient that Dr. C should remove the catheter and warned the patient of the risks of premature removal, he ultimately removed it “for safety reasons” after the patient began pulling it out herself. Dr. A examined the patient’s incision line and documented “seroma at superior edge, fascia intact.” Dr. A removed the staples, evacuated the seroma, and cleaned and packed the wound with a single 4x4.

On 5/18/2012, the plaintiff presented to the nonparty hospital ED with complaints of bleeding from the abdomen, status post-surgery, and abdominal pain rated 7/10 on the pain scale.  She reported that she had surgery 2 weeks prior for uterine fibroids and had her staples removed 5/17/2012 by Dr. A. and on arrival home she began bleeding from the abdominal site. On exam, the surgical wound was noted to be open in the midline of her abdomen and serosanguinous discharge was noted from the wound under the umbilicus.

The patient was placed on 1:1 observation for “suicidality.” She reported a history of domestic violence and bipolar disease. The Attending noted that the patient was aggressive and verbally threatening. She stated that “Dr. A is only concerned because I told him that I’m suing him.” The Attending noted that the on-call psychiatrist felt that the patient was not a danger to herself or others. She was evaluated by a psychiatrist, who recommended that she be discharged, and to follow up with her private psychiatrist the following day.

NEXT: Allegations

Allegations

Plaintiff alleged that the defendants failed to properly perform a laparoscopic hysterectomy, right salpingectomy and uterosacral ligament colpopexy; improperly lacerated, tore and/or entered a blood vessel; caused and/or allowed plaintiff to bleed internally; caused and/or allowed a perforation, laceration and/or other injury to the right ureter; caused and/or allowed a uterovaginal fistula; and caused plaintiff to undergo additional surgical procedures. The plaintiff claimed the following permanent injuries: uterovaginal fistula; urinary incontinence; right ureteral stricture; right hydronephrosis; right hydroureter; perforation, laceration, injury and/or trauma to the right ureter; infection; unnecessary and prolonged hospitalizations.

Discovery

Dr. A explained at his deposition that the injury in this case was likely due to an anatomical variation. He testified that with all the safety profiles he employs during the course of surgery to protect the ureter and identify the uterosacral ligament, the fact that he put in a stitch that caused direct trauma to the ureters suggests that they were much closer to the uterosacral ligament than is typical, or that the woman had extremely weak tissue since the stitch was able to cut through 2.5 cm of the tissue. He testified that “It’s unlikely that the stitch ripped through 2.5 cm” and that as a result, it’s likely that she had a “combination of weak tissue and an abnormal position of ureter to the operative field.”

Our ob/gyn expert agreed that colpopexy was a routine and necessary part of any vaginal hysterectomy, and that when the uterus is removed, the uterosacral ligaments have to be reattached some place and cannot just be left “flopping around.” He also agreed with Dr. A’s opinion that the injury to the ureter occurred during the colpopexy and not the hysterectomy. However, he did not agree that the injury reflected some anatomic anomaly, as such an injury can occur even in the face of normal anatomy. He added that because the patient already had a vertical abdominal incision, he would have performed an abdominal rather than vaginal hysterectomy.

Trial

Plaintiff’s expert gynecologist testified that Dr. A failed to provide the plaintiff with informed consent because he failed to offer her the alternatives to surgery including hormonal therapy, uterine-artery embolization, “watch and wait” because she was perimenopausal, and also failed to do a preoperative drug screen and genetic testing to further evaluate her cancer risk, notwithstanding the family history. He also testified that the alternative treatments should have been undertaken ahead of surgery and that failure to do so constituted a departure from standards of care.  The last departure flowed from the fact that their expert testified that it was ill-conceived to attempt to remove a 20-week/500-g uterus vaginally and that Dr. A should have performed a hysterectomy laparoscopically rather than remove the pieces vaginally.

Cross-examination, supported by our expert, made clear that there was no reason to discuss alternative treatments with the plaintiff as they were not viable under the circumstances because none of them addressed the uterine cancer issue. While the woman’s fibroids may well have been reduced with any of the treatments and have disappeared when she became menopausal, all of those options left her with her uterus in place and, thus, she remained at risk for uterine cancer. We further argued that the concept of genetic testing made no sense because regardless of the test outcome, hysterectomy would  be mandated because of the family history in that not all genetic subtypes of uterine cancer have yet to be identified.

Insofar as the propriety of the vaginal hysterectomy is concerned, on cross it was established that the American College of Obstetricians Gynecologists recommends vaginal hysterectomy as the procedure of choice. It was further established that the ureteral injury didn’t occur during hysterectomy but rather during colpopexy and thus plaintiff’s expert testimony that the uterus couldn’t be successfully removed vaginally was factually inaccurate and irrelevant.  

The verdict

Ultimately, the case settled during jury deliberations for less than half of plaintiff’s pretrial settlement demand.