Malpractice Case Studies

Improperly Placed Pubovaginal Sling and Mesh Erosion Cited for Patient Pain, Incontinence

Written by ProAssurance Risk Management | June 2021

Allegation

The improper placement of a sling led to pain, incontinence, and reconstructive surgery.

The Case                                                                                                                                    

The patient, a 44 YOF (5’8”, 299 lbs.), presented to the defendant urologist with a complaint of no bladder control; she stated she lost urine when she coughed, sneezed, or laughed. Her history was significant for urinary incontinence, chronic UTIs, ovarian cyst removal, removal of both ovaries, hysterectomy, three bladder suspensions, and abdominal bladder repair.

During the office visit, the patient stated she could not control the urge to urinate. A physical exam revealed no palpable masses or organomegaly, and no lymphadenopathy in the groin. She had tenderness in the lower abdomen. The defendant’s impression was stress and urgency urinary incontinence.

After the physical exam, the defendant urologist performed a cystoscopy. The bladder was inspected and showed scattered hemorrhagic spots along the posterior lateral wall suspicious for carcinoma in situ. Biopsies were sent to pathology and the biopsy site was fulgurated. The defendant urologist kept the bladder full and asked the patient to cough and strain; she had significant stress incontinence due to hypermobility of the urethra. She became continent when the urethra was supported indicating a positive Marshall test. The defendant prescribed 500 mg Cipro® BID. He also discussed treatment options, including a Monarc-type pubovaginal sling.

The next month, the patient underwent a pubovaginal sling, a cystoscopy, and cystocele repair. The patient had redundant anterior vaginal wall mucosa due to cystocele. This was trimmed and excessive tissue was removed. Dissection was done on both sides of the urethra to elevate the vaginal mucosa. Two incisions were made on either side of the perineum at the level of the clitoris, and the extra-long Monarc sling was passed.

The sling was lying at the proximal urethra and bladder neck without tension. Cystoscopy was performed. There was no evidence of sling penetration inside the bladder, and no sign of bleeding or violation to the ureteral orifices. The cystoscope was removed. The sling was cut flush with the skin after the plastic sheath was removed. The urethrovaginal mucosa was closed, and the vagina was packed with 2-inch iodoform gauze. The patient tolerated the procedure well.

Two weeks later, the patient returned to the defendant for follow-up. Her stress incontinence was corrected. She still had symptoms of overactive bladder and urgency incontinence. The patient was recovering well and could perform light activities. The defendant urologist gave her a sample of Myrbetriq® to help her urgency incontinence and overactive bladder, and advised her to return in two weeks.

Over the next two months, the patient returned to the defendant for follow-up three times. She had no further stress incontinence, and reported slightly improved overactive bladder symptoms with the medication. The patient tried two different anticholinergic medications, Myrbetriq then Ditropan®. At her third visit, the patient was happy with the results of treatment and was doing well. She was to return in three months for a cystoscopy and reevaluation.

The following week, the patient saw an ob-gyn for ongoing mild pelvic pain, internal vaginal burning/irritation, and an inability to tolerate intercourse since bladder sling surgery. She further complained of frequent leak of urine from her vagina, painful urination, urge incontinence, and urgency. The bladder was tender with sling on tension and pinpoint pain right. The ob-gyn recommended a trial of estrogen cream to re-epithelialize to reduce discomfort. The ob-gyn informed the defendant urologist of the patient’s visit; he noted that if the cream did not reduce her symptoms, she may require mesh removal as a last resort.

One month after visiting the ob-gyn, the patient presented to the ED with complaints of intense pain with urinating and intense bladder contractions. It was documented in the ED record that the patient said she had been examined by her ob-gyn, who felt the sling was causing issues, but her urologist refused to take the sling out.

One week after the ER visit, the patient returned to the defendant urologist. He noted she had no further incontinence. She had symptoms of overactive bladder, but the medication she was taking could have that particular side effect. The urologist recommended an injection to treat her incontinence due to overactive bladder. After an informed consent discussion, the patient wanted to proceed.

The patient had the procedure one week later. Inspection of the bladder neck from the distal urethra showed the patient had incompetent bladder neck confirmed by urodynamics, and urinary incontinence due to intrinsic sphincter deficiency. Using the periurethral injection needle, the tip of the needle could be seen submucosally at the bladder neck, tenting the bladder neck mucosa. One ampule of Coaptite® was injected at the site, and there was satisfactory bulging and coaptation. Similarly, three additional syringes were injected at 15:00, 18:00, and 21:00 hours. At the end of the procedure, there was satisfactory coaptation and closure effect. The patient tolerated the procedure well. This was her last interaction with the defendant urologist.

Over the next 15 months, the patient saw her ob-gyn with complaints of continued vaginal pain. He assessed painful vagina and mild urethra pain associated with the previous Monarc sling and referred her for a second opinion. That patient saw another ob-gyn who attempted to remove the Monarc sling, but aborted the procedure after determining the extent of mesh erosion.

Six months after the attempted removal, the sling was successfully removed by a different urologist. The sling in the vaginal portion was entirely removed. Five portions were left in place due to the patient’s body habitus. The urologist’s operative findings noted the mesh sling eroded into the right side of the bladder neck with encrusted stones a centimeter and a half away from the ureteric orifice. Nine months after removal, a new pubovaginal sling was placed.

The patient’s expert witnesses stated the patient was not a good candidate for the procedure. They further stated the defendant urologist should have attempted conservative treatment before recommending surgery. Finally, they stated the procedure was performed improperly, and the defendant was negligent for placing the sling immediately adjacent to the bladder neck.

Defense experts were supportive, stating the pubovaginal sling mesh was the only available procedure at the time. There was nothing in the operative report or treating records that suggested the procedure was performed improperly. During deposition, one of the experts changed their opinion. Subsequently that expert was released, and became an expert for the plaintiff.

Verdict

Due to wavering support from defense experts and the defendant urologist’s wishes, the case was settled for a confidential amount.

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