A 36-year-old woman (G3 P2012) with stress urinary incontinence (SUI) and abnormal uterine bleeding presented to a gynecologist. She had explored medical therapy for her SUI with no symptom improvement. She had a previous tubal ligation, and the gynecologist ordered urodynamic testing, the results of which led to a discussion of vaginal hysterectomy; anterior, posterior colporrhaphy; and mesh placement. It was felt that the patient had a number of risk factors for incontinence (including pregnancy with vaginal delivery, well-controlled diabetes mellitus, and obesity). She had a long-standing history of chronic pelvic pain, with an established diagnosis of diverticulosis with episodes of diverticulitis in the past.
The gynecologist had the patient keep a bladder diary for 1 week. When asked, the patient reported no problems with sexual dysfunction, stating that her quality of life was “fine” except for the vaginal bleeding and loss of urine refractory to medical therapy. The Urogenital Distress Inventory was administered, and it identified frequent urination, leakage, and incontinence related to activities. An Incontinence Impact Questionnaire also was administered. Physical examination included cotton-tipped swab urethral, or Q-tip, test and cough stress test as part of POP-Q (Pelvic Organ Prolapse Quantification system) evaluation. Urinary tract infection was ruled out. The gynecologist counseled the patient about possible medical therapies for urinary incontinence, and she requested definitive surgery.
The gynecologist obtained informed consent for surgery that included preoperative discussion of potential surgical complications, including bleeding, infection, trauma to surrounding structures, and the possibility of additional surgical procedures secondary to complications. The gynecologist also discussed transvaginal tape versus transobturator tape (TOT) placement, including potential complications and sequelae. The final planned procedure, which was performed by the gynecologist, included vaginal hysterectomy, anterior colporrhaphy, and TOT placement.
Intraoperatively, the patient was identified (upon entering the operating room [OR]); time-out occurred, and the gynecologist proceeded with surgery. During the procedure, the tip of a needle broke off. The gynecologist noted the broken tip as he removed the needle and handed it to the surgical technician. The gynecologist palpated the sidewall in the presumed area of the needle tip and felt it easily. He attempted to remove the tip, but his effort was fruitless. He made the intraoperative decision to leave the tip in situ. A needle and sponge count was performed, reported as correct, and it was felt there was no indication for imaging of the pelvis. The circulating nurse filled out an incident report immediately following the surgery, noting the missing needle tip. The occurrence was discussed by the surgical committee at the hospital.
Postoperatively, while the patient was in the hospital, she was informed of the intra-operative incident.
Three months later, the patient reported vaginal and pelvic pain on the sidewall in the area of the lost needle tip, with radiating pain down the involved extremity. A segment of the TOT was noted to be protruding into the vagina, and this was addressed in the OR with “trimming of such.”
Postoperatively, again the patient reported pain on the involved side. She sought the opinion of another gynecologist, who subsequently performed surgical intervention to remove the needle tip. Her symptoms improved.
The patient sued the original gynecologic surgeon, alleging pain and suffering from the surgery involving the lost needle tip.
A defense verdict was awarded.
Medical evaluation seemed appropriate. Parity is associated with SUI (but not urge incontinence). In general, urinary incontinence is more commonly associated with a history of lower urinary tract infections. The patient in this case was asked about and evaluated for:
- stress incontinence (associated with loss of urine with sneezing, coughing, and exercise)
- urge incontinence (inability to reach the bathroom in time)
- frequency of urination, especially while sleeping
- overflow incontinence
- overall loss of bladder control.
Was information on the broken needle handled appropriately? This case explores the question of what, if any, obligation the surgeon and hospital system have to the patient when informing her of a broken needle and the intraoperative decision-making process that led to its staying in place. When such a situation occurs, which is very uncommon, should an intraoperative x-ray be performed to assess the location of the needle tip? Should the patient automatically be brought back to the OR for removal?
The surgeon’s concern was a legitimate one—that additional attempts at removal could lead to complications far worse than having a small segment of a needle left in place. After all, shrapnel, bullets, etc, remain lodged in various locations throughout the body without subsequent ill effects. He did discuss with the patient the fact that a needle segment was left in the muscle wall. But how do you assess postoperative pelvic pain in a patient who had preoperative chronic pelvic pain? These are questions we as clinicians ask. Clearly, there are no black-and-white answers, and we will call upon our legal consultants for their expertise in addressing these queries.