Presentation and physician action

In January 2012, a 40-year-old woman came to her obstetrician-gynecologist (ob-gyn) for treatment of irregular menstrual bleeding. The ob-gyn ordered an ultrasound, and the patient returned four months later to discuss the results. The ob-gyn reviewed treatment options, including oral contraceptives, a hormonal intrauterine device (IUD), and endometrial ablation with and without a permanent birth control implant. 

On June 1, 2012, the ob-gyn performed an endometrial ablation and implantation of a transcervical contraceptive tubal occlusion device (TOD).

During a follow-up visit four weeks later, the ob-gyn documented the patient’s ablation but did not mention the TOD or mention the need to schedule a 3-month postoperative hysterosalpingogram (HSG) in the visit notes. During subsequent visits, the patient’s contraception was documented as several things, including “none,” “withdrawal,” “ablation,” and “other.” 

In January 2020, the patient returned to the ob-gyn with reports of abdominal and pelvic pain. An ultrasound showed a uterine fibroid accompanied by a radiologist’s note of a “questionable vascular stent along the margin of the uterus.”

The ob-gyn told the patient that the pain was coming from either the uterus or the bowel and recommended discontinuing the hormone replacement therapy to see if symptoms improved. The ob-gyn suggested hysterectomy if pain and symptoms persisted.

When the patient asked about the stent that was described in the ultrasound note, the ob-gyn explained that what the radiologist called a stent was the TOD from the ablation procedure. The patient claimed that this was the first time she was told about the permanent sterilization device in her fallopian tubes. 

Two weeks later, after seeking a second opinion, the patient underwent a laparoscopic hysterectomy with bilateral salpingo-oophorectomy. The pathology report showed that the TOD’s left coil appeared to have been embedded in an intramural nodule and the right coil focally extended into the proximal-most aspect of the fallopian tube. 

Allegations

The patient filed a lawsuit against the ob-gyn with the following allegations:

• failure to explain the TOD procedure and obtain informed consent;
• failure to conduct the required confirmatory testing after implantation of the TOD; and
• necessitating surgical hysterectomy after the TOD procedure. 

Legal implications

The main challenge for the defense in this case was lack of documentation. The patient record was missing consent forms that showed the patient agreed to have the TOD implant along with the ablation procedure.

The available documentation presented more issues: the patient record included conflicting notes about whether the patient wanted one or both procedures, and the operative reports were still in their template form. An operative note stated that an HSG test was recommended after the placement of the TOD, and an HSG order was given to the patient. This procedure was never scheduled, and a reason was not listed in the records. 

The ob-gyn’s office had undergone several EHR changes over the years and had no back-ups from previous systems. The forms obtained by the company that contracted nursing staff during surgery were destroyed seven years after the procedure.

While the consultants and the experts for the defense generally agreed with the course of treatment, one of the consultants stated that the TOD was the cause of the patient’s pain. If the TOD had not been placed, the patient would not have needed the subsequent hysterectomy. 

Disposition

The case was settled on behalf of the ob-gyn.
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‍Risk management for obstetricians and gynecologists

‍About documentation errors

‍About communication errors