A 39-year-old G2P1102 presented to her gynecologist with a complaint of pelvic pressure. She had regular menses and no loss of urine. Her history was significant only for a postpartum bilateral tubal ligation 2 years earlier.
The woman’s examination revealed prolapse of the uterus, with the cervix visible at the introitus. An ultrasound performed by the physician 1 week after her initial presentation revealed a 4.8 4.5 6.8-cm left ovarian cyst. The physician recommended a laparoscopically assisted vaginal hysterectomy (LAVH) and left salpingo-oophorectomy (SP).
The woman was presented with several options for management, including a total abdominal hysterectomy and left salpingo-oophorectomy. The gynecologist reviewed the risks of surgery and potential complications. All the patient’s questions were answered and operative permissions were signed.
The surgery was scheduled for 1 week later.
During surgery, insertion of the Veress needle was without incident. However, upon insertion of the umbilical trocar, profuse bleeding was noted and the patient became bradycardic and hypotensive and experienced cardiac arrest.
She was resuscitated, following which, the gynecologist made a midline vertical incision and noted a laceration in the area of the aorta. A general surgeon was consulted, who could not fully control the bleeding. Thus, pressure was applied to the aorta and the patient was transferred to a tertiary hospital 40 minutes away that had a vascular surgeon.
Upon arrival at the tertiary hospital, the patient was taken immediately to surgery. The vascular surgeon noted transaction of the anterior wall of the common iliac artery encompassing almost half the diameter of the artery. Also noted was a duodenal serosal tear, presumably from the pressure held during transport.
The vascular surgeon also noted thrombi of the common iliac artery, and the right and left iliac arteries. The surgeon repaired the vascular injury with an end-to-end anastomosis, and performed right and left iliofemoral thrombectomies, as well as from the common iliac artery, restoring flow to the right and left common iliac arteries. He then noted that both the patient’s feet had good capillary refill.
The duodenal laceration was repaired without consequence. The patient had a relatively uncomplicated recovery, with the exception of residual neuropathy in her right leg and hip, with foot drop that persisted despite months of occupational and physical therapy.
Approximately 9 months after the attempted LAVH, the patient sought the care of another gynecologist, who noted that her uterus was protruding to the introitus with valsalva.
An ultrasound was obtained, which was interpreted as normal, with no pelvic or ovarian masses or cysts. The physician recommended a total vaginal hysterectomy. Despite being “scared to death,” the patient elected to go forward with the procedure, which was performed without incident. Surgical findings stated that “both tubes and ovaries appeared normal.”
Ultimately, the patient filed suit against the original gynecologist, alleging inadequate and inappropriate preoperative evaluation, improperly performed surgery, with resultant complications, long-term physical deficits, pain and suffering, and loss of life’s enjoyment.
Deposition of the defendant gynecologist revealed several potential concerns.
When questioned if it would be an option to wait and see if the cyst would go away on its own, the gynecologist stated, “I would not consider that to be an option in this case. I was trained that anything over 5 cm is a problem.”
During questioning about the performance of the surgery, the gynecologist described a closed-entry technique, using a Veress needle. A saline-drop test was used to confirm intraperitoneal placement of the Veress needle.
The opening pressure was 7 mmHg. To establish the pneumoperitoneum, the abdomen was insufflated with 2 L of CO2. When questioned if the surgeon insufflates to a particular pressure, for example 15 or 20 mmHg, the gynecologist replied that he does not use a pressure cut off. His reasoning was that “nobody is ever totally relaxed.”
is Professor of Obstetrics and Gynecology and former Chair at the University of Mississippi Medical Center. He is a graduate of the University of Denver College of Law and is a nationally and internationally recognized expert in gynecology ultrasound and minimally invasive surgery.
He actively consults on legal matters in medicine, including liability in ultrasound and gynecologic surgery, as well as issues surrounding privileging and insurance fraud.
Following establishment of the pneumoperitoneum, the patient was placed in Trendelenburg, her abdomen was elevated with the surgeon’s hand, and the trocar was inserted at a 45º angle into the pelvis. The gynecologist suspected that the vascular injury occurred with insertion of the trocar.
In reviewing the gynecologist’s surgical experience, he stated that he had performed thousands of laparoscopies and had assisted on or performed LAVHs since 1990. It was noted that the physician had completed his residency in 1984.
Unfortunately, he could not document any formal continuing education courses, nor additional training or education in ultrasound or more advanced laparoscopy since that time. The physician was board-certified and was current with his maintenance of certification.
The plaintiff’s ultrasound expert reviewed the original ultrasound images and noted a 6.80 4.86 4.49-cm simple, unilocular cyst, consistent with a persistent follicular cyst or a serous cyst.
This expert opined that the current recommendation for follow-up of such a cyst in reproductive-aged women is a repeat ultrasound in 2 to 6 months. Thus, immediate intervention was not indicated. Subsequently, prior to the TVH, an ultrasound revealed that the cyst had completely resolved, confirming that surgical intervention for the ovarian cyst was not required.
Thus, one could have avoided the risk of laparoscopy altogether, particularly with the primary surgical indication of uterine prolapse.
The plaintiff’s laparoscopy expert noted several breeches in the standard of care. Although a closed-entry technique, and even a direct-insertion technique without a pneumoperitoneum, is an acceptable alternative, the method the defendant described was not within the standard of care. Insufflating a specific amount of CO2, for example 2 L, is not adequate.
Contrary to the defendant’s statement, patients are paralyzed for the procedure, and thus, they are totally relaxed. One cannot assume that 2 L of CO2 provides an adequate pneumoperitoneum in all patients. Thus, current practice is to infuse enough CO2 to establish an intraperitoneal pressure of 12 to 15 mmHg prior to insertion of the primary trocar.
In fact, many surgeons insufflate to a pressure of 20 mmHg for initial trocar insertion, reducing this pressure to 12 to 15 mmHg for placement of the secondary trocars. Inadequate intraperitoneal distension subjects the patient to a greater risk of vascular injury, as occurred in this case.
The placement of a patient in Trendelenburg for insertion of the umbilical trocar is not currently recommended. The Trendelenburg position places the aorta and the common iliac vessels in direct line with insertion of a trocar at a 45º angle.
Although this was common practice in the past, current recommendations, literally for several decades, are to maintain the patient in a supine position, with the abdominal wall elevated, for insertion of the umbilical trocar, only changing to the Trendelenburg position for insertion of the secondary trocars.
The plaintiff’s expert opined that placing the patient in the Trendelenburg position for insertion of the umbilical trocar was a breech of the standard of care. Doing so places the patient at risk for the exact vascular injury encountered in this case.
No criticisms were levied against the care of the general surgeon, the vascular surgeon, or the subsequent postoperative care and rehabilitative services. Thus, the defense focused on the criticisms levied against the preoperative evaluation and the surgical technique.
In evaluating the defensibility of the case, the identified lack of documented continuing education and additional surgical training placed the case defense at risk. Unfortunately, proceeding to trial posed a significant risk of losing the case, with subsequent exorbitant damages. It was elected to settle the case prior to trial for $900,000.
This case highlights the importance of remaining cognizant of current literature and surgical practices. All too often, physicians fail to remain current in the various areas of their practices.
One would assume that maintenance of certification would allow physicians to stay current in their practice. However, ongoing education in specific practice areas may be required. Ultrasound, a valuable adjunct to our care of patients, is rapidly changing.
The approach to adnexal masses is constantly evolving, with consensus guidance for management available. In this case, the physician’s lack of awareness of these newer guidelines impacted the preferred management option: observation. If there is any question about diagnosis or management, one can always seek a second opinion from a more experienced sonologist.
As in this case, this functional cyst resolved, negating the need for an abdominal approach. Thus, the physician could have pursued a vaginal hysterectomy, the preferred route, which was ultimately performed, avoiding the risk of laparoscopy.
The need to adapt one’s surgical techniques is particularly true in the rapidly changing surgical environment of minimally invasive surgery. Changes in accepted techniques were not adopted in the current case.
With the physician’s lack of documented continuing education and additional surgical training, this case was at greater risk. The cited breeches rendered the case one with a significant risk of losing at trial. Thus, the best perceived option was settlement.
About the Author
Dr. Shwayder is an Adjunct Professor at the University of Florida. He is a graduate of the University of Denver College of Law and is a nationally and internationally recognized expert in gynecology ultrasound and minimally invasive surgery. He actively consults on legal matters in medicine, including liability in ultrasound and gynecologic surgery, as well as issues surrounding privileging and insurance fraud.