News for Your Practice

Endometrial ablation devices: How to make them truly safe

Author and Disclosure Information

Nonhysteroscopic, minimally invasive ablation devices are not entirely benign. Recognizing that fact is the first step toward a solution.


 

References

CASE: Leaking fluid causes intraoperative burns

G.S. is a 45-year-old mother of three who is admitted for surgery for persistent menorrhagia. She has experienced at least two menstrual periods every month for several months, each of them associated with heavy bleeding. She has a history of hypothyroidism and hypertension, but no serious disease or surgery, and considers herself to be in good physical and mental health.

G.S. undergoes endometrial hydrothermablation (HTA) under general inhalation anesthesia. After the HTA mechanism is primed, the heating cycle is started, with a good seal and no fluid leaking from the cervix.

Approximately 8 minutes into the procedure, a 5-mL fluid deficit is noted, and a small amount of hot fluid is observed to be leaking from the cervical os. Examination reveals a thermal injury to the cervix and anterior vaginal wall. The wound is irrigated with cool, sterile saline, and silver sulfadiazine cream is applied. The patient is discharged.

Could this injury have been avoided? Is further treatment warranted?

A minimally invasive operation does not necessarily translate to minimal risk of serious complications. Although few studies of nonhysteroscopic endometrial ablation techniques report any complications,1,2 Baggish and Savells3 found a number of injuries when they searched hospital records and the Food and Drug Administration (FDA) database (TABLE). They identified serious complications associated with the following devices:

  • HydroThermablator (Boston Scientific), which utilizes a modified operating hysteroscope to deliver 10 to 12 mL of preheated saline into the uterus under low pressure.4 Complications: 16 adverse events were reported to the FDA, 13 of which involved the retrograde leakage of hot water, causing burns to the cervix, vagina, and vulva. Six additional injuries not reported to the FDA were identified at a single institution.
  • Novasure (Cytyc), which employs bipolar electrodes that cover a porous bag.5,6 Complications: 32 injuries, 26 of them uterine perforations.
  • Thermachoice (Gynecare), a fluid-distended balloon ablator.7 Complications: 22 injuries included retrograde leakage of hot water after balloon failure and transmural thermal injury, with spread to, and injury of, proximal structures. One death was reported.
  • Microsulis (MEA), which uses microwave energy to ablate the endometrium.8-10 Complications: 19 injuries, including 13 thermal injuries to the intestines.

Baggish and Savells3 initiated this study after discovering six adverse events within their own hospital system utilizing a single device (HTA). Because these injuries were not reported to the FDA, the overall number of complications is likely higher than the figures given here.

This article describes the proper use of nonhysteroscopic endometrial ablation devices, the best ways to avert serious injury, and optimal treatment when complication occurs.

TABLE

Complications associated with 4 endometrial ablation devices

COMPLICATIONHYDRO THERMABLATOR*THERMACHOICENOVASUREMICROSULIS
Uterine perforation232619
Intestinal injury1113
Retrograde leakage burn196
Infection/sepsis121
Fistula/sinus11
Transmural uterine burn1
Cervical stenosis81
Cardiac arrest11
Death1
Other major314
Total22223220
* Includes author’s data; 6 retrograde leaks
Collateral injury

CASE continued: Patient opts for hysterectomy

In the case just described, G.S. was examined 1 week after surgery and found to have an exophytic burn over the entire right half of the cervix, extending into the vagina. She was readmitted for 3 days of intravenous (IV) antibiotic treatment and wound care. Computed tomography imaging showed gas formation within the damaged cervix.

Six weeks after surgery, the patient was still menstruating heavily, but her cervix and vagina had healed. Six months later, she underwent total abdominal hysterectomy for continued menorrhagia.

When is endometrial ablation an option?

Indications for endometrial ablation using a nonhysteroscopic, minimally invasive technique are no different from those for hysteroscopic ablation.11 Abnormal, or dysfunctional, uterine bleeding is the principal reason for this operation. Dysfunctional bleeding is heavy or prolonged menses over 6 months or longer that fail to respond to conservative measures and occur in the absence of tumor, pregnancy, or inflammation (ie, infection).

A woman who meets these criteria should have a desire to retain her uterus if she is to be a candidate for a nonhysteroscopic, minimally invasive technique. She also should understand that ablation can render pregnancy unlikely and even pathologic. Her understanding of this consequence should be documented in the chart! Last, she should be informed that ablation will not necessarily render her sterile, so contraception or sterilization will be required to avoid pregnancy. This should also be clearly documented in the medical record.

Next Article: