Endometrial ablation devices: How to make them truly safe

Endometrial ablation may also be an alternative to hysterectomy for a mentally retarded woman who is unable to manage menses. Abnormal uterine bleeding in conjunction with bleeding diathesis, significant obesity, or serious medical disorders can also be treated by endometrial ablation.

Avoid endometrial ablation in certain circumstances

These circumstances include the presence of endometrial hyperplasia, endometrial cancer, endocervical neoplasia, cervical stenosis, an undiagnosed adnexal mass, moderate to severe dysmenorrhea, adenomyosis, or a uterine cavity larger than 10 cm.^12-15

Valle and Baggish¹⁵ reported eight cases in which women developed endometrial carcinoma following ablation, and identified the following major risk factors for postablation cancer:

• endometrial hyperplasia unresponsive to progesterone or progestin therapy
• complex endometrial hyperplasia
• atypical hyperplasia.

These conditions are contraindications to endometrial ablation.

Avoid a rush to ablation

The growing popularity of office-based, minimally invasive, nonhysteroscopic techniques, coupled with an increasing desire for and acceptance of elective cessation of menses, may stretch the indications listed above and cut short the discovery of contraindications. Clearly, thorough endometrial sampling and precise histopathologic interpretation are required before embarking on any type of endometrial ablation, to minimize the risk of complications.

How to prevent injury

Reduce the risk of perforation

Uterine perforation occurs for a variety of reasons:

• position of the uterus is unknown
• uterus has not been gently and carefully sounded
• cervix is insufficiently dilated to permit passage of the probe
• device is too long (large) to be accommodated in an individual patient’s uterus
• uterine cavity is distorted by pathology, such as adhesions, myomas, etc.

Attention to these details before surgery can prevent perforation.

When uterine injury occurs, the bowel is also at risk

The intestines can be injured following perforation or transmural injury of the uterus. Bowel injury has been reported with hysteroscopic ablation and resection as well as with Nd-YAG laser ablation.^16-18

Do not activate hot water or electrosurgical energy unless you are 100% certain that the device is within the uterine cavity.

Ideally, manufacturers’ safety studies should guarantee no risk of transtubal spillage of hot liquid.

Hot fluid adds to risk of burns

Devices that permit retrograde leakage of hot fluid, such as the HTA, should be modified to ensure sealing at the level of the external and internal cervical os. The Enable device (Innerdyne), no longer marketed in the United States, had such a sealing mechanism, which minimized retrograde leakage of hot water.

Balloon failure may be an unavoidable injury, but pretesting of the device and careful attention to pressure readings—particularly in a small uterus—may mitigate the risk.

Be alert for electrical leakage

The microwave device operates at the megahertz range of frequency. At this high frequency, the risk of leakage is much greater than with devices that operate in the kilohertz range. Therefore, it is important to pay close attention to grounding sites, such as cardiovascular-monitoring electrodes.

High-power monopolar devices, prolonged application of energy to tissue, and high generator frequency are all associated with leakage and subsequent burns.

Early recognition and treatment are vital to ensure the patient’s safety and reduce the risk of medicolegal liability. I recommend the following steps:

• Stop the procedure immediately if perforation is suspected. If you suspect that hot water has been dispersed within the abdominal cavity, switch to laparotomy and consult a general surgeon to inspect the entire intestine for injury. If perforation occurs during the use of electrosurgical energy, the same action is warranted. If uterine perforation occurs in isolation (ie, there is no thermal energy compounding the problem), admit the patient for careful observation, appropriate blood chemistries and hematologic studies, and radiologic examination.
• When hot liquids are spilled, switch to retrograde flow immediately and generously flush the vulva, vagina, and cervix with cold water. Cleanse the entire area with a soapless detergent, and apply clindamycin cream to the vagina and silver sulfadiazine cream to the vulva. Admit the patient for application of cold compresses, ice packs, and burn therapy, and obtain baseline cultures and hematologic studies and a plastic surgery consult. If third-degree (full thickness) burns are suspected, treat any suspected wound infection aggressively after obtaining cultures. Severe and inordinate pain should be investigated as a possible sign of necrotizing fasciitis. After discharge, follow the patient’s progress at weekly intervals.
• Talk to the patient and her family. It is a good idea to explain the complication in very clear terms. I believe it is reasonable to explain how the complication occurred, without speculation or theatrical explanations. Also be sure to document this conversation, including date and time. It may be useful to have a neutral witness present during the conversation. By and large, the patient and her family are likely to appreciate an honest account of how the complication occurred. Hiding data or attempting to cover up the injury may motivate the patient to seek legal representation.