UPDATE ON TECHNOLOGY

As the manufacturers of global endometrial ablation devices note, heavy menstrual bleeding may arise from an underlying condition, such as endometrial cancer, hormonal imbalance, fibroids, coagulopathy, and so on—and it is important to rule these conditions out before considering endometrial ablation.

For example, in Case 1, the patient is experiencing anovulatory cycles, as evidenced by her irregular menses and the need for ovulation induction to achieve her pregnancies. The success rate of endometrial ablation in the setting of chronic anovulation is unknown. Pivotal trials for all of the nonhysteroscopic endometrial ablation technologies required regular menses or failure of cyclic hormonal therapy prior to enrollment.

In addition, in Case 1, the patient has signs (an enlarged, tender uterus) that suggest the presence of adenomyosis. Endometrial ablation is not recommended as a treatment for women with this condition.

3. Will later surgery be required?

In one study from Kaiser Permanente of Northern California, 21% of women who underwent endometrial ablation for menorrhagia later underwent hysterectomy, and 3.9% underwent other uterine-sparing procedures to alleviate heavy bleeding.³

In that study, women younger than age 45 were 2.1 times more likely to require hysterectomy after endometrial ablation, compared with older women (95% confidence interval [CI], 1.8–2.4). The likelihood of hysterectomy increased with each decreasing stratum of age and exceeded 40% in women aged 40 years or younger.³

In a population-based retrospective cohort study from Scotland, 2,779 (19.7%) of 11,299 women who underwent endometrial ablation for heavy menstrual bleeding required hysterectomy later.⁴ Again, women who required hysterectomy after endometrial ablation tended to be younger than those who did not. Overall, 26.6% of women undergoing endometrial ablation for heavy menstrual bleeding required further surgery.⁴

And in a 5-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation, roughly 30% of women required subsequent surgery for heavy menstrual bleeding.⁵

The need for subsequent surgery following endometrial ablation is likely to be higher among women who do not match the profile of participants in pivotal trials of the devices. All patients considering endometrial ablation should be counseled about the possible need for further surgery.

Related Article The economics of surgical gynecology: How we can not only survive, but thrive, in the 21st Century Barbara S. Levy, MD

4. What is the patient's overall health?

Before selecting an intervention for heavy menstrual bleeding, it is important to consider the patient’s overall health. What comorbidities does she have? Is pain a component of her condition? If so, might she have endometriosis or adenomyosis, as our patient does? If pain is a significant component of her menorrhagia, is it cyclical—that is, does it correspond to the days of heaviest flow? Pain related to the passage of large clots during menses may respond well to endometrial ablation. Pelvic pain occurring before and after the flow probably won’t.

Also keep in mind that the patient in Case 1 has two risk factors for endometrial hyperplasia: anovulatory cycles and obesity. If she undergoes endometrial ablation and subsequently experiences abnormal uterine bleeding, the most prominent sign of endometrial hyperplasia, how will you assess her endometrium 5 years after ablation if she develops abnormal bleeding? Will you be able to adequately sample it?

5. Have less invasive options been tried?

Many of the women studied in pivotal trials of second-generation endometrial ablation devices failed medical therapy prior to undergoing ablation. Because medical therapy is less expensive and noninvasive, it makes  sense to offer it before proceeding to surgery. Common pharmacologic approaches include nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives, and tranexamic acid.

In addition, as I mentioned earlier, Mirena is approved for treatment of heavy menstrual bleeding.

Medical therapy and Mirena should be offered prior to surgery because of their noninvasive, reversible nature. Most physicians now consider Mirena to be the first-line option for heavy menstrual bleeding in women who have normal anatomy.⁶

6. What is the cost of treatment?

With health-care expenses accelerating, we need to be mindful of the cost-effectiveness of the options we recommend.

Let’s assess the expense of managing the patient in Case 1. To address her desire for long-term contraception, we might offer tubal sterilization by laparoscopy followed by endometrial ablation (to address the heavy bleeding), which would require a general anesthetic and management in an ambulatory surgical facility.

If she opts for hysteroscopic sterilization prior to endometrial ablation, the sterilization procedure must be performed at least 3 months prior to ablation (according to FDA labeling) so that tubal occlusion can be demonstrated by hysterosalpingography (HSG) before the uterine cavity is scarred. This means that the patient would require two separate interventions. Although both procedures could be performed in an office setting, the patient would still require time away from work and family.