Clinical UM Guideline

This document addresses endometrial ablation. Ablation or destruction of the endometrium is used to treat abnormal uterine bleeding. The U.S. Food and Drug Administration (FDA) has approved multiple devices for endometrial ablation using a variety of approaches, including, but not limited to: laser, electrical wire loop, rollerball using electric current, thermal ablation using a liquid-filled balloon, microwaves, electrode array, or cryosurgery.

Medically Necessary:

Endometrial ablation is considered medically necessary when the individual meets all of the following criteria (A through D):

1. Is premenopausal; and
2. Has abnormal uterine bleeding; and
3. Has any one of the following:
   1. Failed prior hormone therapy; or
   2. Declined hormone therapy; or
   3. Contraindications to hormone therapy;
      and
4. Has no evidence of polyps or other surgically correctable cause of bleeding on sonogram or hysteroscopy.

Endometrial ablation is considered medically necessary for treatment of residual menstrual bleeding resulting from medically necessary gender affirming androgen therapy.

Not Medically Necessary:

Endometrial ablation is considered not medically necessary when the criteria above have not been met.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met.

Summary

Evidence from randomized controlled trials and observational studies demonstrates that endometrial ablation (EA) reduces heavy menstrual bleeding with outcomes comparable to hysteroscopic techniques. Second‑generation ablation systems achieve similar clinical endpoints while reducing operating time and enabling outpatient procedures under local anesthesia. Cochrane reviews encompassing multiple trials report bleeding reduction or amenorrhea in many treated individuals. Regulatory surveillance data indicate low overall complication rates with device‑specific adverse event profiles. Long‑term cancer surveillance studies show no increased risk of endometrial or breast malignancies. Population‑based analyses indicate that approximately one‑fourth to one‑third of individuals undergo hysterectomy within a decade or more following ablation, with younger age and complex uterine pathology associated with higher reoperation rates. Comparative trials demonstrate equivalent reductions in bleeding between EA and the levonorgestrel-releasing intrauterine system, with lower rates of surgical reintervention following ablation. Professional societies recommend EA after unsuccessful medical therapy in individuals who have completed childbearing, with emphasis on appropriate patient selection and pre‑procedure evaluation.

Discussion

Evolution of Techniques

Roller ball electrosurgery was the earliest hysteroscopic approach to EA, and it provided the benchmark for subsequent device clearances by the FDA (Laberge, 2017). The FDA approval of subsequent devices, designed explicitly for the purpose of endometrial ablation, was at least partially based on results of randomized trials that compared outcomes from these newer devices with those of roller ball ablation techniques, and in general these studies suggested equivalent reductions in abnormal uterine bleeding. Hysteroscopic techniques now include Nd:YAG laser, monopolar resection, and roller ball instruments, each used under direct uterine visualization. Non hysteroscopic, or second generation, systems include thermal balloon devices (ThermaChoice^® Uterine Balloon Therapy System [J and J Ethicon Gynecare, Somerville, New Jersey]), cryosurgical devices (Her Option™ Uterine Cryoablation Therapy™ System [CooperSurgical^®, Trumbull, Connecticut]), radio frequency devices (NovaSure^® Endometrial Ablation System [Hologic, Inc., Marlborough, Massachusetts]), microwave systems (Microsulis Microwave Endometrial Ablation System [Microsulis Medical, Waterloo, United Kingdom]), and hydrothermal ablation devices (Hydro ThermAblator^® Endometrial Ablation System [Boston Scientific Corp., Marlborough, Massachusetts]). These devices have been reported to simplify the learning curve for operators. Procedures are frequently performed in outpatient settings with paracervical block or oral analgesia.

Professional Society Guidance: United States

The American College of Obstetricians and Gynecologists (ACOG) advises that EA is appropriate only after medical therapy fails or is contraindicated and when childbearing is complete, with malignancy excluded before treatment (ACOG, 2013, reaffirmed 2019). A Society for Gynecologic Surgeons (SGS) systematic review supports EA for ovulatory or endometrial bleeding disorders yet recommends hysterectomy when assurance of amenorrhea, less pain or avoidance of further therapy is preferred (Wheeler, 2012). The American College of Radiology (ACR) assigns EA a rating of usually not appropriate in most fibroid scenarios because treatment failure is higher in the presence of submucosal fibroids, while it considers the procedure possibly appropriate when a solitary 3-centimeter intramural fibroid coexists with diffuse adenomyosis (ACR, 2018). The Endocrine Society notes that EA may be used for persistent bleeding in testosterone treated transgender individuals who meet criteria for gonadectomy (Hembree, 2017).

Professional Society Guidance: International

In 2024, the Society of Obstetricians and Gynecologists of Canada (SOGC) reaffirmed recommendations for EA to treat benign abnormal uterine bleeding unresponsive to medical therapy and added a consensus recommendation that ablation may be undertaken at the same sitting as hysteroscopic removal of intracavitary lesions, although the new recommendation was based on a limited evidence consensus statement (Leyland, 2024). These positions illustrate general agreement on the need for careful cavity assessment but differing views on the sequence of lesion removal and ablation.

Effectiveness

A Cochrane review of 28 trials including 4287 participants found no clinically important difference in treatment success between first- and second-generation modalities. First-generation ablation devices require direct hysteroscopic visualization and include roller ball or loop electrode ablation. Second-generation devices do not require direct visualization and include thermal balloon, microwave, thermal free‐fluid, radiofrequency and cryotherapy ablation. This review found that second-generation EA are easier to learn and to perform, are equally safe and effective, and require a mean 14 minute shorter operating time (Bofill, 2019).

A 2023 Cochrane overview that combined direct and network evidence across 27 randomized studies ranked second-line options for heavy menstrual bleeding by 1 year participant satisfaction. Minimally invasive hysterectomy held the highest probability of being most satisfactory, open hysterectomy ranked second, while non-resectoscopic second generation endometrial ablation techniques occupied an intermediate position, outperforming resectoscopic ablation and all medical therapies including the levonorgestrel-releasing intrauterine system (LNG-IUS). The odds of being very or somewhat satisfied were roughly 8-fold higher with minimally invasive hysterectomy and about 1.6-fold higher with non resectoscopic ablation when each was compared with the LNG-IUS, underscoring that ablation offers clinically meaningful but not maximal participant reported benefit (Rodriguez, 2023).

The randomized trial of the Minerva^® Endometrial Ablation System (Minerva Surgical, Redwood City, California) demonstrated a 93% success rate and 72% amenorrhea rate at 12 months, exceeding roller ball results with a mean treatment time of 3 minutes (Laberge, 2017). Earlier objective performance criteria testing of Minerva, based on a Food and Drug Administration analysis of success rates from 5 previously approved devices, showed that 96% of participants achieved pictorial blood loss assessment chart scores of 75 or lower and that nearly 70% achieved amenorrhea at 1 year (Laberge, 2015). In a single center adenomyosis cohort, bleeding was reduced by approximately two thirds at 3 years, although one fourth of participants experienced recurrence between years 1 and 3 (Philip, 2018). Long term data from the MIRA trial revealed that EA and the LNG-IUS resulted in similarly low median scores zero (0) on the pictorial blood loss assessment chart, indicating minimal menstrual bleeding. However, the cumulative rate of reintervention was lower after EA because repeat ablations were not required in that arm (Huijs, 2024).

Safety

Review of 829 Manufacturer and User Facility Device Experience (MAUDE) reports indicated that genital tract or skin burns accounted for the majority of adverse events, with hydrothermal devices responsible for nearly all injuries, whereas radio frequency devices were implicated in most reports of sepsis and thermal injuries to bowel or the uterine wall (Brown, 2012). Four deaths were reported, 2 after radio frequency ablation, 1 after thermal balloon therapy and 1 after cryotherapy. A population‑based cohort analysis comparing 4776 individuals who underwent EA to 229,945 who received medical management found no significant difference in endometrial cancer rates (age‑adjusted hazard ratio [HR], 0.61; 95% confidence interval, 0.20 to 1.89) or time to diagnosis (median 237 days after ablation vs. 299 days with medical management) over a median follow‑up of 4 years (Dood, 2014). A Finnish registry study of individuals (n=5484) found no significant increase in overall cancer incidence and reported standardized incidence ratios below 1 for both endometrial and breast cancer, suggesting no excess malignancy risk after EA (Soini, 2017). Thermal balloon ablation showed similar complication rates in individuals with and without prior cesarean section, with no procedure-related uterine rupture in the cesarean cohort (Enzelsberger, 2024). A multicenter series of bipolar radio frequency ablation documented an 85% success rate, a 4.5% overall complication rate and satisfaction that exceeded 80% even among individuals with prior transverse cesarean deliveries (Alvarez López, 2025).

Long Term Durability

A 2021 Cochrane review of 10 trials offers a nuanced perspective on outcomes following endometrial resection/ablation versus hysterectomy (EA/ER), acknowledging the varying profiles of different hysterectomy approaches. While this review found no clear evidence of a material difference in the overall rate of serious adverse events when comparing EA/ER to open hysterectomy or minimally invasive hysterectomy, it noted that open or unspecified hysterectomy was associated with a greater risk of infection or serious bleeding. There were no significant differences in the rates of adverse events for EA/ER compared to minimally invasive hysterectomy. The review also noted that individuals generally returned to usual activities sooner after ablation than after any hysterectomy approach, a key advantage for shared decision-making. However, this faster recovery was balanced by lower long-term durability. Moderate-certainty evidence from the analysis showed that repeat surgery for treatment failure occurred in about 13% of individuals within 12 months of ablation, compared with none after total hysterectomy. The risk of needing a reintervention remained significantly higher (a risk ratio of 16.75) 2 years after EA/ER compared to minimally invasive hysterectomy. This information is crucial for contextualizing the subsequent hysterectomy rates reported in large cohort and registry studies (Rodriguez, 2021).

A retrospective cohort of 901 individuals treated with EA/ER between 1990 and 1997 reported that 23% later underwent hysterectomy. Three fourths of those procedures occured within 5 years of ablation, indicating durable benefit for most participants over more than 2 decades (Kalampokas, 2017).

A claims analysis of 76,446 United States individuals treated from 2002 through 2017 showed a cumulative hysterectomy incidence of 16% at 5 years, 23% at 10 years and 29% at 15 years, with younger age, complex bleeding diagnosis, and prior abdominal surgery increasing risk. Additional surgeon experience slightly reduced the risk for reintervention (McGee, 2024).

Prospective data for the AEGEA Vapor System™ (currently known as the Mara™ Water Vapor Ablation System [CooperSurgical^®, Trumbull, Connecticut]) demonstrated that 79% of participants met bleeding endpoints at 12 months and that more than 90% were satisfied, with no serious device related events (Levie, 2019).

The Cerene^® Cryotherapy Device (Channel Medsystems, Inc., Emeryville, California) program reported no serious device related events and sustained menstrual and quality of life improvements through 3 years, although 12 hysterectomies and 5 pregnancies were recorded between years 1 and 3 (Curlin, 2021; Curlin, 2022).

Some of the above studies involve the use of the ThermaChoice Uterine Balloon Therapy System and the Microwave Endometrial Ablation System. Those devices are no longer available in the United States.

Peer Reviewed Publications:

1. Alvarez López C, González Paredes A, Martínez Morales S, et al. Retrospective study on the outcomes and satisfaction with endometrial ablation by bipolar energy (NovaSure®) for the treatment of heavy menstrual bleeding. Arch Gynecol Obstet. 2025; 311:385-393.
2. Amso NN, Stabinsky SA, McFaul P, et al. Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-center study. International Collaborative Uterine Thermal Balloon Working Group. Br J Obstet Gynaecol. 1998; 105(5):517-523.
3. Angioni S, Pontis A, Nappi L, et al. Endometrial ablation: first- vs. second-generation techniques. Minerva Ginecol. 2016; 68(2):143-153.
4. Berman JM, Krewson DP, Livingston JM, et al. Analysis of the safety and reliability of a hydrothermal ablation system: a multicenter, prospective postmarket study. J Reprod Med. 2014; 59(5-6):299-305.
5. Brown J, Blank K. Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions. Obstet Gynecol. 2012; 120(4):865-870.
6. Cooley S, Yuddandi V, Walsh T, et al. The medium- and long-term outcome of endometrial ablative techniques. Eur J Obstet Gynecol Reprod Biol. 2005; 121(2):233-235.
7. Cooper K, Breeman S, Scott NW, et al. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomized controlled trial. Lancet. 2019; 394(10207):1425-1436.
8. Corson, SL. A multicenter evaluation of endometrial ablation by Hydro ThermAblator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001; 8(3):359-367.
9. Curlin HL, Anderson TL. Endometrial cryoablation for the treatment of heavy menstrual bleeding: 36-month outcomes from the CLARITY study. Int J Womens Health. 2022; 14:1083-1092.
10. Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021; 28(4):899-908.
11. Dood RL, Gracia CR, Sammel MD, et al. Endometrial cancer after endometrial ablation vs medical management of abnormal uterine bleeding. J Minim Invasive Gynecol. 2014; 21(5):744-752.
12. Enzelsberger S, Reinthaller A, Grimm C. Thermal balloon endometrial ablation in women with and without previous cesarean section: a retrospective cohort study. Arch Gynecol Obstet. 2024;309(3):967-972.
13. Famuyide AO, Laughlin-Tommaso SK, Shazly SA, et al. Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): a clinical and economic analysis. PLoS One. 2017;12(11):e0188176.
14. Hopkins MR, Laughlin-Tommaso SK, Wall DJ, et al. Hysterosalpingography after radiofrequency endometrial ablation and hysteroscopic sterilization as a concomitant procedure. Obstet Gynecol. 2015; 126(3):628-634.
15. Huijs E, Bongers MY, Van Vliet HA, et al. Endometrial ablation versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding: long-term results of the MIRA randomized controlled trial. Am J Obstet Gynecol. 2024; 230(3):352.e1-352.e11.
16. Kalampokas E, McRobbie S, Payne F, Parkin DE. Long-term incidence of hysterectomy following endometrial resection or endometrial ablation for heavy menstrual bleeding. Int J Gynaecol Obstet. 2017; 139(1):61-64.
17. Klebanoff JS, Patel NR, Sloan NL. Utility of anesthetic block for endometrial ablation pain: a randomized controlled trial. Am J Obstet Gynecol. 2018; 218(2):225.e1-225.e11.
18. Laberge P, Garza-Leal J, Fortin C, et al. A randomized controlled multicenter US Food and Drug Administration trial of the safety and efficacy of the Minerva endometrial ablation system: one-year follow-up results. J Minim Invasive Gynecol. 2017; 24(1):124-132.
19. Laberge P, Garza-Leal J, Fortin C, et al. One-year follow-up results of a multicenter, single-arm, objective performance criteria-controlled international clinical study of the safety and efficacy of the Minerva endometrial ablation system. J Minim Invasive Gynecol. 2015; 22(7):1169-1177.
20. Levie MD, Chudnoff SG. A prospective, multicenter, pivotal trial to evaluate the safety and effectiveness of the AEGEA vapor endometrial ablation system. J Minim Invasive Gynecol. 2019; 26(4):679-687.
21. McGee D, Fields K, Kisuule I, et al. Fifteen-year risk of hysterectomy after endometrial ablation in the United States. Obstet Gynecol. 2024; 143(3):184-192.
22. Meyer WR, Walsh BW, Grainger DA, et al. Thermal balloon and roller ball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998; 92(1):98-103.
23. Philip CA, Le Mitouard M, Maillet L, et al. Evaluation of NovaSure^® global endometrial ablation in symptomatic adenomyosis: a longitudinal study with a 36 month follow-up. Eur J Obstet Gynecol Reprod Biol. 2018; 227:46-51.
24. Sambrook AM, Elders A, Cooper KG. Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomized controlled trial. BJOG. 2014; 121(6):747-753.
25. Soini T, Rantanen M, Paavonen J, et al. Long-term follow-up after endometrial ablation in Finland: cancer risks and later hysterectomies. Obstet Gynecol. 2017; 130(3):554-560.
26. Vilos GA, Fortin CA, Sanders B, et al. Clinical trial of the uterine thermal balloon for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 1997; 4(5):559-565.
27. Vitagliano A, Bertin M, Conte L, et al. Thermal balloon ablation versus transcervical endometrial resection: evaluation of postoperative pelvic pain in women treated for dysfunctional uterine bleeding. Clin Exp Obstet Gynecol. 2014; 41(4):405-408.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American College of Obstetricians and Gynecologists. ACOG committee opinion no. 557: Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. Obstet Gynecol. 2013 (Reaffirmed 2019); 121(4):891-896.
2. American College of Radiology. ACR appropriateness criteria for abnormal uterine bleeding. Updated 2018. https://acsearch.acr.org/docs/69451/Narrative/. Accessed on July 18, 2025.
3. Bofill RM, Lethaby A, Grigore M, et al. Endometrial resection and ablation techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019;(1):CD001501.
4. Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine treatment of gender-dysphoric/gender-incongruent persons: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2017; 102(11):3869-3903.
5. Fergusson RJ, Bofill RM, Lethaby A, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019; (8):CD000329.
6. Leyland N, Wolfman W, Allaire C, et alLeyland N, Wolfman W, Allaire C, et al.; SOGC Clinical Practice-Gynaecology Committee. Guideline No. 453: Endometrial Ablation in the Management of Abnormal Uterine Bleeding. J Obstet Gynaecol Can. 2024;46(9).
7. Rodriguez MI, Padrón SL, Martin-Serrano M, et al. Endometrial resection/ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2021;11(11):CD000329.
8. Rodriguez MI, Padrón SL, Martin-Serrano M, et al. Second-line treatments for heavy menstrual bleeding. Cochrane Database Syst Rev. 2023;12(12):CD013843.
9. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. AEGEA Vapor System (AEGEA Medical, Inc. Redwood City, CA). P160047. Rockville, MD: FDA. June 14, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pma&id=394194. Accessed on  July 18, 2025.
10. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Cerene^® Cryotherapy Device (Channel Medsystems, Inc. Emeryville, CA). P180032. Rockville, MD: FDA. March 28, 2019. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180032a.pdf. Accessed on  July 18, 2025.
11. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Her Option Uterine Cryoablation Therapy^™ System (Cooper Surgical, Inc. Trumbull, CT). P000032. Rockville, MD: FDA. April 20, 2001. Available at: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pma&id=319995. Accessed on  July 18, 2025.
12. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Minerva Endometrial Ablation System (Minerva Surgical, Redwood City, CA). P140013. Rockville, MD: FDA. July 27, 2015. Available at: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pma&id=320585. Accessed on  July 18, 2025.
13. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. NovaSure Impedance Controlled Endometrial Ablation System (Hologic, Inc. Marlborough, MA). P010013. Rockville, MD: FDA. Sept. 28, 2001. Available at: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pma&id=320033. Accessed on July 18, 2025.
14. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Cerene Cryoablation Device (Channel Medsystems, Inc. Emeryville, CA). P180032. Rockville, MD: FDA. March 28, 2019. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180032B.pdf. Accessed on July 18, 2025.
15. U.S. Food and Drug Administration (FDA). Premarket Approval (PMA) database. Summary of Safety and Effectiveness. Minitouch 3.8 Era System (Minitouch System [MicroCube, LLC, Fremont, CA]). P230002. Rockville, MD: FDA. July 28, 2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230002B.pdf. Accessed on July 18, 2025.
16. Wheeler TL 2nd, Murphy M, Rogers RG, et al.; Society of Gynecologic Surgeons Systematic Review Group. Clinical practice guideline for abnormal uterine bleeding: hysterectomy versus alternative therapy. J Minim Invasive Gynecol. 2012; 19(1):81-88.

AEGEA Vapor System
Cerene Cryotherapy Device
Endometrial Ablation
Genesys HTA^™ System
Her Option Uterine Cryoablation Therapy System
Hydro ThermAblator System
Intrauterine Ablation
Laser Ablation of the Endometrium
Mara Water Vapor Ablation System
Minerva Endometrial Ablation System
Minitouch System
NovaSure Impedance Controlled Endometrial Ablation System
Rollerball Ablation of the Endometrium

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

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