Clinical UM Guideline |
Subject: Endometrial Ablation | |
Guideline #: CG-SURG-15 | Publish Date: 10/01/2025 |
Status: Reviewed | Last Review Date: 08/07/2025 |
Description |
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.
Clinical Indications |
Medically Necessary:
Endometrial ablation is considered medically necessary when the individual meets all of the following criteria (A through D):
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.
Coding |
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:
CPT |
|
58353 |
Endometrial ablation, thermal, without hysteroscopic guidance |
58356 |
Endometrial cryoablation with ultrasonic guidance, including endometrial curettage, when performed |
58563 |
Hysteroscopy, surgical; with endometrial ablation (eg, endometrial resection, electrosurgical ablation, thermoablation) |
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ICD-10 Procedure |
|
0U5B0ZZ |
Destruction of endometrium, open approach |
0U5B3ZZ |
Destruction of endometrium, percutaneous approach |
0U5B4ZZ |
Destruction of endometrium, percutaneous endoscopic approach |
0U5B7ZZ |
Destruction of endometrium, via natural or artificial opening |
0U5B8ZZ |
Destruction of endometrium, via natural or artificial opening endoscopic |
0UDB7ZZ |
Extraction of endometrium, via natural or artificial opening |
0UDB8ZZ |
Extraction of endometrium, via natural or artificial opening endoscopic |
|
|
ICD-10 Diagnosis |
|
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All diagnoses |
When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met.
Discussion/General Information |
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.
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Index |
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.
History |
Status |
Date |
Action |
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Reviewed |
08/07/2025 |
Medical Policy & Technology Assessment Committee (MPTAC) review. Revised Description, Discussion/General Information, and References sections. |
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Reviewed |
08/08/2024 |
MPTAC review. Revised Discussion/General Information and References sections. |
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Revised |
08/10/2023 |
MPTAC review. Reformatted Clinical Indications section. Revised statement regarding residual menstrual bleeding. Revised Discussion/General Information, References, and Index sections. |
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Reviewed |
08/11/2022 |
MPTAC review. References section updated. |
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Revised |
08/12/2021 |
MPTAC review. The NMN statement has been clarified to include all other conditions not listed as MN. Updated Coding and References sections. |
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Revised |
08/13/2020 |
MPTAC review. The language, “…using an FDA approved device” was removed from the MN statements. The Discussion, References and Index sections were updated. Reformatted Coding section. |
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Reviewed |
08/22/2019 |
MPTAC review. Discussion and References sections updated. |
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Revised |
09/13/2018 |
MPTAC review. MN criteria clarified in Clinical Indications section. Discussion, References, and Index sections updated. |
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Reviewed |
11/02/2017 |
MPTAC review. Discussion, References and Index sections updated. The document header wording updated from “Current Effective Date” to “Publish Date.” |
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Revised |
11/03/2016 |
MPTAC review. Medically Necessary criteria added for residual menstrual bleeding after androgen treatment in a female to male transgender person. Description, Discussion and References sections updated. |
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Reviewed |
11/05/2015 |
MPTAC review. Discussion and References sections updated. Removed ICD-9 codes from Coding section. |
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Reviewed |
11/13/2014 |
MPTAC review. Discussion and References sections updated. |
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Reviewed |
11/14/2013 |
MPTAC review. Discussion and References sections updated. |
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Reviewed |
11/08/2012 |
MPTAC review. Discussion and References sections updated. |
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Reviewed |
11/17/2011 |
MPTAC review. Coding, Discussion and References sections updated. |
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Reviewed |
11/18/2010 |
MPTAC review. Description, Discussion, References, and Index updated. |
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Reviewed |
11/19/2009 |
MPTAC review. Removed place of service. References updated. |
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Reviewed |
11/20/2008 |
MPTAC review. References updated. |
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Reviewed |
11/29/2007 |
MPTAC review. References updated. |
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Reviewed |
12/07/2006 |
MPTAC review. References and discussion updated. |
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Revised |
12/01/2005 |
MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. |
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Pre-Merger Organizations |
Last Review Date |
Document Number |
Title |
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Anthem, Inc.
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None |
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Anthem BCBS |
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None |
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WellPoint Health Networks, Inc. |
06/24/2004 |
3.09.06 |
Endometrial Ablation |
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06/24/2004 |
Clinical Guideline |
Endometrial Ablation |
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