Ablation or destruction of the endometrium is used to treat abnormally heavy uterine bleeding, also known as menorrhagia. Endometrial ablation is typically preceded by hormonal treatment to thin the endometrium. The U.S Food and Drug Administration (FDA) has approved devices for endometrial ablation which include, but may not be limited to: laser therapy, electrical wire loop, rollerball using electric current, and thermal ablation using a liquid-filled balloon, microwave, electrode array, or a cryosurgical device.

Medically Necessary:

Endometrial ablation, using an FDA approved device, is considered medically necessary for premenopausal women with dysfunctional uterine bleeding (menorrhagia or menometrorrhagia) who have failed prior hormone therapy, declined hormone therapy or have contraindications to hormone therapy and who have no evidence of polyps or other surgically correctable cause of bleeding on sonogram or hysteroscopy. 

Not Medically Necessary: 

Endometrial ablation is considered not medically necessary for women:

• Who are pregnant or desire pregnancy in the future;
• With a history of endometrial cancer or pre-cancerous histology;
• With an active genital or urinary tract infection at the time of the procedure;
• With active pelvic inflammatory disease;
• With an intrauterine device (IUD) currently in place;
• With any anatomic or pathologic uterine condition that would preclude ablation.

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.

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Endometrial ablation was originally performed using rollerball ablation. FDA approval of subsequent devices designed explicitly for the purposes of endometrial ablation has been based in part on the results of randomized trials comparing the results of newer devices with rollerball ablation. In general, these studies have suggested equivalent outcomes in terms of reduction in menorrhagia.

Examples of devices approved by the FDA for endometrial ablation are:

• The ThermaChoice^® device (J &J Ethicon Gynecare, Somerville, NJ): Ablates endometrial tissue by thermal energy heating of sterile injectable fluid within a silicone balloon. This technique of ablation will only work when there is direct contact between the endometrial wall and the fluid-filled balloon. Therefore, women with uteri of abnormal shape, such as those with myomas, polyps or large size due to fibroids, are generally not considered candidates for the use of this device.
• Her Option^™ Uterine Cryoablation Therapy^™ System (American Medical Systems, Minnetonka, MN): The system consists of, in part, a cryoprobe that is inserted through the cervix into the endometrial cavity. When cooled, an ice ball forms around the probe, which permanently destroys the endometrial tissue. Cryoablation is typically monitored by abdominal ultrasound.
• The Hydro ThermAblator^® System (Boston Scientific, Natick, MA): The system involves the instillation and circulation of heated saline into the uterus using hysteroscopic guidance. The Genesys HTA^™ system (also Boston Scientific) is a newer version of this technology that includes features such as a smaller console and simplified set-up requirements.
• The Microwave Endometrial Ablation (MEA) system (Microsulis Medical, Waterloo, UK); Delivers fixed frequency microwave energy to ablate the endometrium. The system involves inserting a microwave probe into the uterine cavity, which is moved from side to side, to heat and destroy the endometrium.
• The NovaSure^™ Impedance Controlled Endometrial Ablation System (Cytyc Corp, Marlborough, MA): Consists of an electrode array on a stretchable porous fabric that conforms to the endometrial surface.

There are two groups of techniques typically available for performing endometrial ablation: hysteroscopic procedures and non hysteroscopic procedures. The following have been used for hysteroscopic endometrial ablation: Nd:YAG laser, resecting loop using electric current, and electrosurgical rollerball instruments. The following have been used for non hysteroscopic endometrial ablation: thermal balloon devices, cryosurgical or radiofrequency devices, and microwave endometrial ablation systems.

Guidance on endometrial ablation has been issued from several U.S. organizations including the American College of Obstetricians and Gynecologists (ACOG) and the Practice Committee of the American Society for Reproductive Medicine (ASRM).

ACOG (2007) recommendations which were assessed as being based on good and consistent evidence include:

• For women with normal endometrial cavities, resectoscopic endometrial ablation and nonresectoscopic endometrial ablation systems appear to be equivalent with respect to successful reduction in menstrual flow and patient satisfaction at 1 year following index surgery.
• Resectoscopic endometrial ablation is associated with a high degree of patient satisfaction but not as high as hysterectomy.

 In 2008, the Practice Committee of the ASRM reviewed their 2006 Practice Committee report and reissued their statement on indications and options for endometrial ablation. Conclusions were:

• Endometrial ablation is an effective therapeutic option for the management of menorrhagia.
• Hysteroscopic and nonhysteroscopic techniques for endometrial ablation offer similar rates of symptom relief and patient satisfaction.
• Later definitive surgery may be required in 6% to 20% of women after endometrial ablation.
• Women who undergo hysterectomy after a failed endometrial ablation report significantly more satisfaction after 2 years of follow-up.
• Endometrial ablation generally is more effective when the endometrium is relatively thin.
• Ideally, hysteroscopic methods for endometrial ablation should be performed using a fluid monitoring system to reduce the risks and complications relating to fluid overload and electrolyte imbalance.
• Nonhysteroscopic methods for endometrial ablation require less skill and operating time.

Peer Reviewed Publications:

1. Amso NN, Stabinsky SA, McFaul P, et al. Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centre study. International Collaborative Uterine Thermal Balloon Working Group. Br J Obstet Gynaecol. 1998; 105(5):517-523.
2. 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.
3. 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.
4. Lethaby A, Hickey M, Garry R. Endometrial destruction techniques for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD001501. DOI: 10.1002/14651858.CD001501. pub2.
5. Meyer WR, Walsh BW, Grainger, et al. Thermal balloon and roller ball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998; 92(1):98-103.
6. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American College of Obstetricians and Gynecologists. Endometrial Ablation. 2007 ACOG Practice Bulletin No. 81. Available at: http://www.guidelines.gov/summary/summary.aspx?ss=15&doc_id=10918&nbr=5698=string=. Accessed on September 15, 2011.
2. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Her Option^™ Uterine Cryoablation Therapy^™ System. 2000. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p000032. Accessed September 15, 2011.
3. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Hydro ThermAblator^® Endometrial Ablation System. 2001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P000040. Accessed September 15, 2011.
4. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Microsulis Microwave Endometrial Ablation (MEA) System. 2003. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P020031. Accessed on September 15, 2011.
5. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. NovaSure^™ Impedance Controlled Endometrial Ablation System. 2001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p010013. Accessed September 15, 2011.
6. National Institute for Clinical Excellence (NICE). Balloon thermal endometrial ablation. 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_99. Accessed September 15, 2011.
7. National Institute for Clinical Excellence (NICE). Free fluid thermal endometrial ablation. 2004. Available at: http://www.nice.org.uk/page.aspx?o=IP_124. Accessed September 15, 2011.
8. National Institute for Clinical Excellence (NICE). Microwave endometrial ablation. 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_65. Accessed on September 15, 2011.
9. National Institute for Clinical Excellence (NICE). Photodynamic endometrial ablation. 2004. Available at: http://www.nice.org.uk/page.aspx?o=IP_78. Accessed September 15, 2011.
10. National Institute for Clinical Excellence (NICE). Impedance-controlled bipolar radiofrequency ablation for menorrhagia. 2004. Available at: http://www.nice.org.uk/guidance/index.jsp?action=byID&r=true&o=11127. Accessed September 15, 2011.
11. Practice Committee of American Society for Reproductive Medicine. Indications and options for endometrial ablation. Fertil Steril. 2008; 90(5Suppl):S236-240.

Endometrial Ablation
Her Option^™ Uterine Cryoablation Therapy^™ System
Hydro ThermaAblator^® System
Intrauterine Ablation
Laser Ablation of the Endometrium
Microwave Endometrial Ablation (MEA) system
Rollerball Ablation of the Endometrium
NovaSure^™
ThermaChoice^® 

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.