Ablation or destruction of the endometrium is used to treat menorrhagia which is abnormally heavy uterine bleeding.  Multiple devices using various energy sources have been used: (1) the neodymium-yttrium aluminum garnet (Nd-YAG) laser; (2) a resecting loop using electric current; (3) electric rollerball; and (4) thermal ablation devices, including high-frequency radiofrequency (RF) probes, cryoprobes, liquid-filled balloons, multi-electrode balloons, microwave energy and installation of heated saline.  Endometrial ablation is typically preceded by hormonal treatment to thin the endometrium.

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.

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.

The following devices have been specifically approved by the FDA for endometrial ablation. The ThermaChoice® device 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, patients with uteri of abnormal shape, such as 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 is an FDA approved device consisting 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 involves the instillation and circulation of heated saline into the uterus using hysteroscopic guidance. The NovaSure™ Impedance Controlled Endometrial Ablation System consists of an electrode array on a stretchable porous fabric that conforms to the endometrial surface.

The following techniques require hysteroscopic guidance: Nd:YAG laser, resecting loop, rollerball using electric current or thermal ablation. The following techniques do not require hysteroscopic guidance: liquid-filled balloon, cryosurgical or radiofrequency devices.

Most recently, the feasibility of endometrial ablation using photodynamic therapy (PDT) has been proposed, however, there are no published, well designed clinical studies to support the clinical efficacy and safety of this technique.

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. 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 October 8, 2009.
2. 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/cfPMA/pma.cfm?id=12953. Accessed October 8, 2009.
3. 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 October 8, 2009.
4. 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 October 8, 2009.
5. National Institute for Clinical Excellence (NICE). Balloon thermal endometrial ablation. 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_99. Accessed October 8, 2009.
6. National Institute for Clinical Excellence (NICE). Free fluid thermal endometrial ablation. 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_124. Accessed October 8, 2009.
7. National Institute for Clinical Excellence (NICE). Microwave endometrial ablation. August 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_65. Accessed on October 8, 2009.
8. National Institute for Clinical Excellence (NICE). Photodynamic endometrial ablation. 2003. Available at: http://www.nice.org.uk/page.aspx?o=IP_78. Accessed October 8, 2009.
9. 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 October 8, 2009.

Endometrial Ablation
Her Option™ Uterine Cryoablation Therapy™ System
Hydro ThermaAblator® System
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.