1. Aetna considers endometrial ablation medically necessary for women who meet all of the following selection criteria:

   1. Menorrhagia* unresponsive to (or with a contraindication to) either:

      1. Hormonal therapy or other pharmacotherapy; or

      2. Dilation and currettage;

      (Note: The degree of severity and persistence of the menorrhagia and the failure of prior treatment should be such that the member would otherwise be a candidate for a hysterectomy.)

      and

   2. Endometrial sampling has excluded cancer, pre-cancer, or structural abnormalities (polyps, fibroids) that require surgery; and

   3. Pap smear and gynecologic examination have excluded significant cervical disease.

   Aetna considers endometrial ablation experimental and investigational for all other indications.

   Aetna considers the following endometrial ablation approaches to be established for treatment of women who meet the selection criteria set forth above:

   1. Cryoablation (freezing)
   2. Electrosurgical ablation (e.g., electric rollerball, resecting loop with electric current, triangular mesh with electrical current)
   3. Laser
   4. Radiofrequency ablation
   5. Thermoablation (e.g., thermal fluid-filled balloon, heated saline)
   6. Microwave endometrial ablation

   7. Chemical ablation with trichloroacetic acid.

2. Aetna considers photodynamic endometrial ablation experimental and investigational because there is insufficient scientific evidence to support its effectiveness.

See also CPB 304 - Fibroid Treatment.

Menorrhagia (excessive uterine bleeding) affects approximately 20% of women of reproductive age. It may be due to many causes, including hormonal disorders, fibroids, tumors, or other problems.  Pharmacotherapy and surgery are the mainstay treatments.  Most commonly, hormonal and non-hormonal medications are followed by dilatation and curettage, and ultimately, in many cases, hysterectomy.

Endometrial ablation techniques have evolved as an alternative to hysterectomy.  Ablation techniques (e.g., laser, resecting loop with electric current, electric rollerball, thermal fluid-filled balloon, radiofrequency, freezing, heated saline) remove some of the lining of the uterus in an attempt to control excessive bleeding.  After endometrial ablation, pregnancy is not likely to occur.

The early techniques of endometrial ablation, introduced in the 1980s and still used today involve the use of a hysteroscope with either a "rollerball" or wire loop through which electrical heat travels to remove (resection) the endometrial lining.  After the uterus is filled with fluid to enlarge it for better viewing, the surgeon moves the rollerball back and forth across the lining or uses the wire loop to shave off the tissue.  Potential risks of this ablation method include infection, perforation of the uterus, cervical laceration, and fluid overload.

Bren (2001) reviewed some of the new methods of endometrial ablation.  In 1997, the FDA approved ThermaChoice, the first non-hysteroscopic ablation device to treat excessive uterine bleeding (menorrhagia) due to benign (non-cancerous) causes.  The ThermaChoice Uterine Balloon Therapy System (Gynecare, Somerville, NJ) consists of a balloon that is inserted through the neck of the cervix and into the uterus.  Through a catheter connected to a controller console, the balloon is inflated with fluid and heated to 188°F (87°C) for eight minutes to destroy the uterine lining.

In 2001, the FDA approved three more similar devices.  These devices are to be used only in women who have not yet reached menopause and whose childbearing is completed. The Hydro ThermAblator (BEI Medical Systems Inc, Teterboro, NJ) delivers heated saline solution into the uterus. The heated saline solution is delivered using hysteroscopic guidance.  The heated solution destroys the uterine lining in about 10 minutes.

The Her Option Uterine Cryoblation Therapy System (CryoGen Inc., San Diego, CA) uses a cryoprobe capable of producing temperatures down to minus 148°F (minus 100°C) at the tip.  This extreme cold is applied to the tissue for 10 minutes to freeze and destroy the uterine lining. Ultrasound is used to guide and monitor the procedure.

The NovaSure Impedance Controlled Endometrial Ablation System (Novacept, Palo Alto, A) uses a metallic mesh triangular electrode that is expanded out of a slender tube into the uterus.  A gentle suction brings the tissue into close contact with the triangular electrode, which delivers electrical current to the endometrial tissue, causing its destruction in about 90 seconds. With this method, there is no hysteroscope or ultrasound, so the physician cannot view the uterus during the procedure.

Common side effects after endometrial ablation include nausea, vomiting, and a vaginal discharge that can last from days to weeks. Complications of ablation are rare, but may include blood loss requiring a transfusion, perforation of the uterus, or unintended damage to other internal organs.

An assessment conducted by the National Institute for Clinical Excellence (NICE, 2003) concluded that microwave endometrial ablation is an established method.  In reaching this conclusion, NICE considered a Cochrane systematic review of endometrial destruction techniques.  The systematic review concluded that women undergoing thermal ablation techniques had a similar reduction in bleeding and were as satisfied as women having hysteroscopic resection of the endometrium.  The advantages of thermal ablation techniques were that general anesthesia was not required, and the procedures were quicker and easier to perform.  The systematic review did not come to any conclusions about the relative advantages and disadvantages of the different thermal endometrial destruction techniques.  The NICE assessment noted that other studies found that between 70 and 80 % of women having microwave endometrial ablation were satisfied, and that 95 % of women had returned to normal activities within 3 weeks of having the procedure.

Photodynamic endometrial ablation involves injecting a photosensitive chemical into the uterine cavity through a hysterosalpingography catheter.  A probe inserted through the cervix uses a laser to activate the photosensitive chemical, which destroys the endometrium.  It can often be carried out under local anesthetic on a day-case basis.  An assessment conducted for the NICE (2003) concluded that current evidence on the safety and efficacy of photodynamic endometrial ablation does not appear adequate to support the use of this procedure outside formal research.  The NICE's conclusions were based on the "extremely limited" evidence of the safety and effectiveness of this procedure.

In a prospective, randomized, controlled study, Kucuk and Okman (2005) assessed the effectiveness of trichloroacetic acid (TCA) instillation into uterine cavity for the treatment of patents with dysfunctional uterine bleeding (DUB).  A total of 90 women were randomized to receive only TCA or receive a single dose of gonadotropin-releasing hormone analog 1 month before the procedure.  All subjects underwent an evaluation that included cycle history, body mass index measurement, and transvaginal ultrasonography of pelvis, diagnostic hysteroscopy and endometrial biopsy.  At the end of 12 months, amenorrhea rates in group 1 and group 2 were 26.7 % versus 31.1 %, with pooled amenorrhea, hypomenorrhea, and eumenorrhea rates of 95.6 % versus 97.8 %, respectively.  There was no significant difference between the groups' vis-à-vis post-procedure results.  More than 90 % of women who had this procedure were satisfied with the results.  There were no observed negative effects or related complications with this treatment.  These investigators concluded that an instillation of TCA into uterine cavity produced acceptable results and provided conservative management of DUB.  This is in agreement with the findings of a randomized controlled trial by Kucukozkan et al (2004) who reported that endometrial ablation by TCA may readily be performed as an alternative method in the treatment of DUB.  These investigators also noted that suppression of endometrium with danazol or especially with goserelin acetate before chemical ablation with TCA resulted in significant success rate.

An assessment by the National Institute for Health and Clinical Excellence (NICE, 2006) found limited short-term evidence on the safety and effectiveness of endometrial cryotherapy for menorrhagia appears adequate to support the use of this procedure in carefully selected patients.  Specialist advisors to NICE stated that the evidence from randomized controlled clinical trials is limited, and that this procedure was one of a number of ablation techniques that uses different energy.  The specialist advisors to NICE stated that the procedure appears to be safe, but there are no data available on the incidence of major complications.  The theoretical adverse events include thermal injury to the cervix and vagina.  Anecdotal adverse events include persistent discharge and endometritis.