dysfunctional uterine bleeding & uterine fibroids - Health Plan of ...

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Razavi also studied 111 patients who had an UAE or a myomectomy. They concluded that the UAE was less invasive and safer than myomectomy with a shorter hospitalization, recovery time and duration of pain medication. UAE was also superior for control of menorrhagia, whereas myomectomy was superior for correction of mass/bulk effect. Both procedures were equal with respect to pain control. Of the patients who had complications, 11% were in the UAE group but 25% of the myomectomy patients had complications that were more serious and included blood transfusions, wound infections, ileus and adhesions (Razavi, 2003). According to an evidence report prepared for the Agency for Healthcare Research and Quality (AHRQ), studies comparing uterine artery embolization (UAE) with other procedures reported procedure time and length of stay favoring UAE. However, the absence of key information on longerterm outcomes suggests that the evidence base is inadequate to comment on the relative risks and benefits of UAE versus hysterectomy or myomectomy (AHRQ, 2007). Professional Societies Endometrial Ablation American College of Obstetricians and Gynecologists (ACOG) Endometrial ablation is indicated for the treatment of menorrhagia or patient-perceived heavy menstrual bleeding in premenopausal women with normal endometrial cavities who have no desire for future fertility. The various techniques appear to be equivalent with respect to successful reduction in menstrual flow and patient satisfaction at one year following index surgery (ACOG, 2007). American Society for Reproductive Medicine (ASRM) An ASRM practice bulletin states that endometrial ablation is an effective therapeutic option for the management of menorrhagia in premenopausal women. Hysteroscopic and nonhysteroscopic techniques offer similar rates of symptom relief and patient satisfaction. Endometrial ablation is not indicated in postmenopausal women, in women with endometrial cancer or hyperplasia or in premenopausal women who wish to preserve their fertility (ASRM, 2008). Magnetic Resonance Imaging-Guided Focused Ultrasound Ablation American College of Obstetricians and Gynecologists (ACOG) While short-term studies show safety and efficacy, long-term studies are needed to discern whether the minimally invasive advantage of MRI-guided focused ultrasound surgery will lead to durable results beyond 24 months (ACOG, 2008). Levonorgestrel-Releasing Intrauterine Device American College of Obstetricians and Gynecologists (ACOG) An ACOG practice guideline on the use of noncontraceptive uses of hormonal contraceptives states the following: • Combined oral contraceptives (OC) have been shown to regulate and reduce menstrual bleeding, treat dysmenorrhea, reduce premenstrual dysphoric disorder symptoms and ameliorate acne. (Evidence Level A – based on good and consistent scientific evidence.) • Hormonal contraception should be considered for the treatment of menorrhagia in women who may desire further pregnancies. (Evidence Level B – based on limited or inconsistent scientific evidence.) (ACOG, 2010) WOU001 Dysfunctional Uterine Bleeding & Uterine Fibroids Page 14 of 24
In an updated practice bulletin, ACOG states that the levonorgestrel intrauterine system leads to minimal systemic effects, and the localized endometrial effect is beneficial for treatment of menorrhagia. Small studies suggest that the levonorgestrel intrauterine system may be effective for treatment of heavy uterine bleeding in women with leiomyomas. However, these women may have a higher rate of expulsion and vaginal spotting. (ACOG, 2008) Uterine Artery Embolization American College of Obstetricians and Gynecologists (ACOG) In a committee opinion on uterine artery embolization (UAE), ACOG makes the following statement. Based on current evidence, it appears that uterine artery embolization, when performed by experienced physicians, provides good short-term relief of bulk-related symptoms and a reduction in menstrual flow. Complication rates associated with the procedure are low, but in rare cases can include hysterectomy and death. There is insufficient evidence to ensure its safety in women desiring to retain their fertility, and pregnancy-related outcomes remain understudied. ACOG considers the procedure investigational or relatively contraindicated in women wishing to retain fertility. The use of uterine artery embolization in postmenopausal women is rarely, if ever, indicated (ACOG, 2004). In a separate practice bulletin on alternatives to hysterectomy in managing uterine fibroids, ACOG states that based on long- and short-term outcomes, uterine artery embolization is a safe and effective option for appropriately selected women who wish to retain their uteri (ACOG, 2008). WOU001 U.S. FOOD AND DRUG ADMINISTRATION (FDA) Endometrial Ablation Devices for thermal ablation of the endometrium are regulated by the FDA as Class III devices that are subject to the most extensive regulations enforced by the FDA. See the following website for more information (use product codes MNB or MKN): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed June 30, 2010. The HerOption Uterine Cryoblation Therapy System received premarket approval (PMA) on April 20, 2001. The device is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. See the following website for more information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p000032. Accessed June 30, 2010. ThermaChoice received premarket approval (PMA) on December 12, 1997 for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete. See the following website for more information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=1088. Accessed June 30, 2010. Hydro ThermAblator received premarket approval (PMA) on April 20, 2001 to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom child bearing is complete. See the following website for more information: Dysfunctional Uterine Bleeding & Uterine Fibroids Page 15 of 24
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