Advances in endometrial ablation.
The evolution of the surgical treatment of dysfunctional uterine bleeding has resulted in the design and manufacture of instrumentation that is minimally invasive, has a low risk profile, and is technically simple to operate. Whereas hysterectomy was the only definitive surgical option before 1981, operative hysteroscopy with transcervical resection of the endometrium and rollerball ablation of the endometrium gained favor in the mid-1980s and 1990s. During the past 10 years, devices dedicated entirely to the ablation (or destruction) of the endometrium have been designed, modeled, tested, and approved for clinical use in the United States. This review describes the methods by which the technologies are evaluated and approved for clinical use by the Food and Drug Administration. In addition, the reported efficacy of each approved device is reviewed. The complications associated with the devices, as well as the potential long-term risks of endometrial ablation, also are reported. Finally, the cost for device disposables and nondisposables is presented.


BACKGROUND
Obstetricians & Gynecologists, Family Physicians


OBJECTIVE
After completion of this article, the reader will be able to list the various FDA-approved uterine ablation devices, compare the effectiveness of the various uterine ablation devices, and summarize the various adverse events associated with the use of the uterine ablation devices.
Roy
Kelly H
KH
Department of Obstetrics and Gynecology, Good Samaritan Regional Medical Center, Phoenix, Arizona 85006, USA. Kelly.Roy@bannerhealth.com
Mattox
John H
JH
D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D002986:Clinical Trials as Topic; D003452:Cryosurgery / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D016889:Endometrial Neoplasms / Q000209:etiology; D004717:Endometrium / Q000601:surgery*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology; D012107:Research Design; D013246:Sterilization, Tubal; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014592:Uterine Hemorrhage / Q000150:complications / Q000601:surgery*