AI Article Synopsis
- The evolution of surgical treatments for dysfunctional uterine bleeding has led to the development of minimally invasive devices that are safe and easy to use, moving beyond the traditional hysterectomy approach used prior to 1981.
- From the mid-1980s to the 1990s, techniques like operative hysteroscopy and endometrial ablation became popular, prompting the design of specialized ablation devices approved for clinical use in the last decade.
- The review discusses how these devices are evaluated by the FDA, highlights their reported efficacy and complications, examines potential long-term risks, and outlines the costs associated with disposable and non-disposable device components.
Article Abstract
Unlabelled: 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.
Target Audience: Obstetricians & Gynecologists, Family Physicians
Learning Objectives: 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.
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| http://dx.doi.org/10.1097/00006254-200212000-00003 | DOI Listing |
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