Abstract
Objective: The aim of this study was to determine the number and types of complications associated with the use of minimally invasive nonhysteroscopic methods of endometrial ablation. Method: The Food and Drug Administration (FDA) website was searched and complications associated with the Hydrothermablator, Thermachoice, Novasure, and Microwave ablation devices were tabulated. Additionally, complications associated with the Hydrothermablator were tabulated within a single hospital system to compare with national data recorded by the FDA. Results: Each device was associated with a number of serious complications. Similarly, each device was observed to have particular complications, which uniquely footprinted a given instrument. The Hydrothermablator had 16 adverse events. The single hospital system compiled 6 Hydrothermablator-associated complications alone. None of the latter were included in the FDA data. The Novasure device had 32 adverse events. The Thermachoice had 22 events and 1 death. The Microwave had 20 events, among which 13 were intestinal burn injuries. Conclusions: Nonhysteroscopic ablation devices are associated with a variety of serious complications. The FDA database is incomplete and underreports these adverse events. (J. GYNECOL SURG 23:7)
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