Summary of safety and effectiveness data from FDA: a valuable source of information on the performance of global endometrial ablation devices.
OBJECTIVE
To provide an overview of the approved second-generation endometrial ablation technologies.


METHODS
Data from the FDA Summary of Safety and Effectiveness Data were compared for Thermachoice, HydroThermablator, Her Option and Novasure devices.


RESULTS
At 12 months' follow-up, Novasure and HydroThermablator had the highest amenorrhea rates. Thermochoice and Novasure had the highest success rates at 12 months. Novasure had the lowest adverse event rates in the first 24 hours, between 24 hours and 2 weeks and between 2 weeks and 1 year of follow-up.


CONCLUSIONS
Summary of Safety and Effectiveness Data, obtainable on the FDA Web site, offers objective data for comparing second-generation endometrial ablation technologies.
Cooper
Jay
J
Department of Obstetrics and Gynecology, University of Arizona School of Medicine, Phoenix, USA.
Gimpelson
Richard J
RJ
D000568:Amenorrhea; D017115:Catheter Ablation / Q000379:methods*; D004564:Electrocoagulation / Q000379:methods*; D004566:Electrodes; D004869:Equipment Safety; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006358:Hot Temperature; D006801:Humans; D020407:Internet; D053685:Laser Therapy; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data*; D014592:Uterine Hemorrhage