Objective: To evaluate the feasibility and safety of combining endometrial ablation (EA) with a thermal balloon endometrial ablation system (Gynecare Thermachoice IIIC Uterine Balloon Therapy System; Ethicon Inc., Somerville, NJ) and transcervical sterilization by intratubal insert (Essure Permanent Birth Control System; Conceptus, San Carlos, CA).
Design: Feasibility and safety studies.
Setting: University hospital in Chihuahua, Mexico.
Patient(s): There were 40 volunteers in the feasibility study and 9 in the safety study, all requiring hysterectomies for benign uterine bleeding.
Intervention(s): In the feasibility study, both procedures were performed just before hysterectomy; in the safety study, thermocouples were inserted under the tubal serosa to assess heat transmission from the intratubal insert devices to the tubes and surrounding organs during EA.
Main outcome measure(s): Completeness of EA and possible device dislodgement in the feasibility study; temperature readings in the safety study.
Result(s): No disturbance of the intratubal insert devices was noted, and EA by the thermal balloon endometrial ablation system was complete visually and histologically, although small areas near the tubal ostia exhibited less endometrial destruction. Mean tubal temperatures ranged from 37.1 degrees C to 37.5 degrees C and did not reach the critical temperature of 45 degrees C. No damage to the tubes was noted.
Conclusion(s): Performance of EA and sterilization with these two systems in a one-step approach is safe for women who require EA and permanent contraception.