Concomitant Essure tubal sterilization and Thermachoice endometrial ablation: feasibility and safety.
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).


METHODS
Feasibility and safety studies.


METHODS
University hospital in Chihuahua, Mexico.


METHODS
There were 40 volunteers in the feasibility study and 9 in the safety study, all requiring hysterectomies for benign uterine bleeding.


METHODS
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.


METHODS
Completeness of EA and possible device dislodgement in the feasibility study; temperature readings in the safety study.


RESULTS
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.


CONCLUSIONS
Performance of EA and sterilization with these two systems in a one-step approach is safe for women who require EA and permanent contraception.
Valle
Rafael F
RF
Northwestern University Medical School, Chicago, Illinois 60611, USA. rafaelvalle1@aol.com
Valdez
Jesus
J
Wright
Thomas C
TC
Kenney
Mary
M
D000328:Adult; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004717:Endometrium / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D007044:Hysterectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D007434:Intrauterine Devices / Q000009:adverse effects; D011183:Postoperative Complications / Q000209:etiology; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D013246:Sterilization, Tubal / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome