ASSESSMENT OF THE SAFETY OF INTRAUTERINE INSTILLATION OF HEATED SALINE FOR ENDOMETRIAL ABLATION

Objective: To evaluate the safety of pressure, temperature-controlled, continuously circulating hot saline (EnAbl(TM) system, InnerDyne Medi cal, Sunnyvale, CA) for endometrial ablation using the in vivo human u terus. Design: Clinical safety study. Setting: An academic research en vironment, Patients: Eleven women undergoing abdominal hysterectomy be cause of abnormal uterine bleeding. Intervention: Before uterine remov al, endometrial cavities were exposed to 15 minutes of recirculatory n ormal saline heated to 70-85 degrees C. Main Outcome Measure(s): The u teri were analyzed for extent of thermal damage using standard histopa thological techniques and tissue viability histochemical staining. Int rauterine pressures and serosal and subserosal temperatures were conti nuously monitored by computer. Result(s): In each treated specimen, hi stochemical staining demonstrated a depth of necrosis that extended th rough the entire endometrium and approximately 1-2 mm into the myometr ium, The control specimen showed no thermal or mechanical damage. Ther e were no observed negative effects or related complications with this system, Conclusion(s): The computer-controlled system employing conti nuously circulating hot saline is an effective method to destroy the e ndometrium. In four cases with clearly patent tubes, no spill was obse rved. In all 11 patients, serosal and subserosal temperatures were wit hin safe levels (mean temperature, 37 degrees C). ((C) 1998 by America n Society for Reproductive Medicine.).