Concomitant Tubal Sterilization and Endometrial Ablation Safe

May 11, 2005

Is concomitant sterilization using the ESSURE method with Thermachoice III endometrial ablation feasible and safe? Absolutely yes, said Rafael Valle, MD, from Northwestern University Medical School in Chicago. Data presented during the second session of Papers on Current Clinical and Basic Investigation yesterday afternoon helped convince the Food and Drug Administration to approve the combination procedure.

Is concomitant sterilization using the ESSURE method with Thermachoice III endometrial ablation feasible and safe? Absolutely yes, said Rafael Valle, MD, from Northwestern University Medical School in Chicago. Data presented during the second session of Papers on Current Clinical and Basic Investigation yesterday afternoon helped convince the Food and Drug Administration to approve the combination procedure.

"This combination procedure avoids the need for further procedures for sterilization following endometrial ablation," Dr. Valle said. "It greatly simplifies the overall treatment for both women and their physicians."

The problem, he explained, is that many women seek sterilization following endometrial ablation. The traditional choices were hysterectomy or tubal ligation. More recently, the ESSURE system was developed to deposit a small coil in each fallopian tube, causing scarring and blockage of the tube. The tubes can be implanted with a one-handed device, entering through the vagina and cervix, then into each fallopian tube in turn.

The entire sterilization can be completed in about 25 minutes. With no incision, Dr. Valle noted, the procedure can be completed under light sedation rather than general anesthesia. The device has been used by about 25,000 women worldwide since it was first approved for use in 2002.

The ThermaChoice III uses water heated to 87o C and contained within a balloon-like device inserted vaginally to ablate the endometrium. Tissue damage and death begins at temperatures above 45o C, Dr. Valle noted.

Combining the two technologies into a single procedure seems a logical step, but there were worries that the two devices might interact or that the ThermaChoice might heat the ESSURE coil and burn the fallopian tubes.

Dr. Valle's group recruited 40 volunteers who planned to undergo hysterectomy for benign uterine bleeding to test the two procedures before undergoing hysterectomy. Half the women underwent ESSURE sterilization, then ablation; the others underwent ablation, then sterilization.

The procedure was equally effective in both groups. Thermocouples placed along the serosa of the proximal tubes and uterus after ESSURE placement revealed an average maximum temperature of 37.5o, well below the danger zone. Visual and histologic examination of the extirpated uteri revealed no tissue damage to the fallopian tubes from the ThermaChoice ablation.

Valle RF. Concomitant ESSURE tubal sterilization and ThermaChoice endometrial ablation: feasibility and safety. Obstet Gynecol. 2005;105(4 suppl):6S.