Two New Endometrial Ablation Devices Approved.

Fewer women will end up with unnecessary hysterectomies now that the Food and Drug Administration has approved two new devices for treating abnormal bleeding, experts told this newspaper.

"This is an important development because it offers more options to women with abnormal bleeding. Many are either suffering unnecessarily or resorting to unnecessary hysterectomies," said Dr. David Olive, an ob.gyn. in group practice in San Mateo, Calif.

"They are definitely going to change medical practice," agreed Dr. Joseph Krotec of the Jefferson Medical College in Philadelphia.

Both newly approved devices are endometrial ablators designed to reduce or eliminate bleeding by destroying the lining of the uterus. The Hydro ThermAblator, manufactured by BEI Medical Systems Inc., uses heated saline; the Her Option Uterine Cryoblation Therapy system, manufactured by CryoGen Inc., uses cryotherapy to destroy tissue.

The standard of care for abnormal bleeding is to begin with medical treatment because it preserves a woman's fertility.

But for women who are not concerned about fertility or for whom medical treatment has not worked, classic endometrial ablation methods-either surgical resection or rollerball ablation--have been advised before hysterectomy. The problem with these classic methods is that they are technically very difficult, Dr. Krotec explained.

"Many gynecologists are not com fortable with these techniques. They are difficult to do, they take a lot of skill, and there is a lot of potential for injury so that, in the end, many [gynecologists] choose to treat their patients with hysterectomy," he said.