Microwave ablation device clears FDA advisory panel: some user-related complications reported.(Menorrhagia Treatment)

GAITHERSBURG, MD. -- The first microwave endometrial ablation device for treating menorrhagia in premenopausal women was recommended for approval with conditions by a federal advisory panel.

The unanimous decision by the nine voting members of the Food and Drug Administration's Obstetrics and Gynecology Devices Panel hinged largely on steps already taken by Microsulis, the Hampshire, England-based manufacturer of the device, to virtually eliminate the risk of transmural burns that occurred with commercial use of the device outside the United States. Such injuries involved uterine perforations and bowel wall damage, which in some cases required bowel resection.

The FDA usually follows the recommendations of its advisory panels.

If the device, known as the Microsulis Microwave Endometrial Ablation (MEA) system, is approved, women will most likely require an ultrasound before the procedure to determine the minimum thickness of their myometrium. Hysteroscopy after cervical dilation and before insertion of the applicator may also be required. Physicians who want to use the device would be required to undergo training with an experienced doctor and to have experience in diagnostic hysteroscopy.

MEA is intended only for women who have completed childbearing.

The panel's decision was based on findings from a multicenter, U.S.-based, randomized controlled study of 324 patients showing no significant difference in successful treatment outcomes between MEA and rollerball endometrial ablation (REA).

A successful outcome was defined as a reduction in monthly bleeding, according to the pictorial blood loss assessment chart, from a score of at least 185 to a score of 75 or less at 12 months.