Balloon Tx works over long term: Ablation results after 5 years.

SAN FRANCISCO -- Five-year follow-up data on women with menorrhagia randomized to treatment with either balloon or roller-ball ablation found that bleeding was still well controlled in nearly 70% with either treatment.

Those data, obtained from telephone interviews, add to earlier follow-up data on portions of the original cohort in the randomized, multicenter study that led to U.S. approval of the Gynecare Thermachoice uterine balloon therapy system.

Of the original cohort, 214 were available for follow-up at 3 years, and 147 completed the current 5-year follow-up questionnaire, Dr. Franklin D. Loffer Jr., said in a poster presentation at the annual meeting of the American Association of Gynecologic Laparoscopists.

The poster placed first in the poster competition at the meeting.

Since the beginning of the study, a total of 48 women--half in the rollerball group and half in the balloon group--failed therapy Of the 147 patients who were followed for 5 years, 25 had failed treatment, requiring an additional operative procedure between years 3 and 5.

Still, many of these women who were considered ablation failures had fibroids or uterine prolapse at the time of hysterectomy, so these additional procedures may have been unrelated to the success or failure of the ablation, noted Dr. Loffer of Phoenix, Ariz., and a former paid consultant to Gynecare.

The remaining 122 women (61 in each group) did not have a hysterectomy, repeat ablation, or D&C.