SOMERVILLE, N.J., July 28 /PRNewswire/ -- A new study published in the July 2006 issue of Journal of Reproductive Medicine shows that global endometrial ablation (GEA) is more cost-effective than oral contraceptives or hysterectomy to treat dysfunctional uterine bleeding (DUB), a condition affecting approximately 20% of reproductive age women.
"Best practice guidelines agree that treatment of DUB should begin with the least invasive option, which is oral contraceptives (OCs)," said lead author Michael Broder, MD. "However, OCs produce regular menses in only about 47 percent of women. Our study found that the most cost-effective method was a three-month trial of OCs followed by endometrial ablation."
In the study the authors used a third-party payer perspective to examine the cost-effectiveness of various treatments over an 18-month period, allowing sufficient time to capture the costs associated with short-term complications and retreatment. Successful treatment was defined as a score of less than 100 on the pictorial blood loss assessment chart (PBAC), a commonly reported objective measurement of heavy menstrual bleeding in clinical trials.
"The efficacy and safety profile of GEA suggests that it should receive greater consideration relative to current medical therapies, "said Dr. Broader. "Studies have demonstrated that early ablation can help to achieve higher levels of patient satisfaction and improvement in health-related quality of life, as compared to medical treatment."
The study was funded by ETHICON Women's Health & Urology, makers of the GYNECARE THERMACHOICE* Uterine Balloon Therapy system, a treatment for heavy menstrual bleeding (menorrhagia) due to benign causes in premenopausal women who have completed childbearing.
The treatment, which has been used in more than 400,000 women, uses heat to treat the lining of the uterus during a short, minimally invasive procedure that can be performed with a local anesthetic.
Long-term follow-up studies show that five years after treatment, 95 percent of women still reported normal bleeding or less, and 93 percent of women said they remained satisfied with the treatment. Overall, nearly 7 out of 10 patients avoided further surgical intervention for menorrhagia, such as hysterectomy, dilation and curretage (D&C) or repeat endometrial ablation.
GYNECARE THERMACHOICE Uterine Balloon Therapy is not recommended for women who still want to have children. Since there is a chance pregnancy could occur, contraception or sterilization should be used after treatment. All medical procedures carry risks. Rare, but possible safety risks include, blood loss, heat burn of internal organs, electrical burn, perforation (hole) or rupture of the wall of the uterus, and leakage of heated fluid from the balloon or tissue into the cervix.
ETHICON Women's Health & Urology, is a division of ETHICON, Inc., a Johnson & Johnson company. For more information about GYNECARE THERMACHOICE, please visit www.gynecare.com
*Trademark of ETHICON, Inc.
ETHICON, Inc.CONTACT: Jackie Jankewicz, +1-908-218-2764
Web site: http://www.gynecare.com/
