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New IUD Can Be Used Up to 5 Years.
WASHINGTON --A highly effective, easily reversible intrauterine device that releases a low level of levonorgestrel and can be kept in place for up to 5 years will be available in the United States early this year.
The IUD, which will be marketed under the trade name Mirena, has been available in Europe for 10 years. It was approved by the Food and Drug Administration last month and will be the third IUD on the U.S. market. In studies, Mirena had a 5-year cumulative failure rate that was less than 1%, slightly below that of surgical sterilization.
IUD use among women in the United States has been extremely low, pegged at less than 1% in women who are using contraception. But some of Mirena's features could be especially appealing to certain women, according to two investigators in the U.S. trial of the device who spoke during a teleconference held by Berlex Laboratories, which is marketing the IUD.
Because of its levonorgestrel component, spotting typically occurs for 3-6 months after insertion, but then bleeding gradually decreases and after 1 year, many women have no menstrual bleeding. This is a beneficial effect that "will make IUD convenience and efficacy available to women who might not have been able to use [other IUDs] before," said Dr. Anita Nelson, medical director of the Women's Health Care Clinic at the University of California, Los Angeles.
She pointed out that there are some women who cannot use the ParaGard copper IUD because they already have heavy periods. This IUD, approved in 1988, is also extremely effective, but has the adverse effect of increasing menstrual bleeding by an average of 40%-50% and can increase cramping, according to Dr. David Grimes, another investigator in the U.S. Mirena trial.
Although the Progestasert IUD, which releases 65 [micro]g of progesterone a day and was approved in 1976, also reduces menstrual bleeding and cramping, it is approved for only 1 year of use, said Dr. Grimes, who is vice president of biomedical affairs at Family Health International, a nonprofit foundation in Research Triangle Park, N.C., dedicated to improving reproductive health.
Mirena will be a "boon" for women who have heavy menstrual periods because it is associated with a 90% reduction in monthly blood loss, and ...
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