FDA Approves New IUD

W A S H I N G T O N, Dec. 7 -- A contraceptive IUD that releases tiny amounts of a hormone has won Food and Drug Administration approval.

Called Mirena, the device prevents pregnancy for five years. Ithas long been popular in Europe.

A More Modern IUD

While the FDA called it just another option for birth control,some women’s advocates call Mirena a more modern IUD that may helpre-ignite Americans’ interest in intrauterine devices.

IUDs sit in the uterus to block conception. Worldwide, they arethe most popular birth control device. But Americans were largelyscared away from IUDs by the Dalkon Shield, which was blamed forpainful infections, miscarriages and some deaths before it wasbanned in 1975.

Others IUDS Also Available

Americans can already buy the Paragard IUD, also known as a“copper-T” IUD, which provides 10 years of birth control.

Mirena works through the traditional IUD design and by releasingtiny amounts of the hormone levonorgestrel into the uterus. It’sabout 99 percent effective at preventing pregnancy, but the abilityto become pregnant quickly returns when Mirena is removed, saidmanufacturer Berlex Laboratories.

The FDA cautioned that women should not use Mirena if they havea history of pelvic inflammatory disease or a previous ectopicpregnancy. Nor does Mirena prevent sexually transmitted diseases.

Some Side Effects for New IUD

Berlex said other side effects include breast tenderness,nausea, headaches and mood changes, which generally disappearwithin four months of the IUD’s insertion.

In the first few months after Mirena’s insertion, women mayexperience bleeding between menstrual cycles — but after that, manywomen’s periods become shorter and lighter or even disappear,something the FDA listed as a side effect but that some women maycall a benefit.

Berlex said Mirena will begin selling early next year but didnot disclose a price.