Contraceptive Device Cleared by FDA

A small, flexible T-shaped contraceptive device has been cleared by the U.S. Food and Drug Administration (FDA). Called Mirena, the device is intended for women who prefer a long-acting but reversible contraceptive.

Mirena is inserted into the uterus by a doctor in just a few minutes. It does not contain estrogen. Instead, it releases a low dose of progestin. The device is as effective as tubal ligation (99%) and lasts for five years or until removed. Use of the device may make menstrual periods shorter and lighter.

Mirena has been used in Europe for the past 10 years. Currently, about 80% of U.S. women between 18 and 49 who use long-acting contraception choose sterilization, which is typically not reversible. After the removal of Mirena, a woman's fertility returns rapidly.
The device does not protect against HIV and other sexually transmitted diseases.

Use of intrauterine devices (IUDs) has been associated with an increased risk of pelvic inflammatory disease (PID). The highest risk of PID occurs shortly after insertion. A decision to use Mirena must include consideration of the risks of PID, say doctors. Women who use the device should have no history of ectopic pregnancy or a condition that would predispose to ectopic pregnancy. Mirena is marketed outside the United States by Schering AG (Berlin, Germany).



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