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U.S. women who want a long-lasting contraceptive that they don't have to think about will have a new option beginning late next month.
Implanon, a matchstick-sized rod implanted under the skin of a woman's upper arm, releases a continuous low dose of progestin, a hormone, for three years. Organon USA, its manufacturer, announced Tuesday that the Food and Drug Administration had approved the device late Monday.
Implanon will be the only implantable birth control method in the USA. It has been used by about 2.5 million women in more than 30 countries since 1998, Organon says.
In Australia, as many as one in four women using birth control have chosen Implanon, says Philip Darney, professor of obstetrics, gynecology and reproductive science at the University of California-San Francisco.
Clinical trials involved 942 healthy women of childbearing age, says Scott Monroe, acting director of the FDA division that regulates contraceptives.
Implanon was 99% effective in the trials, making it as effective as other hormonal contraceptives, such as the pill. Only six clinical trial participants got pregnant, Monroe says, and they might have conceived right after the device was removed, not beforehand.
If a woman decides she wants to get pregnant, she can have Implanon removed at any time, and fertility appears to return quickly, Monroe says.
"It's important because it offers another option that's going to help couples avoid an unintended pregnancy," says Darney, who was involved in the clinical trials. "It's not a method that everybody is going to use, because it doesn't provide the regular menstrual bleeding that many people expect."
In 20% of trial participants, menstrual periods stopped after the first couple of months of use, Darney says. But 11% of women in the trials asked that Implanon be removed early because of irregular menstrual bleeding, Monroe said.
Only doctors who take a three-hour training course in how to implant and remove Implanon will be allowed to order it, says Frances DeSena, spokeswoman for Organon.
Training will begin in late August, and Implanon should be available throughout the country by early next year, DeSena says. She says Organon has not yet set a price, but, per month, it should be competitive with other hormonal contraceptives.
Norplant, an implantable contraceptive consisting of six rods, came on the market in 1991, but Wyeth, its maker, stopped selling it in 2000.
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