FDA OKs New Implantable Contraceptive
Device, Called Implanon, Said to Work up to 3 Years
July 18, 2006 -- The FDA today announced approval of an implantable contraceptive called Implanon, which is effective for up to three years, according to its maker, Organon.
About the size of a matchstick, Implanon is implanted by health care workers in the inner side of a woman's upper arm.
Implanon "continually releases a low, steady dose of progestin ... for a period of up to three years via a unique, state-of-the-art implantable technology," says an Organon news release. Progestin is a hormone also found in oral contraceptives, or birth control pills.
The new contraceptive can be removed "at any time at the request of the user, after which the woman's fertility returns to her pre-existing fertility level," the company states.
Implanon has been used worldwide by about 2.5 million women in more than 30 countries since 1998, says Organon.
The company will sponsor a U.S. training program to teach health care workers here how to implant the device. Implanon should become more widely available in the U.S. in 2007, as the training program progresses, according to the company.
Possible side effects include irregular bleeding, which can occur with other progestin-only contraceptives, states Organon. Other possible side effects include headache, acne, and mood swings, which also can occur with other hormonal contraceptives.
In clinical studies, less than 4% of participants had complications such as redness, swelling, and pain at the spot where Implanon was implanted. Removal complications were seen in less than 2% of participants and included broken or damaged implants and implants that had shifted slightly from their original placement.
Cigarette smoking can raise the risk of heart disease and stroke in women who use hormonal contraceptives. Those women are "strongly advised not to smoke," states Organon.
Like other hormonal contraceptives, Implanon doesn't protect against AIDS or other sexually transmitted diseases.
SOURCE: News release, Organon.