FDA: New Implantable Contraceptive Approved
According to its press release of July 18, 2006, Organon has received FDA approval for Implanon, a new implantable contraceptive . Organon's announcement was also cited recently on WebMd Medical News, and labeling requirements are listed at FDA's website.
Implanon claims to be effective for up to three years and is implanted by a health care worker inside a woman's upper arm. Organon, the maker of Implanon, says the device works "to continually release a low, steady dose of progestin . . . for a period of up to three years via a unique, state-of-the-art implantable technology. It 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 contraceptive, which has been in worldwide use since 1998 by more than 2.5 million women runs the risk of the following potential side effects: irregular bleeding, headache, acne, and mood swings. Clinical studies report "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."
As with other contraceptives, the use of cigarettes can raise the risk of heart disease and stroke in women who use hormonal contraceptives. Organon strongly advises these women not to smoke. Similarly, like other hormonal contraceptives, Implanon does not protect against AIDS or other sexually transmitted diseases.
Organon plans to sponsor a U.S. training program to instruct health care workers on how to implant the device. Organon stated that Implanon should "become more widely available in the U.S. in 2007 with implementation of the training program."