Among the 38 million American women using some form of birth control, some have waited patiently for a new implantable contraceptive device to become available to them.
On Tuesday, the women got their wish. The FDA approved Implanon, a progestin-only contraceptive that is effective for three years after it is implanted in a woman's arm. The device is a thin plastic rod about the length of a toothpick.
"Implanon fills a unique niche that has been empty for the past few years," said Dr. David Grimes, a contraceptive expert and clinical professor of obstetrics and gynecology at the University of North Carolina at Chapel Hill.
Implanon will be the only under-the-skin birth control device available to women in the United States.
Norplant, a similar implantable contraceptive device, was approved by the FDA in 1991. However, its manufacturer, Wyeth Pharmaceuticals, discontinued it because of supply limits on its components and reported problems with removing the implants, which consisted of six rods in the arm.
FDA officials said Implanon is safe and "highly effective" at preventing unintended pregnancies. Birth control pills have lower rates of effectiveness, in part because a woman must remember to take the pill at the same time every day. With the newly approved implant, that is not a problem.
"Implanon is in the top tier of effectiveness," said Grimes, who is also vice president of Biomedical Affairs at the Family Health International, a nonprofit organization that helps develop contraceptives in the United States. "It is as effective as male and female surgical sterilization and implantable uterine devices, or IUDs."
Furthermore, it's forgettable and discreet. "You can start it and forget about it," Grimes said.
The Implanon rod will be placed and removed in a simple procedure at the doctor's office. It is implanted under the skin on the inside of the upper arm and is removed within three years. However, the patient does have to remember to get it taken out.
There were no reports of difficulty in removing Implanon from the 942 women who tested the device during the FDA's clinical trial. However, in other parts of the world, where the implant has been available for eight years, there have been rare reports of the device getting lost in a woman's arm. The FDA says the device can be found using ultrasound or MRI.
Another concern about the device is that it has not been tested in obese women. The FDA is unsure how effective Implanon would be for them.
In general, hormonal contraceptives have a higher failure rate in obese women, said Grimes. One reason is that obese women metabolize the drugs in the contraceptives differently.
Implanon is ideal for women who are not planning on having a child soon or who, for medical reasons, cannot tolerate estrogen in their contraceptives. One side effect of the device is irregular menstrual bleeding or no periods at all while using it.
Once the device is removed, a woman can become pregnant quickly, FDA officials said. They reported women getting pregnant as early as 30 days after the device is removed.
Organon USA Inc., the company that makes Implanon, has not yet determined the price for the device. Organon's spokesperson said it would likely cost less than $1,000. Compared with the price of birth control pills, which can cost around $1,800 over three years, according to Consumer Reports Web site, Implanon may save women money in the long run.
Women can expect to see the device become more widely available in 2007.