New Birth Control Implant Approved by FDA
July 19, 2006 — -- 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.