FDA Approves New Implantable Contraceptive
Implanon releases a low dose of the hormone progestin for up to three years
TUESDAY, July 18, 2006 (HealthDay News) -- U.S. health officials have approved the only long-term implantable birth-control product for the American market.
Implanon continually releases a low dose of the hormone progestin for up to three years. The product has already been used by about 2.5 million women in more than 30 countries since 1998.
"Based on clinical trial data and our review of post-marketing data from other countries, Implanon is a highly effective contraceptive that, importantly, does not depend on patient compliance," Dr. Scott Monroe, acting director of the U.S. Food and Drug Administration's Division of Reproductive and Urologic Products, said at a Tuesday teleconference. "This is a very effective contraceptive product," Monroe said.
Health-care providers also welcomed the approval.
"More birth-control options are always welcome for women. The more options that exist, the higher the chance that an individual woman will find one that works for her," said Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City. "Implanon represents one type of birth control that is ideal for the woman who doesn't want to worry about birth control every day, every month."
Implanon is the first implantable birth-control device available in the United States since Norplant, which was voluntarily removed from the market by the manufacturer, Wyeth, in 2002. Problems with Norplant surfaced in 2000, when it was revealed that certain lot numbers of the product did not contain enough progestin to adequately prevent pregnancy.
Monroe said he did not anticipate similar problems with Implanon.
For one thing, Implanon consists of a single rod, about the size of a matchstick, versus Norplant's six rods. "The lesser number of rods is going to reduce the problems that were associated with both insertion and removal," Monroe said.
Implanon is made of medical polymer and is inserted under the skin on the inner side of a woman's upper arm during an office procedure, Monroe explained.
"The product will require a small surgical procedure both for implantation and removal," he said. "Generally, this can be quickly accomplished in the health-care provider's office with a little local anesthetic."
After removal, the woman rapidly returns to her previous level of fertility.
Implanon does not protect against HIV or other sexually transmitted diseases and also carries with it the possibility of irregular or no bleeding.
In clinical trials in the United States, only six pregnancies occurred, all of them within two weeks of removal of the product. This translates into less than one pregnancy per 100 women per year of use, Monroe said.
Experts can't be sure if the pregnancies occurred before the product was removed or after, but, for the sake of caution, are assuming they occurred before.
"It is conceivable that there were no pregnancies that occurred while implants were in place in clinical trials," Monroe said. "We know from post-marketing data that there are situations where the implant was in place where there was an occasional pregnancy. Like anything else, this is not 100 percent effective, but it's certainly highly effective."
Women enrolled in the trial were no more than 130 percent of their ideal body weight, raising the question of whether the product is also effective for overweight women. Post-marketing data from other countries, however, does not indicate that pregnancies occurred only in heavy women, Monroe said.
The product's manufacturer, Organon USA, is launching a comprehensive training program for health-care providers later this year. Only those providers who have been through the training program will be able to order Implanon.
The company hasn't decided on a price for Implanon, but said it would cost less than three years of most other contraceptive methods. The company anticipates that Implanon will become widely available in 2007.
For more on Implanon, visit Family Planning Australia.