Newsday (New York), October 10, 2006
Contraceptive implant now available in the U.S.
By ELLEN MITCHELL
Implanon, a contraceptive recently approved by the Food and Drug Administration, is the only implantable contraceptive now being marketed in the United States.
It comes in the form of a single, thin, polymer rod, no bigger than a matchstick, that is inserted under the skin of a woman's upper arm. And there it remains, almost unnoticeable, for up to three years, providing up to 99.9 percent protection against pregnancy, according to its manufacturer, Organon USA.
"They wanted to produce a novel, long-acting method of contraception that doesn't take any action on the part of the woman day by day," said Dr. Jill Rabin, chief of the division of ambulatory care and the head of urogynecology at Long Island Jewish Medical Center in New Hyde Park.
"This is an implant that will last for three years, and for women who may forget to take their [contraceptive] product, it will still be active."
Implanon is expected to become widely available in this country early next year. Health care providers must complete a clinical training session in how to insert and remove the small, flexible rod before they can offer it to their patients.
Rabin has already received that training and will soon be instructing others to do it. "It's not difficult," she said.
Procedure takes minutes
During an in-office procedure lasting only minutes, the clinician numbs a small area of the upper arm and then inserts the rod. Removal also takes just minutes and must be done by a health care professional. The contraceptive rod can be removed at any time before the end of the three-year life of the implant, and clinical trials have shown that the woman will quickly return to the same fertility level she had before getting the implant.
The implant slowly and constantly releases a small amount of a progestin known as etonogestrel, which does not contain estrogen. Progestin is a synthetic hormone similar to the progesterone made by a woman's ovaries. It works by inhibiting the release of an egg for fertilization and also by thickening the cervical mucus to prevent sperm from entering the uterus.
Before FDA approval, Implanon was tested on more than 2,300 women in this country. However, since 1998 it has been used by 2.5 million women in other parts of the world.
Implanon vs. Norplant
For 10 years starting in 1991 there was another implantable contraceptive rod on the market, which also was inserted in a woman's upper arm. That product, known as Norplant and produced in the United States by Wyeth Pharmaceuticals, consisted of a set of six small silicone capsules filled with a synthetic progestin called levonorgestrel. Norplant was withdrawn from the U.S. market in 2002 after reports of serious side effects, and some lawsuits claiming strokes and blindness.
The progestin used in Implanon is not the same as that used in Norplant.
Implant's side effects
During the clinical trials for Implanon 3.6 percent of the participants reported some swelling and redness of the arm at the insertion site. The most common side effect was irregular bleeding. Periods for most of the women became fewer and lighter, and some women stopped menstruating completely. Some others experienced longer and heavier periods. After about a year of the contraceptive's use, about a third of the implant users reported having no periods at all.
Any hormonal contraceptive can be associated with blood clots, and women using such contraceptives are advised not to smoke so as not to increase the risk of cardiovascular side effects. They are also warned that Implanon does not protect against any sexually transmitted diseases, including HIV.
The cost for the implant is expected to be comparable to the cost of three years of other hormonal contraceptives.
"Providing there are no surprises," Rabin said, "Implanon should become extremely popular." She intends to start offering it to patients at LIJ as soon as it becomes available at the hospital.