Jul 20, 2006 10:34
FDA approves implantable contraceptive
Implanon can be inserted into woman's arm for up to three years
The Associated Press
WASHINGTON - Implanon, a rod-shaped contraceptive implanted in the upper arm
for up to three years, received federal approval, health officials said
Tuesday.
Food and Drug Administration approval clears Organon USA to sell the birth
control rod in the United States, agency spokeswoman Susan Cruzan said.
Implanon, which can stop menstruation in many women, has been sold in more than
30 countries since 1998.
The matchstick-sized implant releases a low, steady dose of progestin to
prevent pregnancy. The rod is inserted by a doctor under the skin of the upper
arm. It can be removed at any time, according to the company, a unit of
Netherlands-based Akzo Nobel.
Progestin is a synthetic hormone similar to the progesterone made in the
ovaries. The hormone typically acts on the body by thickening the mucus in a
women's cervix, preventing the union of sperm and egg. It also can prevent
ovulation, or the release of an egg from the ovaries.
Organon claims the implant provides 99 percent contraceptive protection.
Its approval comes six years after Wyeth Pharmaceuticals stopped U.S. sales of
another implant, Norplant. Norplant worked for up to seven years, or four years
more than Implanon, but spawned lawsuits by women injured having its six rods
removed or disturbed by side effects.
Another implant, a two-rod product called Jadelle, received FDA approval in
1996 but has never been sold in the U.S.
Use of Implanon can cause irregular bleeding and spotting, as well as no
bleeding at all.
Implanon, along with other hormonal contraceptives, is associated with an
increased risk of several serious side effects like blood clots. Smoking can
further increases those risks.
Other hormonal birth control methods include the pill, patch, vaginal ring and
a shot, called Depo-Provera, which provides three months of protection.
Organon did not release the price of Implanon. Spokeswoman Frances DeSena said
it would be comparable to the monthly cost of other hormonal methods.
The implant will be available only through specially trained doctors; the
company intends to start training in August, DeSena said.