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FDA approves new contraceptive injected in arm
San Francisco Chronicle


July 19, 2006

A new contraceptive that is implanted in the upper arm and remains effective for three years will be made widely available in the United States early next year, filling a gap in birth control options for women since Norplant was taken off the market in 2002.

The new contraceptive, called Implanon, is a matchstick-size device that doctors inject into the underside of a woman's arm, where it releases a continuous dosage of the synthetic hormone progestin over three years. The device is 99 percent effective at preventing pregnancy.



Implanon, made by Organon of Roseland, N.J., joins the ranks of increasingly advanced birth control options on the market for women. In the past five years, new birth control devices have included a skin patch that is changed once a month, an intrauterine device that releases low-dose hormones and lasts five years, and a product called the NuvaRing, also made by Implanon, that is inserted into the vagina once a month and releases progestin.

The birth control pill, the most popular form of contraception for women, also has undergone dramatic changes over the past 20 years, with a wide range of pills available with a variety of hormone dosages.

"These are really exciting times. Women have many more options now," said Dr. Glenda Newell, medical director of primary care services at Planned Parenthood Golden Gate in San Francisco. "We've been looking forward to this one (Implanon) coming for a long time."

Implanon won approval from the Food and Drug Administration this week, nearly three years after Organon submitted an application to the agency. Implanon has been available in Europe and elsewhere since 1998 and has been used by about 2.5 million women, according to Organon.

The company has not announced what Implanon will cost, but a spokeswoman said the device would be competitive with other hormonal forms of contraception. Birth control pills cost $20 to $35 a month and often are covered by insurance. When Norplant was available, it cost about $500 for the initial implantation and $100 to $200 to remove the implants.

Norplant was taken off the market by manufacturer Wyeth Pharmaceuticals after women complained of uncomfortably heavy or irregular menstrual cycles and difficult removal .

Organon officials said they don't anticipate similar problems with Implanon, in part because Norplant involved the implantation of six small devices, compared with the one for Implanon. Also, Implanon uses a different form of progestin than Norplant.

"We've been on the market in Europe since 1998. We've learned from that experience, and we've learned from other past competitors on the market," Organon spokeswoman Frances DeSena said.

She said Organon will be developing a nationwide training program to teach doctors proper techniques for implanting and removing the device. Only doctors who receive the training will be able to prescribe Implanon.

The Implanon device is loaded with 68 milligrams of progestin, which is released slowly and regularly during the lifetime of the device. Progestin stops the ovaries from releasing eggs and, at the same time, thickens cervical mucus, preventing sperm from fertilizing any released eggs.

Side effects can include irregular menstrual cycles and, in some cases, no monthly periods at all, as well as pain and swelling at the insertion site in rare cases.


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