FDA approves Implanon, a three-year implantable contraceptive

By E. Janene Geiss

Philadelphia, July 18 - Organon said Tuesday that the Food and Drug Administration approved Implanon (etonogestrel implant) 68 mg, the only single-rod implantable contraceptive that is effective for up to three years.

Implanon is about the size of a matchstick and is made of a soft medical polymer and is inserted subdermally just beneath the skin on the inner side of a woman's upper arm by a health care provider during an in-office procedure, according to a company news release.

Implanon continually releases a low, steady dose of progestin (etonogestrel) for up to three years.

After insertion, Implanon generally is not visible, making it a discreet method of birth control. The efficacy of Implanon does not depend on patient self-administration, officials said.

Removal can occur at any time at the request of the user, after which the woman's fertility returns to her pre-existing fertility level.

Implanon has been used worldwide by about 2.5 million women in more than 30 countries since 1998.

Recognizing that Implanon is unlike anything currently available in the United States, Organon USA said it will be sponsoring a national clinical training program to train health care providers on the insertion and removal procedures.

Only health care providers trained through the Organon-sponsored programs will be able to order Implanon, officials said.

The clinical training program is scheduled to begin later this year. As the training program progresses, Implanon will become more widely available in 2007.

Organon, based in Roseland, N.J., and Oss, The Netherlands, is the human health care business unit of Akzo Nobel.

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