FDA approves Implanon (etonogestrel implant) contraceptive

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Organon announced today that the U.S. Food and Drug Administration (FDA) approved Implanon (etonogestrel implant) 68mg, the first and only single-rod implantable contraceptive that is effective for up to three years.

Implanon, about the size of a matchstick, 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 healthcare provider during an in-office procedure. Implanon continually releases a low, steady dose of progestin (etonogestrel) for a period of up to three years via a unique, state of the art implantable technology. 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. 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 approximately 2.5 million women in more than 30 countries since 1998. Recognizing that Implanon is unlike anything currently available in the U.S., Organon USA will be sponsoring a national clinical training program to train healthcare providers on the insertion and removal procedures. Only healthcare providers trained through the Organon-sponsored programs will be able to order Implanon. The clinical training program is scheduled to begin later this year. As the training program progresses, Implanon will become more widely available in 2007.

http://www.implanon-usa.com/

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