Implantable Contraceptive: Implanonâ„¢, Approved by USFDA

Filed in archive Diagnostics , Treatment on July 21, 2006

The USFDA approved a type of contraceptive that would be implanted in the upper arm to prevent pregnancy for up to three years.

The device is called Implanonâ„¢, made by Organon USA, a Roseland, N.J., unit of the Dutch company Akzo Nobel NV.

Implanonâ„¢ is only about the size of a matchstick, should be inserted under the skin by a health-care provider and designed to release a steady, low dose of the hormone progestin for three years to prevent pregnancy.

Scott Monroe, FDA's acting director of the unit that oversees reproductive drugs said Implanon is "a highly effective contraceptive that, importantly, does not depend on patient compliance."

Clinical studies of the drug as well as post-marketing experience in other countries suggest a pregnancy rate of less than one per 100 women over one year of use.

If a woman wants to try to become pregnant, Implanonâ„¢ can be removed at any time wanted to. This device has been used world wide by some 2.5 million women in more than 30 countries since 1998.

Implanonâ„¢ will become available in the U.S. but will only be available to doctors who undergo the training provided by Organon, its maker.

The approval of Implanonâ„¢ marks the return to the U.S. market of a contraceptive designed to be implanted in women's arms. Until 2000, women in the U.S. had the option of using Norplant, a device implanted for up to five years that used six matchstick-sized rods to release progestin.

Norplant was recalled in 2000 amid concerns some lots of the product weren't releasing the proper amount of the hormone. Norplant's manufacturer, Wyeth later announced in 2002 it would not resume sales of the product.

It should be noted that Implanonâ„¢'s side effects include irregular bleeding, headache and acne and about 3.6% of women in clinical studies of the device experienced temporary swelling, redness or pain after the device was implanted.

Implanonâ„¢ however, does not protect against HIV infection and other sexually transmitted diseases. For more information about Implanonâ„¢ got to its website or you can call 1-877-IMPLANON (1-877-467-5266).

Read the full press release.