FDA Approves Implanon Single-Rod Implantable Contraceptive
Provides Women and Healthcare Providers Built-In Contraceptive Confidence For Up to Three Years
ROSELAND, N.J., July 18, 2006 -- 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.
"We are excited about the approval of Implanon, which represents a real advancement in contraceptive technology and will provide women with a new level of confidence in contraception," stated Michael V. Novinski, President, Organon USA Inc. "Implanon further demonstrates Organon’s ongoing commitment to women’s reproductive health products."
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.
"Even the best intentioned women can have difficulty using their birth control method consistently, which can lead to unintended pregnancy," said Wayne C. Shields, president and CEO of the Association of Reproductive Health Professionals. "The new contraceptive implant, Implanon, is indicated for three years, so it can be a hopeful alternative for women who prefer not to think about birth control every day, week, or month."
Implanon does not protect against HIV infection and other sexually transmitted diseases. As with any progestin-only contraceptive, users of Implanon can experience irregular bleeding. Changes may include more or less frequent bleeding, bleeding for a longer or shorter duration, or absence of bleeding and may vary throughout the duration of use. Other adverse experiences include headache, acne, dysmenorrhea and emotional lability, which are side effects common to hormonal contraception.
Implant site complications were experienced by 3.6 percent of study participants and included: swelling, redness, hematoma and pain. Removal complications were also low (1.7 percent) and included: implant not palpable, broken or damaged implant, difficult localization, slight migration and formation of fibrosis. The use of hormonal contraceptives is associated with increased risks of several serious side effects, including thromboembolic diseases. Cigarette smoking increases the risk of serious cardiovascular side effects; women who use hormonal contraceptives are strongly advised not to smoke.
For more information, please visit www.Implanon-USA.com
Posted: July 2006