About IMPLANON™

IMPLANON™ is a small, thin, implantable hormonal contraceptive that is effective for up to three years. It was approved in July, 2006 by the U.S. Food and Drug Administration.

IMPORTANT RISK INFORMATION

Women should be informed that this product does not protect against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases.

Pregnancy must be excluded before inserting IMPLANON™. IMPLANON™ should not be used in women who have the following conditions: known or suspected pregnancy, current or past history of thrombosis or thromboembolic disorders, hepatic tumors (benign or malignant) or active liver disease, undiagnosed abnormal genital bleeding, known or suspected carcinoma of the breast (or a personal history of breast cancer), or hypersensitivity to any of the components of IMPLANON™.

Serious consequences may be associated with the insertion and removal of IMPLANON™. Failure to insert IMPLANON™ properly may go unnoticed unless the implant is palpated immediately after insertion. Undetected failure to insert IMPLANON™ may lead to an unintended pregnancy. Deep insertions may lead to difficult or impossible removals, which may result in the need for a surgical procedure in an operating room in order to remove IMPLANON™. Any of the possible complications of surgery may occur. In postmarketing use there have been cases of failure to localize and remove the implant, probably due to deep insertion. Failure to remove IMPLANON™ may result in infertility, ectopic pregnancy, or inability to stop a drug-related adverse event. In clinical trials, 1.0% of patients had complications at implant insertion and 1.7% had complications at implant removal.

The use of hormonal contraceptives is associated with increased risks of several serious cardiovascular conditions including myocardial infarction, stroke, venous thromboembolism, deep venous thrombosis, retinal vein thrombosis and pulmonary embolism. IMPLANON™ should be removed in the event of a thrombosis. Consider removal of IMPLANON™ in the event of long-term immobilization due to surgery or illness. Cigarette smoking increases the risk of serious cardiovascular side effects from the use of hormonal contraceptives. Women who use hormonal contraceptives should be strongly advised not to smoke.

Please refer to the full Prescribing Information for other important risk information.

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