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July 18, 2006 — -- Medical Correspondent John McKenzie provides answers about Implanon following a teleconference by Scott Monroe, M.D., acting director of the Division of Reproductive and Urologic Products at the Center for Drug Evaluation and Research in the Food and Drug Administration.
How is Implanon inserted?
It requires a small procedure for implant and removal. The company is planning on requiring training for all health providers who wish to prescribe the device. Only those who receive training will be allowed to order and prescribe the devices.
How was Implanon tested?
The primary clinical trials of Implanon included 942 healthy women of reproductive age. During the trial the device was found to be safe and effective. It is highly effective in that it doesn't depend on patient compliance.
How effective is Implanon?
During the trials with more than 900 women on the implanted contraceptive there were only six pregnancies. A rate of better than 99 percent.
Why did the pregnancies occur?
Whenever a pregnancy occurs close to removing a product it is conceivable that the pregnancy did not occur while device still implanted. Therefore it is possible that no one became pregnant while on the device. However the FDA records this as a pregnancy while on the device to be conservative in their rates of pregnancy while on the device. The device is not 100 percent effective but it is highly effective.
What are the warnings included with Implanon?
The patient and clinician are to ensure that the device is implanted by palpating the skin. This must be documented by the clinician. If the device cannot be located the patient should be warned that it may not have been inserted and therefore she may be at risk of becoming pregnant. The device will also come with an information brochure and consent form for the patient to sign. This will provide informed consent for the patient.
What are the side effects of Implanon?
Women will be informed that they will likely not have regular menstrual bleeding. They may have irregular menses or no periods at all.