Mirena Patient Counseling Information

Instructions for use and handling: Only to be inserted by a trained healthcare professional using aseptic technique.
Mirena is supplied within an inserter in a sterile package which should not be opened until needed for insertion. The exposed product should be handled with aseptic precautions. If the seal of the sterile package is broken, the product should be discarded (see Cautions for Usage for disposal instructions).
How to Insert Mirena: It is strongly recommended that Mirena should only be inserted by physicians/healthcare professionals who are experienced in Mirena insertions and/or have undergone sufficient training for Mirena insertion.
In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, please refer to Precautions.
Mirena is supplied sterile having been sterilised with ethylene oxide. Do not resterilise. For single use only. Do not use if the inner package is damaged or open. Insert before the month and year shown on the label.
Mirena is inserted with the provided inserter into the uterine cavity by carefully following the insertion instructions.
Preparation for insertion: Examine the patient to establish the size and position of the uterus, in order to detect any signs of acute genital infections or other contraindications for the insertion of Mirena and to exclude pregnancy.
Insert a speculum, visualise the cervix and then thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
Use an assistant as necessary.
Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilise the uterus. If the uterus is retroverted, it may be more appropriate to grasp the posterior lip of the cervix. Gentle traction on the forceps can be applied to straighten the cervical canal. The forceps should remain in position and gentle counter traction on the cervix should be maintained throughout the insertion procedure.
Advance a uterine sound through the cervical canal to the fundus to measure the depth and confirm the direction of the uterine cavity and to exclude any evidence of intrauterine abnormalities (e.g. septum, submucous fibroids) or a previously inserted intrauterine contraceptive which has not been removed. If difficulty is encountered, consider dilatation of the canal. If cervical dilatation is required, consider using analgesics and/or a paracervical block.
Insertion: 1. First, open the sterile package completely. Then use sterile technique and sterile gloves.
2. Push the slider forward in the direction of the arrow to the furthest position to load Mirena into the insertion tube.
IMPORTANT: Do not pull the slider downwards as this may prematurely release Mirena. Once released, Mirena cannot be re-loaded.
3. Holding the slider in the furthest position, set the upper edge of the flange to correspond to the sound measurement of the uterine depth.
4. While holding the slider in the furthest position, advance the inserter through the cervix until the flange is approx. 1.5-2.0 cm from the uterine cervix.
IMPORTANT: Do not force the inserter. Dilate the cervical canal, if necessary.
5. While holding the inserter steady, pull the slider to the mark to open the horizontal arms of Mirena. Wait 5-10 seconds for the horizontal arms to open completely.
6. Advance the inserter gently towards the fundus of the uterus until the flange touches the cervix. Mirena is now in the fundal position.
7. Holding the inserter in place, release Mirena by pulling the slider all the way down. While holding the slider all the way down, gently remove the inserter by pulling it out. Cut the threads to leave about 2-3 cm visible outside of the cervix.
IMPORTANT: Should you suspect that the system is not in the correct position, check placement (e.g. with ultrasound). Remove the system if it is not positioned properly within the uterine cavity. A removed system must not be re-inserted.
Removal/replacement: Mirena is removed by pulling on the threads with a forceps. You may insert a new Mirena immediately following removal.
Mirena is removed by gently pulling on the threads with forceps. If the threads are not visible and the system is in the uterine cavity, it may be removed using a narrow tenaculum. This may require dilatation of the cervical canal or other surgical intervention.
After removal of Mirena, the system should be checked to ensure it is intact. During difficult removals, single cases have been reported of the hormone cylinder sliding over the horizontal arms and hiding them inside the cylinder. This situation does not require further intervention once completeness of the IUS has been ascertained. The knobs of the horizontal arms usually prevent complete detachment of the cylinder from the T-body.