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Insertion & Removal
Step-by-Step Instructions
Insertion and removal instructions for
Mirena® using the Bayer inserter
Click through the pages below to review the step-by-step Mirena insertion instructions.
Learn about the insertion process with the Bayer Inserter
For complete insertion instructions, please refer to the accompanying full Prescribing Information for Mirena. Review the preparatory steps to ensure that the patient is appropriate for Mirena. Follow the insertion instructions exactly as described in order to ensure proper placement and avoid premature release of the intrauterine device (IUD) (Mirena)from the inserter. Once released, Mirena cannot be reloaded.
Proceed with the insertion only after completing the preparation steps and ascertaining that the patient is appropriate. Ensure use of aseptic technique throughout the entire procedure.
Preparatory Steps
With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape, and position of the uterus.
Gently insert a speculum to visualize the cervix.
Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and gently apply traction to stabilize and align the cervical canal with the uterine cavity. Perform a paracervical block, if needed. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. This tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure.
Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter any difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block. The uterus should sound to a depth of 6 to 10 cm. Insertion of Mirena into a uterine cavity less than 6 cm by sounding may increase the incidence of expulsion, bleeding, pain, perforation, and possibly pregnancy.
Tools for Insertion
Preparation
- Gloves
- Speculum
- Sterile uterine sound
- Sterile tenaculum
- Antiseptic solution, applicator
Procedure
- Sterile gloves
- Mirena with inserter in sealed package
- Instruments and anesthesia for paracervical block, if anticipated
- Consider having an unopened backup Mirena available
- Sterile, sharp curved scissors
Step 1: Opening of the package
- Open the package. The contents of the package are sterile.
- Using sterile gloves lift the handle of the sterile inserter and remove from the sterile package.
Step 2: Load Mirena into the insertion tube
Move slider all the way to the forward position to load Mirena
- Push the slider forward as far as possible in the direction of the arrow thereby moving the insertion tube over the Mirena T-body to load Mirena into the insertion tube. The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube.
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Maintain forward pressure with your thumb or forefinger on the slider. DO NOT move the slider downward at this time as this may prematurely release the threads of Mirena. Once the slider is moved below the mark, Mirena cannot be
re-loaded.
Step 3: Setting the flange
- Holding the slider in this forward position, set the upper edge of the flange to correspond to the uterine depth (in centimeters) measured during sounding.
Step 4: Mirena is now ready to be inserted
Advancing insertion tube until flange is 1.5 to 2 cm from the cervix
- Continue holding the slider in this forward position. Advance the inserter through the cervix until the flange is approximately 1.5-2 cm from the cervix and then pause.
Do not force the inserter. If necessary, dilate the cervical canal.
Step 5: Open the arms
Move the slider back to the mark to release and open the arms
- While holding the inserter steady, move the slider down to the mark to release the arms of Mirena. Wait 10 seconds for the horizontal arms to open completely.
Step 6: Advance to fundal position
Move Mirena into the fundal position
- Advance the inserter gently towards the fundus of the uterus until the flange touches the
cervix. If you encounter fundal resistance do not continue to advance. Mirena is now in the fundal position. Fundal positioning of Mirena is important to prevent expulsion.
Step 7: Release Mirena and withdraw the inserter
Move the slider all the way down to release Mirena from the insertion tube
- Holding the entire inserter firmly in place, release Mirena by moving the slider all the way down.
- Continue to hold the slider all the way down while slowly and gently withdrawing the inserter from the uterus.
Cutting the threads
- Using a sharp, curved scissor, cut the threads perpendicular, leaving about 3 cm visible outside of the cervix [cutting threads at an angle may leave sharp ends]. Do not apply tension or pull on the threads when cutting to prevent displacing Mirena.
Mirena insertion is now complete. Prescribe analgesics, if indicated. Record the lot number in the patient records.
Important information to consider during or after insertion
- If you suspect that Mirena is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Mirena if it is not positioned completely within the uterus. A removed Mirena must not be re-inserted.
- If there is clinical concern, exceptional pain or bleeding during or after insertion, appropriate steps (such as physical examination and ultrasound) should be taken immediately to exclude perforation.
Patient Follow-up
- Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
Removal of Mirena
Timing of Removal
- For contraception, remove Mirena by the end of the sixth year and replace at the time of removal with a new Mirena if continued use is desired. Replace Mirena by the end of the fifth year if continued treatment of heavy menstrual bleeding is needed.
- If pregnancy is not desired, remove Mirena during menstruation, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle, consider starting a new contraceptive method a week prior to removal. If removal occurs at other times during the cycle and the woman has had intercourse in the week prior to removal, she is at risk of pregnancy.
Tools for Removal
Preparation
- Sterile gloves
- Sterile speculum
Procedure
- Sterile forceps
Removal Procedure
- Remove Mirena by applying gentle traction on the threads with forceps.
- If the threads are not visible, determine location of Mirena by ultrasound.
- If Mirena is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal. After removal of Mirena, the system should be examined to ensure that it is intact.
- Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example syncope), or with seizure in an epileptic patient, especially in patients with a predisposition to these symptoms.
Continuation of Contraception after Removal
- If pregnancy is not desired and if a woman wishes to continue using Mirena, a new system can be inserted immediately after removal any time during the cycle.
- If a patient with regular cycles wants to start a different birth control method, time removal and initiation of new method to ensure continuous contraception. Either remove Mirena during the first 7 days of the menstrual cycle and start the new method immediately thereafter or start the new method at least 7 days prior to removing Mirena if removal is to occur at other times during the cycle.
- If a patient with irregular cycles or amenorrhea wants to start a different birth control method, start the new method at least 7 days before removal.