Timing of Insertion

Tools for Insertion

Note: The inserter provided with Mirena (see Figure 1) and the Insertion Procedure described in this section are not applicable for immediate insertion after childbirth or second-trimester abortion or miscarriage. For immediate insertion, remove Mirena from the inserter by first loading (see Figure 2) and then releasing (see Figure 7) Mirena from the inserter, and insert according to accepted practice.

Preparation for insertion

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Exclude pregnancy and confirm that there are no other contraindications to the use of Mirena.

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With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape and position of the uterus.

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Gently insert a speculum to visualize the cervix.

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Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.

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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. The tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure.

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Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity in centimeters, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block.

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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.

Insertion Procedure

Proceed with insertion only after completing the above steps and ascertaining that the patient is appropriate for Mirena. Ensure use of aseptic technique throughout the entire procedure.

Step 1–Opening of the package

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Open the package (Figure 1). The contents of the package are sterile.

Figure 1: Opening the Mirena Package

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Using sterile gloves lift the handle of the sterile inserter and remove from the sterile package.

Step 2–Load Mirena into the insertion tube

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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 (Figure 2). The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube.

Figure 2: Move slider all the way to the forward position to load Mirena

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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

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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 (Figure 3).

Figure 3: Setting the flange

Step 4–Mirena is now ready to be inserted

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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 (Figure 4).

Figure 4: Advancing insertion tube until flange is 1.5 to 2 cm from the cervix

Do not force the inserter. If necessary, dilate the cervical canal.

Step 5–Open the arms

While holding the inserter steady, move the slider down to the mark to release the arms of Mirena (Figure 5). Wait 10 seconds for the horizontal arms to open completely.

Figure 5: Move the slider back to the mark to release and open the arms

Step 6–Advance to fundal position

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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 (Figure 6). Fundal positioning of Mirena is important to prevent expulsion.

Figure 6: Move Mirena into the fundal position

Step 7–Release Mirena and withdraw the inserter

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Holding the entire inserter firmly in place, release Mirena by moving the slider all the way down (Figure 7).

Figure 7: Move the slider all the way down to release Mirena from the insertion tube

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Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus.

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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 (Figure 8)]. Do not apply tension or pull on the threads when cutting to prevent displacing Mirena.

Figure 8: Cutting the threads

Mirena insertion is now complete. Prescribe analgesics, if indicated. Record the Mirena lot number in the patient records.

Important information to consider during or after insertion

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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. Do not reinsert a removed Mirena.

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If there is clinical concern, exceptional pain or bleeding during or after insertion, take appropriate steps (such as physical examination and ultrasound) immediately to exclude perforation.

​Timing of Removal

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For contraception, remove Mirena by the end of the eighth 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.

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If pregnancy is not desired, remove Mirena during the first 7 days of the menstrual cycle, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle, or the woman does not experience regular menses, she is at risk of pregnancy; start a new contraceptive method a week prior to removal for these women. [See Dosage and Administration (2.5).]

Tools for Removal

Removal Procedure

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Remove Mirena by applying gentle traction on the threads with forceps. (Figure 9).

Figure 9: Removal of Mirena

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If the threads are not visible, determine location of Mirena by ultrasound [see Warnings and Precautions (5.10)].

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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, examine the system to ensure that it is intact. The hormone cylinder may slide over and cover the horizontal arms, giving the appearance of missing arms. This situation generally does not require further intervention once the system is verified to be intact.

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If unable to remove with gentle traction, determine Mirena location and exclude perforation by ultrasound or other imaging [see Warnings and Precautions (5.10)].

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Removal may be associated with:

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pain and/or bleeding, vasovagal reactions (for example, syncope, bradycardia) or seizure, especially in patients with a predisposition to these conditions.

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breakage or embedment of Mirena in the myometrium that can make removal difficult [see Warnings and Precautions (5.5)]. Analgesia, paracervical anesthesia, cervical dilation, alligator forceps or other grasping instrument, or hysteroscopy may be used to assist in removal.