Kyleena (Page 2 of 10)

Tools for Insertion

Note: The inserter provided with Kyleena (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 Kyleena from the inserter by first loading (see Figure 2) and then releasing (see Figure 7) Kyleena from the inserter, and insert according to accepted practice.

Preparation
Gloves
Speculum
Sterile uterine sound
Sterile tenaculum
Antiseptic solution, applicator
Procedure
Sterile gloves
Kyleena with inserter in sealed package
Instruments and anesthesia for paracervical block, if anticipated
Consider having an unopened back-up Kyleena available
Sterile, sharp curved scissors

Preparation for insertion

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

Insertion Procedure

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

Step 1–Opening of the package
Open the package (Figure 1). The contents of the package are sterile.
Package
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Figure 1. Opening the Kyleena Package

Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package.
Step 2–Load Kyleena into the insertion tube
Push the slider forward as far as possible in the direction of the arrow, thereby moving the insertion tube over the Kyleena T-body to load Kyleena 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.
Load Kyleena
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Figure 2. Move slider all the way to the forward position to load Kyleena

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 Kyleena. Once the slider is moved below the mark, Kyleena 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 (Figure 3).
Setting Flange
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Figure 3. Setting the flange

Step 4–Kyleena is now ready to be inserted
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).
Advancing Flange
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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 Kyleena (Figure 5). Wait 10 seconds for the horizontal arms to open completely.
Back to Mark
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Figure 5. Move the slider back to the mark to release and open the arms

Step 6–Advance to 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. Kyleena is now in the fundal position (Figure 6). Fundal positioning of Kyleena is important to prevent expulsion.

Funda Position
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Figure 6. Move Kyleena into the fundal position

Step 7–Release Kyleena and withdraw the inserter
Holding the entire inserter firmly in place, release Kyleena by moving the slider all the way down (Figure 7).
Moving Slider
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Figure 7. Move the slider all the way down to release Kyleena from the insertion tube

Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus.
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 Kyleena.
Cutting Threads
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Figure 8. Cutting the threads

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

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