Kyleena T-body and Inserter
Kyleena T-body and Inserter
Kyleena features the same innovative Bayer Inserter design as other Bayer IUDs
The contents of the package are sterile.
Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package.
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. The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube.
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.
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.
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.
While holding the inserter steady, move the slider down to the mark to release the arms of Kyleena. Wait 10 seconds for the horizontal arms to open completely.
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. Fundal positioning of Kyleena is important to prevent expulsion.
Holding the entire inserter firmly in place, release Kyleena by moving the slider all the way down.
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]. Do not apply tension or pull on the threads when cutting to prevent displacing Kyleena.
Kyleena insertion is now complete. Prescribe analgesics, if indicated. Keep a copy of the Consent Form with lot number for your records.
If you suspect that Kyleena is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Kyleena if it is not positioned completely within the uterus. Do not reinsert a removed Kyleena.
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.
Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
Kyleena should not remain in the uterus after 5 years.