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Mona Lisa

Mona Lisa Caution For Usage

Manufacturer:

Mona Lisa N.V.

Distributor:

CNW
Full Prescribing Info
Caution For Usage
Physician instructions to IUD users: Users should be informed in detail as to the advantages and disadvantages of IUD contraception, not only so that they understand how it works, but above all so that any complications can be detected early. The user must learn how to feel the threads emerging from the cervical canal.
Insertion: First eliminate the possibility of pregnancy: The best time for insertion is during menstruation to prevent insertion during non-diagnosed pregnancy. At this time the external and internal cervical os are physiologically dilated. This facilitates the insertion of the IUD without the need to dilate the canal in most instances.
Alternatively, the IUD may be introduced within 5 days of unprotected coitus or within 15 minutes of delivery of the placenta or abortion in the first trimester. In these last two cases a higher expulsion rate is expected. Insertion immediately after unprotected coitus can increase the risk of PID.
If the IUD cannot be inserted immediately after delivery of the placenta or abortion, insertion should be delayed for at least six weeks. In case of caesarean section insertion should be delayed for 12 weeks after delivery, although this is controversial.
Prior to insertion the vagina, cervix and cervical canal should be cleansed with an antiseptic solution. It is essential to determine the exact position of the uterus by bimanual pelvic palpation so that the Mona Lisa CuT 380A can be inserted along its longitudinal axis. This can be accomplished by grasping the anterior or posterior lip of the cervix, depending on whether the uterus is anteverted or retroverted.
A local anaesthetic may be applied as a gel or can be injected in and around the cervix prior to insertion.
Hysterometry should be carried out and the ascertained depth of the uterus be marked on the Mona Lisa CuT 380A inserter tube with the aid of the movable flange.
Step-by-Step loading instructions: The IUD may be used by trained medical staff only. In order to minimize the risk of contamination we recommend using sterile gloves.
1. Open the sterile packaging of the Mona Lisa CuT 380A. Take the loading capsule and push it over the side arms.
2. Push the side arms as far as they will go into the loading capsule until they fit completely in it and pull the insertion tube back carefully until the Mona Lisa CuT 380A lies freely in the loading capsule.
3. Now squeeze the loading capsule gently on the side and push the insertion tube over the side arms up to the end of the copper sleeves. The side arms may not be further slid into the insertion tube, since otherwise the tube can be stretched too strongly and unpleasant edges can arise.
4. Remove the loading capsule. Mona Lisa CuT 380A fits safely in the insertion tube.
5. Holding the threads straight in the tube, place the plunger into the insertion tube. This prevents that the threads will be disarranged by inserting the plunger.
Adjust the sliding flange so that the length of the tube above it corresponds to the depth of the uterus as previously measured by hystero­metry. Ensure that the wider part of the flange indicates the direction in which the side arms of the IUD will open in the uterus.
Note: The ends of the side arms of the Mona Lisa CuT 380A must not be slid further into the insertion tube than described under 3 and must not remain bended for over five minutes within the insertion tube; otherwise they may not bend back completely and may not return to their original 90° angle.
6. Carefully introduce the insertion tube containing the Mona Lisa CuT 380A into the uterine cavity until it touches the fundus of the uterus. The sliding flange must be in contact with the cervix.
7. Holding the plunger steady, pull the insertion tube downwards to the base of the plunger. The sidearms of the IUD are now entirely released in the uterus.
To prevent pulling the device from its fundal position, first remove the plunger while keeping the insertion tube steady and only then remove the insertion tube.
Cut the threads leaving 2-3 cm visible outside the cervix.
Removal: Mona Lisa CuT 380A should be replaced after 10 years.
Again, the most appropriate time to remove the IUD is during menstruation since both the internal and external cervical os are fully dilated. Grasp threads of IUD with a tenaculum and pull it along the longitudinal axis of the uterus. Try to insert the forceps at the entrance to the cervical canal in order to grasp the vertical arm of the IUD as soon as it has passed the internal cervical os. This avoids excessive tension on the threads, which could cause them to break. While doing this, distract the patient's attention by asking her to cough, and then remove the Mona Lisa 380A with one firm tug.
Insertion and removal of the IUD could cause slight pain and bleeding or may precipitate a vasovagal attack or an epileptic seizure.
After removal, inspect the Mona Lisa CuT 380A to see that none of the arms have been left in the uterine cavity.
In case of a lost IUD or lost parts of an IUD in the uterine cavity either hysteroscopy or ultrasonography or x-rays should be used to determine its location: curettage may be advisable. In very rare cases of uterine perforation laparoscopy may be needed.
Incompatibilities: No known incompatibilities.
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