Mona Lisa

Mona Lisa Special Precautions

Manufacturer:

Mona Lisa N.V.

Distributor:

CNW
Full Prescribing Info
Special Precautions
Before inserting the IUD, a thorough medical history and an examina­tion of the pelvic and abdominal cavity as well as a cervical smear are mandatory. Pregnancy, genital infections or sexually transmitted diseases should be excluded. The position of the uterus and the size of the ute­rine cavity must be determined to ensure correct insertion of the IUD. Mona Lisa CuT 380A is designed for women with a uterine cavity depth of 6 - 9 cm.
One month after the insertion of an IUD the woman must be re-examined to determine whether the IUD is properly placed and if there are signs of infection. Subsequent follow-up examinations are to be performed annually or more frequently if clinically indicated.
Pelvic inflammatory disease during IUD use should be treated without delay. For this reason the user must be instructed to report to her physician if there are suspicious signs such as vaginal discharge, pelvic pain and fever. This can be ascertained by gynaecological examination and/or ultra­sound (if available). If treatment with antibiotics is not effective after 48 hours and signs of PID persist, the IUD must be removed immediately.
Excessive bleeding or dysmenorrhoea during the first cycle after insertion should also be carefully assessed to ascertain if this is caused by the IUD, in which case it might have to be removed.
The possibility of perforation of the uterus during the insertion should always be considered, especially if the nylon threads are invisible or cannot be drawn out of the cervical canal. If there are any doubts about the position of the IUD (e.g. if the IUD is extremely difficult or painful to insert) the appropriate diagnostic techniques should be used (flat x-ray of the pelvis, ultrasonogarphy, hysteroscopy, laparoscopy).
If the nylon threads appear to be longer than at insertion, an ultrasound should be carried out to determine if the IUD has been displaced, what might decrease its contraceptive efficacy.
If the threads are not visible at follow-up examination, at first pregnancy must be excluded. The threads may have possibly been drawn up into the cervical canal or the uterus and usually reappear during the next menstruation. In case of doubt the IUD can be identified by feeling carefully with a suitable instrument, by ultrasound or by x-ray after excluding pregnancy.
In case of accidental pregnancy with the IUD in situ, it is mandatory to determine (by ultrasound) whether the pregnancy is intrauterine or ectopic. Up to the end of the first trimester, if the threads are visible, the IUD should be carefully removed. After that the patient should be offered the option of elective abortion as soon as possible, since there is an increased risk of PID and other obstetric problems, e.g. premature labour, placenta praevia and abruptio placentae.
However, if the woman wishes to continue her pregnancy, close monitoring is mandatory. She should be informed about the risks of keeping the IUD in situ.
There are no contraindications to breastfeeding with an IUD in situ.
Perforation: Perforation or penetration of the uterine corpus or cervix by the IUD may occur, usually during insertion. The risk is increased during the postpartum period and slightly increased if the woman is fully breastfeeding. The device must be removed as soon as possible if this occurs.
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