Mirena, an Italian experience

The aim of this review was to evaluate contraceptive efficacy, compliance, effect on menstrual cycle of a levonorgestrel-releasing device (Mirena®) in an Italian setting.

During the 48 months of recruitment, 128 women accepted the insertion of the LNG-IUS satisfying all inclusion criteria; 71.6% of the women completing five years of use had heavy menstrual blood loss. General and pelvic examination, including an ultrasound scan were performed at recruitment and repeated at 1, 3, 6, months postinsertion. Each subject was given a menstrual diary to report both menstrual patterns and side effects.

Over the 7 308 woman/months of observation, no pregnancy occurred. Menstrual blood flow decreased in all patients, both in terms of quantity and duration. In the vast majority of cases (93.7%), spotting disappeared within six months; within the first six cycles postinsertion, amenorrhoea occurred in 29.5% of all women. In five subjects the device was removed before the planned five years of observation: two women desired a pregnancy and three, in spite of a pre-existing condition of menorrhagia, requested removal within the first nine months, because they could not tolerate amenorrhoea. Three expulsions and one dislocation of the device were also detected, all within the first eight months.

Although in Italy intrauterine contraception is poorly accepted, once started on Mirena® women found that the device represents a safe and effective contraceptive modality, particularly indicated in the presence of heavy or prolonged bleeding. The only important side effect reported was breast tenderness; in addition the transient appearance of ovarian cystic images was observed.