The Femilis LNG-IUS: contraceptive performance-an interim analysis.

OBJECTIVE

To provide an update on the experience with the Femilis levonorgestrel-releasing intrauterine system (LNG-IUS) used for up to five years by parous and nulliparous women, particularly with regard to its contraceptive performance.

STUDY DESIGN

An interim, open, prospective non-comparative study of the Femilis LNG-IUS releasing 20 microg of levonorgestrel/day.

RESULTS

Two-hundred and eighty insertions were carried out in women with a mean age of 35.7 years (range 17-48), 60% of whom were parous and 40% nulliparous. Twenty-four women with uterine pathology (e.g., fibroids, menorrhagia) were included in the study. The cumulative gross discontinuation life table rates were determined. The total observation period was 8,028 woman-months. The LNG-IUS was easy to insert in 95.7% of the cases, and no perforations occurred. No pregnancies were observed and only one expulsion took place (rate 0.4/100 women at five years). The cumulative total use-related discontinuation rate was 14.7/100 at five years. There were nine removals because of pain, six of which were in nulliparous women. Four women requested removal of the IUS for bleeding problems. Fourteen removals were done for 'other' medical reasons among which mood disturbances (five cases) were the most frequent, and 12 for non-medical reasons. Fifteen removals were requested for pregnancy wish. Twelve of these women became pregnant within one year and all had uneventful pregnancies. The Femilis LNG-IUS was equally well accepted by nulliparous as by parous women. Most women with heavy menstrual bleeding prior to insertion, whether associated with fibroids or not, reported much less bleeding, scanty bleeding or even no bleeding at all after insertion.

CONCLUSION

This study suggests that the Femilis LNG-IUS, which releases 20 microg LNG/d, is a highly effective, well tolerated and well retained contraceptive both in parous and nulliparous women. The shorter crossarm of the LNG-IUS has simplified its insertion technique, which may contribute to its safety. This could promote use by non specialist providers and enhance the application of the method.