Ease and safety of insertion, contraceptive performance and
effect on menstrual blood loss of a new LNG-IUS, Femilis™, in parous and
nulliparous women
D. Wildemeersch
Contrel Research, Zwijnaarde, Ghent, Belgium
Objective To evaluate ease and safety of insertion,
contraceptive performance and effect on menstrual blood loss of a new LNG-IUS),
Femilis™, releasing 20 mg of LNG/day.
Design and methods An open, prospective non-comparative
study (interim analysis). Two- hundred and thirty-five insertions were performed
in fertile women seeking contraception, 143 (60.8%) parous and 92 (39.2%)
nulliparous women. The LNG-IUS was inserted using a simplified push-in technique.
In 60 women, MBL was assessed with the visual assessment technique after 4 to 30
months.
Results The push-in technique of insertion was considered
simple and safe. Insertion was reported ‘easy’ in virtually all women (97.9%).
No pregnancies were observed. There was one expulsion in the nulliparous and one
in the parous group. Ten removals were performed for medical reasons (mainly
bleeding and pain). One pelvic infection occurred which resolved without
removing the IUS. Femilis was well tolerated which resulted in a high
continuation rate (94.04%). An update of the study will be given during the
congress. MBL scores dropped significantly during the observation period in all
women except one. Twenty women developed amenorrhea (33%). Most of the remaining
women had oligomenorrhea requiring the use of a few panty-liners only.
Conclusion The Femilis LNG-IUS is an effective
contraceptive and is easily inserted. The simple and safe insertion procedure
could be an advantage for use by non-specialist providers such as nurses,
midwives, general practitioners, and for those not inserting intrauterine
devices regularly. The strong effect on MBL of this contraceptive method offers
an important health benefit and improvement in quality of life, particularly in
women with heavy bleeding and anemia, as other treatment modalities are less
effective, more costly, more invasive or not readily available.