Objectives. This study was undertaken to determine the performance of the levonorgestrel intrauterine system (LNG IUS)
IntroductionThis report concludes the study of which the 12-month and 24-month results have been published. 1,2 The concept of intrauterine administration of a progestin-only contraceptive as an alternative to oral, parenteral or subdermal implants was first considered in 1970. 3 Experiments with various slow-release membranes and intrauterine contraceptive device (IUD)-carrying frames resulted in the development of an intrauterine system (IUS) releasing levonorgestrel, now marketed as Mirena ® which was introduced in Finland in 1990 and in the UK in May 1995.Very low pregnancy rates have been reported, between 0.5 and 1.1 cumulative gross rates per 100 users at 5 years [4][5][6] (Table 1). Expulsion rates have been similar to that of other IUDs. The Mirena ® is recommended for use up to 5 years, although very low pregnancy rates have also been reported after up to 7 years of use. 7 The endometrium remains atrophic while the levonorgestrel is at a sufficient level to suppress it, 8 and therefore changes in menstrual patterns are likely to occur. Sivin and Stern, 9 reporting a multicentre study, commented that 'menstrual patterns during contraception were radically altered by the LNG'.Several randomised trials have found that discontinuation rates because of heavy or prolonged menstrual blood flow were significantly lower with the LNG IUS than with copper IUDs. 10 Sivin et al. 11 found that discontinuation attributable to amenorrhoea was the principal contributor to differences in continuation rates between the LNG IUS and the Cu T380A ® IUD.There is a need to determine the performance of the LNG IUS in British women with particular regard to the nature and incidence of side effects.
Methods
Key message pointsAt 5 years of use the LNG IUS (Mirena ® ) has been shown to have a very low pregnancy rate and a low expulsion rate. The rate for removal for complaints of bleeding problems was high during the first year. There is a need for careful counselling before fitting to prepare women for changes in bleeding patterns during the first 12 months of use. Removals were also required for side effects that may be due to absorbed levonorgestrel. The reductions in duration and quantity of periods in many women were significant advantages.