The levonorgestrel-releasing intrauterine system in heavy menstrual bleeding: a benefit-risk review.

Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age and can cause irritation, inconvenience, self-consciousness and fear of social embarrassment. Our objective was to review and appraise literature identified from the MEDLINE and EMBASE databases to evaluate the clinical evidence and provide an update on the risks and benefits of using the levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of HMB. The LNG-IUS consistently reduces menstrual blood loss (MBL) in women with HMB, including those with underlying uterine pathology or bleeding disorders. The available data suggest that it reduces MBL to a greater extent than other medical therapies, including combined oral contraceptives, oral progestogens (both short- or long-cycle regimens), tranexamic acid and oral mefenamic acid. In addition, the LNG-IUS and endometrial ablation appear to reduce MBL to a similar extent. The adverse effects reported with the LNG-IUS in women with HMB are similar to those typically observed in women using the system for contraception. Uterine perforations were not reported in any of the studies reviewed, but expulsion rates may be higher than in the general population of LNG-IUS users. Overall, the LNG-IUS has a positive effect on most quality-of-life domains, at least comparable to those achieved with hysterectomy or endometrial ablation, and is consistently a cost-effective option across a variety of countries and settings. In conclusion, the LNG-IUS is an effective treatment option for women with HMB, including those with underlying organic pathology or bleeding disorders.