ABSTRACT & COMMENTARY
Bleeding Patterns and Patient Satisfaction with LNG-IUS
By Jeffrey T. Jensen, MD, MPH
SYNOPSIS: Almost all of the women who elected to continue use of a levonorgestrel intrauterine system by replacement after the first 5-year interval had favorable bleeding patterns during the second 5 years of use, with almost half experiencing amenorrhea.
SOURCE: Heikinheimo O, et al. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: Results of a prospective 5-year study. Hum Reprod 2014;29:1182-1188.
This paper provides extended follow-up of the 2010 study that reported preliminary results from a cohort of European women who requested a second levonorgestrel intrauterine system (LNG-IUS) after 5 years of initial use. A total of 204 women were enrolled in this prospective multicenter study in four European countries and followed up until the end of the first year of the second IUS. At the end of the first year, 170 women continued into the extension phase of the study, and 144 continued up to the full 5 years of use of the second IUS. This paper reports the extension phase of the study. Subjects had a mean age of 39 years and had used the first LNG-IUS for either contraception or treatment of heavy menstrual bleeding. Bleeding patterns were recorded using daily diaries. The authors analyzed bleeding using 90-day reference periods (RP). For the first year of the second IUS use, all four RPs were assessed. For years 2-5, data were collected for only the last RP of the year. During use of the second LNG-IUS, the proportion of women without bleeding (e.g., spotting only) increased after the first year and remained at 72% during years 2-5. The proportion of women without any bleeding and spotting (e.g., amenorrhea) increased after the first year (34%) and remained at 44-49% during years 2-5. Absence of bleeding was associated with high overall satisfaction and continuation rates. The cumulative expulsion rate during the 5-year study period was 1.2%, and there were no treatment-related serious adverse events.
Although these same authors presented initial results of this study in 2010,1 the long-term findings provided in this manuscript add additional evidence useful for counseling women. The bottom line is that women who are doing great with an LNG-IUS will continue to do great after replacement. Although there is some short-term bleeding seen in relation to the replacement procedure, the prolonged bleeding and spotting seen following initial placement (mean days of bleeding and/or spotting during placement of the first device during RP1 is 432) does not occur following replacement of the device. This is good news for women, as the unfavorable initial bleeding pattern is one of the principle problems seen during initiation of use. Other important information from the initial series of publications includes the finding that most replacements were straightforward, and that misoprostol did not improve the placement experience.3
Use of the LNG-IUS is increasing everywhere that women have access to the device. The main factor motivating women in my area is the desire for light or absent bleeding. The fact that bleeding becomes predictably better during the use of the LNG-IUS is a major advantage of this long-acting method compared to the bleeding pattern seen with the etonogestrel implant. Counseling women that the initial bleeding will be disrupted, but will improve, has been associated with better continuation and satisfaction. When women see this as an investment of time that will result in a tangible health benefit, my experience has been that the acceptability of the initial bleeding disruption is high. Most women become satisfied users, and we regularly see patients return for a second or even third consecutive device. Providing reassurance that the bleeding patterns will be very acceptable after the change and that replacement is uneventful can ease the stress of the anticipated changeover.
Whether all women desiring continuing use of an LNG-IUS should undergo replacement at 5 years is a hot topic. While there are no studies that assess pregnancy rates with the currently marketed LNG-IUS beyond 5 years, these are likely to remain low. Recall that even inert plastic IUDs are more than 96% effective, and that many women are looking at replacement in their 40s when pregnancy rates are naturally low. While there is no absolute answer to this question, if your patient is amenorrheic and over 35, it may be very reasonable to defer and reassess the decision for replacement after 6 -12 additional months. Younger women have the highest natural fertility and will benefit the most from replacement. However, since bleeding patterns also deteriorate over time, many women may want to choose replacement to take advantage of the stable bleeding seen in this study of consecutive use.
For women in the perimenopausal years, replacement allows for use of the device for endometrial protection. Since this is off-label in the United States, I try to time replacement to the late reproductive years so that insurance coverage as a contraceptive is allowed.
- Gemzell-Danielsson K, et al. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)—a multicentre prospective study. Hum Reprod 2010;25:354-359.
- Jensen JT, et al. Subject and clinician experience with the levonorgestrel-releasing intrauterine system. Contraception 2008;77:22-29.
- Heikinheimo O, et al. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception 2010;81:481-486.