An interesting study! - "Mirena: the other side of the story"

I saw a reference to this study, but had a hard time finding the text. Wonder if Bayer is out there deleting references to it or something. Hopefully more of these studies will be done so that the truth can come out! Note where he says the dosage in the bloodstream is like taking 2 minipills daily.

Mirena: the other side of the story
AAA Ewies a
a Consultant Gynaecologist, The Ipswich Hospital NHS Trust, Suffolk, UK
Copyright 2007 The Authors Journal compilation
ABSTRACT


No Abstract

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Accepted 23 May 2007.

DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1471-0528.2007.01439.x About DOI


Article Text
Sir,

I read with interest the article by Halmesmaki et al.1 that only 48.7% of women randomised to the levonorgestrel (LNG)-releasing intrauterine system Mirena, kept it in situ until their 5 years follow-up visit, while the rest either had it prematurely removed (8.5%) or underwent a hysterectomy (42.7%). It supports the growing evidence that women's satisfaction with Mirena (Schering Health, Newbury, UK) is limited. I do not find this surprising. A colleague and myself previously reported (as an abstract) a survey including 160 Mirena users in Suffolk in which we found that 46% of women had had the system removed within 3 years of insertion (median duration = 260.5 days; range = 4–1460 days). The most common reasons for early removal were unscheduled bleeding, abdominal pain and progestogenic adverse effects; including bloatedness, headache, weight gain, depression, breast tenderness, excessive hairiness, greasiness of skin and lack of sexual interest.2 Our data related to a selected population who had the Mirena inserted under general anaesthetic after hysteroscopic examination of uterine cavity to exclude lesions, such as submucous fibroids. I would expect the continuation rate to be lower in women having the system inserted without prior exclusion of intrauterine pathology. The satisfaction rate in our cohort of women, as assessed by visual analogue scale of 0–10 cm, was only 49% (unpublished data).

Halmesmaki et al.1 reasonably attributed the detrimental effect of Mirena on the sexual function to the higher incidence of lower abdominal pain in users when compared with those who underwent hysterectomy. Furthermore, the decreased satisfaction of sexual partners could be due to the inhibiting effect of the irregular bleeding, which is the most common adverse effect of using Mirena.2,3 The observed decrease in women's sex drive could also be due to the systemic effect of the progestogen absorbed into the circulation, indirectly affecting the sexual partner. The argument used by the authors that serum concentration of LNG is extremely low and that its influence on ovarian function is limited has been disputed recently by many investigators. Xiao et al.4 found that Mirena was associated with substantial systemic absorption of LNG and recorded serum levels of around 500 pmol/l. This is equivalent to two LNG-containing 'minipills' taken daily on a continuous basis. Moreover, a retrospective observational study documented that 21% of Mirena users experienced progestogenic adverse effects.3 Wahab and Al-Azzawi5 reported that Mirena suppresses oestrogen production, inducing a clinical situation similar to a premature menopause in at least 50% of treated women. The prolonged oestrogen deprivation will have a profound negative effect on women's sex drive, which may explain the sexual partners' decreased satisfaction.

In fact, despite the popularity of Mirena as a contraceptive method and in treating menorrhagia, the continuation rate and women satisfaction level have not been adequately assessed in the UK population. A large well-designed study is required to evaluate these important factors so that women can be adequately counselled. The idea that Mirena works entirely as a local source of progestogen should be revised, and the recent concerns about Mirena should be made clear to women regardless of the marketing pressures.5


AAA Ewies a


References


1 Halmesmaki K, Hurskainen R, Teperi J, Grenman S, Kivela A, Kujansuu E, et al. The effect of hysterectomy or levonorgestrel-releasing intrauterine system on sexual functioning among women with menorrhagia: a 5-year randomised controlled trial. BJOG 2007;114:563–8. Links
2 Daud S, Ewies A. Continuation rate and reasons of early removal of the levonorgestrel-releasing intrauterine system. Endocr Abstr 2006;12:P93. Links
3 Macnab JL, Lowles IE. Levonorgestrel-releasing intrauterine system for menstrual dysfunction: patient satisfaction in the district general hospital setting. J Obstet Gynaecol 2002;22:402–5. Links
4 Xiao B, Wu SC, Chong J, Zeng T, Han LH, Luukkainen T. Therapeutic effects of the levonorgestrel-releasing intrauterine system in the treatment of idiopathic menorrhagia. Fertil Steril 2003;79:963–9. Links
5 Wahab M, Al-Azzawi F. The use of levonorgestrel-releasing intrauterine system for treatment of menorrhagia in women with inherited bleeding disorders. BJOG 2005;112:1455–6. Links

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