Mirena Product Monograph, Bayer Corporation, Substantial Proof, Some Earlier Posts, Reproductive System
There are many new posts on here from women describing their experiences, and then I've noticed a few on here also who appear almost angry that women are "blaming" Mirena for all of these issues. So it has become apparent that those few select women have not read through many of the earlier posts, or have taken the time to educate themselves enough on Mirena. ... more »
There are many new posts on here from women describing their experiences, and then I've noticed a few on here also who appear almost angry that women are "blaming" Mirena for all of these issues. So it has become apparent that those few select women have not read through many of the earlier posts, or have taken the time to educate themselves enough on Mirena.
So I thought I'd hop back on and reiterate some earlier posts: There is substantial proof and documentation of all of these side effects, and many more, as written in the product monograph which was released in Canada by the Bayer Corporation themselves. This site will delete links, and it's almost 50 pages, so I won't copy and paste. If anyone is interested in the link to this information, let me know, I'll send it in a private e-mail.
Additionally, there have been several other studies done in the UK...those are short enough that I'll copy and paste those below.
Suffering Women: YOU ARE NOT CRAZY! This product can cause catastrophic issues for us. I say that it "can" not that it always "does".
Yes, there are women who have had good results with Mirena. And many of the women on here are not pissed just because there are side effects...it's that we were not warned that these COULD BE side effects, and when we go to our doctor's, many of them are discounting our symptoms as being "all in our head" when there absolutely is a reason behind all this.
To those of you who want to be nasty on here...go find someone else to whine to...we don't want to hear it. We are here to support each other through a very real time for us. You are outnumbered. You may call us "middle-aged"...and I guess to those of you barely out of puberty, being 30 might be considered just that; however the correct terms would simply be more mature, and much more wise, than you. (And I wouldn't have a need for birth control if my reproductive system was so "undesirable" and "non-functioning" now would I?) ;)
Here's those studies...sorry this is so long:
"Kingman et al.'s success in controlling menorrhagia in women with inherited bleeding disorders (BJOG 111:1425–1428) echoes numerous reports in women without complicating haematological conditions. However, they ignore the metabolic effects. The LNG-IUS is associated with high systemic absorption of the progestogen, and serum levels of levonorgestrel (LNG) have been recorded around 511 pmol/L.1 This is the equivalent of two LNG-containing minipill tablets daily continuously. LNG suppresses Apolipoprotein AI (Apo AI) formation by inhibiting the ABCA1 transporter protein.2 The synthesis of Apo AI is a fundamental step in the initiation of reverse cholesterol transport, which is enhanced by oestradiol and statins and when deficient, the ensuing atherosclerosis in animal models can be reversed by the administration of Apo AI.3
The epidemiological observation of the relationship of breast cancer with the use of progestogen only contraceptives goes to the 1980s,4 but these were mentally rejected by many physicians because it did not conform with the doctrine of ‘oestrogen induced’ mammary carcinogenesis. The validity of the latter hypothesis was challenged in a randomised clinical trial of oestrogen only treatment5 and a wealth of biological data show that progesterone and progestogens in general and LNG in particular being established mammary epithelial mitogens.
The LNG-IUS also suppresses oestrogen production, inducing a clinical situation not unlike a premature menopause in at least 50% of treated women. Oestrogen deprivation for the number of years such treatment is being administered will have a profound effect on bone mass and vascular reactivity. Similar concerns have recently been widely circulated regarding the use of depot MPA contraceptive preparations.
Given that it is unlikely that a randomised controlled trial of the size of the Women's Health Initiative one will ever be mounted to test the long term effects of the LNG-IUS, caution is required, particularly in treating older women, for whom treatment may bring forward the menopause.
The idea that LNG-IUS works entirely as a local progestogen should be revised, and patients and doctors should be warned about the metabolic and carcinogenic risks, whatever the marketing pressures.
May WahabaaObstetrics and Gynaecology, George Eliot Hospital, Nuneaton, Warwickshire, UK & Farook Al-AzzawibbObstetrics and Gynaecology, University Hospitals of Leicester, Leicestershire, UK"
"Mirena: the other side of the story
AAA Ewiesaa Consultant Gynaecologist, The Ipswich Hospital NHS Trust, Suffolk, UKa Consultant Gynaecologist, The Ipswich Hospital NHS Trust, Suffolk, UK
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 Ewiesaa Consultant Gynaecologist, The Ipswich Hospital NHS Trust, Suffolk, UK"