Product monograph symptoms and conditions

I have Crohns and had a flare up so I'm back on 40mg of Prednisone. I've been on 40mg now for 3 weeks and I start to tapper off in another 3 weeks. Well every time I start the prednisone again I get new side effects. This time, my gum are bleeding all the time and the pain in my knees are horrible! I still get the regular side effects, ie: Mood swings, joint pain, sleeplessness, sweating, swelling of my legs and hands, wanting to eat everything under the sun, moon face and my hair falls out! I wish the drug manufactures could develop a drug that would not be so hard on our bodies. I have to struggle with the pros and cons with every flare up. Do I want the weight gain, mood swings and hair loss or do I want to look good and be very sick! I'm 37 and was 16 when I found out I had Crohns.

Monthly wicked migraines, right before period starts. Sometimes lasting on and off for 2 1/2 days. I had one so bad I had to go to the ER. I've never had problems with migraines before in my whole life. A few were very bad and makes me not want to do anything all day. I went to the neurologist just to get a pain medication for this.

Also was diagnosed with allergies last summer because I had 2 bad sinus infections.

Recently I have started to have acid reflux every night and now sometimes in the mornings. This sucks!! I am getting this removed.

I did several internet searches over the past several months and all these symptoms are caused by progestin (levonogestrol). This is not worth it.

I've had this thing in for over a year now, but all these symptoms appeared after getting this thing in.

Ive also been very moody around the time of the month, super irritable and bitchy.

My gyne suggested to take another drug to counteract, (basically prozac with another name) but that's like taking speed to counteract a downer. No thanks!!!!!!!!!!

I got this thing put in because of heavy periods, but it is totally NOT WORTH IT!! My health has suffered because of this.

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"

-and-

"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
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 Ewiesaa Consultant Gynaecologist, The Ipswich Hospital NHS Trust, Suffolk, UK"

I can't believe some of the things you people are blaming on the Mirena! There is NO substantial evidence that supports ANY of your claims! I had the Mirena put in on the May 16 and, while it was painful to put in, I haven't had pain since! My only complaint is that I haven't stopped spotting. My sex drive is IMPROVED if anything but the bleeding has made it hard to "engage". As soon as the spotting lightens enough, I "engage" and then right after, I start bleeding again. But that is no big deal since I was told to expect this pattern. As for those of you little teeny boppers who are just dating and haven't had a child yet...What the hell are you even doing on the Mirena??? Did you not hear that you aren't a good candidate for it????

I had my Mirena IUD removed on Monday, May 5, 2008. I had it inserted on November 10, 2005. I was having major side effects from the birth control, and every doc I went to said that there is no way that Mirena would cause the side effects I was having because the "progesterone amounts are too low to cause these side effects". I have had the following side effects:
WEIGHT GAIN
JOINT PAIN
LUMPS IN BREASTS
BREAST TENDERNESS
HUNGER (as if i were pregnant)
DEPRESSION
LOSS OF SEX DRIVE
HAIR LOSS
SWOLLEN ABDOMEN (BLOATED?)
HEADACHES
GROUCHY/ON EDGE
ACNE
CYST (had a couple weeks ago... i was on vacation in Vegas and had a cyst burst.. never had these issues... this was the last straw)
STABBING PAINS IN ABDOMEN AND IN AREA OF OVARIES
PMS SYMPTOMS EVERY OTHER WEEK FOR TWO YEARS
BREAST GROWTH D TO DD
VAGINAL BLEEDING AFTER INTERCOURSE
FATIGUE
TENDERNESS OF ABDOMEN
BACK PAIN
HIP PAIN

As of today, Friday, May 9, 2008 (4 days after Mirena has been removed) I have lost 9 pounds. I am sure this is probably water weight? I am feeling a little better every day. The night I got home from having it removed, I had major mood swings... would be happy one minute and crying my eyes out the next!!! I would not recommend this IUD to ANYONE.. not even on my worst enemy (if I had one). This needs to be taken off the market. It is not safe! I have spent thousands of dollars on ultrasounds on my breasts (thinking i could have cancer because the lumps i had in my breast) and on other doctors bills to figure out what was wrong with me.. only to find out that "Mirena is not the cause"!!!!

Hi ladies,

I have had Mirena out for a week. I feel better. "Nyrek" posted yesterday about Bayer and the information on their website. here is the web address: ******
Scroll down and look for Mirena. Hit the first PDF for Product Monograph. She is absolutely right!
Quite upsetting to know that within 2 YEARS I may be able to get pregnant! I don't have that much time to spare. My little girl will be turning 5 at the end of May. It is now or never. I hope that I was able to get rid of much of the hormone from my body. I have been feeling way better. No crazy fatigue. Nothing. Some nausea (my period) and some joint pain but I had those before Mirena. Not as severe now. i have Fibromyalgia. Hopefully that goes away too.
There is a huge difference now compared to before. My body has been adjusting and coming back to its normal state. It is amazing! I am really ticked to have read that the hormone enters the bloodstream in 15 min. I thought it was a localized thing. It explains the extreme bloating and weight gain those weeks after insertion. Plus acne. Then I lost weight once the anxiety and depression set in. No wonder we are all messed up! Not cool at all!
If you all need my account for that class action suit, let me know. They make this thing out to be so wonderful when all it does is make you a walking wreck. Absolutely scary. It does work against pregnancy but at what cost?
One side effect that always got me was that I felt these spasms in my uterus, much like the ones I got when I was near the end of my pregnancy. It was crazy! At times I thought the thing had failed and I was truly pregnant. Anyone else had these weird spasms or cramping up? I still urinate a lot. Still feel some pressure down there but not like before. I still think it is my period as I'm at the end of the cycle. I have this bad feeling that although they say the hormones leave at half life, each woman reacts differently. While I felt relief on Day 1 of removal, others have taken longer. Just how long does it truly take? Especially when it has wreaked so much havoc in our bodies? I hope it does not affect my ability to conceive. That is definitely not nice!
Well, if anyone could let me know about the weird spasms, i would appreciate it! If any of you have had a baby after Mirena, how long did it take you to conceive???
As always, Good Luck, Ladies!

I had the Mirena put in in Feb 07 and while at first it was all great and a great thought of not having to take a daily pill and such a good form of bc I thought why not? I have adenomiosis which is in the inner lining of the uterus (like endometriosis but inside instead of outside) which causes many issues like extra pain/cramping, my body bloating even more during ovulation, and then irritating all of the other organs in there since the uterus is irritated which leads to more swelling and discomfort, as well as pain during intercourse. This was prior to my last pregnancy which was in May 06. I've been pregnant 6 times and have 4 children. We aren't in a position to have anymore right now. Since Oct/Nov 07 I have begun gaining weight - mainly at the times I am probably 'ovulating' and the bloat can last about 3 weeks out of the month - I'm talking 15+ pounds. Mood swings out that wazoo and pain during intercourse which I think is what has led to my very low sex drive. Also, and I don't know where this is coming from or if there is any normalcy to it, but my breasts are leaking (I haven't breastfed since Dec 06). My GP put me on Prozac and I tried them but didn't find myself any better, just more tired. Now I'm taking some vitamins, but don't know what else to do. I had an ultrasound last week that showed all is fine and that the Mirena is in its right position. I re-meet with my Ob/Gyn the 19th to see where to go next. This sucks.

I had the mirena inserted in December of 07 and didn't realize that I was having some serious issues with this thing until about 4 months after insertion, my weight would not budge, I stayed at 220 for 4 months and I walked 90 minutes a day and am eating very healthy, some weeks I'd lose 3 pds and the following week would gain them right back, this happened for the entire 4 months, I didn't think anything of it until I did some online searching and found many woman complaining about weight gain with Mirena and other horrible side effects. I was having panic attacks and was always extremely emotional, I was also very bloated all the time, my husband looked at me one day and said you are exercising and eating healthy, why does your belly look so big? So, that was it, I knew it was the mirena. He also noticed my facial acne, which I never had in the 7 years he's been with me. I finally had the mirena removed on 4/14/08 and instantly found relief, I mean, when I say instantly, you may think I'm crazy, but it was immediate relief, I felt so much better in a matter of seconds. I did read somewhere that the mirena after it's inserted goes into your blood after 15 minutes so, not sure how true that is, but I believe it, after all I went through. I lost 1 pd in one day after the mirena was removed, and now 5/7/08 I've lost 9 pds so far. Not only was it a relief for the weight, I've also noticed a major change in my mood, I was always cranky and started to get nausea and felt bloated and just miserable all the time, my acne is clearing up, my hair also stopped falling out, which was another problem I had which I believe was a major side-effect, everyone said that it was because I just recently had a baby and it was normal, but after a while it was just falling all over the place so now I'm actually seeing the difference and my hair is starting to grow back in. I'm so glad I had it removed!!

My experience and a question...

Hello all,
I had mine placed 6 days ago. First 2 days were a little painful. But I was able to go to school and work (in my final year of college and am having a hard enough time in Calculus without missing a day). I have been on many different kinds of birth control (patch, pill, and shot). My problem is I suffer from severe migraines. At the worst point in my life, they were 3-5 times a week. The patch worked the best for me. I lost weight, periods didn't change at all, migraines went to 2-4 a month and I (still to this day) have never really experienced cramps. However, because of the cost and my financial situation at the time, I couldn't afford it. The shot was the worst. Gained 10 pounds every 3 months, very emotional and depressed all the time, and the migraines slowly became more frequent. Changed to the pill (Kariva) and took it so that I only had a period every 3 months. My migraines almost went away completely but I had a lot of lower abdomen pain. Had every test under the sun and they found nothing wrong. My doctor suggested changing my birth control so here I am. My question is are there any signs of complications from the placement of Mirena? About once a day or more I get a sharp pain in my lower left side. Not sure if this is just the same pains I had from the pill (didn't take anything for birth control for 2 months and all the pain stopped. didn't start up again till placement) or if others have experienced this when something was wrong. I am scared they may be something wrong but being a broke college student, don't really have $100 to spend at the doctor to have the usually *shrug*. Thanks! email ******

I just got back from an appt. to check my Mirena inserted almost 2 yrs ago
I mentioned some S/E's I thought could be from it & he said no possible way HUH????

I've had NO sex drive
poss. painful sex Can't 100% prove that yet though
vision-floaters
an attack of extreme muscle/joint aches in my legs that lasted 5 days (came out of Nowhere) assuming it's the mirena
also have anxiety seems to have gotten worse since being on the Mirena??
lazy feeling no energy

Wow ladies!! First off, thank you, all of you, for taking the time to share your stories.

I had my Mirena inserted mid March 2008. It is April 3rd today, and so far I'm not a fan.

Insertion was easy. I barely felt anything. Minor cramping afterwards, some spotting. The worst part was the black gritty sand like discharge. (previous poster compared it to coffee grounds) Every time I sat down or stood up I could feel the grit rubbing inside me. It was the most AWFUL feeling in the world.

I have been spotting every single day since insertion. I did have a full period (started a few days before Easter) and it lasted about a week and a half. It was moderate to heavy. I did have more than usual cramping for me. And with every cramp I felt a sharp stab in my uterus. I imagined it was my uterus pressing down on the IUD. It was very uncomfortable. Now my "period" is over and I am still spotting! Its strange though. My discharge is clear, but with streaks of purpleish/brown blood. Its not typical spotting. But i've ruined one too many pairs of good underwear so its starting to get on my nerves!!!! I thought this was supposed to STOP bleeding. I've bleed every day in some shape or form.

My one month checkup is on the 10th. I am going to express my concerns with my doctor, but I know she'll blow me off like everyone else. I am getting a lot of pressure from my husband to keep it, despite the side effects. We already have 4 children, and dont want any more for a few more years.

Other side effects I am experiencing that I can only assume are from the Mirena (they might not be, but I cant explain them any other way):

- I feel stupid! Im spacey, i cant think straight. Very forgetful. Simple jokes go over my head.
- my vision is wacky. I feel like im staring through a haze. I have a hard time focusing on objects or fine print. I have never had a vision problem before!
- i feel weak and woozy occasionally.
- extra crampy. and often feel pings and pangs in my uterus.
- increased thirst
- slight paranoia. I actually feel like all my friends are mad at me, when i know they arent.
- I sweat at night.
- moody.
- my nails are all dry and splitting. I normally have very healthy nails
- a general feeling of laziness. It takes a ton of motivation to get up sometimes. I have 4 kids and I work full time...I'm not a lazy person! I cant be! So this feeling is very frustrating!
- I'd rather sleep than have sex. which for me is abnormal. I am more of a hornball than my husband usually. hahaha

wow this list is longer than I thought!!

I'm going to give this thing more time. But so far I am not a fan. I know it works for some women....but these things were not in the little pamphlet they pass out! I guess if they were no one would get this thing!

Thanks for listening!

i experienced all the above mentioned symptoms but in addition did anyone have problems with their vision as a sense of having blurry vision and sensitivity to light?

i am sitting here with my middle son on my lap hoping to God that my beautiful wife comes back to me. i have been telling her for months that the mirena was making her a different person; she is convinced that she needs some sort of drug to make her "normal" again. i would like her to get this damn thing removed asap. she has had all of the symptoms you ladies have mentioned. i am glad that there are some women who seem to do ok with it, but the overwhelming majority seem to have major issues. i cannot imagine what it is like to go through what women do; i do not believe that i could handle their travails. i will do whatever it takes to bring my perfect wife back to our 3 sons, and for what its worth i will pray for the rest of you. God Bless You. Dum Spiro, Spero