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FDA Receives Reports of Serious Mirena Side Effects

. By
Boston, MAThe number of reports of women suffering from Mirena side effects continues to grow, but even though the US Food and Drug Administration (FDA) receives the reports, it has not changed its stance on the safety of Mirena birth control. Side effects reportedly associated with the intrauterine device include Mirena uterine perforation, a potentially serious condition.

According to the US Food and Drug Administration (FDA) Adverse Event Reporting System, in response to a Freedom of Information request, the FDA has received thousands of cases of side effects linked to Mirena from April 2, 2008 to April 2, 2013. The report, which was obtained by WXYZ News (8/27/13) and runs more than 13,000 pages, notes that total cases may include duplicate patient reports from different sources about the same patient. Not all reports of adverse events are as serious as uterine perforation. Some, for example, involve irregular periods. But others report device dislocation, device expulsion and vaginal hemorrhage. Some reported infertility linked to their use of Mirena.

The ages of the patients in the reports range from 14 years old to more than 50 years old.

Patients who have written to Lawyers and Settlements complain about pain, severe cramping, heavy bleeding and perforation of the uterus.

Mirena is an intrauterine device, implanted in the woman’s uterus. But some women have reported side effects, including having the birth control migrate out of the uterus, possibly causing damage to other internal organs and requiring surgery to remove the device.

In 2009, Bayer received a warning letter concerning its marketing of Mirena. The letter accused Bayer of overstating the efficacy of Mirena, presenting unsubstantiated claims, minimizing the risks and including false or misleading information. According to the FDA, Bayer failed in the promotional material at issue to properly convey that a woman could “lose her baby or her fertility” if she were to become pregnant while using Mirena.

Lawsuits have been filed against Bayer, maker of the Mirena IUD birth control, alleging women suffered serious side effects as a result of using the device. So far, according to WXYZ, there are more than 220 lawsuits filed claiming women were not adequately warned about the risk of device migration.

One such lawsuit (federal case number 2:13-cv-04419-JP) was filed by a woman who says she received the device in spring 2009, and suffered device migration requiring surgery to remove the IUD. According to The Pennsylvania Record (8/1/13), the lawsuit alleges Bayer knew the Mirena IUD had a higher risk of migration than other IUDs but did not adequately disclose that risk. The plaintiff seeks compensatory damages, punitive damages, and attorney’s fees and costs.

Bayer has also faced lawsuits for some of its other birth control products, including Yasmin and Yaz. Those lawsuits allege Yasmin and Yaz - birth control pills - are linked to an increased risk of blood clots.

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READER COMMENTS

Posted by

on
Have been going crazy trying to understand my body recently.

I recently visited my obgyn to have a annual review. I have had the copper iud for going to 7 years and was advised by Doctor to switch to MIRENA due to extreme heavy cycles with boold cloths. It was hurting my blood and iron.

I was fine with switching because of the benefits I was explained and over all want to feel better. April 5 I started my cycle and went in the following day to switch. It was painful to a just but was ok. No blood cloths. The following Monday I started with a rash on shoulder. By Wednesday night it had explained to a itchy rash.

I began taking over the counter creams to help but it was to much. Would wake me from my sleep at night. Had the worst weekend. The sun would give me a burning sensation on my arms.

I made a call to obgyn nurse, see said it didn't sound like a side effect to go see a family doctor and that it was just a switch of iud. This was even after I told her I thought it was a allergic reaction because it was everywhere. I was doing benadryl every 4 hour, cream 4-5 times a day.

General Doctor said I was negative to strep throat, poison ivy, scabes and blood work was fine. Advise Benadryl, I told him that wasn't enough. Got me something for my itch/pain. 4 days later itch has been control but rash/hives are everywhere. My face to my toes. I have become nausea and no apatite. (Sexually or Food)

I'm scared that if my outside looks this bad, what my internal can result in. Try to wait until Monday because I can afford to go to ER. Please provide more information that can help. 17 days with Mirena and wish I had my 14 day long cycle with BC. That was my crazy normal and now I don't know what to expect......

Posted by

on
I had the Mirena inserted in Feb. 2014 and removed Dec 2015 I started noticing its side effects about 2 months after insertion but I did not know it was related to the Mirena!
First, I had Anal fissures after 1 month, when i noticed blood on the toilet paper it was also painful to pass the bowel (Dr prescribed creams).

After about 3 months, I started to have severe eczema on my hand, I was prescribed cortisone cream which would help for a period of time. My sex drive plummeted to zero after 4-5 months.
Started to have acne in my face (which i never had before!)
After 5 months I also noted knee joint pain and joint pain in my hands, hair loss, especially my long eyelashes were so SHORT.

Then came the Hive-like RASHES all over my lower body....it was severely bad! I started out having dry, very itchy raised patches on my skin all over my legs and buttocks, I excused it as perhaps an allergy to something was eating regularly.
BUT then it became worse..it got to the point where I was bleeding from opening old scabs and I could not SLEEP because of the itching.
The Doctor told me it could be scabies and did not think it was from the coil...(so i did a scabies treatment,...did not work) the dermatologist told me its eczema..(which I never had this severe) So i was given more steroid creams!!

Throughout this dilemma I started researching if other people had these side effects online, and there it was! Hundreds of complaints, similar stories like mine. Took it out as soon as I could..and lord behold...ALL my symptoms faded and were completely gone after about 2 months post removal!!
I FEEL LIKE MYSELF AGAIN After LOSING 1 almost year of my life!

These were my symptoms in a nutshell that STARTED and STOPPED after the Mirena:
HIVES (especially lower body)/ ECZEMA, HYPERALERGIC REACTIONS, JOINT PAIN, ACNE, HAIR LOSS, VAGINAL DRYNESS, ANGER, ANXIETY, LOW SEX DRIVE.

Now, I have some friends who don't have any complains, its important to know that every human body is different, thus everyone reacts differently to things.. I hope someone reads this and it will help them!

Cheers.

Posted by

on
I had the Mirena inserted almost 6 months ago. My OBGYN suggested it as the best means of birth control for me since I was 37 at the time and have a history of hypertension. She said I might have some spotting to period like bleeding for up to a month after the insertion, but my period would eventually subside to a very light flow to possibly even no bleeding at all. My periods were normally every 28 days and were on the heavy side, lasting for about 5-6 days. I was excited about having little to no periods. My life has been miserable ever since I had this thing implanted! It started with horrible cramping that I had to take Ibuprofen around the clock for. On the second day I started having excruciating back pain. I'm a nurse, so my job requires me to lift, push and pull. I attributed the pain to something I may have done at work, so I didn't see the doctor. On night #5 I had a panic attack. I've never had anything like this before! My moods were all over the place. I was crying and feeling angry and panicked all in the same hour. The bleeding got heavier and heavier and the pain in my back was horrendous! I was taking so much Ibuprofen that I started having stomach pain and had to start taking antacids. Around month 2, I started having generalized body pains, almost like arthritic type pain that would last for about a week in each area. I've never had body pain either. Finally the bleeding slowed down a little so I thought my body was starting to regulate. The back pain diminished by month 5. The body pains continued though. My period is like a reverse period, with heavy bleeding for 4 days, no bleeding for 4 days, then spotting for 20 days. I documented it on my period calendar and it's like clockwork. I am coming up to month 6. I had read somewhere that it can take up to six months for your body to regulate, so I wanted to give it a chance. I am ready to remove this nightmare from my body! I am in constant pain, my moods are unbearable, the bleeding has me drained (literally) and I have gained 20 lbs! I had to pay a nice chunk of change to have this implanted and I am to the point that I will gladly pay whatever I need to to have it removed. I wish I would have known about this before. I would have never had it inserted! I feel like I was mislead and it was at the cost of my health and my sanity. I wish I would have read some of the blogs and postings on the internet from so many other woman that have experienced these horrible side effects.

Posted by

on
I had the Mirena imserted in 2011, I began having problems of back pain, hip pain, loss of appetite, hair loss, and horrible stomach pains, and also very bad mood swings and depression.. I had the Mirena removed 01/08/2014..I was positive for infections caused from the Mirena..but still the doctor refused to remove it when requested..I am now having to go to a doctor to have further testing done to see what damage this device has caused..

Posted by

on
I was recently diagnosed with breast cancer. I am 36years old. I had the Mirena inserted 5 years ago and had complications from the beginning. I had it remove In May. I asked my surgeon how long I had breast cancer and she said she thought it had been there 4 or 5 years.I am negative for the BRCA gene. It makes me wonder if the Mirena had something to do with it????

Posted by

on
I had the Mirena inserted last year on August 28, 2012. In November 2012(a little over a month later) I started having right hip pain. It gradually got worse as the months went by and caused me to stop exercising by February 2013. The hip pain got so intense that I finally went to the doctor. Through an MRI they saw that I had a right hip labrum tear. We assumed that was what was causing the hip pain so I did physical therepy, steroid injections, and then even surgery(June 12, 2013) to repair the right hip labrum. My left hip started hurting in May 2013 before my right hip surgery. I had an MRI of the left hip the same day that I had the right hip surgery. The scan showed that I had a labrum tear in the left hip as well. Therefore, we scheduled surgery for the left hip 6 weeks after my right hip surgery. At my post operative appointment and my 6 week appointment I was still in lots of pain from the right hip surgery and felt worse than before surgery. Therefore, we canceled the left hip surgery until the right one started to feel better. At 8 weeks I still had no relief and both hips were giving me horrible pain. The surgeon finally agreed that the labrum tear wasn't the source of my pain in the beginning. The hip surgeon released me and said I needed to go get another opinion because my pain was not fixed from surgery.
I then researched and found horrible stories that have happened to women with the Mirena IUD. I was so desperate to get relief that I went and had my Mirena removed. It was a horrible procedure to have it taken out. It has now been over a month and I have absolutely no pain. The day after I the Mirena taken out I saw signs of relief and now no pain!
I would just like all of my medical bills, the nanny I had to hired and any expenses the Mirena caused me to be paid for. The last 6 months of my life have been horrible and I would never of had to go through any of it if I didn't have the Mirena.

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