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.
READ MORE MIRENA IUD LEGAL NEWS
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.
READER COMMENTS
Daisy
on
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......
sara
on
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.
Heidi
on
brittany blackburn
on
Robyn
on
Katherine Louise Miller
on
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.