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Mirena IUD - Risk of Uterine Perforation & Pseudotumor Cerbri


Mirena, an intrauterine device inserted directly into the uterus to prevent pregnancy, has been associated with mirena uterine perforation and other serious side effects. The birth control device has recently been associated with neurological side effects, including pseudotumor cerebri (PTC). As of June 30, 2012, The US Food & Drug Administration (FDA) received 45,697 reports of a serious Mirena birth control side effect. Consequently, Mirena lawsuits have been filed against Bayer, including Mirena uterine perforation and Mirena brain injury.

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Mirena Injuries

According to AdverseEvents.com, the top three adverse events related to the use of Mirena were device expulsion, device dislocation and vaginal hemorrhage, with more than six percent of patients requiring hospitalization or surgery. Mirena birth control side effects can include:

  • Uterine perforations
  • Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)
  • Intrauterine pregnancy (a pregnancy with Mirena in place)
  • Group A streptococcal sepsis
  • Pelvic inflammatory disease (PID)
  • Embedment of the device in the uterine wall
  • Perforation of the uterine wall or cervix
  • Infertility, abscesses, erosion of adjacent areas such as the vagina
  • Pseudotumor cerebri (PTC), also known as Idiopathic Intracranial Hypertension (IIH)

Mirena was approved by the FDA in 2000 as a contraceptive device and in 2009 it was approved for the treatment of heavy menstrual bleeding for women who prefer an IUD as their method of birth control.

The Mirena IUD is a T-shaped device that is implanted directly into the uterus and can remain in place for up to five years. It works by slowly releasing levonorgestrel, a synthetic “hormone” to prevent pregnancy and to treat heavy menstrual bleeding. Levonorgestrel is a hormone commonly used in combined oral contraceptives.

Mirena, Levonorgestrel and Pseudotumor Cerebri

Pseudotumor Cerebri (PTC) is a condition that causes neurological issues and can mimic the effects of a brain tumor. Another name for PTC is Idiopathic Intracranial Hypertension, meaning “high pressure inside the skull for unknown reasons.”

Since the early 1990s PTC has been associated with levonorgestrel. It is believed that levonorgestrel can elevate levels of cerebrospinal fluid in the brain, which increases pressure in the brain, similar to a tumor. Two cases were reported in 1993. In 1995 researchers warned in the New England Journal of Medicine that levonorgestrel could increase the risk of PTC. In Mirena clinical trials, 7.7 percent of women reported headaches/migraines.

The Mayo Clinic lists the following symptoms associated with PTC:
  • moderate to severe headaches originating behind the eyes that worsen with eye movement
  • ringing in the ears that pulses in time with a person’s heartbeat
  • dizziness, nausea or vomiting
  • blurred vision
  • double vision
  • seeing light flashes
  • temporary or passing blindness
  • neck, shoulder or back pain


Bayer Mirena Warnings

The FDA issued a warning to Bayer in 2009 for overstating the effectiveness of Mirena, while minimizing the risks associated with it. Up until the FDA’s reprimand for deceptive marketing of Mirena, Bayer held live presentations as part of its “Simple Style” program that targeted “busy moms” and claimed that the IUD would help increase libido and “look and feel great”. Instead, and included in the FDA warning letter, “at least 5 percent of Mirena IUD users reported decreased libido in clinical trials.”

The FDA’s Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) concluded that the benefits of Mirena were overstated through this program while downplaying its side effects.

(The German pharmaceutical giant had already received a similar warning from the FDA regarding how it advertised Yasmin and Yaz products, along with a large fine against the company.)

As a probable result of Bayer’s multi-million dollar advertising campaign of its IUD directly to the consumer, by 2009 the use of IUDs implanted in American women using birth control had doubled in just two years (about 7.5 percent of all American women using birth control had IUDs).

In 2010 a joint safety information statement issued by Bayer Inc. and Health Canada stated that women in the US and Canada reported injuries related to use of Mirena. Bayer AG and Health Canada said that uterine perforation is a rare complication associated with all intrauterine contraceptive devices/systems, including Mirena. Perforation occurs at a rate between 1/1,000 and 1/10,000 insertions. The statement was issued because Bayer Inc, had received reports of uterine perforation associated with the use of its device. The statement also noted that the risk of perforation may be increased after pregnancy, during lactation, and in women with atypical uterine anatomy.

Mirena Lawsuits


Bayer is facing a number of lawsuits by women who have suffered injuries from the Mirena IUD device. For claims involving injuries caused by migration of Mirena and perforation of the uterus, a Multi-District Litigation (MDL 2434) has been centralized in federal court in New York, involving more than 500 lawsuits. Nearly 800 additional lawsuits are pending in state court in New Jersey.

Bayer is facing a number of lawsuits by women who have suffered injuries from the Mirena IUD device. The company has petitioned that all cases be consolidated to the New Jersey Superior Court in Middlesex County, where Bayer is headquartered.

A Pennsylvania woman filed a Mirena lawsuit (Civil Action No. MRS-L-272412) against Bayer Healthcare Pharmaceuticals on November 5th, alleging numerous damages as a direct result of Mirena and Bayer’s wrongful conduct and negligence, including severe and permanent injuries and pain and suffering. Further, the lawsuit is also asking for financial compensation due to lost wages and the decreased ability to earn future wages.

According to the lawsuit, the woman had the Mirena IUD implanted in 2008 but did not experience pain until 2010. In November 2010 a CT scan revealed that Mirena was no longer inside her uterus. She underwent a subsequent laparoscopic surgery to have the device removed.

A Florida woman also claims that the Mirena IUD caused physical and emotional damages. Her complaint (also filed Nov 5th, Civil Action No. MRSL-2723-12) states that she had the Mirena IUD implanted in 2008 and in July 2010 suffered from pelvic pain. She had laparoscopic surgery in December 2010 in order to remove the IUD. The lawsuit alleges that the Mirena caused a number of damages, including severe and permanent physical injuries, pain and suffering, and economic losses in the form of medical expenses and lost wages.

Mirena Pseudotumor Cerebri Lawsuits

In March 2014 the first Mirena pseudotumor cerebri(PTC) and/or idiopathic intracranial hypertension (IIH)lawsuit was filed in Alabama. A federal judge allowed the lawsuit to proceed after plaintiff Shenika Houston sufficiently claimed negligent design, strict liability, breach of express warranty, and fraud. The lawsuit states that patients who develop PTC might continue to use Mirena because the label does not include warnings about this potential risk. This could contribute to the development or progression of PTC or IIH.

In May 2014, Law 360 reported that lawyers, on behalf of plaintiffs, asked a panel of federal judges to centralize nine Mirena lawsuits involving PTC/IIH into an MDL in the U.S. District Court for the Middle District of Tennessee, which is separate from the MDL 2434 (above).

Plaintiffs allege that Bayer failed to adequately warn about the link between the hormone levonorgestrel, present in Mirena, and PTC/IIH. The lawsuits allege that levonorgestrel can elevate levels of cerebrospinal fluid in the brain, which increases pressure in the brain, similar to a tumor.

In September 2015 a Florida woman filed a complaint in the U.S. District Court for the Western District of Tennessee, alleging that Mirena caused her to suffer severe migraines, cognitive problems, vision problems, memory loss and other problems. Nicole Hamill claims that she experienced PTC symptoms just one month after being implanted with the IUD in 2004. Hamill required lumbar punctures to relieve intracranial pressure and had the Mirena IUD removed. However, the punctures do not cure the condition.

All plaintiffs claim that Bayer knew or should have known about the link between Mirena and levonorgestrel and PTC, and Bayer should have provided stronger warnings about the risk of PTC/IIH.

The intracranial hypertension from Mirena often presents as a swelling of the optic nerves, called papilledema. Bayer has included information about the risk of papilledema on its warning labels in several countries, such as South Africa and Hong Kong. It has not given doctors or Mirena consumers in the US the same warning.

Mirena IUD Legal Help

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Last updated on Nov-5-15

MIRENA IUD LEGAL ARTICLES AND INTERVIEWS

Mirena Lawsuits Claim Intracranial Hypertension and Wrongful Death
Mirena Lawsuits Claim Intracranial Hypertension and Wrongful Death Newark, NJ: Another lawsuit alleging the Mirena IUD caused Intracranial Hypertension, also known as pseudotumor cerebri, has been filed against Bayer Pharmaceuticals. And a wrongful death lawsuit was filed this month [READ MORE]

Mirena Litigation Setback for Plaintiffs
Mirena Litigation Setback for Plaintiffs New York, NY: Expert testimony for Mirena plaintiffs was blocked by a New York federal judge last week. About 1,200 Mirena cases are pending in the Mirena MultiDistrict Litigation (MDL) [READ MORE]

File Mirena Lawsuits Sooner than Later
File Mirena Lawsuits Sooner than Later Bergen County, NJ: Four Mirena lawsuits against Bayer were thrown out last month - the judge ruling that the women had filed too late [READ MORE]



READER COMMENTS

Posted by
There's another issue you haven't addressed
on
It's adenomyoma. My uterus was twice the size. Had two mirenas and feel that it co tributed to my problems since it it lead to accumulated tissue and my enlarged uterus. No doubt it played a hand in that.

Posted by
Kristin
on
I had the mirena inserted February 6th 2012. In the month of February 2015 I went to the hospital for abnormal bleeding and abdominal pain. After testing they found out that I was pregnant. I then got an ultrasound immediately to discover the mirena had moved outside of my uterus and the pregnancy was ectopic. Once they gave me methotrexate to eliminate the pregnancy they scheduled times to try and remove the mirena. The first attempt was vaginally with no success. Following that I had two more unsuccessful surgeries due to the mirena being to embedded where if they did remove it, it would cause more damage. The mirena is still embedded somewhere in my body.

Posted by
Louisiana
on
I have had pelvic inflammatory disease, a cyst on my ovaries and painful menstrual cycles.

Posted by
New Mexico
on
I had an ectopic pregnancy. The Mirena was embedded in my fallopian tubes and still after two years of being removed, it caused a miscarriage. I had two healthy pregnancies and I am a healthy woman. The Mirena caused four years of pain and no menstrual cycle.

Posted by
Anonymous
on
I am sharing my story in hopes that another women will not have to experience this horrific situation that has forever changed my life. I do believe in my heart 100% that it was a direct cause of the merina iud. This is what happened ...


I initially had the merina implant to regulate my periods. I had wanted the mirena out the very next day after the Dr. put it in. My body just felt weird. I ended up having nausea, headaches, foggy thinking, extreme fatigue, constipation, abdominal bloating, severve moodiness, depression urinary tract infections, severe abdominal pain. So I went to the Dr. to talk about how I was feeling and my concern that I felt the mirena had moved .

He said it was in place and he refused to have it remove it and said give it time.
I went to ER to get it out but they wouldn't either. So against my better judgment I complied with their direction.

Meanwhile my symptoms got worse . The bleeding continued to get heavier and I ended up bleeding ever since the insertion
on September 19,2013 until April 23, 2014.
I went to the ER numerous times with a diagnosis of dysfunction uterine hemorrhage. On Saturday October 19,2013 I had a lot of abdominal pain very similar to contractions during childbirth .Huge clots kept coming out. I had never seen such large blood clots ranging from the smallest about the size of a golf balls to the size of a softballs. In one of the blood clots was the merina. I put the merina in a in a zip lock bag along with some blood clots and went to the emergency room. The zip lock bag was almost filed to the top with clots. By taking the zip lock bag to the emergency room I was hoping they would send it to the pathology lab in hopes of finding out why I was bleeding so much. I left without any more information than I had before I
went there.

I ended up having three blood transfusions in a six month period. I also had to face the fact that my hair was falling out alot. I ended up spending alot of time in the shower.

I finally stopped going to the Dr. in December because he was unable to stop the bleeding, despite giving me bith control pills, the Depo-Provera shot repeatedly as well as the ER trying with various medication with no success.

At that point I gave up and was just waiting to bleed to death. My hemorrhaging was so bad that I rarely left the house. Eventually I found another Dr. and she ended up giving me D and C, which stopped the bleeding on April 23, 2014.



The implant is out however, I still am dealing with the aftermath. My Dr. said if it starts up again, we may need to explore the option of a hysterectomy. The teacher I have worked with for years had to get another educational assistant because I was unable to work. I was not working for the entire year which meant I was unable to provide for my family. My life was put on hold because I thought I was going to bleed to death. My physical health still is not back to what is before this happened. My body is still trying to recover after this horrific ordeal. I'm still have a lot of emotional scars from the trauma, I continue to experience on and off again pain in my lower abdominal as well as lower back pain, which I never had before the implant. My sex life has changed, I continue to fell pain while having sex. I just want to get my life back to how it was before the implant. At this time I need some kind of resolution in order to put this nightmare behind me.


Please note:

The implant was not surgically removed.

Posted by
Kansas
on
I have suffered from long-term bleeding and pain from the Mirena IUD and now have PID.

Posted by
Mississippi
on
I have to have surgery because it has been causing tissue and parts of my uterus to come out. It has caused me to be extremely sick and has caused cysts all over my right uterus. I may not be able to have any more babies after my surgery.

Posted by
Nevada
on
Cyst on ovaries, constant abnormal bleeding and now possible pregnancy.

Posted by
British Columbia
on
I had a Mirena IUD and all I did was bleed for the 4-6 months. I had it non-stop. No doctor would touch me or take it out. The specialist who put it in wouldn't return my calls to remove it until we threatened to take her to the news board, and medical board. I was so sick and lost so much weight. When we finally got her to remove it, she sat there saying she didn't think it was a good idea. And that I should leave it in for longer and take male hormones.

Posted by
California
on
I had the Mirena inserted a few years back and I thought it would be fine, I had no period for three years but as it got closer to the fourth year, my teeth began to break off. I had horrible migraines that I visited the emergency room multiple times. I was not aware of the source until I did some research on it and asked other women who had it inserted. I had it removed this year because my fiance and I were planning to conceive. We have been unsuccessful, and I'm praying that the Mirena hasn't caused me to not be able to conceive.

Posted by
Ontario
on
My Mirena IUD perforated my uterus and was removed during laparoscopic surgery. It was inserted in May 2009.

Posted by
Kansas
on
I had Mirena implanted in April of 2013. Before this I had two perfect pregnancies and no miscarriages; I had no issues while the Mirena was in and my husband and I decided to try again in July 2014. We had it removed July 7th and by August, we were expecting. Unfortunately, we lost the baby almost immediately and we put it off as a fluke; then again in October we found out we were expecting again, had a sonogram at six weeks and all was good; went for another sonogram at 10 weeks and it showed that the baby had stopped aging at eight weeks and there was no heartbeat. Needless to say we were devastated, and to top it off, the fetus wouldn’t naturally expel. I'm terrified to try again and have the same problem occur. Please help!

Posted by
Texas
on
I had the Mirena inserted after I gave birth to my son in September of 2007. In 2011, I had a new Mirena put in. I had surgery to remove cysts on my ovaries in 2012. I finally got the Mirena taken out in February of 2014, because I wanted to conceive. After eight months, I found out I was pregnant. At eight weeks, I suffered a miscarriage. I believe I wasn't told about the complications or the risks associated with this type of birth control, and I'm beyond disappointed and scared. I want another baby so badly. I was only 17 when I had my first, my only. Now I'm stable, I have so much to give. I'm scared I won't be able to have another one, and I don't know what to do. I was told this birth control was safe, and that as soon as I had it removed, I could start conceiving. I waited eight months, and still had a miscarriage. It's not right.

Posted by
Washington
on
Had an emergency DNC surgery due to the Mirena that I had in for one month due to complications with the IUD, which they took out while the surgery took place.

Posted by
Utah
on
Had my one and only daughter at 20 years old in 2008. Mirena IUD was inserted. Before it I never had irregular periods or heavy bleeding. Right after getting it, I started bleeding heavily. Every single day. I bled every single day for a year and had lower abdominal pain. I went back to the doctor three times. She just kept brushing it off and saying it will get better, give it a few more months. It never got better. After a year I told her to take it out, in 2009. Met my husband also in 2009. We have been trying to get pregnant since 2010. Four years later, still nothing. The only thing that could have caused infertility is the Mirena IUD. I'll never be able to have a child again. It's affected my whole life.

Posted by
Ontario
on
Hi, a few years back I had the Mirena IUD inserted and within weeks I had extreme pain and nonstop bleeding. When my family doctor tried to remove it, she could not find it and had to send me to a specialist immediately to have it removed. The specialist was able to remove it but it was very painful and hurt for days.

Posted by
Florida
on
I have been using Mirena every since I had my second child four years ago. Complications started within my body in the form of migraines and severe stomach pain. I thought that it may have been my kidneys as I do have complications with that as well; however, coming up to the time for the Mirena to be changed, I have become pregnant twice and both times I have experience vaginal blood and severe pain as if I'm having miscarriages.

Posted by
Anonymous
on
I had the marina iud put in feb 2008 after my first born child. I kept going in to my doc about cramping they told me it will happen. After having the marina iud in for 6 months I started having my period everyday all the time with a lot of cramping. My doctor told me my period will slow down n should stop. Well 6 months after having my period all the time with a lot of cramping. They decided to preform a ulartsound as they were finally going taken it out.! They search for an hour to find my iud, they couldn't located it. So they told me they were going preform surgery, as there not too sure where abouts it's located.. So they put me out to preform surgery fed 27 2009, put a small camera through my belly button to search for my iud. They finally located my iud n pull it out, they found it behind my uterus.. After my iud was taken out I thought I was safe from pain and heartache. Nope I had more n more pain afterwards, I went back in they preform another ulartsound told me I had 3 cysts both of ovaries. Caused by the marina iud, I still get then to this day n still in pain of them. They grow up to 5-7cm before popping, I also could not conceive another child tell 6 years later. I kept have a epoitc pregnancies over n over again, I was told I probably wasn't going to be able to have safe pregnancy to keep. After 6 long years I finally had pregnancy that was safe to keep, but couldn't carry to full-term as the scaring on my uterus from the iud. I safely delivered my second child just shy couple weeks early. I normally get cysts on my ovaries monthly, witch makes my period much more pain full n a lot more bleeding. I'm normally in the hospital monthly about the pain n getting an ulartsound to check in my cysts.

Posted by
British Columbia
on
Multiple infections for four months causing lost days of work. Upon removal, IUD had fused to me and had to be torn out; extremely painful procedure.

Posted by
Arkansas
on
I have suffered very heavy bleeding after I got the IUD Inserted in 2005. Also lots of abdominal pain and heavy cramping, which never occurred before having it inserted. Then all of a sudden, it just fell out on its own after having it in for about two and a half years.

Posted by
Ontario
on
Its been about 2yrs-spotting to heavy bleeding...
-cyst growing out of the uterus wall
-bloating and pain always in the lower part of the stomach and also in the uterus

Posted by
California
on
I had the Mirena IUD for a year before I started experiencing complications. One day I was doubled over in pain and had my husband take me to the ER. After a CT scan I was diagnosed with Hydrosalpinx which was believed to have been the result of my IUD. I later had an ultrasound where the tech said the Mirena had gotten lodged through the uterine wall and was stuck inside my uterus. After two doctors and a couple of months of living in pain, I finally found someone who was able to get it out but it was one of the most painful, traumatic experiences I have ever been through - and that's saying a lot because I have lost a child. Having the Mirena removed did cure the hydrosalpinx, but I still get uterine pain from time to time.

Posted by
Michigan
on
ectopic pregnancy after use of mirena
damages suffered...loss of income endless medical bills and extreme pain and suffering

Posted by
Pennsylvania
on
I became pregnant after I had the Mirena in place for 13 months. I miscarried the baby.

Posted by
California
on
I'm constantly feeling abdominal pain, it sometimes feels like I'm having contractions due to the pain, I've been to the E.R. numerious amounts of times. The doctors tell me I have ovarian cyists because of the Mirena IUD and they are bursting inside me.

Posted by
Florida
on
In 2007 she had the Mirena inserted then taken out. She found out in 2009 that a piece was still inside her. She has suffered many medical complications.

Posted by
Indiana
on
Severe bleeding with anemia, unable to get pregnant so I had a laser curettage due to endometriosis. Ongoing cramping.

Posted by
North Carolina
on
Development of fibroid tumors, ovarian cysts, surgical menopause which has caused severe, chronic dry eye, loss of libido and weight gain. I am unable to take any form of hormone replacement therapy.

Posted by
Arkansas
on
Mirena shifted and moved out of my uterus and caused serious bleeding. Ive been trying to conceive but im not able to anymore because of the damage from the mirena.

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