Lawsuit Over Mirena IUD Imported From Canada Filed By Texas A.G.
The state of Texas has filed a lawsuit against a women’s healthcare clinic for allegedly using Mirena IUD birth control devices that were illegally obtained from Canada.
Texas Attorney General Greg Abbott filed a deceptive acts and practices lawsuit over Mirena (pdf) against the Women’s Integrated Healthcare clinic in Grapevine, Texas, for providing women with versions of the Intra Uterine Device (IUD) that were acquired from an on-line Canadian pharmacy. The lawsuit accuses the clinic of causing confusion and misunderstanding among patients who believed that the Mirena IUDs were the same as those sold in the U.S.
The clinic claims that there is no difference between the IUDs sold in the U.S. and those sold in Canada. In a press release, clinic officials say they have stopped providing the birth control devices and that the only effect of the lawsuit will be to prevent women the clinic serves from obtaining affordable birth control.
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Learn MoreIn May 2008, Bayer sent out a “Dear Healthcare Professional” letter (pdf) warning U.S. doctors not to buy foreign versions of the Mirena IUD for use in the U.S. The company said that it understands that there is a price difference between those sold abroad and those sold in the U.S., where it is generally more expensive.
“[T]he foreign product is not FDA approved, and use of a foreign product raises important patient care and legal considerations,” Bayer warned doctors throughout the United States. “We are writing now to make sure that you are aware of these issues and to caution you against using the foreign product.”
Bayer further warned that the products may have passed through a number of countries before being shipped to the U.S. and there is no guarantee that the products are not counterfeits, have been properly stored and protected, and said that there are product differences from country to country that can affect insertion and “appropriate post-insertion monitoring and patient care.”
The FDA followed up with a similar Mirena import alert in July 2010, which says that the practice of importing the Mirena IUD began in Rhode Island and spread to other states. The FDA also warned that devices acquired abroad could be fakes, tampered with or manufactured with different specifications.
“Unapproved products bring a lot of unknowns into the equation,” said Kathleen Anderson, an FDA compliance officer. “An Internet ad may claim to sell IUDs made in Canada, but there’s no way to be sure. They might have been made anywhere in the world and in unsanitary or undesirable conditions.”
The Mirena IUD was approved by FDA in 2000 as a birth control device. In addition to placement as to prevent sperm and egg contact, it also releases the progestin levonorgestrel to futher prevent pregnancy.
A number of women have reported experiencing potentially serious problems with Mirena IUDs, including perforation of the uterine wall, migration of the IUD, infections, ectopic pregnancies (where the egg grows outside the uterus) and an increased risk of pelvic inflammatory disease.
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19 Comments
traceyJuly 16, 2013 at 4:21 pm
I had an iud put in for heavy periods.my periods stopped which was good but the iud after a few months went out of place.i began to have dizzy spells and migraine headaches as wll as tingling in my feet.i had to go to several doctors to figure out what was wrong.i ended up having pid and having to go on very strong antibiotics.i lost weight and was very sick.i would have to say,this device is just[Show More]I had an iud put in for heavy periods.my periods stopped which was good but the iud after a few months went out of place.i began to have dizzy spells and migraine headaches as wll as tingling in my feet.i had to go to several doctors to figure out what was wrong.i ended up having pid and having to go on very strong antibiotics.i lost weight and was very sick.i would have to say,this device is just not worth the risk.
vanessaMarch 22, 2013 at 2:58 am
I had an IUD inserted after having my 1st kid May 2009 and I could feel discomfort and pain/ I was told it was normal...I had weight gain, memory loss, cramps, headaches, among other issues. Come to find out the IUD was not FDA approved!
tammyJanuary 26, 2013 at 1:06 pm
My daughter got mirena put in after her firt baby.she new she did not want any more kids right now.since she has had mirena put in ..nothing but problems,ance really bad,weight gain at least 30pounds or more depression.Now its been at least a year she has had it in and they tink she is pregant and the do not know where the mirena is..or has it fallen out.my poor daughter is not stuck in deciding t[Show More]My daughter got mirena put in after her firt baby.she new she did not want any more kids right now.since she has had mirena put in ..nothing but problems,ance really bad,weight gain at least 30pounds or more depression.Now its been at least a year she has had it in and they tink she is pregant and the do not know where the mirena is..or has it fallen out.my poor daughter is not stuck in deciding to have a baby or what side effects this will have..She crys all the time..how can something like this happen when you was doing everything possible to prevent now you are ...well to be cont..please pray for her she is only 21..thanks for this page
MichelleFebruary 7, 2012 at 1:50 am
I got Mirena in 2004 after having my son. It hurt so bad trying to insert it the doctor gave me a script for muscle relaxers and told me to come back in 2 days. I had major cramps for months after... He said I need to give it at least a year before he will take it out. I was very young so I did not see another doctor, I sucked it up. A few years later I got admitted to the ER because the same[Show More]I got Mirena in 2004 after having my son. It hurt so bad trying to insert it the doctor gave me a script for muscle relaxers and told me to come back in 2 days. I had major cramps for months after... He said I need to give it at least a year before he will take it out. I was very young so I did not see another doctor, I sucked it up. A few years later I got admitted to the ER because the same doctor said I had an ectopic pregnancy. I told him to please remove the IUD while he was in there... After my surgery the doctor told me that he HAD removed it... I went on about my life. The next year me and my husband could not get pregnant so I went to an infertility clinic. During the "dye test" they asked if I'd ever had an IUD and I immediately looked up at the screen. The doctor had not removed the IUD from my body, it was now in my abdomin putting off way too much hormone which is why I could not get pregnant. So I had to go in for yet another surgery. A few months later, I found out I had a fibroid, which was "probably" caused by the hormones in the IUD and about a year later I had to get my gallbladder taken out from gallstones (which can also be cause by the hormone in birthcontrol). I tried to contact an attorney and was told I could not sue (even the first doctor) unless it caused permanent damage. As far as I'm concerned it has.... Keep in mind I'm only 26, I had to have 3 surgeries within 3 years all due to what I believe were complications due to Mirena.
SousanOctober 11, 2011 at 3:02 am
I've had minrena for the passed 6 years. I have reported peliv pain, stomach pain, headche (migrane like), weight gain, sleep disorder, dizziness, all body aches and joint pains. My sed rate is too high that doctor suggested I have fibromyalgia and need to be on anti inflementary drugs.. Please tell me these are th side affects of this device and If I remove it I would be fine.
MiracleSeptember 27, 2011 at 6:58 pm
I received the Mirea IUD December 2008. I didnt get any periods on the iud. I begin to get mood swings, depression, memory loss, hair begin to fall out, very bad cramps, i gained alot of weight, severe headaches. For about 6months straight in the year of 2010 my stomach was hurting to bad where i decided i wanted the Mirena removed. I went to the doctor and they couldn't find it. So they scuduled[Show More]I received the Mirea IUD December 2008. I didnt get any periods on the iud. I begin to get mood swings, depression, memory loss, hair begin to fall out, very bad cramps, i gained alot of weight, severe headaches. For about 6months straight in the year of 2010 my stomach was hurting to bad where i decided i wanted the Mirena removed. I went to the doctor and they couldn't find it. So they scuduled me for an ultrasound and it was stuck in utrine cavity. SO i had to have surgery to get it removed and they said if they couldn'y get i would have to have an hysterectomy. I wasn't warned about any of the side effects that i went through. It was very hard to fucntion on a day to day basis. I feel like i should be compensated.
laceySeptember 14, 2011 at 2:03 am
I had a Mirena IUD put in when i was 16 and had it removed at 21, since then i rarely have had periods. i saw my doctor about this and he put me on the pill to regulate my period. but as soon as i stopped taking the pill my periods went away again. my husband and i have been trying to get pregnant, but, im afraid the mirena made me infertle. ive considered seeing the doctor again but have little f[Show More]I had a Mirena IUD put in when i was 16 and had it removed at 21, since then i rarely have had periods. i saw my doctor about this and he put me on the pill to regulate my period. but as soon as i stopped taking the pill my periods went away again. my husband and i have been trying to get pregnant, but, im afraid the mirena made me infertle. ive considered seeing the doctor again but have little faith he can really help me.
melanieAugust 22, 2011 at 5:39 pm
My 5 yr. mirena is due to be removed november of this year. I didnt notice the connection the first 2 years. I thought i had cancer or aids or liver failure.... something irreversible. Always having been so fit and life loving i tried to continue taking care of those around me - hoping some doctor would help me. The insurance issues, doctors amount of actual knowledge all this keeps me running to[Show More]My 5 yr. mirena is due to be removed november of this year. I didnt notice the connection the first 2 years. I thought i had cancer or aids or liver failure.... something irreversible. Always having been so fit and life loving i tried to continue taking care of those around me - hoping some doctor would help me. The insurance issues, doctors amount of actual knowledge all this keeps me running to a er. There is a condition called acidosis which im believing may be the way that we are becoming ill.Many times it starts at the place of foreign object placement. please try taking the juice of one lime, mixed with 1/2 teaspoon of baking soda and 4 oz. of water. pls. no tap water and look into ph balances higher than 8. . take this tincure once in the morning and at night for 3 weeks and please post your experience. i thought noone could ever help me but i found a site called earthclinic.com that has given me back my life energy and now im on a mission. shouldnt be long!!!!! god bless.
samanthaAugust 19, 2011 at 7:29 pm
i am so sorry to hear how awful the effects of this has been on some of you. i also had a mirena inserted when i was 22. I had it for about three years, and those were the worst three years of my life. i was always in pain, it did stop my period but its like all the hormones that were just buildin up in my system. i was diagnosed with pid (pelvic inflamatory diesase. i thankfully was able to conci[Show More]i am so sorry to hear how awful the effects of this has been on some of you. i also had a mirena inserted when i was 22. I had it for about three years, and those were the worst three years of my life. i was always in pain, it did stop my period but its like all the hormones that were just buildin up in my system. i was diagnosed with pid (pelvic inflamatory diesase. i thankfully was able to concieve and i had a son in march of 2009.... but it did take me three years to concieve and i was luky i was able to.
MalindaAugust 8, 2011 at 1:59 am
Thank you ladies, I have also suffered from extreme headaches, dizziness, nervousness and often confusion. I have also been to my physcian regarding these symptoms. I will be getting this removed. I feel this has impacted my life in a negative manner. I do not recommend the iud mirena. Thank you for reading and sharing your stories!
NWalkerAugust 4, 2011 at 12:01 am
I also have the IUD. I have had it going on 5 years and at age 27, I have developed a condition that is directly related to the IUD. After severe migraines, headaches, pain and discomfort, depression, severe mood swings, and anxiety, I have made an appointment to have it removed and will not be replacing it.
mistyJuly 30, 2011 at 3:43 am
i also have been having sharp stabbing pains in my stomach and vagina. been to the ob/gyn so many times and they don't know they keep cutting the strings on my mirena i have heard on tv of a lawsuit going on now about mirena but after i started paying attention to the tv i haven/t seen in on again. has anyone else heard of this in the past month
AmberJuly 6, 2011 at 8:38 pm
I have had mirena iud for two years and in these two years I have had more problems medically with no explanation. Befire I rarely went to a doctor except for prego visits. I have been diagnosed with depression anxiety and mussel pains and back issues. Seen chiro and primary. I cant deal with my own children and am now in the middle od a divorce bc of it. And untill today had no idea it was the iu[Show More]I have had mirena iud for two years and in these two years I have had more problems medically with no explanation. Befire I rarely went to a doctor except for prego visits. I have been diagnosed with depression anxiety and mussel pains and back issues. Seen chiro and primary. I cant deal with my own children and am now in the middle od a divorce bc of it. And untill today had no idea it was the iud. I dont have insurance niw and want it out. Ive lost everything. I need help.
GenelleMay 13, 2011 at 5:41 am
I have had two iuds. I am on the 2nd one. I have had this one for almost 3 years now and I found out today it has been lost in my body. I have no insurance, so I have to now figure out a way to pay for an OB to have it removed....Thats just the iceing on the cake. The first one I had I developed (the so called 1% of women).. P.I.D. The IUD was not removed at that time. I found out today not only s[Show More]I have had two iuds. I am on the 2nd one. I have had this one for almost 3 years now and I found out today it has been lost in my body. I have no insurance, so I have to now figure out a way to pay for an OB to have it removed....Thats just the iceing on the cake. The first one I had I developed (the so called 1% of women).. P.I.D. The IUD was not removed at that time. I found out today not only should it had been removed but another should never had been put in. I am now facing surgy, and I may never be able to give birth again. I am 29 years old and this really shouldn't have happened to me....There is no telling were this thing is in my body and the damage it has caused....
MandyApril 12, 2011 at 4:42 am
Oh my god I would love to share my horrible experience I've had with the Mirena! I've always been super healthy until I had the Mirena placed in June 2011! After insertion I started having extreme headaches, neurological symptoms, I've had CT scans , MRI's , Even a Lumbar Puncture.... My life started falling apart I couldn't take care of my self or my 3 children. I've always been a PTO mom , I vol[Show More]Oh my god I would love to share my horrible experience I've had with the Mirena! I've always been super healthy until I had the Mirena placed in June 2011! After insertion I started having extreme headaches, neurological symptoms, I've had CT scans , MRI's , Even a Lumbar Puncture.... My life started falling apart I couldn't take care of my self or my 3 children. I've always been a PTO mom , I vollenteer for my community and always been very involved with family. My life has completely fell apart !! Still almost a year later and I'm still having issues . My head feels like it's gonna jerk back and I get very confused and dizzy. I now have extreme anxiety it wakes me up out of a dead sleep. Some how Iadies we need to find answers this mirena has posined us and is some how malfuntioning. I know I'm not alone out there. Women speak up!!!!!! There is much more to my story and pages of medical records I got sick of every doctor I seen saying they can't find anything. I have been posined . Please read this blog" My Mirena hell and what I'm doing" IT WAS THE ANSWER TO ALL MY PRAYERS. God Bless _Mandy
bobbiMarch 25, 2011 at 3:18 am
i have been using Mirena for about two and a half years. i was having severe side pains mistaken them with a simple kidney infection. come to find out i had severe damage from the Mirena IUD. so severe that it has caused me to have to have a Hysterectomy. only at the age of 22.
Vanessa DMarch 18, 2011 at 3:23 pm
In. April, 2009 I had the Merena removed from my abdomen! It had perforated my uterus. Shortly after it was removed, I was pregnant! Although, she was a bit early she has no health issues. Not the same great news for mom! I had a circlauge placed, and removed! C-section followed by 2 bloodtransfusions. Then tubes tied, and a procedure called an endometrialoblashion and now at 29, I'm told I need[Show More]In. April, 2009 I had the Merena removed from my abdomen! It had perforated my uterus. Shortly after it was removed, I was pregnant! Although, she was a bit early she has no health issues. Not the same great news for mom! I had a circlauge placed, and removed! C-section followed by 2 bloodtransfusions. Then tubes tied, and a procedure called an endometrialoblashion and now at 29, I'm told I need a hysterectomy!!! Thankfully, I have 4 beautiful children, now the only challenge is staying out of the OR long enough to enjoy them!
MELISSAJanuary 26, 2011 at 8:18 pm
I HAVE HAD THE MIRENA FOR 3 1/2 YRS NOW, I HAVE HAD SHARP PAINS IN MY STOMACH SINCE THE DAY THEY PUT IT IN. I HAVE GONE BACK AND FORTH TO THE DOCTOR SEVERAL TIMES ABOUT THIS ISSUE, AND THEY ALWAYS TELL ME THEY DONT SEE ANYTHING WRONG. I HAVE ALSO BEEN THROUGH A PERIOD WHERE I HAD A HEAVY MENSTRUAL CYCLE THAT LASTED 3 MONTHS, AND THE DOCTOR ALSO TOLD ME THIS WAS NOT UNUSUAL. IVE HAD A LOT OF PROBLE[Show More]I HAVE HAD THE MIRENA FOR 3 1/2 YRS NOW, I HAVE HAD SHARP PAINS IN MY STOMACH SINCE THE DAY THEY PUT IT IN. I HAVE GONE BACK AND FORTH TO THE DOCTOR SEVERAL TIMES ABOUT THIS ISSUE, AND THEY ALWAYS TELL ME THEY DONT SEE ANYTHING WRONG. I HAVE ALSO BEEN THROUGH A PERIOD WHERE I HAD A HEAVY MENSTRUAL CYCLE THAT LASTED 3 MONTHS, AND THE DOCTOR ALSO TOLD ME THIS WAS NOT UNUSUAL. IVE HAD A LOT OF PROBLEMS IT SEEMS LIKE SINCE THIS HAS BEEN PLACED.
BaileyJanuary 13, 2011 at 3:50 am
I have been a person that rarely had an headache,now I discovered since I was on the Mirena I've been having, anxiety,depression problems,body aches, and some days I feel like my days is over. .