FDA Calls Mirena, Byetta, Cymbalta Claims Misleading

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The FDA has warned four drug makers that they have made false and misleading statements about several different medications, including the diabetes drug Byetta, the antidepressant Cymbalta, the lymphoma treatment Treanda and the birth control implant Mirena.

The FDA letters were sent to Amylin Pharmaceuticals, Eli Lilly and Co., Bayer Healthcare Pharmaceuticals and Cephalon, alerting the companies that federal regulators were aware of statements made by representatives that provided misleading or false information about the benefits of their products. In some cases, the companies also promoted their drugs for uses not approved by the FDA.

In a letter to Amylin Pharmaceuticals regarding Byetta (exenatide) , the agency said that representatives speaking at the Endocrine Society’s Annual Meeting (ENDO) in June promoted the drug for off-label uses, saying that it could be used as a stand-alone diabetes treatment, when Byetta was only approved at the time for use with other diabetes medications. Since that time, Byetta has been approved for solo use. The letter also says that representatives exaggerated the potential weight loss benefits of Byetta, and overstated its efficacy.

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Byetta is a type 2 diabetes drug that is used to control blood sugar levels. It is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels.

The letter is just the latest problem for the drug maker. In November, the FDA issued a new warning indicating that they have received at least 78 post-marketing reports that link Byetta side effects to kidney problems, including 62 cases where the users experienced kidney failure. And in October 2007 and August 2008, the FDA issued safety alerts about reports of Byetta pancreatitis problems, including severe cases of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal. Symptoms of pancreatitis, which is an inflammation of the pancreas, include nausea, vomiting, severe pain in the upper abdomen and back, a rise or fall in blood pressure, and increased heart or respiratory rates.

The FDA letter to Eli Lilly was sent over their antipsychotic Cymbalta (duloxeitine hydrochloride), citing the company for direct-to-consumer print advertisements that made false or misleading claims about the drug’s effectiveness while failing to note any Cymbalta health risks in the main ad. The health risk information was on an adjacent page in a way that appeared unconnected to the main advertisement, FDA regulators noted.

The warning letter regarding Bayer’s contraceptive intrauterine device (IUD) Mirena (levonorgestrel) claims that the company overstated the drug’s effectiveness, made unsubstantiated claims and minimized the risks in a live consumer-directed program, where representatives travel to consumers’ homes.

Bayer has run into trouble in the past with the FDA over marketing claims involving its contraceptive products. In late 2008, the FDA and several state attorney generals forced Bayer to run a $20 million corrective advertising campaign for its Yaz birth control pills because prior marketing contained false claims about the drug’s acne and PMS-fighting benefits, and did not clearly state all of the known Yaz side effects, drowning some of them out with loud music. As a result of the misleading advertisements, Bayer agreed that the FDA will screen future Yaz ads for six years before they can be aired.

A fourth letter targeted at Cephalon’s leukemia medication Treanda (bendamustine hydrochloride), citing problems with pocket dosing cards that omit information on Treanda health risks and dosing information.

All of the companies have been warned to immediately cease any false or misleading advertisements and have been ordered to explain whether they intend to comply with the request and how or why they believe the false and misleading drug advertisement claims are incorrect.

Tags: Amylin, Bayer, Birth Control, Byetta, Cephalon, Cymbalta, Eli Lilly, Mirena, Treanda, Yaz

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89 Comments

Beverly
Cymbalta OMG this is a wonder drug for my back nerve pain. It is a nightmare drug to get off. The benefits is NOT worth what you go thru to get off. The surges are worse than you can imagine. You have to be STUPID if you consider this drug. I can’t get off been on for 5 years. Tried coming off slow with other meds. It makes your heart feel like it’s coming out of your chest. I have never been on any meds. and wish I never took this one.
dk
I have had absolutely no problems with mirena for the past 5 years. Just had it replaced. Sorry so many of you are having problems – the irritability and tirednes makes sense – hormones and hormonal changes. The rest…..? I just thought there should be a positive response after all of the negative. Everyone reacts differently to medications and it shouldn’t be expected to be any different with Mirena. However, I am in low 40s the reason for the Mirena was to continue birth control until menopause so maybe that is why many of the issues do not affect me.
Julie
I just wanted to voice MHO regarding Vic’s comments on Cymbalta. First of all, I’m so glad you’re feeling better Vic! That’s great to hear. Yes, Cymbalta can be a great drug – I also take it. Initially it was prescribed for chronic pain and depression, now I take it for major depression, as it did nothing to quell the chronic pain. However, Cymbalta’s not just for anyone with depression. My doctor refers to it as “the big guns”. I started on it both parents died and I developed post partum depression within a 6 mo period. It’s for people with major depression, not mild or seasonal depression. I’m not a doctor, but this is what my doctor has told me. I’m not saying it wouldn’t work for the latter, but other medications would probably be tried first. And that’s best because of the type of thing Suzi is experiencing – the brain surges, or brain zaps! Weaning off of Cymbalta isn’t supposed to be so difficult – not anywhere near like the nightmare it is to get off the drug Effexor. They’re both SNRI’s, but with vastly different 1/2 lives – which is why getting off of them is different. At one point I also tried to get off of Cymbalta, and had the brain zaps, dizziness, etc… I went back on when I realized the post partum depressed was still there, but when I forget to take a dose or two, I get the brain zaps and dizziness again. I’m sure it’s not to the extent Suzi gets this, but it was uncomfortable. There’s no documented withdrawl syndrome from Cymbalta, so many doctors will say you can just wean off, but I dont’ think that’s the case for everyone. Suzi if you’re still out there, you can go to a web site – I think it’s dr-bob.org and go to psychobabble withdrawl for great info from some really well informed people who can often be of great help. Of course there are others who aren’t – but such is the way of the web! There’s also a page called psychobabble medication – so people can avoid some of the more awful side effects of medications – like the ones you which can make you gain 20 – 40 pounds in a month, and cause diabetes! Of course, those same medications can save lives, but they’re not always prescribed properly. : / As for all of you who’ve taken Mirena, my heart goes out to you! I’ve never heard of anything SO awful, and I’ll be sure to tell our daughters, when they’re that age, to stay away from Mirena!
momnatty
I am recovering from surgery removing the Mirena that was imbedded in the utuerine muscle. Since I can’t do anything else, I decided to research and am completely blown away! The last five years of my life now makes sense. The pain, hot flashes, mood swings, hair loss, symptoms of pregnancy…I though it was all stress-related and that I just neeed to “bow up and deal with life”. Ever since I came home from the hopsital a couple of days ago, all I have done is yell at my two boys (ages 5 and 7). They are naturally loud and rambunctious, but I’m not usually that short-tempered with them. Then, I found an article on the “Mirena Crash” which explains that also. ….and, the saga continues
Lois
I have two wonderfull children, a girl and a boy and after I had my son in december of 2007 I had the mirena put in February of 2008. It was so painful that the doctor had to do an untra-sound then and there to see if it was placed in properly. I had to stay at the doctors office for an additional 45mins before I was able to stand up and drive home. I bleed and was in pain for the next two months. I have had headaches, back pains, feeling of depression, sleeplessness, obdominal pains, tiredness, rashes and a slu of other side effects. My husband kept telling me from the beginning that I was changing and was not the bubbly person he knows since I put in the mirena put in. I was happily married then but now seperated. I cant go to work, get out of bed or even get in bed as some times I will stay up for days. I am having mirena revomed in two days, it wont undo the last two years but I pray I can get my life back together without further losses. I would advise any woman thinking of birth control to stay away from mirena if you want to safe your life, family and liveliwood.
Lois
I have two wonderfull children, a girl and a boy and after I had my son in december of 2007 I had the mirena put in February of 2008. It was so painful that the doctor had to do an untra-sound then and there to see if it was placed in properly. I had to stay at the doctors office for an additional 45mins before I was able to stand up and drive home. I bleed and was in pain for the next two months. I have had headaches, back pains, feeling of depression, sleeplessness, obdominal pains, tiredness, rashes and a slu of other side effects. My husband kept telling me from the beginning that I was changing and was not the bubbly person he knows since I put in the mirena put in. I was happily married then but now seperated. I cant go to work, get out of bed or even get in bed as some times I will stay up for days. Had to start taking sleeping pills. I am having mirena revomed in two days, it wont undo the last two years but I pray I can get my life back together without further losses. I would advise any woman thinking of birth control to stay away from mirena if you want to safe your life, family and liveliwood.
amber
I had mirena and experienced weight gain about 5 lbs that won’t come off – even with low carb diet and eating clean – i have been having a period for three weeks now – though its light it is aweful to have a period for so long…as time goes by it is getting longer.
Tiffany
I have had mirena for a year now. I have been depressed, crying spells, dizzy spells, painful intercourse and i’m sure more. I have been in pain for several months, i finally went to the doctor and discovered that it is no longer where it’s supposed to be that it has moved to my stomach so now i have to have surgery to get it removed.
Veronica
I had Mirena for five years and recently had it removed. It wasn’t until four days post mirena that horrible symptoms started. Depression, horrible anxiety, strange thoughts, nausea, feeling like I have the flu, diarrhea, crying spells…… the list goes on and this has devastated me. I had Mirena taken out September 17th, 10 and I have lost a month of who I really am, and it infuriates me!!!! I have seen 4 doctors, have been laid off of work until my symptoms go away. I can not afford to be off work and the doctor bills are piled high. I wish I would have never gotten Mirena or could have been advised of symptoms post Mirena. This really has happened to me and I can’t believe it. I understand this doesn’t happen to all, but this truly happened to me and women need to be aware of what is could possibly happen and be able to get the help they need if something like this happens. I was not like this before and never have been, I was the happiest person on the planet, really!
EMILY
well i have had the mirena put in 4/16/08 at first i loved it but now for a little over a year i have be haveing dizzy spells severe abdomial pain headaches back pain but now fro almost three months i have had so many symptoms i just want to know what is wrong with me and i have been to the dr. at lest 8 times since the dizzy spells started they gave me some pills to take when i have the dizzy spell but last week when i had a dizzy spell the pills didnt help just made me worst so im go to the dr. again to find out what is wrong with me but after reading very thing i can find on the mirena iud for the last week i think i know what is wrong and that is this thing needs to come out now so i can start feeling better
Tonya
I had my mirena inserted in dec 09 after my 2nd child was born. My doctor insisted it was a better option than tieing my tubes. Insertion was so painful I had to lie down for 30 minutes after just so until the dizziness and faintness went away enough so I could drive home. I cramped and bled for about a month afterward. Since insertion i have constant pain in my lower abdomen, pain/bleeding after sex, and constant headaches/migraines. I am even being treated for anxiety. And all of this isn’t even the worst part. Thurseday of last week I woke up with a cramp in my left leg. the cramp spread to my entire leg and my toes went numb. When the pain got unbearable i went to the ER. They found a blood clot in my left leg. I spent 2 days in the hospital, I have been on bedrest since to prevent a pulmonary embolosm, and I have been taking blood thinner shots in the stomach twice a day and am on 3 blood thinner pills a day for at least the next 4 to 6 months. The other night I went back to the ER for severe abdominal pain and after many medical tests and several hours of horrible pain the ER doctors found nothing (except the existing blood clot) that could cause so much pain. And as soon as the doctors were aware that I am being treated for anxiety their attitude changed. They treated me like some drug addicted who was just there for more meds. It was humiliating. I HATE my mirena!!!
Amy
Just another woman whos life was screwed by the Mirena. Sure I didnt get pregnant but now Im 26 with a real bad case of Alopecia and spent months on end anxious and paranoid. Developed lesions and rashes, was treated for fungus infections, anxiety, depression, chronic fatague…I could go on and on. Why the hell dont doctors know to look to that evil thing when patients come in with every single symptom that is listed in the “less then 5% of the population”. I cant even go out without a hat. No one will even tell me what happened to me. I just keep hearing ” the mirena cant do that”. Bayors disgusting marketing tactics have the doctors spittting the same bogus crap the commericals do. Its not fair that woman have to go through this. My kids saw me thinking I was dieing! I looked like I had a nervous break down!
Amy
I had switched to Mirena as I was told by myOBGYN it would be a better option since there wasn’t estrogen. I had been struggling with melasma and acne for years and was told shouldn’t use estrogen. Insertion was HORRIBLY painful and lasted for about 2 days. Could feel it was there but after a few weeks I got used to it and enjoyed that I no longer had period. However, the melasma on my face continued to ge worse. My OBGYN and dermatologist said it wasn’t the Mirena making it worse, so i kept it in. 2 years later melasma and cystic acne is so bad that i am embarrased to show my face, i found a new dermatologist and he says to remove it immediately as its making my hormone out of whack…. Appt is tomorrow, hopefully it won’t be as painful coming out as i was going in. DRs need to have more information on how Mirena can really screw with a persons hormones. Can’t wait for tomorrow, I WANT THIS OUT OF ME
Christie
I had Mirena inserted and 2 months later Cystic Acne took over my back and below my chin. Acne is one thing but this Cystic Acne is painful. After going to the dermatologist and told what was going on with me I had the Mirena removed the following week. However now I’m spending hundreds of dollars to try get rid of the Cystic Acne and the scars that it left. My lower back is horribly scarred and I’m mortified over it. I do not recommend Mirena to anyone.
LMD
I have an appointment to get my Mirena out next Monday after about 10 months having it in. I have been a completely different person this past 6 months. Thought I was going crazy; have had anxiety attacks, uncontrollable rage, depression – completely unlike me. Complete lack of sex drive, cramping for 18-24 hours after orgasm. Headaches, insomnia, lack of appetite. Had a child 2/08, another 9/09, Mirena went in after the second one. Lost baby weight within 3-4 months the first time, lost most of it before Mirena, gained back within 5 pounds of delivery weight and have been unable to get the weight off. Fatigue/lack of energy. Very strange back pain, made me think I was having kidney failure until I realized I didn’t have any other symptoms; intense dull ache in kidney area in waves for 1-3 days at a time, then it would go away, and return a few weeks later. But the worst has been the personality change. I lost about 6 months of my life. Can’t wait for Monday.
melissa
About 5 years ago i had the mirena iud inserted for birth control. I was recently divorced and had worked my way to management in retail cosmetic working for Dillards. Within a few months I started experiencing muscles spasms in my back neck and groin. Then nerve pain that made standing, walking and even laying down extremely painful. Each doctor i was referred out to was told about the iud and i questioned many times if it could be causing this. I was told i had shingles, possibly fibromyalgia. I was legally declared disabled and unfit to work due to severe pain and sedation. Typical pain pills were not effective, so i was on anti spasm and nerve pain meds such as lyrica. as the pain and spasms grew worse it not only debilitated my body but my mind as well. after suffering in a traumatic violent act against me, I suffered from a mental breakdown and was sedated even more. All tests were coming back normal with the exception of a cat scan that shows my whole back in spasms. I had my gallbladder removed as it became sick and not functioning. In October of 09 a friend of mine had a family member who has some of the same symptoms as me who had been very sick. She had the same iud and shortly after having it removed had a full recovery. This encouraged me so i had mine removed. The months following I noticed the spasms dissipating and was able to wean off of all medications. I spoke with my gynecologist about the connection and was shrugged away. The inserting doctor has since passed away. I have attempted working again only to realize i have problems with short term memory loss as well as facial recognition (i still have nerve pain in the groin area as well as rib cage muscle spasms). My gen practitioner who had managed my care this entire time refused to extend my medicaid referral to my neurologist, siting they could manage my care. I believe this was done in an effort to cover the fact that they as well as other docs had missed the fact that the iud they were well aware of was in fact what had been making me ill. I have since stopped seeing them and have found an equally disinterested doctor since not many doctors are interested in taking medicaid. I have lost 4 years of my life and career. not to mention the drastic emotional effects this has taken on my young son who is now 13. i have suffered a loss of cognitive & physical function which i am thankful for regaining, but it dosent seem right that this is still on the market. Even on the fda’s website it now has a warning. I dont understand why it is still legal, the main ingredient was banned but is now ok? none of this seems right and every attorney i contact wants nothing to do with my case. now my life is ruined and so is my health. i have lost faith in our legal system sine our gov allows us to be victimized so openly especially since i live on the gulf coast and we are being poisoned anyways i guess none of these even matters since i probably wont make it to age 40 FML
Devon
It really fusterates me. I did my research and read all the info on the mirena. I knew that there were some big side effects but Beyer gave info that made them seem few and far betwen. I have had mine for over a year and a half and I am having it removed next week. Im keeping my fingers crossed for no complications. I have 4 kids and do not want any more but between the weight gain, fatigue, moodiness, breast pain, cervical pressure, and cramps, I am done. half of these symptoms aren’t even in the info, but really all these women have suffered from the same thing. We are not dilusional, we just want to feel normal and live our life with our kids. Please DO NOT GET THE MIRENA. I feel guilty because I thought it was a great choice at first, boy was I wrong.
Tracey
I had my Mirena put in after by daughter was born in 2006. I have an appointment set up for next Monday to finally have it removed. About a year ago my GP talked me out of it, telling me that my depression, mood swings, anxiety and lack of sex drive was just a stage all mothers go through in life. Well, here I’am my husband has finally had enough, we’ve decided a seperation is the best thing for our family. He claims nothing he does makes me happy and I can’t blame him he’s right. Too bad I didn’t listen to my gut a year ago and had this horrible thing removed. All I can hope for is that the side affects go away, so my children don’t hate me too.
Chelsea
I have had the Mirena in since September of 2007. I am finally getting it removed this week. I hate the side effects that I have gotten from it. Hair loss, greasy hair, horrible cramps where I have to have my husband massage below my belly button, awful headaches, dizziness, have a hard time catching my breath, weight gain (& cannot get the weight off, for months I was eating very low carb which you should lose fast anyways, pilates & jogging & I lost 3 lbs), major depression, anxiety w/ panic attacks. Please those of you, who are thinking of getting the Mirena, CHANGE YOUR MIND.
Heather
I had the Mirena inserted about a year after the birth of my second child. I had pain, cramping, and constant spotting for about 6 months, but then things seemed to level out. After about a year, though, my personality was affected – and also, of course, my marriage. We stuck it out, but then I began getting severe headaches. Also many migraines. Then I found out that I have a benign meningioma in my head (brain tumor) that blocks the majority of the blood flow through my saggital sinus. I had to have a shunt inserted to drain my brain fluid. It is permanent. I have also required gamma knife radiosurgery to stop the growth of the tumor so I can retain what blood flow that remains. I have had quite a bit of abdominal pain the past year or so. I finally had the Mirena removed yesterday. Very little abdominal pain so far. Already an improvement. Could this tumor be related to the Mirena? The timing seems right. Anyone else out there with related issues?
Jodi
I am a 30 year old mother of 3 amazing boys… After my 3rd son was born in Feb 2009, I decided that I wanted to try Mirena. So at my 6 week check up I had Mirena inserted. At my 1 month check up of the Mirena, I had my dr remove it, at that time he discovered that I had an infection caused by the Mirena. I was in such severe pain that I couldn’t function. I was having trouble moving at all. There was no need to worry about getting pregnant, I didn’t want to be touched at all. I couldn’t even sit my baby on my lap and enjoy the time with him that a mother should. I had endured a lot of pain, even after Mirena was removed. I had blacked out on my stairs, 12 steps up, falling against the wall, I kept blacking out, I was doubling over in so much pain that I was vomiting, I still had no desire what so ever to be touched. Finally the pain got the best of me and I told my dr that something had to be done. So in August of 2009 I had laproscopic surgery done. Come to find out, the Mirena caused me to get PID, and my pain was coming from my uterus swelling. I had a c-section and my scar tissue had wrapped itself around my bladder and my uterus. So, when my uterus was swelling it was crushing my bladder and squeezing. 2 Weeks after my laproscopic surgery I had to have a hysterectomy. My dream of one day having a little girl was gone, just like that. Thank God that I have 3 wonderful, healthy sons. I am still getting used to my hormones being out of wack, but hopefully it will get better in due time. Unfortunately, because I chose Mirena, I lost time with my sons and I will never be able to have another child. I do not recommend Mirena to ANYONE!!! I will say one more thing, Thank God I have an amazing doctor who took the time to make sure I was going to be okay.
marsha
I had the mirena after my daughter in 2008, never had som many problems with that, I thank got pregnant shortly after removed so my hormones realy got out of wack very long time. on progesterone cream noe to regulate my hormones
Jason
My wife had Mirena removed about a year ago due to vaginal discharge, cramps, hair loss, depression, bleeding, fatigue and infection. Now that it has been out for about a year she still suffers from discharge, hair loss, fatigue and depression. She is 27, I am 26. You should have seen the clumps of hair falling out with the Mirena in and we were told it was due to a hormone imbalance which the Mirena may have caused. Now that it is out the doctor says it may be years before the hormones are balanced again. We can no longer have sex as she still contracts vaginal infections regularly and always has discharge. Her periods show symptoms a week before and a week after the period. This thing has really put a big strain on our marriage….
Tiffany
I also forgot to mention the bloating and lack of a menustral period.
Tiffany
I have experienced nothing but hardship since getting the Mirena. It was inserted January 2008 after having my second child. I did not want the Mirena and the doctors would not tie my tubes even though I was a high risk patient. I do not have insurance and I can not afford to go to the doctor. Since getting it I have gained 40 lbs. I suffer with migranes, severe abdominal and pelvic pains, back pain, muscle spasms in my legs, rash on my body, and brown discharge occassionally. The pain lasts between 24hrs – 4 days. Whenever I try to exercise to take the weight off, the pain escalates. I apply a heating pad and take pain killers to try to ease the pain. I am tired all of the time and get irritated quickly. I cry a lot and feel depressed. I have had vomiting. I took a pregnancy test to check to see if I was pregnant and it was negative. Recently, I woke up and went to use the bathroom and blood was running down both sides of my legs. I got the Mirena to prevent getting pregnant, but I constantly have the symptoms of being pregnant or the feeling of childbirth. I am afraid to find out exactly what damage the Mirena has caused my body. I would highly recommend women to avoid the Mirena. It is not worth the trouble.
Candice
Why is it that so many women, (myself included), asked their doctor to remove the IUD and they “refuse”??? List of the symptoms I have experienced with Mirena: Extreme fatigue Breast Lumps Cervical Pain Irritability Depression Headaches Scarring Acne Dizzy Spells Painful Intercourse anxiety panic attacks Mirena has taken moments of my life away from me.
Heidi
Had the Mirena IUD inserted January/February of 2006 after my son was born and had it for a year. I (29) did not have any complications at insertion but after about eight or nine months in I started to have pain and a doctor I was seeing acted as if it was in my head due to all the blood work coming back somewhat normal. They did another test and an x-ray to come to the conclusion that something had been left at my appendectomy but I had never had it removed and so they told me to go see my OB/GYN about the IUD so after seeing the x-ray scheduled me for surgery and after the surgery was complete the operating Dr. said it had been there for about six months judging from the scar tissue. I have had more problems since the surgery (now 32) I have depression, weight gain, unexplained soft tissue swelling, no menstrual cycles and sever fatigue. Golf ball nodules of swelling short term but all the time in various parts of the body. I never wanted an IUD to decide for me when I was supposed to stop having children. It was supposed to be safe and the best form of birth control outside of abstinence that is.
Ashli
I had the mirena iud for 10 months but i had really bad pain. And I finally went to the Dr. and they had to put me asleep to get it out of me it was embedded into my uterine wall and the strings were tangles all the way around it. I am still in pain from them having to take it out and I am hoping that my insurance covers the cost!! The first 3 months I bled like crazy and it looks like I am going to have the same issue now that its taken out! And I mean everyday for 3 months I had a period!
Suzi
Weaning off Cymbalta has been a nightmare for me. I was not in any way warned of the side effects of this drug. The “brain surges” have been merciless. They continue invading my day several times each hour. I weaned off very, very slowly and it has now been two weeks and the surges have not lessened at all. I wouldn’t go back on this medication for any reason. No one tells you about the horrid surges and withdrawls. Not your doctor and not the makers of the drug. Should be illegal. I have learned more from other consumers than anyone responsible for making this drug available for use.
Suzanne
Cymbalta for peripheral neuropathy due to MS. I had a lower GI bleed that landed me inn the ER. I needed 5 bags of blood to replace what I lost.
Liz
I had the mirena for about three years. I just had it removed about 2 weeks ago. I have been threw about every side effect you can imagine, and im still going threw it. Tomarrow im going to have a ct scan because im still having troubling pain in the right side of my belly and shooting left leg pain,also pain in my left side of my back. The mirena ruined my life. I have almost lost my job and im sky high into medical bills. I’m onlu 20 years old. I should be outside running around and being able to take care of my animals. I have 9 dogs. Now im selling them because im unable to take care of them anymore. This mirena needs to be off the market. This thing is killing me .
carole
My experience with the Mirena IUD was not satisfactory. I am 40 years old with a very uncomplicated medical history and no chronic health problems. I had the Mirena IUD inserted in September, 2009, four months following the birth of my second child. My ob/gyn recommended Mirena in lieu of my request for tubal ligation. I wanted to avoid the use of birth control pills because of the potential associated risks for a woman my age and I have no intention of ever having any more children. She touted this as a less invasive means to prevent pregnancy over the tubal ligation procedure without the complications that may result from birth control pills. Following insertion of the device I experienced extreme discomfort from cramping and heavy bleeding that was unremitting until the device was expelled three months later when I removed a tampon. I also gained 17 pounds during the three month timeframe I had the device. The side effects of the device clearly outweighed the benefits, as a simple surgical procedure would have provided me with my desired outcome and all of my suffering could have been avoided. In addition, I contacted my insurance provider, United Healthcare for information regarding approval for the device, specifically and was assured that my insurance would cover 100% of the charges. It was after my ordeal (including moderate to severe cramping, heavy bleeding every day for three months, weight gain, and subsequent expulsion of the device), that I learned that United Healthcare refused to cover the cost of insertion which amounted to approximately 650 dollars that I had to pay out of pocket. My ob/gyn offered to insert a new device at no additional charge and I refused because I could not bear the thought of going through all of the cramping and bleeding again. My experience led me to wonder what kind if marketing tactics are being utilized with physicians, because as a clinician (I am a doctoral level licensed psychologist) I could not recommend the use of such a product to a consumer seeking sterilization based on the associated research. I cannot believe that this product is continuing to be marketed to women. It is criminal.
Sabrina
I had the Mirena implanted in the early part of May 2010. My doctor informed me after the insertion that I may have some cramping, but that it should go away within a few days. Well, the pain and discomfort has never gone away and even now that I had it removed after only 6 weeks, i am still having cramping and severe abdominal pain. I am not sure what to do from here
Shirley
I had my mirena implanted in nov of 06.. totally regret it now!! I have had many side affects . headaches, extreme fatigue, bloating, feelin ill all the time(like mornin sickness) depression, anxiety and panic attacks. thats just a few of my problems i had with mirena.. And I seriously thought that I was goin crazy!! I have a appointment this tuesday with my dr . im goin to tell her get this evil thing out of me NOW!!!
Alexis
I currently have the mirena birth control floating somewhere in my body. The part that pisses me off the most is that i have been in pain from this thing for over a year and still no help. The first thing a lawyer wants to ask is what did u lose is there any permant damage. If i knew and was a doctor do you think i would be calling your too smart ass for help no. People don’t understand when your in constant pain daily don’t know if your going even live from day to day because it hurts the last thing you want is to hear a person so book smart their common sense dumb. I hate that i even got this stupid thing in the pain and side effects are too damn much please if you don’t have it don’t get it ever
vic
At age 50, for the first time in my life, I understand what it’s like to feel “normal.” Cymbalta has changed my life. No more suicide thoughts, depression down 90%, and constant cycle of worry has stopped. I am sure I would be dead by now if not for Cymbalta. If nothing else has worked, please try it!
Lisa
I had mirena inserted five years ago and removed two years ago. I became pregnant two months after removal and lost the baby at six months into pregnancy. The following year I became pregnant and lost the baby again at six months. Both were due to an early rupture of membranes. I have now been diagnosed with Graves disease.
lori
Had the Mirena inserted June of 2009. On March 9th, 2010 I was informed by my doctor that the Mirena had perforated my Uterus and is now in my abdominal cavity. Scheduled for invasive surgery for the removal of the Mirena. I urge anyone considering this option to reconsider.
cassandra
i was on the mirena iud after my youngest was born in july 2007. we had it removed about 9 months later due to how uncomefertable it was. in june of 2009 we desided to try again for baby three. we were sussful but lost the baby in oct. doc wanted us to wait a full cycle to try again. we were praganet by dec. and lost the baby in jan 2010. im hearing rumors of a recall about a recall due top infertilty and loss of a pragancys????? if this is true i would like more info on the subject plz.
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