A health scandal is currently growing. Bayer’s Mirena hormonal IUD is reported by thousands of women in the United States, Spain and France. This one would have side effects sometimes very serious, but that the gynecologists deny en bloc. The offending contraceptive is also marketed in Switzerland, Spain, the United States, with thousands of complaints against the deleterious side effects of the IUD. In France, testimonials arrive in the hundreds every day on the Internet, while the National Agency for the Safety of Medicines and Health Products begins to recognize the side effects of the Bayer contraceptives.
“I started feeling dizzy and depressed (…) I felt very bad, depressed, I had pains in my breast, I asked my gynecologist if it could be related to my Mirena, he told me no, and that the depression was purely psychological (…) I had big migraines, and more libido, anxiety attacks that triggered without any reason explainable, my gynecologist told me that it was normal at my age, that I should not worry … “: these types of testimonials are surfing the Internet for a few months, and begin to make waves. It must be said that until then, hardly anyone had dared to come to contest the safety of the Mirena hormonal IUD.
The word of women who have – or have had – this type of intrauterine hormonal device (hormonal IUD) is released today in France, after that of Spanish, German or American women. The flagship contraceptive product of Bayer Laboratories, which has been on the market for about fifteen years, is now being blamed by thousands of women for its deleterious side effects, women who had not – until now – managed to make the link between hormonal IUD which often stops the menstruation and the different affections that they underwent. It must be said that in France, the medical profession obviously did not help them much.
Known side effects
The side effects of the Mirena IUD – according to the thousands of testimonies that have been pouring in for months in France – are worrying, and above all, have put patients in great difficulty, deprived of professional listening attentive to their troubles.
All the women went to inquire by Facebook and not in a medical office! Me, my gynecologist completely denied what I had, almost to treat me crazy.
Christelle G., creator and administrator of the Facebook group “Victims of MIRENA Hormonal Sterility”
Beyond depression, anxiety attacks, dizziness, breast pain and loss of libido, some women have also suffered vision loss, gallstones, hair loss, or tachycardia. Marie L., a professional paramedic and moderator of the Facebook group “Victims of Hormone Sterile MIRENA” testifies to its own difficulties: “After twelve to eighteen months wearing the IUD, I began to have significant vertigo, panic attacks, and a state of almost permanent anxiety, bordering on the state of depression. The whole thing was accompanied by a significant loss of libido, and I did not make the connection with the IUD right away. I spoke to a visit to the gynecologist, eighteen months after the onset of symptoms, it was three years that I had the Mirena. My gynecologist completely denied the phenomenon and almost laughed at me “.
The central problem around these undesirable side effects is not that they are hidden, since the Bayer notice indicates their possible appearance (see box at the end of the article) – in very few cases depending on the company – but that the gynecologists do not inform, most of the time, their patients of the possibility of appearance of these side effects, and do not practice any control between 4 and 6 weeks after the installation of the hormonal IUD.
Since the pharmacovigilance statements are almost never made, the Mirena’s benefit-risk balance is completely distorted.
This control is supposed to verify that no adverse effect has occurred, and that the patient supports the contraceptive device. Christelle G. denounces this lack of information on the undesirable effects of the Mirena IUD: “After having my problems with this IUD, I found lots of women’s stories on forums, and I found it completely crazy to see all these women who speak, who speak, with doctors who do not listen to them, or refuse to take into account their problem. All women affected by Merina went to Facebook and not to a doctor’s office! Me, my gynecologist completely denied what I had, almost to treat me crazy. My goal is that at least women have the record when we put this device, and they have the controls that go with it. There is no information from the gynecologists about the side effects of Mirena, my gynecologist always told me that it was the revolution, that it was a super and perfect device, that she even had worn and she had never had any problems, etc … “
Denial of the professionals The omerta of the gynecologists
What women denounce most is a lack of information and follow-up from the gynecologist. Many of them go back to their doctor to complain about very serious side effects.
Only, according to the testimony of these women, a majority of gynecologists deny all connection with the contraceptive, going so far as to refuse to withdraw it, and advising to consult a psychologist.
Reading the testimonies, there is like the sensation of an omerta practiced by gynecological doctors, accused by their patients of having denied in most cases the causal link between one or more disorders suffered and the wearing of the Bayer hormonal IUD. Phrases such as “You get ideas, it’s in your head, you go too much on the Internet, your Mirena is for nothing in your troubles, it’s age, it’s normal” are commonplace in the mouths of gynecologists face patients who came to complain about their vertigo and migraines or loss of libido – the most common symptoms in the testimonials of side effects of Mirena blooming on the canvas
Christelle G. is very up on the subject: “I am very surprised by the speech of gynecologists who refuse to see the effects of Mirena in many symptoms such as loss of libido, since these adverse effects are described in the leaflet. There is a gap between the record and the medical discourse, and then as the pharmacovigilance statements (see below: What does the ANSM?) Are almost never done, necessarily the benefit-risk balance of the Mirena is completely distorted. I have a friend who is a midwife and who, like me, does not understand why gynecologists have this speech, there is surely something that escapes me, but these doctors prefer to tell a woman to go see a psychologist for seek treatment, rather than withdrawing their Mirena. Of course, there are gynecologists who agree to recognize side effects and remove the Mirena, but they seem to be in the minority.
In the health magazine “Allo Doctors”, on France 5, in January 2016, a gynecologist and sexologist challenged by a listener who “has no sexual desire for months” after the installation of a Merina, believes that the hormonal IUD is not the cause. The side effects are reduced to very little by the professional:
You know, today is more and more fashionable to find side effects
Gérard Lévy, President of the Ethics Commission of the French National College of Gynecologists and Obstetricians
The president of the Ethics Commission of the National College of French Gynecologists and Obstetricians (CNGOF), Gérard Lévy, contacted by telephone, also does not see any problem at the Mirena: “I asked a lot of Mirena and I never had the slightest problem. On side effects, the now retired gynecologist has a theory: “You know, today is more and more fashionable to find curious side effects to all devices and all products. As for the loss of libido that many women are witnessing, the professional is very categorical, and shares the same discourse reported by the patients as that of their gynecologists: “The libido is so multifactorial, that to say that is the Mirena that is involved, you have to get up early. For the libido, it is surely not the Mirena who is involved. “
Knowing the thousands of testimonials from women who had lost their libido after Mirena’s break and found her after withdrawing the device, the Ethics Commission president concluded: “The Mirena are still local administration hormones that do not pass into the general circulation, so it seems odd to me. Never in my career have women complained, and they were very happy to have their periods decreased or stopped. But I see that there is a snowball effect: as soon as there are some people who make statements [on side effects, note], it leads to a series of other “.
What does the ANSM do?
The National Agency for the Safety of Medicines and Health Products (ANSM) has not yet responded to these problems and continues to issue authorizations for the Mirena Hormone IUD.
This approach of pharmacovigilance reporting to the ANSM is very important, since from a number of declarations on the whole territory, the agency is obliged to trigger a reassessment of the device.
Marie L. Paramedical professional and moderator of the Facebook group “Victims of MIRENA Hormonal Sterility”
This passivity is not the result of chance or a willingness of the public authority to deny the problems, but simply a consequence of the lack of rigor of the medical profession and the passivity of the patients. It is indeed impossible for the ANSM to create an alert or reevaluate a medical device if no pharmacovigilance information is sent to it. What gynecologists should have done every time a patient complained about the side effects she was experiencing. And as gynecologists do not want – obviously in the great majority – to recognize these side effects, it is up to the patients to do it. Gerard Lévy of the CNGOF explains this phenomenon by “A laziness of doctors who do not want to bother with these statements”.
The ANSM, if statements are addressed to him, is thus informed and then recognizes for each person the undesirable effects. Marie L. explains the ultimate interest of this approach, if a maximum of patients make their declaration: “This approach of pharmacovigilance reporting to the ANSM is very important, since from a number of statements throughout the territory, the agency is obliged to trigger a re-evaluation of the system. It can lead to a change in the record, but also to a change in protocol, like what exists in Germany, since in this country, a gynecologist is obliged to have a paper signed with the list of all the side effects to any patient to whom he poses a Mirena (German site translated into French: Ed). In my case, the record of the Mirena was never given to me, I arrived with a closed box and the gynecologist threw it with the record. If I had read this leaflet, I would have refused the pose. “
Return of the pharmacovigilance declaration sent by Marie L. on the undesirable side effects of the Mirena IUD. The AMSN is obliged to re-evaluate the device if it receives enough statements about this product.
Court actions of thousands of women
Across the Atlantic, where “class-action” practices are common, patients have not remained in the only complaint on social networks and the call to issue requests for pharmacovigilance. After a lawsuit in 2013 for perforations of the uterus, a new collective complaint attacks the Bayer group for possible cases of tumors and cerebral hypertension caused in the United States by the Mirena. The cause of migraines, depressive states could indeed be due to the hormones delivered by the IUD that would increase the blood pressure of the cranial box. In Spain, 27,600 complaints were filed against Bayer for an anti-coagulant and two contraceptives, including 2,900 complaints for Mirena alone.
In France, voices are now raised to bring action also in collective justice: the case of the hormone IUD Mirena is in its infancy, and the scandal could explode in France too, in the weeks or the coming months.
[ Update May 16, 2017 ]: Following the publication of this article, thousands of women have registered on the Facebook group “Victims of MIRENA Hormonal Steroids” to testify side effects that affected them with the insertion of the IUD hormonal Mirena. This group now has more than 9,000 members (and as many testimonials), difficult to manage according to its administrators. A forum was thus created (430 members on May 16) to make it easier to inform the worried users and to collect the testimonies which continue to flow. An association was created today: Hormones Vigilance Sterility. She can be contacted for the time at this address.
The ANSM has meanwhile started an investigation and made contact with the head of the forum and future president of the association, since the number of pharmacovigilance reports has exploded in a few days following the publication of this article.
” The National Agency for the Safety of Medicines and Health Products (ANSM) has seen in recent days an increase in reports of adverse effects that may be related to the drug Mirena (intrauterine device levonorgestrel). Most reported adverse reactions are reported in the patient information leaflet. The ANSM is nevertheless attentive to this increase in the declarations and to the appearance of new signals which are currently the object of investigations. The ANSM reiterates the importance of respecting the recommendations for use of this medicine, as well as the obligation to inform patients by health professionals. In addition, the undesirable effects of the Mirena intrauterine device, found in various European countries, are currently evaluated within the European Medicines Agency. “
On the ANSM website, the manufacturer’s leaflet indicates the following undesirable side effects, up to … breast cancer:
Like all medicines, MIRENA can have side effects, although not everybody gets them.
Very common side effects (in more than 10 women in 100) are:
· Headache (headache)
· Pains in the abdomen and abdomen, abdominal swelling;
· Menstrual problems including bleeding between periods, more or less heavy, prolonged or shortened periods, or prolonged periods without bleeding;