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Thousands of complaints concerning adverse effects in different countries including France were expressed in 2017, by women wearing the hormonal Mirena® IUD. After the complaints expressed on social networks, the Medicines Agency had looked into all the declarations of adverse effects and in particular those not appearing in the product leaflet. In November 2017, the European Medicines Agency concluded that there was not enough data to directly link adverse effects, including anxiety, to the device.
In 2017, thousands of women reported numerous side effects related to the Mirena® hormonal IUD in Spain, the United States or Germany. In February 2023, the National Agency for the Safety of Medicines (Ansm) indicated in its press release that the hormonal intrauterine device (IUD) with levonorgestrel could have a link with depressive disorders.
Definition of the Mirena® IUD
THE IUDcalled intrauterine device (IUD) in gynecological terms, is a medical device in T shape placed in the uterus. It is indicated for women seeking contraception or patients who suffer from functional menorrhagia (uterine bleeding under hormonal influence). The IUD is impregnated with levonorgestrel, an active synthetic hormonal substance which blocks ovulation, by thickening the cervical mucus between the vagina and the uterus. This drug prevents the passage of sperm, thus ensuring its contraceptive role.
In France, reports have been made by women via the Internet or social networks, and they have been very numerous. The product, marketed since 1995, has been questioned by thousands of women around the world because of numerous side effects.
An open investigation into the adverse effects of the Mirena® IUD
In a press release dated May 12, 2017, the ANSM states that “new side effects such as anxiety, dizziness, fatigue or irritability, not currently mentioned in the information documents intended for healthcare professionals and patients, have been reported at European level. These side effects are being assessed by the European Medicines Agency (EMA) and results are expected from June 2017.“.
The ANSM affirms that it is also carrying out investigations at the national level on all the reports of adverse effects received in connection with the IUD Mirena®.
The first results of the pharmacovigilance survey, presented on October 10 during the CTPV, reveal, concerning Jaydess, that only 67 reports of adverse effects have been received since the start of its marketing in 2014 in France (29 before May 15, 2017 and 38 after this date). Concerning Mirena, since its marketing in 1997 and until May 15, 2017, 510 cases including 272 serious cases have been reported. After May 15, 2017 and until August 4, 2017, 2,714 cases including 1,789 reported as serious by women, that is to say declared as having consequences on their family, professional or social life.
No direct link for some effects, according to the European Agency
The results of the national survey relating to “anxiety” type effects were sent to the European Medicines Agency (EMA) as part of the assessment of psychiatric adverse effects started in January 2017. Regarding anxiety, the EMA considers that there is, at this stage, insufficient data to establish an association between the use of an IUD containing levonorgestrel with isolated anxiety, a panic attack, sleep disturbances or hustle. Mood disorders were considered to be related to depression or depressed mood, already mentioned in the documents intended for healthcare professionals (RCP) and for women (leaflet).
The cases of arthralgia were also assessed by the EMA, which considered that the vigilance data were not at this stage sufficient to modify the information given in these documents.
Marketing Authorization Holders for IUDs containing levonorgestrel should continue to monitor these events in accordance with the regulations in force.
Reinforce patient information
The ANSM also recalls that patients must be informed of the benefits and potential adverse effects of the device by their doctor when choosing contraception and inserting the IUD.
The ANSM also specified that “Mirena is an intrauterine device (IUD) marketed for almost twenty years. It is indicated to prevent pregnancy (contraception) or to treat heavy periods (functional menorrhagia). It is inserted into the uterine cavity where it acts by releasing a progestogen (levonorgestrel) for a period of 5 years. A follow-up examination should be carried out 4 to 6 weeks after insertion of the IUD, then every year.
The ANSM is currently preparing an information document for women, in close collaboration with the association “SVH ASSO IUD Vigilance Hormones”, in order to provide more information to women who choose this type of contraception.
No questioning of the product for the moment
But according to the ANSM, to date, with regard to the available data, the increase and the nature of the declarations do not call into question the benefit/risk ratio of Mirena, which remains positive in its current indications, but additional investigations are will continue.
What are the side effects of the Mirena® IUD known to date?
Very common side effects of the drug
The following effects are known in more than 10 out of 100 women:
- Headaches (headaches);
- Pelvic pain and abdominal swelling;
- Menstrual disorders: spotting, heavy or light flow, prolonged or shortened periods, etc. ;
- Vaginal discharge;
- Vulvitis or vaginitis.
Common health effects
The following disorders are observed in 1 to 10 women in 100:
- Migraines;
- Decreased libido;
- Dizziness;
- Nausea;
- Hirsutism;
- Acne, oily skin;
- back pain;
- Painful periods ;
- Ovarian cysts;
- Breast pain;
- Partial or total expulsion of the Mirena® IUD;
- Weight gain.
Uncommon drug effects
One to ten women in 1,000 experience one or more of the following reactions:
- Uterine perforation or relocation of the IUD;
- Alopecia;
- Upper genital tract infection, endometritis, cervicitis;
- Pruritus, eczema;
- Chloasma;
- Edema.
Other reported effects of the Mirena® IUD
Other reactions may occur, without knowing the frequency:
- Hypersensitivity or allergic reaction:
- Increased blood pressure;
- Sepsis;
- Breast cancer ;
- Fatigue and general weakness.
Mirena® IUD and risk of depression, a proven but weak link
The ANSM and the Cnam (National Health Insurance Fund) have set up a scientific group called GIS Epi-phare. The latter conducted an epidemiological study to to study the consumption of psychotropic drugs (antidepressants, hypnotics and anxiolytics) within two years of the insertion of a hormonal levonorgestrel IUD. The researchers found a link between wearing this type of IUD and risk of depression or depressed mood.
Indeed, the study demonstrates a increased use of antidepressants within 2 years of IUD insertion with high levonorgestrel dosage (52 mg) compared to an IUD with a lower progestin dose. The results, published in the Journal American Medical Association (JAMA), however did not show an increase in the use of anxiolytics or hypnotics.
Even if the risk seems low, these results must be supplemented by other studies.
What to do if symptoms appear?
If side effects occur after the insertion of an IUD, in the event of a change in mood or the appearance of depressive symptoms, women are recommended to consult their doctor or gynecologist.