Hormonal IUD

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Hormone coil with correct position

The IUS is a progestin -releasing intrauterine device (IUD) which is in the uterus , prevent the woman is used to pregnancy. In distinction from the intrauterine devices comprising copper included, but no hormones ( spirals ), the hormone-containing spiral is also called intrauterine system designated (IUS). It is one of the most effective methods of contraception. The manufacturer of the hormone IUDs available on the German market is Jenapharm GmbH & Co. KG, a Bayer AG company .

Areas of application

The first hormonal IUD has been approved in Germany since 1996 for the prevention and treatment of heavy menstrual bleeding . Another smaller system with a somewhat lower progestin release has been approved in Europe since 2013, but it is only approved for contraception. An IUD can also protect against excessive build-up of the uterine lining during estrogen replacement therapy during menopause.

A reduction in menstrual cramps and a possible benefit in the treatment of endometriosis are also known .

According to the package insert for the Mirena IUD, the IUD is not the method of choice for women who have not yet given birth.

functionality

The hormone coil consists of a T-shaped plastic body about 3 cm long that releases the progestin levonorgestrel after it has been inserted into the uterus .

The T-shape of the plastic body allows it to be adapted to the shape of the uterus. The active ingredient is located in a cylindrical reservoir on the vertical part of the plastic body and is released into the body in a constant amount (20 or 14 µg in 24 h). At the lower end of the IUD there is an eyelet to which the control threads are attached, which the patient can feel for herself. Both the plastic body with its special T-shape and the hormone levonorgestrel prevent pregnancy in the following ways:

  • Levonorgestrel makes the mucus in the cervix thick and therefore more impermeable to the sperm.
  • The mobility of the sperm, which still pass through the cervix, is inhibited.
  • Egg maturation and ovulation are influenced and suppressed in some women.
  • The build-up of the uterine lining is reduced, and as a result, the menstrual blood flow is reduced.

The hormone coil is inserted by a doctor, the costs are around 250 to 400 euros. The costs for women with statutory health insurance in Germany according to Section 24a SGB ​​V up to the age of 20 are covered by the health insurance and for women entitled to social assistance according to Section 49 SGB ​​XII by the responsible social assistance provider . If the IUD is prescribed exclusively for the treatment of heavy menstrual bleeding, the costs may be covered by the health insurance in Switzerland, but not in Germany.

Obstetricians and gynecologists are obliged to hand over the instructions for use and a consent form before inserting a hormonal IUD and to have the woman sign the receipt.

Risks and Side Effects

Possible complications of IUS are ejections ( expulsions ) (% 6-7), slippage of the spiral (can be reduced thereby preventing protection) in the first two months of application and a violation of the uterus , in particular during insertion of the IUD. The risk of injury can be increased if the IUD is inserted after childbirth , in women who are breastfeeding and if the uterus is abnormal . Such an injury can cause the coil to migrate into the abdominal cavity and must then be surgically removed. Up to 2009 455 cases of uterine perforation and 170 cases of migration were reported in the database of the Federal Institute for Drugs and Medical Devices.

Since the active ingredient of the hormonal IUD acts on the entire body via the bloodstream, systemic side effects can also occur. The alleged "local" effect is not possible, not scientifically proven and even the manufacturer admitted when asked that it had not been proven.

Very common side effects (affects more than 1 user in 10): headache, abdominal pain, pelvic pain, change in bleeding pattern: increased bleeding (hypermenorrhea), menstrual bleeding that is too rare (oligomenorrhea), decreased bleeding (hypomenorrhea), no menstrual period (amenorrhea) , Spotting, inflammation of the vagina and external genitals (vulvovaginitis), vaginal discharge .

Common side effects (affects 1 to 10 users in 100): Depressed mood, depression, migraines, nausea, nervousness, decreased sex drive (libido), acne, excessive hair growth with a male distribution pattern (hirsutism), back pain, ovarian cysts, painful menstrual bleeding (dysmenorrhea), Breast pain, breast tenderness, expulsion of Mirena (a product of hormone contraception), weight gain.

Uncommon side effects (affects 1 to 10 users in 1,000): flatulence, hair loss (alopecia), itching (pruritus), eczema, discoloration of the skin (chloasma), increased pigmentation of the skin (hyperpigmentation), inflammation in the pelvic area, inflammation of the lining of the cervix ( Cervicitis ) and uterus (endometritis), Papanicolaou smear normal, class II, water retention in the tissue (edema)

In 2009, the Ärzteblatt warned of psychiatric side effects of the hormone IUD, such as panic attacks, feelings of fear, mood swings, sleep disorders and restlessness.

The risk of lobular and ductal breast cancer is increased under the hormonal IUD.

criticism

According to a 2007 UK study, 46% of the participants had the IUD removed prematurely because of the side effects. A British study on Jaydess comes to a similar conclusion. There, 57% of Jaydess users kept them for the full three years.

In 2014, the pharmaceutical company Bayer came under fire because it turned out that it had commissioned an Austrian agency to post fake positive contributions regarding the hormone IUD in social networks. In addition to the agency, Bayer was also reprimanded by the Austrian Ethics Council in 2015.

In 2017, the European approval authority (EMA) is checking whether psychiatric side effects such as panic attacks, feelings of fear, mood swings, sleep disorders and restlessness should be included in the package insert. These side effects were reported in the database of the Federal Institute for Drugs and Medical Devices. The suspicion of psychiatric side effects is supported by a study published in 2017 by the Erasmus University Medical Center in Rotterdam, in which increased stress levels were measured in women with an IUD.

Commercial preparations

Mirena (D, A, CH), Jaydess (Europe), Skyla , Liletta (USA), Levosert (D, A, CH); FibroPlant (variant without T-shaped plastic frame )

Web links

Individual evidence

  1. ↑ Jenapharm: love, life, health. Retrieved November 14, 2017 .
  2. ↑ a b Medicines Commission of the German Medical Association. Scientific Committee of the German Medical Association: Changed risk information on the Mirena IUD ; June 2007.
  3. ↑ Jaydess 13.5 mg intrauterine drug delivery system
  4. ^ Hans Concin: News: Intrauterine Contraception. Speculum - Journal of Gynecology and Obstetrics 2013; 31 (2) (edition for Austria), 19-21, online .
  5. ↑ Instructions for use: [1]
  6. ↑ A. Anpalagan, G. Condous: Is there a role for use of levonorgestrel intrauterine system in women with chronic pelvic pain? J Minim Invasive Gynecol. November-December 2008 15 (6): 663-666, PMID 18774757 .
  7. ↑ Instructions for use [2]
  8. ↑ Federal Center for Health Education (BZgA): Hormonspirale .
  9. ↑ Gynecologists on the Internet: Other hormonal methods: Hormonspirale ( Memento of the original from February 16, 2008 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. . @1@ 2Template: Webachiv / IABot / www.frauenaerzte-im-netz.de
  10. ↑ declaration of consent [3]
  11. ↑ Cases of uterine perforation and migration [4]
  12. ↑ Script for a broadcast about the hormone IUD, p. 12 [5]
  13. ↑ Ärzteblatt on psychiatric side effects of the hormonal IUD, 2009: [6]
  14. ↑ Instructions for use: [7]
  15. ↑ Drugs Commission of the German Medical Association. Scientific Committee of the German Medical Association: Risks of uterine perforation and expulsion of Mirena®, an intrauterine device containing levonorgestrel ; 2002.
  16. ↑ T. Soini, R. Hurskainen, S. Grénman, J. Mäenpää, J. Paavonen, H. Joensuu, E. Pukkala: Levonorgestrel-releasing intrauterine system and the risk of breast cancer: A nationwide cohort study. In: Acta Oncologica . Volume 55, number 2, 2016, pp. 188-192, doi : 10.3109 / 0284186X.2015.1062538 , PMID 26243443 .
  17. ↑ AAA Ewies: Mirena: the other side of the story. In: BJOG: An International Journal of Obstetrics & Gynaecology. 114, 2007, p. 1307, doi : 10.1111 / j.1471-0528.2007.01439.x .
  18. ↑ Drug and Therapeutics Bulletin, Study, England, 2015 [8]
  19. ↑ Süddeutsche: Hidden advertising for cars and contraceptives November 10, 2014 [9]
  20. ↑ Standard: Ethics Council reprimands agency because of paid postings, September 10, 2015 [10]
  21. ↑ Ärzteblatt: EMA tests levonorgestrel-containing hormone IUDs for psychiatric side effects, June 14, 2017 [11]
  22. ↑ J. Aleknaviciute, JH Tulen, YB De Rijke, CG Bouwkamp, ​​M. van der Kroeg, M. Timmermans, VL Wester, V. Bergink, WJ Hoogendijk, H. Tiemeier, EF van Rossum, CG Kooiman, SA Kushner: The levonorgestrel-releasing intrauterine device potentiates stress reactivity. In: Psychoneuroendocrinology. Volume 80, June 2017, pp. 39-45, doi : 10.1016 / j.psyneuen.2017.02.025 , PMID 28315609 .