Etonogestrel implant
An implant containing etonogestrel is a hormonal, implanted contraceptive for women, which has been approved and available in Germany since June 15, 2000. It is marketed by Organon under the trade name Implanon .
It is a thin, flexible stick made of plastic, which contains etonogestrel , a sex hormone from the group of gestagens . It is placed under the skin of the upper arm . There the hormone is gradually released and has the same effect as the birth control pill . It inhibits ovulation and causes changes in the mucus of the cervix , uterine lining, and fallopian tube . This will reduce the possibility of pregnancy .
The doctor pushes the stick under the skin on the inside of the upper arm under local anesthesia. To end the contraception, the doctor will remove it.
effect
The Pearl Index is according to the manufacturer under 0.1. As a result, it is one of the safest contraceptives. The hormone etonogestrel used and its delivery rate correspond to the desogestrel-containing mini pill . Many doctors recommend trying a mini pill containing the progestogen desogestrel for three months before inserting to see whether the hormone is tolerated. The contraceptive effect of Implanon depends on the plasma level of etonogestrel, which is inversely related to body weight and decreases over time. Clinical experience with Implanon in women weighing over 80 kg is limited. It cannot be ruled out that the contraceptive protection is reduced in these women during the third year of use. Another requirement for reliability is the correct deposit, which should be checked.
Interactions
There are interactions with some medications such as broad spectrum antibiotics, St. John's wort, anti-tuberculosis drugs, some anti-epilectic drugs, and some psychotropic drugs. The contraception may then be reduced.
advantages
The implant can also be used by women who for health reasons are not allowed to use estrogen-based contraceptives or cannot tolerate such contraceptives.
unwanted effects
The undesirable effects of these hormone implants are roughly the same as those that occur when taking a pill with the same active ingredient. Very common are acne , headache, weight gain, tension and pain in the breasts, vaginal infections, irregular bleeding. Mood swings, depressive moods, nervousness, decreased sex drive, dizziness, loss of appetite, abdominal pain, nausea, flatulence, hair loss, painful menstrual bleeding ( dysmenorrhea ), small fluid-filled blisters in the ovaries (= cysts), flu-like symptoms, loss of weight, pain , Fatigue and reactions at the implantation site.
An increase in blood pressure has rarely been observed. Bruising and, in rare cases, pain, itching, or infection may occur during the insertion or removal of Implanon. A sheath of connective tissue, a scar or an abscess can form at the implantation site . A feeling of numbness or numbness (or numbness) may occur. If the implant is not inserted correctly, it is possible that it will be ejected. Occasionally, chloasma (light yellow to dark brown patches of pregnancy, especially on the face) can occur, especially in women who have had this before during a previous pregnancy or hormonal treatment. There have been repeated reports of problems with removing the implant.
Use in active thromboembolic diseases, gestagen-dependent tumors, liver diseases and existing vaginal bleeding that has not been clarified is contraindicated.
In many women, the treatment results in irregular bleeding.
Costs and assumption of costs
The stick costs (including the insert) between 300 and 350 euros. Statutory health insurance women in Germany up to the age of 20 are entitled to reimbursement / reimbursement of costs by the health insurance company according to Section 24 SGB V and for women entitled to social assistance according to Section 49 SGB XII from the responsible social assistance provider . However, it is often no longer granted under the Statutory Health Insurance Modernization Act. Clinical studies have shown that Implanon is also effective against severe menstrual pain , but the preparation is not approved for this . One application for such complaints is an off-label use and usually excludes the assumption of costs / reimbursement by the health insurance company.
history
The principle of the release of a hormone into the skin via plastic sticks has been known for a long time. A product called Norplant has been available in many countries around the world, including the USA, since the early 1990s . It contains another hormone ( levonorgestrel ), consists of six silicone sticks, and is contraceptive for five years.
Critics of this method of contraception criticize the fact that it is propagated in some countries for purposes of population policy; they fear that certain social groups could be put under pressure to wear the implant.
Compensation litigation
In 2006 the Federal Court of Justice ruled that a doctor is liable for the maintenance loss of his patient if he makes a treatment error while using Implanon and gives birth to an unwanted child.
In 2009, the Cologne Regional Court also had to deal with a claim for damages relating to Implanon. The court was unable to convince itself of a medical error on the part of the doctor: There was a typical scar on the plaintiff's arm, and the implant was also palpable. What happened to the stick later - whether it was still in the body or not - could not be explained.
In 2012, the Heidelberg Regional Court dealt with a lawsuit from a patient: In the then 15-year-old, the implantation of the Implanon had failed, resulting in an unwanted pregnancy.
Unwanted pregnancy despite correct use of Implanon
Since 2005, the information that has not yet been fully confirmed has been circulating in specialist circles that unwanted pregnancies can occur even with the correct use of Implanon. The Federal Institute for Drugs and Medical Devices has long known how difficult it is to use the Implanon. In the meantime, the BfArM has expressed the criticism in this regard in a procedure under Art. 29 of Directive 2001/83 / EC. In particular, it was criticized that the insertion of the preparation was difficult to handle, that the stick “wandered away” from the place where it was used, or that some of those affected had difficulties removing it (combined with scarring). According to the BfArM, there are now 101 pregnancies in Germany that are associated with incorrect use or with the incorrectly acting Implanon.
Web links
- Hormone implant. Familienplanung.de; Information portal of the Federal Center for Health Education (BZgA)
- Rote-Hand-Brief on Implanon NXT January 15, 2020
Individual evidence
- ↑ Pro Familia: " Hormonimplantat " profamilia.de
- ↑ Specialist information ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. in the Swiss Open Drug Database
- ↑ Pro Familia: " Hormonimplantat " profamilia.de
- ↑ Pro Familia: " Hormonimplantat " profamilia.de
- ↑ Patient information. Swiss Medicines Compendium
- ↑ Unsuccessful explantation of the implantable contraceptive Implanon® (from the ADR database): Announcement of the Drugs Commission of the German Medical Association (AkdÄ) (2006)
- ↑ Norplant (levonorgestrel implants (Unavailable in US)): Uses, Dosage, Side Effects, Interactions, Warning. Retrieved April 29, 2020 .
- ↑ Volker Stollorz, Mia Eidlhuber: Sex with chopsticks. A hormone implant under the skin should reliably prevent pregnancy . In: Die Zeit , No. 18/2000
- ^ BGH 6th civil senate, judgment of November 14, 2006, Az .: VI ZR 48/06
- ^ LG Cologne 25th civil chamber, judgment of March 4, 2009, AZ: 25 O 221/07
- ^ LG Heidelberg 4th civil chamber, judgment of August 1, 2012, Az .: 4 O 79/07
- ↑ arznei-telegramm.de
- ↑ bfarm.de ( Memento from July 16, 2013 in the web archive archive.today )
