Discharge after installation of the Mirena coil. Removal of the intrauterine system

Mirena spiral for menopause - consequences, reviews, cost, rules of use, you need to find out in advance. The contraceptive is different from the regular IUD, which prevents pregnancy. It contains a synthetic hormone - progesterone. Mirena normalizes hormonal levels and protects against unwanted pregnancy.

Action of the Mirena spiral

T-shaped device with 2 antennae. In the body of the Mirena coil there is a cavity filled with hormones. The body receives an equal amount of progesterone daily in the form of levonorgestrel - 20 mcg. The hormone belongs to the group of gestagens. Prevents the formation of the endometrium and the growth of cancer cells. The Mirena spiral balances progestins and estrogens. Does not interfere with the functioning of the ovaries. Prevents the development of pathological processes in the pelvic organs, reduces the manifestation of menopause. Used as a means of contraception. Its effect is especially useful at the initial stage of menopause, when you can still get pregnant. The spiral thickens the discharge and prevents sperm from penetrating into the uterine cavity. Prevents the development of hyperplasia and endometriosis.

Mirena and uterine fibroids

One of the reasons for the development of fibroids is hormonal imbalance. There is a high probability of a tumor appearing during menopause. Uterine fibroids provoke painful, heavy periods, bleeding during menopause. The Mirena spiral evens out hormonal levels, prevents the development of neoplasms or helps reduce them. While a regular IUD is contraindicated, Mirena is recommended by doctors for the prevention of many diseases. The product regulates estrogens and prevents the development of the endometrium. Scanty menstruation may be present in the first months of treatment, then disappears altogether.

An increased amount of estrogen provokes the growth of fibroids. As reproductive functions decline, the amount of estrogen in a woman’s body decreases, but it is replenished with drugs containing a synthetic hormone. As a result, a situation arises with a high level of estrogen. The spiral allows you to balance this level. Since it contains progesterone, it is possible to use drugs with estradiol. But the treatment regimen must be selected by the doctor, taking into account the individual characteristics of the body. According to women, Mirena copes quite well with fibroids. It either remains at the same level or disappears completely.

Heavy discharge after insertion of the IUD

When using this remedy, spotting and spotting may be present during the first 4 months, which is normal during menopause. This is how the body adapts to new living conditions and the hormonal levels stabilize. At the same time, the risk of developing inflammation is high. Often, pathology is the cause of bleeding after installation of the coil. Firstly, the body tries to free itself from a foreign object, and secondly, the hormonal background changes. If bleeding occurs, you should consult a specialist. Even if there are no other alarming symptoms.

How long does the bleeding last?

During menopause, the Mirena coil helps to avoid spotting and bleeding. During the first 2 months there may be heavy bleeding if the IUD was placed at the beginning of menopause. But after 4 months everything returns to normal - there is no discharge or it is too scanty. Bleeding lasts from 5 to 7 days. After installing the Mirena spiral, the doctor should consult the woman. Tell her what consequences await her. In what cases should you seek help from gynecologists? In general, you should visit your doctor twice a year. And also 1-2 months after installing the spiral.

Contraindications

The product is not suitable for everyone. Before installing the Mirena spiral, it is necessary to undergo an examination of the whole body. Contraindications are:


Consequences of installing a spiral

At first, side effects may appear. If they are not significant, continue to use the product. Otherwise you will have to abandon it. What could it be?

If the body accepts the remedy without side effects, the disappearance of menopause symptoms can be felt immediately. Headache, excessive sweating, hot flashes, irritability, and other unpleasant symptoms of menopause go away.

However, there is a second side to the coin. Progesterone promotes fluid retention, possibly swelling of the legs and weight gain. An allergic rash and acne appear on the skin. There is constant nausea, an incomprehensible state, a foggy state, laziness and apathy appear. Facial hair may grow and fall out in clumps on the head. Doctors usually say that the system improves the condition of hair and skin, and fewer wrinkles appear. If the above symptoms are present, you need to double-check your hormonal levels and consult with specialists. You may have to remove it. Hormone deficiency and excess have a negative effect on the body. Doctors allow such negative effects of the system for 3 months. Then the body adapts to the new living conditions, excess weight goes away, and the woman feels healthy again, without side effects or symptoms of menopause.

Using Mirena during menopause

The doctor installs the product after a preliminary examination of the woman’s body. The procedure itself does not take much time. Immediately after installation, the woman can leave the gynecologist's office. Lifting heavy objects is prohibited for 2 weeks. In the future, when using the spiral, you should avoid heavy physical activity. There is no discharge during menopause. The use of Mirena requires constant monitoring by the gynecologist, the woman herself. If pink or bloody discharge appears, you should consult your doctor. Otherwise, the woman leads a full life.

Using Mirena prevents unwanted pregnancy. In the first years of decline of reproductive functions, conception is quite possible. However, it is almost impossible to determine pregnancy by your own feelings - they resemble manifestations of menopause. Menstruation may be absent due to menopause. The pregnancy test is also not as accurate as it used to be. Since the level of hCG during menopause in women is increased. Corresponds to the first weeks of pregnancy. Thus, a negative test result may mean pregnancy, while a positive test result may deny it. Using Mirena allows a woman to have sex without the threat of conception.

The most popular intrauterine hormonal contraceptive is the Mirena device (IUD). Intrauterine contraceptives (IUDs) have been used since the middle of the last century. They quickly fell in love with women due to many positive qualities: the absence of a systemic effect on the female body, high performance, ease of use.
The spiral does not affect the quality of sexual contact, is installed for a long period, and requires virtually no control. But the IUD has a very significant disadvantage: many patients develop a tendency to metrorrhagia, as a result of which they have to abandon this type of contraception.

In the 60s, intrauterine systems containing copper were created. Their contraceptive effect was even higher, but the problem of bleeding from the uterus was not solved. And as a result, in the 70s, the 3rd generation of VMK was developed. These medical systems combine the best qualities of oral contraceptives and IUDs.

Description of the Mirena intrauterine device

Mirena has a T-shape, which helps to securely fit into the uterus. One of the edges is equipped with a loop of threads designed to remove the system. In the center of the spiral is a whitish hormone. It slowly enters the uterus through a special membrane.

The hormonal component of the IUD is levonorgestrel (gestagen). One system contains 52 mg of this substance. An additional component is polydimethylsiloxane elastomer. The Mirena IUD is inside a tube. The spiral has individual vacuum plastic and paper packaging. It should be stored in a dark place, at a temperature of 15-30 C. Shelf life from the date of manufacture is 3 years.

Effect of Mirena on the body

The Mirena contraceptive system begins to “release” levonorgestrel into the uterus immediately after installation. The hormone enters the cavity at a rate of 20 mcg/day; after 5 years, this figure drops to 10 mcg per day. The spiral has a local effect, levonorgestrel is almost all concentrated in the endometrium. And already in the muscular layer of the uterus the concentration is no more than 1%. The hormone is contained in the blood in microdoses.

After inserting the spiral, the active ingredient enters the bloodstream in about an hour. There its highest concentration is reached after 2 weeks. This indicator can vary significantly depending on the woman’s body weight. With a weight of up to 54 kg, the level of levonorgestrel in the blood is approximately 1.5 times higher. The active substance is almost completely broken down in the liver and evacuated by the intestines and kidneys.

How Mirena works

The contraceptive effect of Mirena does not depend on a weak local foreign body reaction, but is mainly associated with the effect of levonorgestrel. The fertilized egg is not implanted due to the suppression of the activity of the uterine epithelium. At the same time, the natural growth of the endometrium is suspended and the functioning of its glands is reduced.

Also, the Mirena coil impedes the motility of sperm in the uterus and its tubes. The contraceptive effect of the drug increases the high viscosity of the cervical mucus and thickening of the mucous layer of the cervical canal, which complicates the penetration of sperm into the uterine cavity.

After installation of the system, a restructuring of the endometrium is observed for several months, manifested by irregular spotting. But after some time, proliferation of the uterine mucosa provokes a significant decrease in the duration and volume of menstrual bleeding, up to its complete cessation.

Indications for use

An IUD is installed primarily to prevent unwanted pregnancy. In addition, the system is used for very heavy menstrual bleeding for an unknown reason. The possibility of malignant neoplasms of the female reproductive system is preliminarily excluded. As a local gestagenic agent, the intrauterine device is used to prevent endometrial hyperplasia, for example, during severe menopause or after bilateral oophorectomy.

Mirena is sometimes used in the treatment of menorrhagia, if there are no hyperplastic processes in the uterine mucosa or extragenital pathologies with severe hypocoagulation (thrombocytopenia, von Willebrand disease).

Contraindications for use

The Mirena spiral is an internal contraceptive; therefore, it cannot be used for inflammatory diseases of the genital organs:

  • endometritis after childbirth;
  • inflammation in the pelvis and cervix;
  • septic abortion performed 3 months before installation of the system;
  • an infection localized in the lower part of the genitourinary system.

The development of acute inflammatory pathology of the pelvic organs, which is practically untreatable, is an indication for removal of the coil. Therefore, internal contraceptives are not prescribed if there is a predisposition to infectious diseases (constant change of sexual partners, severely decreased immunity, AIDS, etc.). To protect against unwanted pregnancy, Mirena is not suitable for cancer, dysplasia, fibroids of the body and cervix, and changes in their anatomical structure.

Since levonorgestrel is broken down in the liver, the spiral is not installed in case of malignant neoplasm of this organ, as well as in case of cirrhosis and acute hepatitis.

Although the systemic effect of levonorgestrel on the body is insignificant, this progestin substance is still contraindicated in all gestagen-dependent cancers, for example, breast cancer and other conditions. This hormone is also contraindicated for stroke, migraine, severe forms of diabetes, thrombophlebitis, heart attack, and arterial hypertension. These diseases are a relative contraindication. In such a situation, the question of using Mirena is decided by the doctor after laboratory diagnostics. The spiral should not be installed if pregnancy is suspected and hypersensitivity to the components of the drug.

Side effects

Common side effects

There are several side effects of Mirena, which occur in almost every tenth woman who has the IUD installed. These include:

  • disorders of the central nervous system: short temper, headache, nervousness, bad mood, decreased sexual desire;
  • weight gain and acne;
  • gastrointestinal dysfunction: nausea, abdominal pain, vomiting;
  • vulvovaginitis, pelvic pain, spotting;
  • chest tension and tenderness;
  • back pain, as with osteochondrosis.

All of the above signs appear most clearly in the first months of using Mirena. Then their intensity decreases, and, as a rule, unpleasant symptoms disappear without a trace.

Rare side effects

Such side effects occur in one patient out of a thousand. They are also usually expressed only in the first months after the installation of the IUD. If the intensity of manifestations does not decrease over time, the necessary diagnostics are prescribed. Rare complications include bloating, frequent mood swings, itching, swelling, hirsutism, eczema, baldness and rash.

Allergic reactions are very rare side effects. If they develop, it is necessary to exclude another source of urticaria, rash, etc.

Instructions for use

Installation of the Mirena coil

The intrauterine system is packaged in a sterile vacuum bag, which is opened before inserting the IUD. If the system is opened in advance, it must be disposed of.

Only a qualified person can install the Mirena contraceptive. Before this, the doctor must conduct an examination and prescribe the necessary examination:

  • gynecological and breast examinations;
  • cervical smear analysis;
  • mammography;
  • colposcopy and pelvic examination.

You need to make sure there is no pregnancy, malignant neoplasms or STIs. If inflammatory diseases are detected, they are treated before placing Mirena. You should also determine the size, location and shape of the uterus. The correct position of the spiral ensures a contraceptive effect and protects against system expulsion.

For patients of fertile age, an IUD is inserted in the first days of menstruation. In the absence of contraindications, the system can be installed immediately after an abortion. If the uterus contracts normally after childbirth, Mirena can be used after 6 weeks. You can replace the IUD on any day, regardless of your cycle. To prevent excessive growth of the endometrium, the intrauterine system should be inserted at the end of the menstrual cycle.

Precautionary measures

After installation of the IUD, you need to see a gynecologist in 9-12 weeks. Then you can visit the doctor once a year, more often if complaints arise. So far, there are no clinical data proving a predisposition to the development of varicose veins and thrombosis of the leg veins when using the spiral. But if signs of these diseases appear, you need to consult a doctor.

The effect of levonorgestrel negatively affects glucose tolerance, as a result of which patients with diabetes need to systematically monitor blood glucose levels. If there is a threat of septic endocarditis in women with valvular heart defects, insertion and removal of the system should be performed with the use of antibacterial agents.

Possible side effects are minor

  1. Ectopic pregnancy is extremely rare and requires emergency surgery. This complication can be suspected if symptoms of pregnancy occur (long delay of menstruation, dizziness, nausea, etc.) together with severe pain in the lower abdomen and signs of internal bleeding (severe weakness, pale skin, tachycardia). There is a higher likelihood of developing such a complication after severe inflammatory or infectious pathologies of the pelvis or a history of ectopic pregnancy.
  2. Penetration (ingrowth into the wall) and perforation (perforation) of the uterus usually develop when the IUD is inserted. These complications may be accompanied by lactation, recent childbirth, or unnatural position of the uterus.
  3. Expulsion of the system from the uterus occurs quite often. For its early detection, patients are recommended to check the presence of threads in the vagina after every menstruation. It’s just that, as a rule, it is during menstruation that the probability of the IUD falling out is high. This process goes unnoticed by the woman. Accordingly, when Mirena is expelled, the contraceptive effect ends. To avoid misunderstandings, it is recommended to inspect used tampons and pads for loss. The manifestation of the beginning of the IUD falling out in the middle of the cycle can be bleeding and pain. If incomplete expulsion of the intrauterine hormonal device occurs, the doctor must remove it and install a new one.
  4. Inflammatory and infectious diseases of the pelvic organs usually develop in the first month of using the Mirena system. The risk of complications increases with frequent changes of sexual partners. The indication for removal of the coil in this case is recurrent or severe pathology and the lack of results from the treatment.
  5. Amenorrhea develops in many women while using an IUD. The complication does not occur immediately, but about 6 months after Mirena installation. When you stop menstruating, you must first rule out pregnancy. After removing the IUD, the menstrual cycle is restored.
  6. Approximately 12% of patients develop functional ovarian cysts. Most often, they do not manifest themselves in any way and only occasionally may pain during sex and a feeling of heaviness in the lower abdomen occur. Enlarged follicles usually return to normal within 2-3 months on their own.

Removal of the IUD

The spiral must be removed 5 years after installation. If the patient does not plan pregnancy further, then the manipulation is carried out at the beginning of menstruation. By removing the system in the middle of the cycle, there is a possibility of conception. If desired, you can immediately replace one intrauterine contraceptive with a new one. The day of the cycle does not matter. After removing the product, you need to carefully inspect the system, since if there are difficulties in removing Mirena, the substance may slip into the uterine cavity. Both insertion and removal of the system may be accompanied by bleeding and pain. Sometimes fainting or a seizure occurs in patients with epilepsy.

Pregnancy and Mirena

The IUD has a strong contraceptive effect, but not 100%. If pregnancy nevertheless develops, then first of all it is necessary to exclude its ectopic form. In a normal pregnancy, the IUD is carefully removed or a medical abortion is performed. Not in all cases, it is possible to remove the Mirena system from the uterus, then the likelihood of premature pregnancy increases. It is also necessary to take into account the likely adverse effects of the hormone on the formation of the fetus.

Use during lactation

Levonorgestrel IUD enters the bloodstream in small dosages and can be excreted in milk when breastfeeding. In this case, the hormone content is about 0.1%. Doctors say that at such a concentration it is impossible that such a dose could affect the general condition of the baby.

FAQ

The price of Mirena is quite high, and the use of a contraceptive can cause many side effects. Does the product have any positive effect on the female body?

Mirena is often used to restore the condition of the endometrium after bilateral ovarian removal or during pathological menopause. Also intrauterine device:

  • increases hemoglobin levels;
  • prevents endometrial cancer and hyperplasia;
  • reduces the duration and volume of idiopathic bleeding;
  • restores iron metabolism in the body;
  • reduces pain during algomenorrhea;
  • carries out the prevention of fibroids and endometriosis of the uterus;
  • has a general strengthening effect.

Is Mirena used to treat fibroids?

The spiral stops the growth of the myomatous node. But additional diagnostics and consultation with a gynecologist are needed. It is necessary to take into account the volume and localization of the nodes, for example, in case of submucosal formations of fibroids that change the shape of the uterus, installation of the Mirena system is contraindicated.

Is Mirena intrauterine drug used for endometriosis?

The IUD is used to prevent endometriosis because it stops the growth of the endometrium. Recently, the results of studies proving the effectiveness of treating the disease were presented. But the system provides only a temporary effect and each case must be considered individually.

Six months after the introduction of Mirena, I developed amenorrhea. Is this how it should be? Will I be able to get pregnant in the future?

The absence of menstruation is a natural reaction to the influence of the hormone. It gradually develops in every 5 patients. Just in case, take a pregnancy test. If it is negative, then there is no need to worry; after removal of the system, menstruation resumes and you can plan a pregnancy.

After installing the Mirena contraceptive, can you experience discharge, pain or uterine bleeding?

Typically, these symptoms appear in a mild form, immediately after the introduction of Mirena. Severe bleeding and pain are often indications for IUD removal. The cause may be ectopic pregnancy, improper installation of the system, or expulsion. Contact your gynecologist immediately.

Can the Mirena IUD affect your weight?

Weight gain is one of the side effects of the drug. But you need to take into account that it occurs in 1 woman out of 10 and, as a rule, this effect is short-lived; after a few months it disappears. It all depends on the individual characteristics of the body.

I protected myself from unwanted pregnancy with hormonal pills, but often forgot to take them. How can I change the drug to the Mirena spiral?

Irregular oral hormone intake cannot completely protect against pregnancy, so it is better to switch to intrauterine contraception. Before this, you need to consult a doctor and undergo the necessary tests. It is better to install the system on days 4-6 of the menstrual cycle.

When can I get pregnant after taking off Mirena?

According to statistics, 80% of women become pregnant, if that is what they want, of course, in the first year after removing the IUD. Thanks to its hormonal action, it even slightly increases the level of fertility (fertility).

Where can I buy the Mirena spiral? And what is its price?

The IUD is available only with a prescription and is sold at pharmacies. Its price is determined by the manufacturer, and varies from 9 to 13 thousand rubles.

Indications for use
- Contraception
- Idiopathic menorrhagia
- Prevention of endometrial hyperplasia during HRT

INFORMATION IS PROVIDED STRICTLY
FOR HEALTH PROFESSIONALS




Mirena - official instructions for use

Registration number:

P N014834/01 - 130617

Trade name of the drug:

International nonproprietary name:

Levonorgestrel

Dosage form:

Intrauterine therapy system

Compound:

Active substance: levonorgestrel micronized 52 mg
Excipients:
core made of polydimethylsiloxane elastomer, membrane made of polydimethylsiloxane elastomer containing colloidal anhydrous silicon dioxide 30-40% wt.
Other components: T-shaped polyethylene body containing barium sulfate 20-24% by weight, thin thread of brown polyethylene, colored with black iron oxide< 1,0 % масс.
Delivery device: conductor - 1 pc. The composition is given for one intrauterine therapeutic system with a guide.

Description:

The Mirena® Intrauterine Therapy System (IUD) is a T-shaped levonorgestrel-releasing device placed in a guide tube. The components of the guidewire are the insertion tube, plunger, index ring, handle and slider. The IUD consists of a white or off-white hormonal elastomeric core placed on a T-shaped body and covered by an opaque membrane that regulates the release of levonorgestrel. The T-shaped body has a loop at one end and two arms at the other. Threads are attached to the loop to remove the system. The IUD is free from visible impurities.

Pharmacotherapeutic group:

Gestagen

ATX code:

G02BA03

Pharmacological properties

Pharmacodynamics

The drug Mirena® is an intrauterine therapeutic system (IUD) that releases levonorgestrel and has a mainly local gestagenic effect. Progestin (levonorgestrel) is released directly into the uterine cavity, which allows it to be used in an extremely low daily dose. High concentrations of levonorgestrel in the endometrium help to reduce the sensitivity of its estrogen and progesterone receptors, making the endometrium resistant to estradiol and having a strong antiproliferative effect. When using Mirena®, morphological changes in the endometrium and a weak local reaction to the presence of a foreign body in the uterus are observed. An increase in the viscosity of the cervical secretion prevents the penetration of sperm into the uterine cavity; due to a decrease in sperm motility and changes in the endometrium, the likelihood of fertilization of the egg decreases. In some women, ovulation is suppressed. Previous use of Mirena® does not affect reproductive function. Approximately 80% of women who want to have a child become pregnant within 12 months after removal of the IUD.
In the first months of using Mirena®, due to the process of inhibition of endometrial proliferation, an initial increase in “spotting” bloody discharge from the vagina may be observed. Following this, a pronounced suppression of endometrial proliferation leads to a decrease in the duration and volume of menstrual bleeding in women using Mirena®. Scanty bleeding often transforms into oligo- or amenorrhea. At the same time, ovarian function and the concentration of estradiol in the blood plasma remain normal.
Mirena® can be used to treat idiopathic menorrhagia, i.e. menorrhagia in the absence of hyperplastic processes in the endometrium (endometrial cancer, metastatic lesions of the uterus, submucous or large interstitial myomatous node leading to deformation of the uterine cavity, adenomyosis), endometritis, extragenital diseases and conditions accompanied by severe hypocoagulation (for example, von Willebrand disease, severe thrombocytopenia) , the symptoms of which are menorrhagia. After 3 months of using Mirena®, menstrual blood loss in women with menorrhagia is reduced by 62-94% and by 71-95% after 6 months of use. When using Mirena® for two years, the effectiveness of the drug (reduction of menstrual blood loss) is comparable to surgical treatment methods (ablation or resection of the endometrium). A less favorable response to treatment is possible with menorrhagia caused by submucous uterine fibroids. Reducing menstrual blood loss reduces the risk of iron deficiency anemia. Mirena® reduces the severity of dysmenorrhea symptoms.
The effectiveness of Mirena® in preventing endometrial hyperplasia during chronic estrogen therapy was equally high with both oral and transdermal estrogen administration.

Pharmacokinetics
Absorption
After administration of the drug Mirena®, levonorgestrel begins to be immediately released into the uterine cavity, as evidenced by measurements of its concentration in the blood plasma. The high local exposure of the drug in the uterine cavity, necessary for the local effect of Mirena® on the endometrium, provides a high concentration gradient in the direction from the endometrium to the myometrium (the concentration of levonorgestrel in the endometrium exceeds its concentration in the myometrium by more than 100 times) and low concentrations of levonorgestrel in plasma blood (the concentration of levonorgestrel in the endometrium exceeds its concentration in the blood plasma by more than 1000 times). Rate of release of levonorgestrel into the uterine cavity in vivo initially approximately 20 mcg per day, and after 5 years it decreases to 10 mcg per day.
Distribution
Levonorgestrel binds nonspecifically to plasma albumin and specifically to sex hormone-binding globulin (GSP1). About 1-2% of circulating levonorgestrel is present as the free steroid, while 42-62% is specifically bound to SHBG. During use of the drug Mirena®, the concentration of SHBG decreases. Accordingly, the fraction associated with SHBG decreases during the period of use of Mirena®, and the free fraction increases. The average apparent volume of distribution of levonorgestrel is approximately 106 L. After administration of Mirena®, levonorgestrel is detected in the blood plasma an hour later. The maximum concentration is achieved 2 weeks after administration of Mirena®. In accordance with the decreasing release rate, the median plasma concentration of levonorgestrel in women of reproductive age with body weight above 55 kg decreases from 206 pg/ml (25th - 75th percentile: 151 pg/ml - 264 pg/ml), determined after 6 months, up to 194 pg/ml (146 pg/ml - 266 pg/ml) after 12 months and up to 131 pg/ml (113 pg/ml - 161 pg/ml) after 60 months. Body weight and plasma SHBG concentrations have been shown to influence systemic levonorgestrel concentrations, i.e. with low body weight and/or high SHBG concentrations, levonorgestrel concentrations are higher. In women of reproductive age with low body weight (37 - 55 kg), the median concentration of levonorgestrel in blood plasma is approximately 1.5 times higher.
In postmenopausal women using Mirena® simultaneously with the use of estrogens intravaginally or transdermally, the median concentration of levonorgestrel in the blood plasma decreases from 257 pg/ml (25th - 75th percentile: 186 pg/ml - 326 pg/ml), determined after 12 months, up to 149 pg/ml (122 pg/ml - 180 pg/ml) after 60 months. When using Mirena® simultaneously with oral estrogens, the concentration of levonorgestrel in the blood plasma, determined after 12 months, increases to approximately 478 pg/ml (25th - 75th percentile: 341 pg/ml -655 pg/ml), which due to the induction of SHBG synthesis.
Biotransformation
Levonorgestrel is extensively metabolized. The main metabolites in blood plasma are unconjugated and conjugated forms of 3a, 50-tetrahydrolevonorgestrel. Based on the results of in vitro and in vivo studies, the main isoenzyme involved in the metabolism of levonorgestrel is CYP3A4. The isoenzymes CYP2E1, CYP2C19 and CYP2C9 may also be involved in the metabolism of levonorgestrel, but to a lesser extent.
Elimination
The total plasma clearance of levonorgestrel is approximately 1.0 ml/min/kg. Unchanged levonorgestrel is excreted only in trace amounts. Metabolites are excreted through the intestines and kidneys with an excretion coefficient of approximately 1.77. The half-life in the terminal phase, represented mainly by metabolites, is about a day.
Linearity/nonlinearity
The pharmacokinetics of levonorgestrel depends on the concentration of SHBG, which, in turn, is influenced by estrogens and androgens. When using the drug Mirena®, a decrease in the average concentration of SHBG by approximately 30% was observed, which was accompanied by a decrease in the concentration of levonorgestrel in the blood plasma. This indicates the nonlinearity of levonorgestrel pharmacokinetics over time. Given the predominantly local effect of Mirena®, the effect of changes in systemic concentrations of levonorgestrel on the effectiveness of Mirena® is unlikely.

Indications for use

  • Contraception.
  • Idiopathic menorrhagia.
  • Prevention of endometrial hyperplasia during estrogen replacement therapy.

Contraindications

  • Pregnancy or suspicion of it.
  • Acute or recurrent inflammatory diseases of the pelvic organs. Infections of the external genitalia. Postpartum endometritis.
  • Septic abortion within the last three months.
  • Cervicitis.
  • Diseases accompanied by increased susceptibility to infections.
  • Cervical dysplasia.
  • Diagnosed or suspected malignant neoplasms of the uterus or cervix.
  • Progestogen-dependent tumors, including breast cancer.
  • Uterine bleeding of unknown etiology.
  • Congenital or acquired anomalies of the uterus, including fibroids, leading to deformation of the uterine cavity.
  • Acute liver diseases or tumors.
  • Hypersensitivity to the components of the drug.
  • Mirena® has not been studied in women over 65 years of age, so the use of Mirena® is not recommended for this category of patients.
Carefully

In the following conditions, Mirena® should be used with caution after consultation with a specialist:

  • congenital heart defects or heart valve disease (due to the risk of developing septic endocarditis);
  • diabetes.
The advisability of removing the system should be discussed if any of the following conditions are present or first occur:
  • migraine, focal migraine with asymmetric vision loss or other symptoms indicating transient cerebral ischemia;
  • unusually severe headache;
  • jaundice;
  • severe arterial hypertension;
  • severe circulatory disorders, including stroke and myocardial infarction.

Use during pregnancy and breastfeeding

  • Pregnancy
  • The use of Mirena® is contraindicated during pregnancy or suspected pregnancy.
    Pregnancy in women who have Mirena® installed is extremely rare. But if the IUD falls out of the uterine cavity, the woman is no longer protected from pregnancy and should use other methods of contraception before consulting a doctor.
    While using Mirena®, some women experience no menstrual bleeding. The absence of menstruation does not necessarily indicate pregnancy. If a woman does not have menstruation, and at the same time there are other signs of pregnancy (nausea, fatigue, breast tenderness), then it is necessary to consult a doctor for examination and a pregnancy test. If a woman becomes pregnant while using Mirena®, it is recommended that the IUD be removed, as any intrauterine contraceptive device left in situ increases the risk of spontaneous abortion, infection, or premature birth. Removing Mirena® or probing the uterus may lead to spontaneous abortion. If careful removal of the intrauterine contraceptive device is not possible, the feasibility of medical abortion should be discussed. If a woman wants to continue the pregnancy and the IUD cannot be removed, the patient should be informed about the risks, in particular about the possible risk of septic abortion in the second trimester of pregnancy, postpartum purulent-septic diseases that can be complicated by sepsis, septic shock and death, as well as possible consequences premature birth for the baby.
    In such cases, the course of pregnancy should be carefully monitored. It is necessary to exclude ectopic pregnancy. The woman should be explained that she must inform the doctor about all symptoms that suggest pregnancy complications, in particular the appearance of cramping pain in the lower abdomen, bleeding or spotting from the vagina, and increased body temperature.
    The hormone contained in Mirena® is released into the uterine cavity. This means that the fetus is exposed to a relatively high local concentration of the hormone, although the hormone enters it in small quantities through the blood and placenta. Due to the intrauterine use and local action of the hormone, it is necessary to take into account the possibility of a virilizing effect on the fetus. Due to the high contraceptive effectiveness of Mirena®, clinical experience regarding pregnancy outcomes with its use is limited. However, the woman should be informed that at this time there is no evidence of birth defects caused by the use of Mirena® in cases of pregnancy continuing until childbirth without removal of the IUD.

  • Breastfeeding period
  • Breastfeeding a child while using Mirena® is not contraindicated. About 0.1% of the dose of levonorgestrel can enter the child's body during breastfeeding. However, it is unlikely to pose a risk to the baby at doses released into the uterine cavity after Mirena® insertion.
    It is believed that the use of Mirena® six weeks after birth does not have a harmful effect on the growth and development of the child. Monotherapy with gestagens does not affect the quantity and quality of breast milk. Rare cases of uterine bleeding have been reported in women using Mirena® during breastfeeding.

    Directions for use and doses

    Mirena® is injected into the uterine cavity and remains effective for five years.
    The in vivo release rate of levonorgestrel is initially approximately 20 mcg per day and decreases after five years to approximately 10 mcg per day. The average release rate of levonorgestrel is approximately 14 mcg per day for up to five years. The Mirena® IUD can be used in women receiving oral or transdermal hormone replacement therapy (HRT) containing estrogen only.
    With correct installation of Mirena®, carried out in accordance with the instructions for medical use, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is approximately 0.2%. The cumulative rate, reflecting the number of pregnancies in 100 women using contraception for 5 years, is 0.7%.
    Instructions for use of the Mirena® IUD

    Mirena® is supplied in sterile packaging, which is opened only immediately before installation of the intrauterine system. It is necessary to observe aseptic rules when handling an opened system. If the sterility of the packaging appears to be compromised, the IUD should be disposed of as medical waste. The IUD removed from the uterus should be treated in the same way, since it contains hormone residues.
    Installation, removal and replacement of the intrauterine system
    It is recommended that Mirena® be inserted only by a physician who has experience with this IUD or is well trained in this procedure.
    Before installation With Mirena®, a woman should be informed about the effectiveness, risks and side effects of this IUD. It is necessary to conduct a general and gynecological examination, including examination of the pelvic organs and mammary glands, as well as a smear examination from the cervix. Pregnancy and sexually transmitted diseases should be excluded, and inflammatory diseases of the genital organs should be completely cured. The position of the uterus and the size of its cavity are determined. If it is necessary to visualize the uterus, an ultrasound examination of the pelvic organs should be performed before inserting the Mirena® IUD. After a gynecological examination, a special instrument, the so-called vaginal speculum, is inserted into the vagina and the cervix is ​​treated with an antiseptic solution. Mirena® is then injected into the uterus through a thin, flexible plastic tube. It is especially important that Mirena® is correctly positioned in the fundus of the uterus, which ensures a uniform effect of the gestagen on the endometrium, prevents expulsion of the IUD and creates conditions for its maximum effectiveness.
    Therefore, you should carefully follow the instructions for installing Mirena®. Since the technique for installing different IUDs in the uterus is different, special attention should be paid to practicing the correct technique for installing a specific system.
    The woman may feel the insertion of the system, but it should not cause her severe pain. Before insertion, if necessary, local anesthesia of the cervix can be applied.
    In some cases, patients may have cervical canal stenosis. Excessive force should not be used when administering Mirena® to such patients. Sometimes after insertion of the IUD, pain, dizziness, sweating and pale skin are observed. Women are advised to rest for some time after receiving Mirena®. If, after staying in a quiet position for half an hour, these phenomena do not go away, it is possible that the intrauterine system is not positioned correctly. A gynecological examination should be performed; if necessary, the system is removed. In some women, the use of Mirena® causes allergic skin reactions.
    The woman should be re-examined 4-12 weeks after installation, and then once a year or more often if clinically indicated.
    In women of reproductive age, Mirena® should be inserted into the uterine cavity within seven days from the start of menstruation. Mirena® can be replaced with a new IUD on any day of the menstrual cycle. An IUD can also be installed immediately after an abortion in the first trimester of pregnancy, provided there are no inflammatory diseases of the genital organs.
    The use of an IUD is recommended for women with a history of at least 1 birth.
    Installation of the Mirena® IUD in the postpartum period should be carried out only after complete involution of the uterus, but not earlier than 6 weeks after birth. With prolonged subinvolution, it is necessary to exclude postpartum endometritis and postpone the decision to administer Mirena® until the involution is completed. If there is difficulty inserting the IUD and/or very severe pain or bleeding during or after the procedure, a pelvic examination and ultrasound should be performed immediately to rule out perforation.
    To prevent endometrial hyperplasia during HRT with drugs containing only estrogen, in women with amenorrhea, Mirena® can be prescribed at any time; in women with continued menstruation, the installation is performed in the last days of menstrual bleeding or “withdrawal” bleeding.
    Delete Mirena® by carefully pulling the threads grasped with forceps. If the threads are not visible and the system is in the uterine cavity, it can be removed using a traction hook to remove the IUD. This may require dilation of the cervical canal.
    The system should be removed five years after installation. If a woman wants to continue using the same method, a new system can be installed immediately after removing the previous one.
    If further contraception is necessary in women of reproductive age, removal of the IUD should be performed during menstruation, provided that the menstrual cycle is maintained. If the system is removed mid-cycle and a woman has had sexual intercourse during the previous week, she is at risk of becoming pregnant unless a new system is installed immediately after the old one is removed.
    Installation and removal of the IUD may be accompanied by some pain and bleeding. The procedure may cause syncope due to a vasovagal reaction, bradycardia, or seizures in patients with epilepsy, especially those with a predisposition to these conditions or in cases of cervical stenosis.
    After removing Mirena®, the system should be checked for integrity. When it was difficult to remove the IUD, there were isolated cases of the hormonal-elastomer core slipping onto the horizontal arms of the T-shaped body, as a result of which they were hidden inside the core. Once the integrity of the IUD is confirmed, this situation does not require additional intervention.
    Stoppers on the horizontal arms usually prevent the core from completely separating from the T-body.
    Additional information for certain patient groups
    Children and teenagers
    Mirena® is indicated only after the onset of menarche (establishment of the menstrual cycle).
    Elderly patients
    Mirena® has not been studied in women over 65 years of age, so use of the drug
    Mirena® is not recommended for this category of patients.
    Mirena® is not a first choice drug for postmenopausal women under 65 years of age with severe uterine atrophy.
    Patients with liver disorders
    Mirena® is contraindicated in women with acute diseases or liver tumors (see also section “Contraindications”).
    Patients with kidney disorders
    Mirena® has not been studied in patients with renal impairment.

    Side effect

    For most women, after installing Mirena®, the nature of cyclic bleeding changes. During the first 90 days of using Mirena®, an increase in the duration of bleeding is noted by 22% of women, and irregular bleeding is observed in 67% of women, the frequency of these phenomena decreases to 3% and 19%, respectively, by the end of the first year of its use. At the same time, amenorrhea develops in 0%, and rare bleeding in 11% of patients during the first 90 days of use. By the end of the first year of use, the frequency of these events increases to 16% and 57%, respectively.
    When Mirena® is used in combination with long-term estrogen replacement therapy, cyclic bleeding gradually stops in most women during the first year of use.
    The table shows data on the frequency of adverse drug reactions reported with the use of Mirena®. According to the frequency of occurrence, adverse reactions (ARs) are divided into very frequent (> 1/10), frequent (> 1/100 to<1/10), нечастые (от >1/1000 to<1/100), редкие (от >1/10,000 to<1/1000) и с неизвестной частотой. В таблице НР представлены по классам системы органов согласно MedDRA. Данные по частоте отражают приблизительную частоту возникновения НР, зарегистрированных в ходе клинических исследований препарата Мирена® по показаниям «контрацепция» и «идиопатическая меноррагия» с участием 5091 женщин. НР, о которых сообщалось в ходе клинических исследований препарата Мирена® по показанию «профилактика гиперплазии эндометрия при проведении заместительной терапии эстрогенами» (с участием 514 женщин), наблюдались с той же частотой, за исключением случаев, обозначенных сносками (*, **).
    System-organ class Often Often Infrequently Rarely Frequency unknown
    Immune system disorders Hypersensitivity to the drug or component of the drug, including rash, urticaria and angioedema
    Mental disorders Depressed mood, depression
    Nervous system disorders Headache Migraine
    Gastrointestinal disorders Abdominal pain/pelvic pain Nausea
    Skin and subcutaneous tissue disorders Acne
    Hirsutism
    Alopecia
    Itching
    Eczema
    Skin hyperpigmentation
    Musculoskeletal and connective tissue disorders Backache**
    Disorders of the genital organs and breast Changes in blood loss, including increases and decreases in bleeding intensity, spotting, oligomenorrhea and amenorrhea
    Vulvovaginitis*
    Discharge from the genital tract*
    Pelvic organ infections
    Ovarian cysts
    Dysmenorrhea
    Pain in the mammary glands* *
    Breast engorgement
    Expulsion
    IUD (full or partial)
    Uterine perforation (including penetration)***
    Laboratory and instrumental data High blood pressure
    * “Often” according to the indication “prevention of endometrial hyperplasia during estrogen replacement therapy.”
    ** “Very often” for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy.”
    ***This frequency is based on data from clinical studies that did not include breastfeeding women. In a large, prospective, comparative, non-interventional cohort study of women using IUDs, uterine perforation in women who were breastfeeding or who had an IUD inserted before 36 weeks postpartum was reported to be “uncommon” (see Precautions section). .

    Terminology consistent with MedDRA is used in most cases to describe certain reactions, their synonyms, and associated conditions.

    Additional Information
    If a woman becomes pregnant while taking Mirena®, the relative risk of ectopic pregnancy increases. The partner may feel the threads during intercourse.
    The risk of breast cancer when using Mirena® for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy” is unknown. Cases of breast cancer have been reported (frequency unknown, see Precautions and Precautions).
    The following adverse events have been reported in connection with the installation or removal of Mirena®: pain during the procedure, bleeding during the procedure, vasovagal reaction associated with installation accompanied by dizziness or fainting. The procedure may provoke a seizure in patients with epilepsy.
    Infection
    Cases of sepsis (including group A streptococcal sepsis) have been reported following IUD insertion (see section "Special Instructions").

    Overdose

    Not applicable.

    Interaction with other drugs

    The metabolism of progestogens may be enhanced by concomitant use of substances that are enzyme inducers, especially cytochrome P450 isoenzymes involved in the metabolism of drugs, such as anticonvulsants (for example, phenobarbital, phenytoin, carbamazepine) and drugs for the treatment of infections (for example, rifampicin, rifabutin, nevirapine , efavirenz). The effect of these drugs on the effectiveness of Mirena® is not known, but it is believed that it is not significant since Mirena® has mainly a local effect.

    special instructions

    Before installing Mirena®, pathological processes in the endometrium should be excluded, since irregular bleeding/spotting is often observed in the first months of its use. Pathological processes in the endometrium should also be excluded if bleeding occurs after starting estrogen replacement therapy in a woman who continues to use Mirena®, previously prescribed for contraception. Appropriate diagnostic measures must also be taken when irregular bleeding develops during long-term treatment.
    Mirena® is not used for postcoital contraception.
    Mirena® should be used with caution in women with congenital or acquired valvular heart disease, keeping in mind the risk of septic endocarditis. When inserting or removing an IUD, these patients should be given prophylactic antibiotics.
    Levonorgestrel in low doses can affect glucose tolerance, and therefore its concentration in the blood plasma should be regularly monitored in women with diabetes mellitus using Mirena®. As a rule, no dose adjustment of hypoglycemic drugs is required.
    Some manifestations of polyposis or endometrial cancer may be masked by irregular bleeding. In such cases, additional examination is necessary to clarify the diagnosis.
    The use of intrauterine contraception is preferable in women who have given birth. The Mirena® IUD should not be considered as a method of choice in young nulliparous women and should only be used if other effective methods of contraception cannot be used. The Mirena® IUD should not be considered as the first choice method in the postmenopausal period in women with severe uterine atrophy.
    Available data indicate that the use of Mirena® does not increase the risk of developing breast cancer in postmenopausal women under 50 years of age. Due to the limited data obtained during the study of Mirena® for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy,” the risk of breast cancer when using Mirena® for this indication cannot be confirmed or refuted.
  • Oligo- and amenorrhea
  • Oligo- and amenorrhea in women of fertile age develops gradually, in approximately 57% and 16% of cases by the end of the first year of using Mirena®, respectively. If menstruation is absent within six weeks of the start of the last menstrual period, pregnancy should be ruled out. Repeated pregnancy tests for amenorrhea are not necessary if there are no other signs of pregnancy. When Mirena® is used in combination with continuous estrogen replacement therapy, most women gradually develop amenorrhea over the first year.

  • Pelvic inflammatory disease (PID)
  • The guide tube helps protect Mirena® from infection during insertion, and the Mirena® delivery device is specially designed to minimize the risk of infection. PID in women using intrauterine contraception is often caused by sexually transmitted infections. Having multiple sexual partners for a woman or multiple sexual partners for a woman's partner has been found to be a risk factor for PID. PID can have serious consequences: it can impair reproductive function and increase the risk of ectopic pregnancy. As with other gynecologic or surgical procedures, severe infection or sepsis (including group A streptococcal sepsis) may develop after insertion of an IUD, although this is extremely rare.
    In case of recurrent endometritis or PID, as well as in severe or acute infections that are resistant to treatment for several days, Mirena should be removed. If a woman has persistent pain in the lower abdomen, chills, fever, pain associated with sexual intercourse (dyspareunia), prolonged or heavy spotting/bleeding from the vagina, or a change in the nature of vaginal discharge, you should consult your doctor immediately. Severe pain or fever that occurs soon after insertion of an IUD may indicate a serious infection that must be treated immediately. Even in cases where only individual symptoms indicate the possibility of infection, bacteriological examination and monitoring are indicated.

  • Expulsion
  • Possible signs of partial or complete expulsion of any IUD are bleeding and pain. Contractions of the muscles of the uterus during menstruation sometimes lead to the displacement of the IUD or even to its expulsion from the uterus, which leads to the cessation of contraceptive action. Partial expulsion may reduce the effectiveness of Mirena®. Since Mirena® reduces menstrual blood loss, an increase in blood loss may indicate expulsion of the IUD. A woman is advised to check the threads with her fingers, for example, while taking a shower. If a woman shows signs of the IUD being dislodged or falling out, or cannot feel the threads, she should avoid sexual intercourse or use other methods of contraception, and consult a doctor as soon as possible. If the position in the uterine cavity is incorrect, the IUD must be removed. A new system may be installed at this time.
    It is necessary to explain to the woman how to check the threads of Mirena®.

  • Perforation and penetration
  • Perforation or penetration of the body or cervix of the IUD may occur mainly during insertion, which may reduce the effectiveness of Mirena®. In these cases, the system should be removed. If there is a delay in diagnosing perforation and IUD migration, complications may occur, such as: adhesions, peritonitis, intestinal obstruction, intestinal perforation, abscesses or erosions of adjacent internal organs.
    In a large prospective comparative non-interventional cohort study of women using IUDs (N=61,448 women), the rate of perforation was 1.3 (95% CI: 1.1 - 1.6) per 1000 insertions in the entire study cohort; 1.4 (95% CI: 1.1 -1.8) per 1000 administrations in the Mirena® study cohort and 1.1 (95% CI: 0.7 -1.6) per 1000 administrations in the study cohort with copper-containing IUDs. The study demonstrated that both breastfeeding at the time of insertion and insertion up to 36 weeks postpartum were associated with an increased risk of perforation (see Table 1). These risk factors were independent of the type of IUD used.

    Table 1. Perforation rates per 1000 insertions and risk ratios stratified by breastfeeding and time postpartum at insertion (parous women, entire study cohort).

    An increased risk of perforation when inserting an IUD exists in women with a fixed abnormal position of the uterus (retroversion and retroflexion).

  • Ectopic pregnancy
  • Women with a history of ectopic (ectopic) pregnancy, tubal surgery, or pelvic infection are at higher risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially if it is combined with cessation of menstruation, or when a woman with amenorrhea begins to bleed.
    The incidence of ectopic pregnancy in clinical studies with Mirena® was approximately 0.1% per year. In a large prospective comparative non-interventional cohort study with a follow-up period of 1 year, the incidence of ectopic pregnancy with Mirena® use was 0.02%. The absolute risk of ectopic pregnancy in women using Mirena® is low. However, if a woman becomes pregnant with Mirena® installed, the relative likelihood of ectopic pregnancy is higher.

  • Lost threads
  • If, during a gynecological examination, the threads for removing the IUD cannot be detected in the cervical area, it is necessary to exclude pregnancy. The threads can be drawn into the uterine cavity or cervical canal and become visible again after the next menstruation. If pregnancy is ruled out, the location of the threads can usually be determined by careful probing with an appropriate instrument. If the threads cannot be detected, perforation of the uterine wall or expulsion of the IUD from the uterine cavity is possible. Ultrasound can be used to determine the correct placement of the system. If it is unavailable or unsuccessful, X-ray examination is used to determine the localization of Mirena®.

  • Ovarian cysts
  • Since the contraceptive effect of Mirena® is due mainly to its local action, women of fertile age usually experience ovulatory cycles with rupture of follicles. Sometimes follicular atresia is delayed and follicular development may continue. Such enlarged follicles cannot be clinically distinguished from ovarian cysts. Ovarian cysts were reported as an adverse reaction in approximately 7% of women using Mirena®. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or pain during intercourse.
    As a rule, ovarian cysts disappear on their own within two to three months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound, as well as therapeutic and diagnostic measures. In rare cases, it is necessary to resort to surgical intervention.

  • Use of Mirena® in combination with estrogen replacement therapy
  • When using Mirena® in combination with estrogens, it is necessary to additionally take into account the information specified in the instructions for use of the corresponding estrogen.

  • Fertility
  • After Mirena® is removed, fertility is restored in women.

    Excipients contained in Mirena®
    The T-shaped base of Mirena® contains barium sulfate, which becomes visible during X-ray examination.
    It must be borne in mind that Mirena® does not protect against HIV infection and other sexually transmitted diseases!

    Additional information for patients
    Regular checkups
    Your doctor should examine you 4-12 weeks after insertion of the IUD; thereafter, regular medical examinations are required at least once a year.
    Consult your doctor as soon as possible if:

    • You no longer feel the threads in your vagina.
    • You can feel the lower end of the system.
    • You think you are pregnant.
    • You experience persistent abdominal pain, fever, or notice a change in your normal vaginal discharge.
    • You or your partner feel pain during intercourse.
    • You notice sudden changes in your menstrual cycle (for example, if you had light or no periods and then began to have constant bleeding or pain, or your periods became excessively heavy).
    • You have other medical problems, such as migraine headaches or severe recurring headaches, sudden changes in vision, jaundice, increased blood pressure, or any other diseases or conditions listed in the Contraindications and Precautions sections.
    What to do if you want to get pregnant or remove Mirena® for other reasons

    Your doctor can easily remove the IUD at any time, after which pregnancy becomes possible. Removal is usually painless. After removing Mirena®, reproductive function is restored.
    When pregnancy is undesirable, Mirena® should be removed no later than the seventh day of the menstrual cycle. If Mirena® is removed later than the seventh day of the cycle, you should use barrier methods of contraception (for example, a condom) for at least seven days before its removal. If you do not have menstruation while using Mirena®, you should start using barrier methods of contraception seven days before removing the IUD and continue using them until menstruation resumes. You can also insert a new IUD immediately after removing the previous one; in this case, no additional measures to prevent pregnancy are required.

    How long can Mirena® be used?
    Mirena® provides protection against pregnancy for five years, after which it should be removed. If you wish, you can install a new IUD after removing the old one.

    Restoring the ability to conceive (Is it possible to get pregnant after stopping the use of Mirena®)
    Yes, you can. Once Mirena® is removed, it no longer affects your normal reproductive function. Pregnancy may occur during the first menstrual cycle after Mirena® is removed.

    Effect on the menstrual cycle (Can Mirena® affect your menstrual cycle)
    Mirena® affects the menstrual cycle. Under its influence, menstruation may change and acquire the character of “spotting,” become longer or shorter, occur with more or less bleeding than usual, or stop altogether.
    In the first 3-6 months after installation of Mirena®, many women experience, in addition to their normal menstruation, frequent spotting or scanty bleeding. In some cases, very heavy or prolonged bleeding is observed during this period. If you notice these symptoms, especially if they do not go away, tell your doctor.
    It is most likely that when using Mirena®, the number of days of bleeding and the amount of blood lost will gradually decrease with each month.
    Some women eventually find that their periods have stopped completely. Since the amount of blood lost during menstruation usually decreases when using Mirena®, most women experience an increase in hemoglobin levels in the blood.
    After the system is removed, the menstrual cycle returns to normal.

    Absence of periods (Is it normal to not have periods)
    Yes, if you are using Mirena®. If after installing Mirena® you notice the disappearance of menstruation, this is due to the effect of the hormone on the uterine mucosa. There is no monthly thickening of the mucous membrane, therefore, it is not rejected during menstruation. This does not necessarily mean that you have reached menopause or that you are pregnant. The concentration of your own hormones in the blood plasma remains normal.
    In fact, not having periods can be a big benefit to a woman's comfort.

    How can you find out if you are pregnant?
    Pregnancy in women using Mirena®, even if they do not menstruate, is unlikely.
    If you haven't had a period for six weeks and are concerned, take a pregnancy test. If the result is negative, there is no need to do further tests unless you have other signs of pregnancy, such as nausea, fatigue or breast tenderness.
    Can Mirena® cause pain or discomfort?
    Some women experience pain (similar to menstrual cramps) in the first two to three weeks after having an IUD inserted. If you experience severe pain or if the pain continues for more than three weeks after installation of the system, contact your doctor or the healthcare facility where you had Mirena® installed.
    Does Mirena® affect sexual intercourse?
    Neither you nor your partner should feel the IUD during sexual intercourse. Otherwise, sexual intercourse should be avoided until your doctor is sure that the system is in the correct position.
    How much time should pass between the installation of Mirena® and sexual intercourse?
    To give your body a rest, it is best to abstain from sexual intercourse for 24 hours after Mirena® is inserted into the uterus. However, Mirena® has a contraceptive effect from the moment of installation.
    Can I use tampons?
    It is recommended to use sanitary pads. If you use tampons, you should change them very carefully so as not to pull out the Mirena® threads.
    What happens if Mirena® spontaneously leaves the uterine cavity
    Very rarely, expulsion of the IUD from the uterine cavity may occur during menstruation. An unusual increase in blood loss during menstrual bleeding may mean that Mirena® has passed through the vagina. Partial expulsion of the IUD from the uterine cavity into the vagina is also possible (you and your partner may notice this during sexual intercourse). If Mirena® is completely or partially removed from the uterus, its contraceptive effect ceases immediately.
    What are the signs that indicate that Mirena® is in place?
    You can check for yourself whether the Mirena® threads are still in place after your menstruation has ended. After your period ends, carefully insert your finger into your vagina and feel the threads at the end, near the entrance to the uterus (cervix).
    Don't pull threads, as you may accidentally pull Mirena® out of the uterus. If you cannot feel the threads, consult a doctor.

    Impact on the ability to drive vehicles and machinery

    Not observed.

    Release form

    Intrauterine therapeutic system, 20 mcg/24 hours.
    1 intrauterine therapeutic system with a guide is placed in a sterile blister made of polyethylene film coated with white non-woven material with an adhesive coating and polyester (PETG - polyethylene terephthalate glycol or APET - amorphous polyethylene terephthalate). The blister along with instructions for use is placed in a cardboard box.

    Storage conditions

    Store at a temperature not exceeding 30°C.
    Keep out of the reach of children.

    Expiration date (before administration)

    3 years.
    Enter no later than the expiration date indicated on the package.

    Vacation conditions

    On prescription.

    Manufacturer

    Bayer Oy, Finland
    Pensiontje 47, 20210 Turku, Finland
    Bayer Oy, Finland
    Pansiontie 47, 20210 Turku, Finland

    Additional information can be obtained at:
    107113 Moscow, 3rd Rybinskaya st., 18, building 2.

    Application

    Instructions for introduction

    Installed only by a doctor using sterile instruments.
    Mirena® is supplied together with the guidewire in sterile packaging, which must not be opened prior to installation.
    Do not re-sterilize. For single use only. Do not use Mirena® if the inner packaging is damaged or opened. Do not install Mirena® after the month and year indicated on the package have expired.
    Before installation, please read the information on the use of Mirena®.

    Preparing for the introduction

    • Carry out a gynecological examination to determine the size and position of the uterus and to exclude any signs of acute inflammatory diseases of the genital organs, pregnancy or other gynecological contraindications for the installation of Mirena®.
    • Visualize the cervix using speculums and completely clean the cervix and vagina with the antiseptic solution.
    • If necessary, use the help of an assistant.
    • Grasp the anterior lip of the cervix with forceps. Using gentle traction with forceps, straighten the cervical canal. The forceps should be in this position throughout the entire administration of Mirena® to ensure gentle traction of the cervix towards the inserted instrument.
    • Carefully moving the uterine probe through the cavity to the fundus of the uterus, determine the direction of the cervical canal and the depth of the uterine cavity (the distance from the external os to the fundus of the uterus), exclude septa in the uterine cavity, synechiae and submucosal fibroids. If the cervical canal is too narrow, it is recommended to widen the canal and possibly use painkillers/paracervical blockade.
    Introduction

    1. Open the sterile package (Figure 1). After this, all manipulations should be carried out using sterile instruments and wearing sterile gloves.
    Picture 1

    2. Move the slider forward in the direction of the arrow to its farthest position to retract the IUD into the guide tube (Figure 2).
    Figure 2

    Important information!
    Do not move the slider downward as this may cause Mirena® to be released prematurely. If this happens, the system will not be able to be placed back inside the conductor.

    3. Holding the slider in the farthest position, adjust the upper edge of the index ring in accordance with the distance measured from the external os to the fundus of the uterus by the probe (Figure 3).

    Figure 3

    4. Continuing to hold the slider at its farthest position, advance the guidewire carefully through the cervical canal and into the uterus until the index ring is approximately 1.5 to 2 cm from the cervix (Figure 4).

    Figure 4

    Important information!
    Do not force the conductor forward. If necessary, the cervical canal should be expanded.

    5. While holding the guidewire still, move the slider to the mark to open the horizontal arms of Mirena® (Figure 5). Wait 5-10 seconds until the horizontal shoulders are fully open.

    Figure 5

    6. Gently advance the guidewire inward until the index ring contacts the cervix. Mirena® should now be in the fundal position (Figure 6).

    Figure 6

    7. Keeping the guidewire in the same position, release Mirena® by moving the slider as far as possible downwards (Figure 7). Keeping the slider in the same position, carefully remove the conductor by pulling on it. Cut the threads so that their length is 2-3 cm from the external os of the uterus.

    Figure 7

    Important information!
    If you have doubts that the system is installed correctly, check the position of Mirena®, for example, using ultrasound or, if necessary, remove the system and insert a new, sterile system. Remove the system if it is not completely in the uterine cavity. The removed system should not be reused.

    Removal/replacement of Mirena
    Before removing/replacing Mirena®, please read the instructions for use of Mirena®.
    Mirena® is removed by carefully pulling the threads grasped with forceps. (Figure 8).

    Figure 8

    You can install an IUD immediately after removing your old one.

    The issue of contraception is relevant for every woman of childbearing age. Today there are many effective ways to avoid unwanted pregnancy, among which intrauterine contraceptives are especially popular. When an IUD is placed, before or after menstruation, many girls turn to doctors with this question.

    Intrauterine contraceptives have been used since the mid-20s of the last century. Then they were a ring made of an alloy of brass and bronze, to which a small amount of copper was added. In 1960, a safer product made from elastic material appeared.

    Modern spirals have different shapes, some of them contain hormonal drugs. The contraceptive effect is achieved by releasing a small amount into the cavity of the reproductive organ. In addition, the spiral has a mechanical effect on the inner lining of the uterus, preventing the attachment of the egg after fertilization.

    The spiral significantly complicates the advancement of male reproductive cells and weakens them, which does not allow pregnancy to occur.

    During this time, the cervix is ​​slightly open so that the procedure for introducing a contraceptive is the least traumatic and easy to implement. The onset of menstruation is one of the signs that a woman is not pregnant, so it is at this time that it is preferable to install the IUD.

    Before installing an intrauterine device, an examination should be scheduled to exclude the presence of infections and pathologies associated with the reproductive organs. The standard list of diagnostic procedures looks like this:

    • smears of the cervix and vagina;
    • tests for syphilis, hepatitis and HIV;
    • general urine test;
    • tests that detect sexually transmitted infections;
    • ultrasound examination of the uterus.

    An ultrasound is prescribed not only to make sure that a woman has no changes that would prevent the use of an intrauterine contraceptive. Its purpose is also to make sure that the woman is not pregnant at the time of installation of the IUD. To do this, you will have to do a test to determine the level of hCG.

    The installation procedure is carried out exclusively in a gynecological office under sterile conditions. The woman sits in a chair with her feet on the holders. Before inserting the IUD, the doctor treats the cervix and vagina with a disinfectant. Additionally, local anesthesia is performed. Usually a special gel is used for anesthesia, sometimes injections.

    Only after this, the doctor, using special instruments, opens the cervix, measures the depth, and then inserts the contraceptive into the uterine cavity. The doctor brings the so-called “antennae” up to 2 cm long out into the vagina. This is done so that the spiral can be removed. During hygiene procedures, a woman should check from time to time whether these “antennae” are in place.

    The installation procedure is virtually painless. Only sometimes women feel pain, which quickly passes. Some women experience attacks of dizziness and fainting. But this is an extremely rare phenomenon that goes away after a few minutes.

    With the IUD you can have sex within a few days. In the first month, until the immune system adapts to the presence of a foreign body, it is better for a woman to refrain from visiting the bathhouse or swimming pool. Strong physical activity should also be avoided.

    Contraindications for IUD insertion

    The intrauterine device is a convenient and relatively inexpensive means of contraception. But, like many medications, it has contraindications, under which it cannot be used to protect against unwanted pregnancy. The main ones are listed below:

    • cervical dysplasia;
    • malignant and benign neoplasms in the reproductive organs;
    • a woman has previously had an ectopic pregnancy;
    • severe trauma to the cervix during childbirth;
    • blood diseases.

    For girls who have never given birth, doctors usually do not recommend the IUD. Other contraceptives are selected for them individually.

    IUD after childbirth or abortion

    After the birth of the baby, women try to take some “pause” before planning a new pregnancy. And this is understandable - the body needs to get stronger after pregnancy and childbirth, and the family needs to get used to new rules and routines.

    It is believed that in the first months, while there are no periods and the young mother is breastfeeding, she cannot become pregnant. However, this is not the case, and very often a woman finds out that a little man has settled in her womb again when all the signs of pregnancy become apparent.

    This is why it is very important for women who have recently given birth to use proper protection. And the optimal choice during this period is Mirena or another spiral.

    It can be installed when the uterus reaches normal size. This occurs approximately 6-12 weeks after the birth of the child, although it is also practiced to install the IUD immediately after natural birth. If delivery occurred via cesarean section, the intrauterine device can be installed after 6 months.

    According to many practicing doctors, with whom researchers from the United States also agree, positive results are obtained by inserting a device into the uterus immediately after an abortion, regardless of whether it was caused by natural causes (miscarriage) or performed surgically.

    If a contraceptive is introduced into the uterus 15-20 minutes after surgery, this minimizes the possibility of an unwanted pregnancy. In addition, there is no need to use anesthetics again and dilate the cervix.

    Advantages and disadvantages of the intrauterine device

    The IUD is considered a reliable method of protection: its effectiveness reaches 95%. Many women note as a positive factor that you can live with the same device for up to 5 years, and in some cases longer. This saves time and money that would otherwise have to be spent on purchasing other contraceptives. In addition, intrauterine devices have other advantages:

    • you do not need to strictly follow the dosage schedule, unlike birth control pills;
    • allowed for use by women who are breastfeeding;
    • Once removed from the uterus, you can quickly become pregnant.

    Hormone-containing coils, for example, Mirena, not only prevent pregnancy, but also have an anti-inflammatory effect on the reproductive organs and prevent endometriosis. In addition, after installing the Mirena coil, periods become practically painless and shorter.

    Despite all the positive aspects, using a spiral can sometimes have negative consequences. First of all, this is a restriction that applies to nulliparous girls. It is due to the fact that their uterine cavity is small and also too narrow. Because of this, the procedure for placing a contraceptive is more complex and painful. In rare cases, it ends with perforation of the wall of the reproductive organ.

    The spiral is suitable for women who have a regular sexual partner, since the risk of infectious diseases increases, especially in the first month after installing a contraceptive. A foreign body inside the uterus contributes to the rapid spread of infection. If not treated in a timely manner, the inflammation can result in infertility.

    The use of an IUD is associated with regular visits to the gynecologist. First to install it, and then preferably every six months. In addition, the woman has to independently control the antennae, the ends of which are located in the vagina. This is necessary to make sure that the spiral does not fall out. To remove the contraceptive, you will have to go to the doctor again.

    Is it possible to remove the IUD myself?

    Some women are interested in whether it is possible to remove the IUD without menstruation or on their own? Experts categorically do not recommend conducting experiments at home. To do this, you need to contact a gynecologist. The extraction procedure should be carried out when menstruation occurs (in the first days) under sterile conditions.

    If you remove the IUD yourself, there is a high risk of damaging the genital mucosa and causing infection.

    Removing the IUD by a gynecologist is a virtually painless procedure if there are no inflammatory processes. Before her, the doctor conducts an examination. If the spiral is intact, then pull it out by pulling the antennae. If there are no threads in the vagina or the contraceptive is destroyed, microsurgical intervention is used - hysteroscopy.

    After removing the IUD from the uterus, the doctor takes a smear from it, which is sent to the laboratory for cytological examination. This procedure is followed in most cases, but is not mandatory.

    Types of IUDs

    If there are no contraindications, then, after consulting with your doctor, almost every woman can choose an IUD. Among the devices available on the market today are those that are shaped like an umbrella or a spiral, an egg and a ring. The materials from which they are made are also different.

    Taking into account the location and structure of the uterus, the doctor will recommend a certain type of IUD to the woman. The first generation S-shaped contraceptives made of polyethylene are practically no longer used. This is due to their low efficiency and frequent cases of spontaneous prolapse from the uterus.

    Relatively inexpensive modern copper-based IUDs are very effective. They oxidize the environment in the uterus, so sperm entering it becomes less active. Since copper is released quickly, such a coil is replaced every 3-5 years.

    There are not only copper spirals, but also those that contain silver, platinum and gold. Particularly effective are medicated intrauterine systems containing levonorgesterol or progesterone in the stem. Every day a small dose of the hormone is released into the uterus.

    The most popular among such spirals are Mirena, Levonova and others. They improve the condition of the endometrium and fallopian tubes, and have a positive effect if periods are too heavy and painful. Disadvantages include the appearance of intermenstrual discharge. You can install the Mirena coil or another one containing the hormone for up to 5 years.

    The choice of contraceptive should be made together with your doctor. Based on whether menstruation is regular and assessing the condition of the genital organs, he will determine which type of IUD will be optimal.

    Whether married or out of wedlock, a man and woman living together have to think about protection from “unwanted pregnancy” - no matter how much this phrase itself grates on anyone’s ears. And a woman, as a person more responsible in matters of giving birth and raising a child, has to think about such protection more. In this article we will describe in detail the Mirena intrauterine device, the features of its use and possible contraindications.

    Here is just an incomplete list of ways to protect yourself from unwanted pregnancy:

    1. Barrier method
      • Local chemical reagents in the form of pastes, gels, capsules inserted into the vagina before coitus
      • Mechanical barriers to sperm entering the uterus (female condoms, cervical caps, vaginal diaphragms)
    2. Hormonal contraception (mainly taking drugs orally, less often - intramuscular injections)
    3. Surgical methods of contraception
      • Fallopian tube ligation using laparoscopy
      • Minilaparotomy
      • Sterilization with the possibility of colpotomy access
    4. Intrauterine devices

    Use against unwanted pregnancies is rightfully considered one of the most effective methods of birth control. True, due to female anatomical features and the complexity of installation, an IUD can only be inserted into the uterus by a gynecologist and only if there are indications for such installation.

    5 advantages of spiral contraception:

    1. Greater efficiency of the method. There are no more than 0.01% cases of pregnancy with a correctly installed IUD.
    2. Rapid return to fertility after removal of the IUD.
    3. Does not need to be combined with another contraceptive (except for condoms used as a means of protection against STDs)
    4. After fixing the uterine device in place, only one follow-up visit to the gynecologist is required to make sure that the device is installed correctly and that the device is not rejected by the body.
    5. When installing a progestin-containing intrauterine device, pain during menstruation is guaranteed to disappear.

    The Mirena hormonal device is easy to install, inexpensive and always available.

    Mirena intrauterine device

    Mirena belongs to the third generation of spirals, which uses a membrane container, from which, after installation in the uterus, levonorgestrel begins to be released in microdoses - a hormone that prevents both the attachment of the egg to the walls of the uterus during fertilization, and the fertilization of the egg itself by suppressing the vital activity of spermatozoa that managed to reach it. get there.

    The Mirena intrauterine therapeutic system is a T-shaped hormonal-elastomer core with an outer membrane that releases microdoses of levonorgestrel into the bloodstream of the uterine mucosa. The membrane was developed using nanotechnology, and its thickness is calculated so as to release a strictly dosed amount of drug from the contents of the spiral. The spiral is in a folded state in the conductor tube, from which, during installation in the uterus, it is pushed out by a special pusher. At this moment, the T-shaped outgrowths straighten out and block the possible paths for the passage of seminal fluid and sperm into the uterus.

    The amount of hormone-containing product in the spiral container is about 52 mg. It is released into the uterus at an average rate of 20 mcg per day. With normal functioning, by the end of the 5th year, the release of the hormone decreases to 10 mcg per day, then the effectiveness of the Mirena spiral decreases, the barrier function remains mainly mechanical, that is, its presence in the uterus in the form of an obstacle.

    The hormone released through the membrane acts locally and gestagenically. The mechanism of its antiproliferative action is that the accumulation of levonorgestrel in the epithelium of the uterine walls helps reduce the sensitivity of its progesterone and estrogen receptor cells, so the endometrium stops responding to estradiol, causing the uterus to be indifferent to the very process of possible conception. In addition to the suppression of sperm entering the uterus in about half of women, there is also suppression of the production of the eggs themselves from the follicles of the uterus.

    The Mirena spiral has no effect on female fertility.

    Therapeutic effect

    Proliferation (division) of the mucous layer, or endometrium, lining the uterus from the inside, in the first months of use is inhibited by the drug, therefore it is rejected more actively, and during this period an increase in spotting is possible in intermenstrual periods. Then, in women using Mirena, there is a clearly noticeable suppression of endometrial proliferation, and the flow time and the amount of menstrual bleeding themselves are reduced. But the functioning of the ovaries and the level of estradiol in the blood do not fall and remain normal.

    A good therapeutic effect of using the IUD has also been proven for the diagnosis of “idiopathic menorrhagia”, that is, there were heavy periods, perhaps even with bloody clots. Unless, of course, there are hyperplastic phenomena in the mucous membrane, such as submucosal or large interstitial fibroid nodes that cause a change in the configuration of the shape of the uterus, or identified oncology of the mucus-producing layer, as well as any other conditions in which there is pronounced hypocoagulation, the symptoms of which are often and menorrhagia occurs.

    During the first three months of using the drug contained in the spiral, blood loss from menstruation is reduced by 60-90%. And after 6 months – already by 70-95%. If the duration of the Mirena coil in the uterus was up to two years, the effect of this can be compared with radical surgical intervention. As if complete removal of the endometrium had been performed. But for submucous fibroids that are not noticed in time, when the Mirena coil has already been installed, the effectiveness of the drugs will no longer be as good. In most cases, reducing blood loss during menstruation will have a positive effect on reducing the symptoms of iron deficiency anemia, if they have already occurred.

    Levonorgestrel spiral

    The levonorgestrel released by the spiral has a purely local effect on the uterus. This means that the concentration of the hormone in her muscles compared to the adjacent mucus-producing layer is 100 times less. And the hormone in the blood is so vanishingly small that it can only be detected using special blood testing methods, similar to methods for detecting doping in athletes, when they try to find hundred thousandths of a percent of substances. Naturally, such shares do not have any noticeable effect on the vital functions of the body.

    The concentration of the drug in the endometrium is directly dependent on the woman’s body weight. Those 52 mg of the drug that are in the coil’s reservoir are designed for an average weight of about 65 kg. In women of a slight build with a lower body weight, the concentration of the hormone in the endometrium may be increased. Accordingly, in overweight women the stated 20 mcg/day may also be unattainable. When choosing this particular spiral model, this dependence must be kept in mind.

    The main effect of the action of the hormones contained in the system is that the contraceptive effect is achieved mainly not from the fact that the active component gets inside, but due to its reaction to the presence of a foreign object in it. This means that the inserted IUD causes local inflammation of the endometrium, and such inflammation makes it impossible for the egg to attach to the uterine walls. This is achieved due to

    • Inhibition of standard processes of endometrial formation
    • Active changes in submucosal layers
    • Decreased glandular function of the uterus

    The direct effect of levonorgestrel will be expressed in

    1. Significant narrowing of the lumen of the uterine canal on its side (internal cervical canal)
    2. The viscosity of the mucus in it and in the fallopian tubes will become higher.

    These factors become an almost insurmountable barrier for sperm. The most active individual specimens will be suppressed by the direct influence of the hormone, and they will lose any remaining mobility.

    Indications for installation

    1. A woman’s desire not to become a mother with a long-term (up to 5 years) perspective.
    2. Unreliability of other types of contraception, whatever the reasons.
    3. The desire to protect yourself while breastfeeding a child (fatigue from childbirth, lack of sleep and other factors)
    4. Considerations of economy and convenience: the installation of the IUD is done for several years, while other types of contraception can be forgotten.
    5. Copious bleeding during menstruation is not pathogenic.
    6. Prevention of uncontrolled growth of the uterine mucosa during treatment with estrogens.
    7. without obvious pathology

    Based on many years of clinical practice, doctors are inclined to install the Mirena IUD not only for contraception, but also to normalize pathogenic processes such as menorrhagia, which exhaust a woman’s body with heavy bleeding and can lead to anemia - unless, of course, this does not occur against the background of excessive growth of the endometrium.

    The effectiveness of the hormones contained in the drug is such that within six months after installation of the system, the intensity of bleeding drops by half, and by the end of the five-year period of use of the spiral, with a favorable course of processes, the effect is comparable in effectiveness to uterine resection.

    Non-standard situations

    Most often, women are concerned about the fact of a sharp decrease or even sometimes a complete cessation of menstruation after they have inserted the IUD. An additional worrying factor is that in the first two to three months, bleeding, on the contrary, was stronger. But both the first and the second are the result of a restructuring of the endometrial metabolism, when its proliferation is suppressed by the introduced hormone.

    Installation of the Mirena coil

    Only a gynecologist can insert the Mirena intrauterine device into the uterus; a woman should undergo some procedures before her.

    1. Analyzes
      • Blood and urine (general)
      • HCG level to exclude pregnancy
      • Confirmation of the absence of sexually transmitted infections
    2. Examination by a gynecologist with two-handed examination
    3. Diagnosis of precancerous pathologies
    4. Ultrasound of reproductive organs

    In order to have an idea of ​​the manipulations performed by the doctor and not worry about the process, it is useful for women to know how the process of inserting an IUD occurs.

    After inserting a gynecological speculum into the uterus, its cervix is ​​treated with a disinfecting solution. Controlling the process with a mirror, the doctor inserts a guidewire with the IUD contained inside in a rolled (folded) state. Correctly, in accordance with the location of the fallopian tubes, the system is installed and the guide is removed from the uterine cavity, leaving the spiral in a straightened form. After this, the woman is given the opportunity to rest and recover for 25-30 minutes.

    Mirena is installed in the first week of the cycle. True, this recommendation is not valid in the case of installation of a spiral not only for contraceptive purposes, but also for therapeutic purposes, if the effect of levonorgestrel is indicated. It is also possible to install an IUD after an artificial termination of pregnancy, performed in its first trimester, if there was no inflammation of the uterine mucosa after the abortion procedure itself.

    Possible complications

    Hormonal regulation of life processes is one of the most subtle and delicate. Even microscopic portions of substances entering the bloodstream in people who are particularly sensitive to this can cause disruptions in the functioning of the central nervous system. Possible expressions of this include irritability, headaches, and depression. It is up to the patient to keep the IUD during such symptoms: if such side symptoms do not disappear after 2-4 months after installation, the gynecologist who installed the device may also recommend removing the IUD.

    Another worrying factor that serves as a reason and reason for removing the inserted intrauterine device is severe bleeding within the same 2-3 months from the start of installation. The effect of the hormone on the central nervous system and the intensity of discharge may have a direct connection, so it always makes sense to wait a little - with a decrease in blood loss due to thinning of the endometrium, other unpleasant consequences of the initial action of the coil disappear.

    In addition to the listed signs, in the first days of the IUD, there are also disturbances in the functioning of the digestive and gastrointestinal tract: nausea and even vomiting, abdominal pain, loss of appetite.

    If there is hypersensitivity to levonorgestrel, then some weight gain and acne are possible.

    Expulsion

    Complications include expulsion - loss of the device during menstruation or even during the intermenstrual period.

    Expulsion can go unnoticed during heavy discharge, so women with an IUD installed should carefully inspect their hygiene products to monitor possible loss. During the intermenstrual period, you can verify the integrity of the IUD by feeling its threads. With espulsion, if it occurs in the middle of the cycle, extracurricular bleeding begins, so even at this time the loss of the coil cannot go unnoticed.

    Perforation

    Even more dangerous is perforation - a perforation of the uterine wall, which usually occurs during the installation of an intrauterine device. It occurs as a complication due to difficult childbirth, in the midst of breastfeeding, and with an atypical location of the uterus. But usually the cause of perforation is the inexperience of the gynecologist installing the spiral.

    When to see a doctor

    There are situations when going to a gynecological office with an already installed IUD is not only desirable, but also necessary:

    • Delay of menstruation by one and a half to two months, but pregnancy is excluded
    • Prolonged pain in the lower abdomen for more than a month
    • Unpleasant sensations during sex, anorgasmia
    • Fever with chills, profuse sweating at night
    • Significant increase in the volume of menstrual flow
    • Changes in the color, smell, consistency of menstruation, in general any unusual appearance.

    Contraindications

    Like any effective medical device, IUDs also have contraindications.

    1. Current pregnancy
    2. Sexual infections, cystitis
    3. Suspicion of oncology of the reproductive system
    4. Bleeding of unknown etiology
    5. The uterus is deformed due to the presence of a large fibroid node or a tumor of other (non-oncological) origin
    6. Severe liver damage
    7. Allergic incompatibility with the composition of the contraceptive
    8. Old age (over 65)
    9. Thromboembolism, thrombophlebitis, other vascular pathologies
    10. Severe forms of migraine with temporary asymmetric vision loss

    In addition, there is a list of diseases in which the installation of an intrauterine system is problematic:

    • Diabetes mellitus of any type.
    • A heart attack noted in a personal medical record, regardless of its statute of limitations.
    • Severe hypertension.
    • Migraine, headaches of unknown etiology.
    • Cardiac ischemia.
    • Pathologies of heart valves.

    For women on this list, if they decide to install an intrauterine device, and the doctor has not found any obvious reasons for refusing this procedure, they need to carefully monitor all sudden changes in their well-being.

    Spiral validity period

    The Mirena hormonal device is designed for five years of continuous use as a contraceptive. The IUD is removed in the gynecologist's office. The doctor uses the threads coming out of the IUD into the vagina to pull the contraceptive out of the installation site. When extracted, women often feel unpleasant sensations, even severe pain - the spiral seems to grow into the flesh, and it is not so easy to remove it.

    If pregnancy occurs with the IUD installed (and such cases, although rare, are not excluded), its removal is definitely indicated - an unremoved IUD can cause a miscarriage or premature birth.

    Conclusion

    The Mirena IUD is a good solution if you intend to purchase a reliable product that protects against unwanted pregnancy, despite its high cost (about 12,000 rubles).

    Mirena is indicated for women with good compatibility with gestogenic drugs. It will be especially useful for those who normally have heavy and painful periods. But, keeping in mind the possibility of incompatibility of the body with the medicine, it is better to discuss the purchase and installation of the Mirena spiral with a doctor who will suggest a different model if there are possible risks of installation.

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