Mirena hormonal device: indications, consequences, reviews of women and doctors. Mirena spiral: indications, contraindications, instructions for use

Endometriosis often occurs as a result of an abortion, so after this the woman needs best practices protection from unwanted pregnancy. Mirena spiral except therapeutic effect and contraceptive. Moreover, it is valid for up to five years, showing same degree efficiency. Its benefits have been repeatedly confirmed by gynecologists, since the installation inhibits the growth of endometrial lesions and myomatous nodes. Reviews about the Mirena intrauterine device are positive; women like the ease of insertion and high degree of effectiveness. The method has a number of nuances, you need to familiarize yourself with them before starting the procedure.

Composition and release form

Mirena spirals are produced in Finland and Germany. Basics active substance- this is levonorgestrel. It is contained in one spiral 52 mg. Polydimethylsiloxane elastomer in the same volume is included as an additional substance.

The release form of the medicine is a spiral. It has a white core of the main substance and is located in the body. The base is in the shape of the letter T. Covered with a membrane, almost ghostly. Membrane protection is needed to regulate the supply of the active ingredient. A loop with a thread for removal is attached to the body at the bottom.

Delivery is carried out in sterile blisters. One package contains one spiral.

Mechanism of action

The main active ingredient has a progesterone effect. As a result of the fact that only a certain part of the substance is released, it comes in small doses. The drug gradually comes out and at the same time has a constant effect on the body.

Contraceptive in medicinal purposes contains small doses active component, its effect is local, that is, it does not enter the system bed. Spiral for endometriosis is inserted painlessly into the uterus. Moreover, in addition to the obvious contraceptive effect, it affects pathologies. In particular:

decrease in the rate of follicle exit;
change hormonal balance in the direction of reducing the activity of the hormone progesterone;
reduction in the size of the uterine walls, which affects the frequency of menstruation and volume;
reduction in the speed of movement of sperm entering the vagina.

The Mirena spiral protects against conception for endometriosis for five years. In addition, it also has a number of medicinal effects, which are described above. Hormonal system It also allows you to establish regular discharge. During its use, periods are not as heavy and there is less pain.

Indications for use

The Mirena IUD protects against unwanted conception for five years. However, this is not the only property. Helps cure the following diseases:

uterine fibroids;
endometriosis;
uterine leiomyoma;
disruption of the female organ after removal;
endometrial hyperplasia;
uterine polyp;
bleeding of the uterus during premenopause;
painful critical days;
heavy periods;
duration critical days more than 5, with the formation of anemia.

Indications do not always guarantee that the IUD will be able to cope with these diseases. Hormonal IUDs They do not help everyone; a consultation with a gynecologist is required before using them. Only a specialist can understand how suitable method they are for a particular patient, calculate the risk of complications and make a decision on the effectiveness and safety of using a medical product.

Contraindications

Mirena coils are not always used. There are a number of contraindications that reduce its effectiveness. It should also be remembered that hormonal therapy, even in small doses, can cause harm not only female organs, but also to the entire body as a whole. So, the spiral cannot be used when:

the likelihood of pregnancy (the active ingredient can cause a miscarriage);
acute viral and infectious diseases in active stage(it is not clear how hormones can affect the course of the disease and the body’s ability to resist viruses and infections);
malignant neoplasms in the body (they can be localized in any part of the body, on any organ);
inflammation gynecological nature;
sexually transmitted infections (this includes any infections of this type);
frequent uterine bleeding, the cause of which has not been identified;
genetic or acquired deformations of the uterine cavity.

Only a gynecologist can identify the risk during an examination. You must agree with him on your decision to use the IUD as a contraceptive and therapeutic agent.

Preparatory conditions

In order to determine whether the remedy will be effective and whether its use will cause side effects, a woman needs to undergo a thorough examination by a doctor. An intrauterine device is placed only if, after the test results, no viral or sexually transmitted diseases are detected. The following studies are required:

transvaginal ultrasound examination;
taking smears for the presence or absence of infectious diseases;
examination for chronic diseases(gynecological nature);
bacterial culture.

Research methods make it possible to determine whether a woman has contraindications. If they are present, then treatment is carried out first, and only then you can put a candle. But this does not happen in all cases. For example, if genetic pathologies of the development of the uterine cavity are detected, then the product cannot be used.

Therapeutic effect

The Mirena spiral has a number of therapeutic effects. The package contains attached instructions for use, which indicate the indications. But there are actually more effects. The use of the drug for fibroids and endometriosis provides therapy for a number of diseases and conditions:

pregnancy prevention;
removal of pain during menstruation and sexual intercourse;
stopping the progress of endometriosis and uterine fibroids;
Creation favorable conditions for intimacy (eliminates the risk of some infection);
reduction of blood loss during critical days (even if this is associated with the resulting anemia);
restoration of hormonal balance in the female body (by regulating progesterone levels);
therapy for anemia (as a result of less blood loss, the disease becomes less obvious).

Also, suppositories cope with adenomyosis, which is characterized by frequent pain symptoms, disturbances in the frequency and abundance of menstruation. Candles also control the psycho-emotional state. A woman who is used to them experiences less stress if she does not want to given time conceive a child.

Main advantages of use

The advantages of using the IUD against endometriosis have been confirmed by gynecologists. If there are no contraindications, then this method of contraception becomes best choice for protection against unwanted pregnancy and treatment gynecological diseases. The main advantages of the technique:

therapeutic effect against endometriosis and fibroids;
high degree of effectiveness against unwanted pregnancy (up to 98-99 percent);
reduction of blood loss during heavy periods;
temporary loss of reproductive function (after removal of the IUD, the ability to conceive a child is restored on average in three to six months).

In addition, one cannot fail to note the obvious fact of the ease of use of the spiral. You will not need to perform any manipulations other than the installation itself, constantly monitor how it works, and the like. Combination high efficiency in terms of contraception and confirmed healing effect make such coils an obvious choice for women with some gynecological diseases. Reviews of the Mirena intrauterine device are positive in this regard. The product is called one of the most effective.

Disadvantages of the technique

Despite the ease of installation, the mass positive properties The Mirena spiral also has disadvantages. Among them, the main one is high cost. According to women's reviews, the price is quite high. But it is important to understand that this is a one-time investment for five years. On average, purchasing contraception and pills for the treatment of fibroids and endometriosis is more expensive. The following disadvantages of protection using a spiral are also identified:

changes in the menstrual cycle in the first months of use;
some side effects, for example, dizziness, changes in taste preferences.

Side effects and adverse consequences uses are observed only during the adaptation period of the organism to the spiral. The adaptation time varies among women, but, as a rule, it is from three months to six months.

Side effects

Side effects occur in the first months of use; their manifestations bother women for no more than six months. During this time, it is important to be observed by a gynecologist, who will note whether the treatment is effective. If the side effects are minor, but have been bothering you for more than six months, then this is a reason to cancel.

Adverse reactions of the body occur mainly due to hormonal changes in the body. Despite the fact that the dose of the active component is small, it can cause discomfort. At first, the following reactions from the body are possible:

nausea and changes in taste preferences;
headaches, up to severe migraines;
impaired ability to concentrate;
emergence of scarce bleeding at a time when menstruation should not occur;
violation of cyclicity, frequency of menstruation;
change in the abundance of discharge during critical days;
the appearance of rough areas in the mammary glands (can be isolated or very pronounced);
changes in the skin (the appearance of acne, rashes, blackheads, blackheads);
increased greasiness of the epidermis and scalp.

There are other negative reactions, but they are extremely rare. These include disorders of the psycho-emotional background, in particular, frequent changes mood, the occurrence of depressive and unconditional states. It is also possible for a small cystic type to form in the ovaries. If any adverse reactions are detected, a woman should immediately contact a gynecologist. In this case, the spiral should be removed and another treatment method should be chosen, for example, hormonal tablets with a lower concentration of the active substance.

There are many negative reactions, but in 98 percent of cases they all go away after several months of use. Hormonal background women stabilize and the body begins to work as before. After six months, patients forget about the gynecological problems that bother them and get used to the installed Mirena contraceptive-therapeutic device.

Examinations during use of the spiral

A woman needs examination by a gynecologist in certain time after installation. This is necessary in order to understand how effectively the spiral works and to identify the risk of adverse reactions. Visits are preventive, in the absence of pathologies, take tests or undergo thorough examination no need.

After the gynecologist performs necessary tests and will understand that there is no risk that the spiral will be ineffective, installation is taking place. You will need to visit a specialist three times during the first year of use (or more often if adverse reactions). It is usually necessary to visit a gynecologist:

seven days after installation of the spiral;
a month after continuous wearing;
six months after installation.

It is worth remembering that the period of use should not exceed five years. After this period, very little of the active active component remains or it is completely exhausted. In this case, the already expired IUD will not have a therapeutic gynecological effect, in addition, the chances of conceiving a child increase many times over. After five years, it is removed or replaced with a new one.

The most popular intrauterine device hormonal contraceptive is the Mirena IUD (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: absence on female body systemic impact, high efficiency, ease of use.
The spiral does not affect the quality sexual contact, installed on long period, 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 best qualities 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 introduction of a fertilized egg is not carried out 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. As a progestational agent local action, intrauterine device 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.

Development of acute inflammatory pathology of the pelvic organs, which is practically not amenable to therapy, is an indication for removal of the IUD. Therefore, internal contraceptives are not prescribed if there is a predisposition to infectious diseases (constant change sexual partners, strong decline 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 diabetes mellitus, thrombophlebitis, heart attack, 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 there is hypersensitivity to the components of the drug.

Side effects

Common side effects

There are several side effects Mirenas, which are found in almost every tenth woman who has installed a spiral. These include:

disorder 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 pass 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, it is prescribed necessary diagnostics. Rare complications are bloating, frequent mood swings, itchy skin, 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 gynecologist can install the Mirena contraceptive. Before this, the doctor must conduct an examination and prescribe the necessary examination:

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

You need to make sure there is no pregnancy, malignant neoplasms or STIs. When found inflammatory diseases, before placing Mirena, they are treated. You should also determine the size, location and shape of the uterus. The correct position of the spiral ensures 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. At normal contraction uterus after childbirth, you can use Mirena 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.

Precautions

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, clinical data proving a predisposition to the development varicose veins and thrombosis of the leg veins when using the spiral are absent. 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 mellitus you need to systematically monitor your blood glucose levels. When threatened 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

Ectopic pregnancy - develops extremely rarely and requires emergency surgical intervention. This complication can be suspected if symptoms of pregnancy occur ( long delay 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 chance of developing such a complication after suffering severe inflammatory or infectious pathologies pelvis or a history of ectopic pregnancy.

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.

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 device occurs hormonal agent, then the doctor must remove it and install a new one.

Inflammatory and infectious diseases pelvic organs usually develop in the first month of using the Mirena system. The risk of complications increases with frequent changes 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.

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 spiral menstrual cycle is being restored.

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 performed 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 have one intrauterine contraceptive Replace with a new one immediately. 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 it occurs fainting or seizure 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. At normal pregnancy the spiral 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 termination of 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 general condition crumbs.

Frequently Asked Questions

The price of Mirena is quite high, and the use of a contraceptive can cause many side effects. Does it have any positive influence remedy for 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 it is necessary additional diagnostics and consultation with a gynecologist. It is necessary to take into account the volume and localization of nodes, for example, when submucosal formations 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?

Lack of menstruation - natural reaction on 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?

Usually these symptoms appear in a mild form, immediately after the introduction of Mirena. Heavy 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 the help of hormonal pills, but often forgot to drink 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. She thanks hormonal action 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.

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.

Description of the Mirena intrauterine device

Effect of Mirena on the body

How Mirena works

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.

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 there is 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.

Precautions

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

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.
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.
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.
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.
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.
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 performed 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

Frequently Asked Questions

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?

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, will there be discharge, pain or uterine bleeding?

Usually 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?

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?

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.

Intrauterine contraceptive

Active ingredient

Levonorgestrel (micronized)

Release form, composition and packaging

Intrauterine therapeutic system (IUD) is a T-shaped levonorgestrel-releasing structure placed in a guide tube (guide components: 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 (20 mcg/24 hours). 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.

Excipients: core made of polydimethylsiloxane elastomer; membrane made of polydimethylsiloxane elastomer containing colloidal anhydrous silicon dioxide 30-40% by weight.

Other components: T-shaped body made of polyethylene, containing 20-24 wt.%, thin thread of polyethylene brown, colored iron oxide black ≤1% wt.
Delivery device: conductor - 1 pc.

IUD (1) - sterile blisters (1) - cardboard packs.

Pharmacological action

The drug Mirena is an intrauterine therapeutic system (IUD) that releases levonorgestrel and has a mainly local gestagenic effect. Gestagen (levonorgestrel) is released directly into the uterine cavity, which allows its use in 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 the drug Mirena, observed morphological changes endometrium and weak local reaction for presence in the uterus foreign body. An increase in the viscosity of the cervical secretion prevents the penetration of sperm into the uterus. The drug Mirena prevents fertilization due to inhibition of sperm motility and function in the uterus and fallopian tubes. In some women, ovulation is also 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 may be observed. bloody discharge from the vagina. 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 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, submucosal or large interstitial node uterine fibroids, leading to deformation of the uterine cavity, adenomyosis), endometritis, extragenital diseases and conditions accompanied by severe hypocoagulation (for example, von Willebrand's 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 2 years, the effectiveness of the drug (reduction in menstrual blood loss) is comparable to surgical methods treatment (ablation or resection of the endometrium). A less favorable response to treatment is possible with menorrhagia caused by submucous myoma uterus. Reducing menstrual blood loss reduces the risk 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

Suction

After administration of Mirena, levonorgestrel begins to be immediately released into the uterine cavity, as evidenced by measurements of its concentration in 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 the blood plasma (the concentration of levonorgestrel in the endometrium exceeds its concentration in the blood plasma by more than 1000 times). The rate of release of levonorgestrel into the uterine cavity in vivo is initially approximately 20 mcg/day, and after 5 years it decreases to 10 mcg/day.

After administration of the drug Mirena, levonorgestrel is detected in the blood plasma after 1 hour. Cmax is achieved 2 weeks after administration of the drug Mirena. According to the decreasing release rate, the median plasma concentration of levonorgestrel in women 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, 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.

Distribution

Levonorgestrel binds nonspecifically to serum and specifically to sex hormone binding globulin (SHBG). 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 during the period of use of Mirena decreases, and the free fraction increases. The average apparent V d of levonorgestrel is about 106 L.

Body weight and plasma SHBG concentrations have been shown to influence systemic levonorgestrel concentrations. those. with low body weight and/or high concentration SHBG concentration is higher than levonorgestrel. 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 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 Mirena is used concomitantly with oral estrogen therapy, the plasma concentration of levonorgestrel, determined after 12 months, increases to approximately 478 pg/ml (25th-75th percentile: 341 pg/ml-655 pg/ml), which is due to induction SHBG synthesis.

Metabolism

Levonorgestrel is extensively metabolized. The main metabolites in blood plasma are unconjugated and conjugated forms of 3α, 5β-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.

Removal

The total plasma clearance of levonorgestrel is approximately 1 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. T1/2 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 action of Mirena, the effect of changes in systemic concentrations of levonorgestrel on the effectiveness of Mirena is unlikely.

Indications

- contraception;

- idiopathic menorrhagia;

— prevention of endometrial hyperplasia during estrogen replacement therapy.

Contraindications

— pregnancy or suspicion of it;

— inflammatory diseases of the pelvic organs (including recurrent ones);

- infections of the external genitalia;

— postpartum endometritis;

- septic abortion within the last 3 months;

- cervicitis;

- diseases accompanied by increased susceptibility to infections;

— cervical dysplasia;

- diagnosed or suspected malignant neoplasms uterus or cervix;

- progestogen-dependent tumors, incl. ;

— uterine bleeding unknown etiology;

- congenital and acquired anomalies of the uterus, incl. fibroids leading to deformation of the uterine cavity;

- acute liver diseases, liver tumors;

— age over 65 years (studies have not been conducted in this category of patients);

— increased sensitivity to the components of the drug.

With caution and only after consultation with a specialist should the drug be used for the following conditions:

— birth defects heart disease or heart valve disease (due to the risk of developing septic endocarditis);

- diabetes mellitus.

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;

- pronounced arterial hypertension;

— severe violations blood circulation, incl. stroke and myocardial infarction.

Dosage

Mirena is injected into the uterine cavity. Efficiency lasts for 5 years.

The in vivo release rate of levonorgestrel at baseline is approximately 20 mcg/day and decreases after 5 years to approximately 10 mcg/day. The average release rate of levonorgestrel is approximately 14 mcg/day for up to 5 years.

The Mirena IUD can be used in women receiving oral or transdermal replacement medications. hormone therapy(HRT) containing only estrogen.

With correct installation of the Mirena drug, carried out in accordance with the instructions for medical use, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using contraception during the year) is approximately 0.2% within 1 year. The cumulative rate, reflecting the number of pregnancies in 100 women using contraception for 5 years, is 0.7%.

Rules for using the IUD

Mirena is supplied in sterile packaging, which is opened only immediately before insertion of the IUD. 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 IUD

Before installation With Mirena, women should be informed about the effectiveness, risks and side effects this IUD. It is necessary to conduct a general and gynecological examination, including examination of the pelvic organs and mammary glands, as well as examination of a smear 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, a pelvic ultrasound should be performed before inserting the Mirena IUD. After a gynecological examination, a special tool, the so-called vaginal speculum, and treat the cervix with an antiseptic solution. Mirena is then injected into the uterus through a thin, flexible plastic tube. Particularly important correct location Mirena drug in the fundus of the uterus, which ensures a uniform effect of 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 inserting different IUDs into the uterus is different, special attention should be processed correct technique installation of a specific system. A woman may feel the insertion of the system, but it should not cause her severe pain. Before administration, if necessary, you can apply local anesthesia cervix.

In some cases, patients may have cervical canal stenosis. Excessive force should not be used when administering Mirena to such patients.

Pain, dizziness, sweating and pallor are sometimes experienced after insertion of the IUD. skin. 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 IUD is not positioned correctly. A gynecological examination must 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 placed in the uterine cavity within 7 days from the start of menstruation. Mirena can be replaced with a new IUD on any day of the menstrual cycle. The IUD can also be inserted 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 one birth. Installation of the Mirena IUD in the postpartum period should be performed 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.

For the prevention of endometrial hyperplasia when conducting HRT drugs containing only estrogen, in women with amenorrhea, Mirena can be installed at any time; in women with continued menstruation, installation is carried out in last days 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 5 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 childbearing age, IUD removal should be performed during menstruation, provided that the menstrual cycle is maintained. If the system is removed mid-cycle and the 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 an IUD may involve certain painful sensations and bleeding. The procedure may cause syncope due to a vasovagal reaction, bradycardia, or seizure in patients with epilepsy, especially in patients with a predisposition to these conditions or in cases of cervical canal 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.

Special groups of patients

Children and teenagers Mirena is indicated only after the onset of menarche (establishment of the menstrual cycle).

women over 65 years of age Therefore, the use of 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.

Mirena is contraindicated in women with acute diseases or liver tumors.

Mirena has not been studied in patients with impaired renal function.

Instructions for inserting an IUD

Installed only by a doctor using sterile instruments.

Mirena is supplied with a guidewire in a sterile package that must not be opened prior to installation.

Should not be re-sterilized. The IUD is intended for single use only. Do not use Mirena if the inner packaging is damaged or opened. You should not install Mirena after the month and year indicated on the package have expired.

Before installation, you should read the information on the use of Mirena.

Preparing for the introduction

1. Conduct 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.

2. The cervix should be visualized using speculums and the cervix and vagina should be completely cleaned with an antiseptic solution.

3. If necessary, you should use the help of an assistant.

4. The anterior lip of the cervix should be grasped with forceps. Straighten with careful traction with forceps 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.

5. Carefully moving the uterine probe through the cavity to the fundus of the uterus, you should 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 fibroma. 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. After this, all manipulations should be carried out using sterile instruments and wearing sterile gloves.

2. Move the slider forward at the very far position in order to retract the IUD into the guide tube.

The slider should not be moved downward, because this may cause Mirena to release 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, set top edge index ring in accordance with the distance measured by the probe from the external pharynx to the fundus of the uterus.

4. Continuing to hold the slider in the farthest position, the guidewire should be carefully advanced through the cervical canal into the uterus until the index ring is approximately 1.5-2 cm from the cervix.

The conductor should not be pushed forward with force. If necessary, the cervical canal should be expanded.

5. Holding the guide still, move the slider to the mark to open the horizontal shoulders of the Mirena drug. You should wait 5-10 seconds until the horizontal shoulders are completely opened.

6. Carefully push the guidewire in until the index ring will not touch the cervix. The Mirena drug should now be in the fundal position.

7. While holding the guide in the same position, release the Mirena drug, moving the slider as far as possible. Keeping the slider in the same position, carefully remove the conductor by pulling it. Cut the threads so that their length is 2-3 cm from the external os of the uterus.

If the doctor has doubts that the system is installed correctly, the position of the Mirena drug should be checked, for example, using ultrasound or, if necessary, the system should be removed and a new, sterile system should be inserted. The system should be removed if it is not completely in the uterine cavity. The removed system should not be reused.

Removing/replacing Mirena

Before removing/replacing Mirena, you should read the instructions for use of Mirena.

Mirena is removed by carefully pulling the threads grasped with forceps.

The doctor can determine new system Mirena immediately after removing the old one.

Side effects

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 using Mirena in combination with long-term replacement therapy With estrogens, in most women, cyclic bleeding gradually stops during the first year of use.

Below are data on the frequency of occurrence of unwanted drug reactions that have been reported with Mirena. Frequency determination adverse reactions: very often (≥1/10), often (from ≥1/100 to< 1/10), нечасто (от ≥1/1000 до <1/100), редко (от ≥1/10 000 до <1/1000) и с неизвестной частотой. Hежелательные реакции представлены по классам системы органов согласно MedDRA . Данные по частоте отражают приблизительную частоту возникновения нежелательных реакций, зарегистрированных в ходе клинических исследований препарата Мирена по показаниям "Контрацепция" и "Идиопатическая меноррагия" с участием 5091 женщин.

Adverse reactions reported during clinical trials of Mirena for the indication “Prevention of endometrial hyperplasia during estrogen replacement therapy” (involving 514 women) were observed with the same frequency, with the exception of cases indicated by footnotes (*, **).

Very often	Often	Uncommon	Rarely	Frequency unknown
From the immune system
				Hypersensitivity to the drug or component of the drug, including rash, urticaria and angioedema
Mental disorders
	Depressed mood Depression
From the nervous system
Headache	Migraine
From the digestive system
Abdominal/pelvic pain	Nausea
From the skin and subcutaneous tissues
	Acne Hirsutism	Alopecia Itching Eczema Skin hyperpigmentation
From the musculoskeletal system
	Back pain**
From 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 of the IUD (full or partial)		Uterine perforation (including penetration) ***
Laboratory and instrumental data
				Increased 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.”

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).

The following adverse reactions have been reported in connection with the Mirena insertion or removal procedure: pain during the procedure, bleeding during the procedure, vasovagal reaction associated with insertion accompanied by dizziness or fainting. The procedure can provoke an epileptic seizure in patients suffering from epilepsy.

Infection

Cases of sepsis (including group A streptococcal sepsis) have been reported following IUD insertion.

Overdose

With this method of administration, an overdose is impossible.

Drug interactions

It is possible to enhance the metabolism of gestagens with the simultaneous use of substances that are enzyme inducers, especially isoenzymes of the cytochrome P450 system involved in the metabolism of drugs, such as anticonvulsants (for example, 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 unknown, but it is assumed that it is not significant since Mirena has mainly local effects.

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 the start of 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 tolerance to, 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 Mirenane IUD should be considered the method of choice in young nulliparous women and should be used only if other effective methods of contraception cannot be used. The Mirenane IUD should be considered as the first choice method in postmenopausal women with severe uterine atrophy.

Available evidence suggests that 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 6 weeks after the start of the last menstrual period, pregnancy should be ruled out. Repeated pregnancy tests for amenorrhea are not necessary unless there are other signs of pregnancy.

When Mirena is used in combination with continuous estrogen replacement therapy, most women gradually develop amenorrhea over the first year.

Inflammatory diseases of the pelvic organs

The guide tube helps protect Mirena from infection during insertion, and the Mirena delivery device is specially designed to minimize the risk of infection. Inflammatory diseases of the pelvic organs in women using intrauterine contraception are often caused by sexually transmitted infections. Having multiple sexual partners has been found to be a risk factor for pelvic infections. Pelvic inflammatory diseases can have serious consequences: they 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) can develop after insertion of an IUD, although this is extremely rare.

In case of recurrent endometritis or inflammatory diseases of the pelvic organs, 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 severe 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 uterine muscles 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 notices 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 Mirena threads.

Perforation and penetration

Perforation or penetration of the body or cervix of the IUD occurs rarely, mostly during insertion, and 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 such as adhesions, peritonitis, intestinal obstruction, intestinal perforation, abscesses or erosions of adjacent internal organs may occur.

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 insertions in the Mirena cohort and 1.1 (95% CI: 0.7-1.6) per 1000 insertions in the copper IUD cohort.

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 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 with Mirena use is 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 was 0.02%. The absolute risk of ectopic pregnancy in women using Mirena is low. However, if a woman becomes pregnant while taking Mirena, the relative likelihood of an 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. An ultrasound can be performed to determine the correct placement of the system. If it is unavailable or unsuccessful, an x-ray examination is performed to determine the localization of the Mirena drug.

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.

Excipients contained in Mirena

The T-shaped base of the Mirena drug 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.

Impact on the ability to drive vehicles and operate machinery

Not observed.

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 developed 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, high blood pressure, or any other diseases or conditions listed in the Contraindications section.

What to do if you are planning a pregnancy or want to remove the drugMirenafor 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 7th 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 7 days before its removal. If you do not have menstruation while using Mirena, you should start using barrier methods of contraception 7 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 you use Mirena?

Mirena provides protection against pregnancy for 5 years, after which it should be removed. If you wish, you can install a new IUD after removing the old one.

Restoring fertility (Is it possible to get pregnant after stopping 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” discharge, 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 in their 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 is unlikely in women using Mirena, even if they are not menstruating.

If you have not had a period for 6 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 2-3 weeks after having an IUD inserted. If you experience severe pain or if pain continues for more than 3 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?

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 leaked out 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 period 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, because You may accidentally pull Mirena out of your uterus. If you cannot feel the threads, contact your doctor.

Pregnancy and lactation

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 pregnancy occurs in a woman while using Mirena, it is recommended to remove the IUD, because Any intrauterine contraceptive device left in situ increases the risk of spontaneous abortion and 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 her pregnancy and the IUD cannot be removed, the patient should be informed 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 the possible consequences of premature birth for the child. 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 the placental barrier. 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 congenital effects caused by the use of Mirena in cases of pregnancy continuing until delivery 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 is inserted.

It is believed that the use of Mirena 6 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 lactation.

Fertility

After Mirena is removed, women's fertility is restored.

For liver dysfunction

Contraindicated in acute liver diseases, liver tumors.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 30°C. Shelf life - 3 years.

Latin name: Mirena
ATX code: G02BA03
Active ingredient: Levonorgestrel
Manufacturer: Bayer Schering Pharma Oh,
Finland
Conditions for dispensing from a pharmacy: By prescription

Mirena is an intrauterine hormonal system that is installed for contraceptive or therapeutic purposes.

Indications for use

For contraception
In the presence of myomatous nodes and endometriosis
For the implementation of preventive therapy for hyperplasia of the endometrial layer of the uterus or for HRT (hormone replacement therapy).

Compound

One intrauterine system (IUD) contains 52 mg of the main hormonal component, represented by levonorgestrel. Additionally, a polydimethylsiloxane elastomer is present.

Medicinal properties

Mirena is a hormonal contraceptive that is inserted intrauterine and exhibits a local gestagenic effect. Thanks to levonorgestrel released from the IUD, the susceptibility of certain receptors in the endometrial layer of the uterus (estrogen and progesterone) is significantly reduced, this manifests itself in a pronounced antiproliferative effect.

The Mirena intrauterine device affects the inner layer of the uterus, so a slight local reaction to the existing foreign body may be observed. Under the influence of hormones, the mucous membrane lining the cervical canal thickens, which prevents male germ cells from entering the uterus, and the motor activity of sperm is inhibited. In some cases, suppression of ovulatory function is observed.

With Mirena, the nature of menstrual-like discharge also changes. During the first months of using this contraceptive, scanty bleeding occurs. Such periods with the spiral are normal. With the gradual development of the pharmacological action of the Mirena spiral, when the inhibition of proliferative processes reaches maximum levels, a period of minor bleeding is observed, which subsequently turns into amenorrhea or oligomenorrhea.

The Mirena spiral for fibroids has an anti-estrogenic effect, the therapeutic effect of the hormone-releasing IUD is manifested in a significant reduction in existing nodes, and the risk of developing serious health consequences is reduced. In addition, the fibroid will not grow in the future and surgical intervention will not be needed.

With adenomyosis, Mirena will help eliminate the disease.

The Mirena spiral for endometriosis will help normalize menstruation (the amount of blood released will decrease). During menstruation, the severity of painful prolapses will decrease.

After three months of using the intrauterine hormonal system, blood loss is significantly reduced, from approximately 62 to 94%, and after six months this figure is 71-95%. Due to the ability of the Mirena IUD to change the nature of menstrual-like discharge, the intrauterine hormonal device is used for medicinal purposes, namely for idiopathic menorrhagia. Such treatment can be compared even with conservative methods of treatment.

After the Mirena intrauterine device is installed, the release of its hormonal component is immediately observed and active absorption by the mucous membranes occurs. This effect is evidenced by the level of the hormone in plasma. The release rate of levonorgestrel after installation of the IUD is initially 20 mcg per day, and then gradually decreases, reaching 10 mg per day after five years.

When a synthetic hormone enters the general bloodstream, it binds with blood proteins: 40-60% with albumin, 42-62% with selective transporters of sex hormones. Approximately 1-2% of the total levonorgestrel dosage is recorded in the bloodstream in the form of the free steroid.

After installing the spiral inside the uterus, the active substance is detected in the blood after an hour, the highest level is observed after two weeks. As a result of numerous studies, it was concluded that the concentration of levonorgestrel is associated with a woman’s weight. With low body weight or with increased levels of selective sex hormone transporters, the level of the active component of the Mirena IUD in the blood is higher.

Levonorgestrel undergoes a transformation process involving a special isoenzyme. Unchanged synthetic gestagen is excreted only in small amounts. Its total clearance from blood plasma is 1 ml per minute per 1 kg of body weight. The half-life of metabolic products does not exceed 24 hours.

Release form

The Mirena system is represented by a milky-white hormonal-elastomer core, which is located on a T-shaped body, its coating is an opaque homogeneous membrane (regulates the release of gestagen). The T-shaped body with two arms has a loop to which a thread is attached, thanks to which the Mirena coil is removed.

The IUD is placed in a guide tube and is free of any visible impurities. Mirena is produced in sterile blister packs made of a special material called TYVEK or polyester. Inside one blister there is a Mirena intrauterine device, instructions are attached.

Mirena: detailed instructions

Price: from 11,495 to 14,294 rubles.

The Mirena IUD is placed inside the uterus, where it exhibits pharmacological effects over the next 5 years. The average rate of elimination of the synthetic hormone during the entire period of use is approximately 14 mcg per day.

If the intrauterine system was positioned correctly, the Pearl index usually does not exceed 0.2% over 12 months. The same figure over 5 years can reach 0.7%. Mirena exhibits a high degree of protection against pregnancy compared to conservative (barrier) contraceptive measures and the use of spermicides.

The contraceptive drug should be removed after 5 years; this procedure may be accompanied by unpleasant symptoms: pain in the lower abdomen, possible uterine bleeding (minor). In some cases, local anesthetics may be used to avoid severe consequences.

What to do before installing the spiral

Before a contraceptive device is installed, you should be examined by a gynecologist to exclude the presence of diseases that are contraindicated for use and pregnancy.

The specialist first determines the position of the uterus itself, as well as its approximate size, this will help to correctly position the IUD, which will facilitate the uniform effect of levonorgestrel on the endometrial layer, as well as ensure maximum effectiveness of the drug.

Procedure for installing an IUD

Installation of the contraceptive must be carried out according to the instructions:

Before installation, the cervix is visualized using gynecological mirrors.
Then the surface of the cervix is treated with antiseptics.
After the preliminary treatment has been done, the upper lip of the cervix itself is grabbed using forceps, the cervical canal is straightened, this position is fixed until the Mirena is installed.
It is necessary to gradually advance the uterine probe directly to the fundus of the uterus, and then identify the direction of this cervical canal and determine the depth of the uterine cavity. It is important to exclude some pathologies (synechia, septa, submucosal fibroma). If the cervical canal is quite narrow, the use of an anesthetic for its subsequent expansion may be indicated.
The integrity of the package with the spiral is checked.
The blister pack is opened and the Mirena hormonal coil is removed. Now you can install this drug.
After this, the existing slider is moved to the far position, thus the entire system is drawn into the conductor tube itself and transformed into a small stick.
It is necessary to hold the slider in the same position, then the upper part of the index ring is installed, taking into account the measurements taken to the very bottom of the uterus.
The guide will need to be advanced through the cervical canal until the ring is placed 1.5-2 cm from the cervical area.
When the Mirena hormonal coil takes the desired position, you can move the slider to the indicated mark so that the shoulders open. After 5-10 seconds. The installation of the Mirena coil is almost complete; it has acquired a T-shape.
Then the conductor moves to the fundal position, while the contact of the index ring itself with the neck will be felt.
Now you will need to briefly fix the conductor in the same position, releasing the drug from the lowest position of the slider. Next you will need to remove the conductor.
The final stage of the installation procedure is cutting the threads to a minimum length (no more than 2-3 cm), taking into account the distance from the outer pharynx.
After this, an ultrasound scan should be performed, which will confirm the correctness of the procedure. The doctor who installs the IUD must tell you what symptoms are a reason to see a doctor.

Removal of the intrauterine system

If an intrauterine contraceptive device was installed more than 5 years ago, it is necessary to resort to its removal, since the contraceptive effect is significantly reduced. In addition, with long-term use of intrauterine devices, inflammatory diseases of the internal genital organs can develop.

The IUD is removed in compliance with aseptic rules. It is pulled out using a thread that is grabbed with gynecological forceps. It is also possible to use a traction hook (if the threads are not visible), in some cases it will be necessary to expand the cervical canal. Will it hurt during removal, is bleeding possible after it, you should ask your gynecologist

After removing the drug from the uterine cavity, it will be necessary to carefully examine it and evaluate its integrity. In some cases, complications may occur (parts of the IUD may remain in the uterus), and gynecological intervention is inevitable.

Use during pregnancy and pregnancy

The IUD should not be used during pregnancy.

Is it possible to get pregnant with the IUD? Yes, this is not excluded. If the Mirena IUD is installed and pregnancy occurs, it is necessary to remove it as soon as possible, since the use of contraceptive IUDs increases the likelihood of miscarriage or premature birth.

It is worth noting that removing these contraceptives or probing the uterus can also lead to miscarriage. If the system cannot be removed without consequences, it is worth considering the option of terminating the pregnancy. If a woman becomes pregnant and does not want to have an abortion and does this in order to save the life of the child, it is worth informing her about the possible consequences that may occur if the IUDs are not removed. Pregnancy with the Mirena spiral should proceed under the strict supervision of a gynecologist. If uncharacteristic symptoms appear (pain, fever) and there is heavy discharge, you should immediately consult a doctor.

During use of the drug, a teratogenic effect on the fetus is possible, and congenital malformations are possible.

Levonorgestrel, which contains the Mirena hormonal spiral, enters mother's milk in low doses, but this in no way affects the growth and development of a child on breastfeeding. This remedy with medicinal properties will reliably protect against unwanted pregnancy.

Contraindications

Excessive sensitivity to components
Suspicion of pregnancy
Chronic inflammatory gynecological ailments
Infection of the genitourinary system
Development of endometritis after childbirth
Previous septic abortion (occurred within the previous 3 months)
Diagnosing cervicitis
Cervical dysplasia
Oncological processes occurring in the internal genital organs
Hormone-dependent neoplasms
Frequent uterine bleeding of unknown origin
Abnormalities of the uterus, including fibroadenoma, which provoke deformation of its cavity
Liver pathologies.

Precautions

After installing Mirena, the next examination must be completed after 4-12 weeks, each subsequent one after a year. If necessary (if indicated), a full examination by a gynecologist should be carried out regularly.

Levonorgestrel, even in small amounts, can lead to increased glucose tolerance, so a woman with diabetes should regularly monitor her sugar levels. In case of heart defects, installation and removal of the coil must be carried out with the parallel use of antibacterial drugs. Thus, it will be possible to prevent the occurrence of septic endocarditis.

Possible complications

Complications may develop after the IUD is installed.

Perforation and penetration of the uterus

These phenomena are extremely rare. Perforation or penetration of the IUD into the walls of the uterus is usually recorded precisely when the doctor installs the IUD. Such complications are most often diagnosed after a recent delivery, during the lactation period, or with an atypical location of the uterus itself. In case of perforation and penetration, it will be necessary to remove the system; this should be done as soon as possible to prevent the development of pathological conditions.

Ectopic pregnancy

This complication is rare; if the diagnosis is confirmed, surgery should be performed immediately. Ectopic pregnancy can be recognized by paroxysmal pain in the lower abdomen, as well as symptoms of internal bleeding (lethargy, pale skin, severe dizziness, increased or weakened pulse). The risk of developing such a complication increases if there is a history of infectious and inflammatory gynecological diseases.

Infectious and inflammatory diseases

There is a high probability of developing such complications during the first month of using the IUD.

The risk of infection increases when changing sexual partners.

In case of chronic infectious and inflammatory diseases and frequent relapses, it is not recommended to install a spiral.

Expulsion IUD

The helix falling out is a common occurrence. In this regard, a woman should check for the presence of threads after each menstrual-like bleeding (it is during menstruation that the IUD most often falls out). Signs of the onset of expulsion are pain in the abdominal area, as well as the onset of uterine bleeding. It will be necessary to remove the IUD if it falls out, as its contraceptive effect is reduced. What is best to use for contraceptive purposes should be checked with your doctor.

Functional cysts

The pathology usually occurs without any symptoms; often the presence of cysts can be indicated by pain and heaviness in the abdomen during sexual intercourse. Typically, cysts resolve on their own without treatment, but if this does not happen, an ultrasound scan will be required.

Many women are interested in whether amenorrhea can develop. This phenomenon is not uncommon and occurs within six months after the installation of the IUD. If monthly menstruation disappears, pregnancy should be ruled out. The menstrual cycle is restored after Mirena is removed.

Cross-drug interactions

Increased biochemical transformation of levonorgestrel is caused by some enzyme inducers, anticonvulsants, and antibacterial agents.

Side effects

Among the most common side effects are changes in the cyclicity of menstrual-like bleeding. By the end of the first month of use, amenorrhea or infrequent bleeding may develop.

Violations on the part of the following may also be observed:

CVS: sharp rise in blood pressure
Immune system: rash development angioedema
NS: migraine-like headaches, depression
Reproductive system: tenderness and engorgement of the mammary glands, uncharacteristic discharge from the genital tract, vulvovaginitis, cystic changes in the ovaries, prolapse of the IUD, uterine perforation
Dermatological manifestations: acne, alopecia, development of hirsutism
Gastrointestinal tract: epigastric pain, very severe nausea.

If you have the described side symptoms, your doctor may advise you to remove the IUD and switch to birth control pills, after taking a short break. When taking the tablets, your general condition will noticeably improve and most adverse reactions will disappear.

Overdose

Didn't register.

Storage conditions and shelf life

Mirena should be stored in its original packaging away from direct sunlight at a temperature of no more than 30 C. The drug is valid for 3 years from the date of manufacture.

Analogs

Jaydess

Bayer Schering Pharma, Germany

Price from 4340 to 5255 rub.

Jaydess - IUD, is an analogue of Mirena, as it contains the same hormonal component - levonorgestrel. Which of these drugs is best should be checked with your doctor. Jaydess is used as both a therapeutic and a contraceptive drug.

Pros:

Releases small amounts of hormone
Can be used for hepatitis B
Reliable modern contraceptive.

Cons:

Placed for three years
Difficult to find in the pharmacy chain.