Mirena severe rashes on the body. Hormonal IUD: pros and cons

In gynecological practice, intrauterine devices (IUDs) have been used for a long time. They are mainly composed of copper and silver. Currently, the latest generation hormonal IUD, Mirena, has become particularly popular. Based on clinical trial data, we can conclude: the IUD has established itself as a reliable contraceptive and therapeutic agent, which distinguishes it from all other IUDs.

Before purchasing a hormonal system, which is not cheap, a woman must weigh the pros and cons, naturally, if the IUD was suggested to be installed by a doctor. Such a device is placed only if indicated, due to the fact that it not only protects against unwanted pregnancy, but also performs a therapeutic function.

Therefore, only after undergoing a comprehensive diagnostic examination is the issue of installing or prohibiting the hormonal system decided. Some diseases, unfortunately, are an obstacle to installing an IUD.

The opinions of many specialists in the field of gynecology agree that Mirena is one of the best contraceptives and therapeutic and prophylactic agents used for the treatment of gynecological diseases, which acts directly in the uterus.

Levonorgestrel is released daily from the intrauterine system into the uterine cavity in microdoses. The medicine practically does not enter the systemic bloodstream, but acts only inside the uterus, thinning the endometrium.

The hormonal IUD has been installed for 20 years, and during this time many reviews from practicing doctors have been collected about the advantages and disadvantages of this method of contraception. Let's take a closer look at them.

Advantages of using Mirena according to doctors' reviews

Practicing gynecologists systematized observations of patients using the Mirena IUD and identified the main advantages:

• long-term use of the spiral (5 years);
• the contraceptive effect occurs on the first day of installation;
• the degree of protection against unwanted pregnancy is 99–100%, which does not require additional protective equipment;
• after removing the IUD, reproductive function is quickly restored; a woman can become pregnant already in the first menstrual cycle;
• the IUD can be removed at any time at the woman’s request (the procedure is painless);
• during intimate relationships, the IUD does not cause discomfort (if desired, a woman can hide the presence of an IUD from her partner);
• the quality of sexual life improves (the fear of getting pregnant during intercourse goes away);
• protection of the pelvic organs from inflammatory processes by increasing the viscosity of mucus in the cervical canal area;
• against the background of the spiral, it is allowed to take other medications and perform surgical operations of various profiles;
• does not affect appetite;
• the pain of menstruation decreases;
• blood loss is sharply reduced, until the discharge completely disappears;
• high effectiveness of IUDs in the treatment of endometrial hyperplasia, uterine fibroids and endometriosis;
• the possibility of using the IUD in women for whom other methods of contraception are contraindicated for medical reasons;
• in some cases it helps to avoid gynecological operations;
• protection against the development of endometrial cancer processes.

Disadvantages of Mirena according to doctors

Usually, side effects appear during the first time after insertion of the IUD. More often this period ranges from several months to six months. The body is adapting to the spiral. Any foreign body must “make friends” with the body, and then the negative symptoms gradually disappear.

In the first year of use, the spiral sometimes tends to fall out (no more than 7% of cases). The reason for this may be heavy periods, which have not yet had time to normalize under the influence of levanorgestrel.

In the first months, prolonged spotting is observed due to thinning of the endometrium (inner layer of the uterus). Therefore, many women begin to panic and cannot come to terms with their new condition. This leads to psychological problems: nervousness and irritability appear.

In rare cases (no more than 5%), bleeding may occur when installing the IUD due to damage to the cervix or its body. This is due to the low qualifications of the doctor installing the system.

There are complaints of stitching or aching pain in the uterine area. This condition occurs due to displacement of the IUD or individual hypersensitivity. In such cases, removal of the spiral is required.

Often, Mirena causes headaches, migraines, depression, decreased libido and back pain, similar to sciatica. There are complaints of hair loss, acne on the face and back. Allergic reactions and eczema occur very rarely.

The hormonal IUD cannot protect against sexually transmitted infections, and in some cases it itself provokes an inflammatory process in the uterus. This happens with individual intolerance and if the spiral was installed without following the rules of asepsis and antisepsis.

Important! If there are pre-tumor processes in any organs, the spiral cannot be used.

According to doctors, the IUD should only be installed in women who have given birth and are over 25 years old. In general, Mirena shows high effectiveness, and many women have no side effects at all. This is an excellent method of stabilizing proliferative processes, especially in premenopause, when there is a high risk of developing cancer processes in the female genital area. Therefore, today Mirena is considered the best therapeutic contraceptive!

Modern methods of contraception allow a woman to prevent the onset of an unplanned pregnancy and thereby avoid problems associated with it. Among the variety of modern contraceptives, the Mirena intrauterine hormonal device can be distinguished. In addition to its main purpose, the Mirena spiral can be prescribed as a treatment for certain diseases of the female genital area.

The Mirena intrauterine device has the form of a T-shaped frame, from which (after its insertion into the uterine cavity) a certain amount of the hormone levonorgestrel, the main component of any new generation contraceptive, enters the woman’s blood every day. This intrauterine contraceptive device has a predominantly local effect. The Mirena spiral is installed for five years, after which it is replaced with a new one.

Mechanism of action.
The principle of operation of the hormonal IUD is similar to the action of combined oral contraceptives, hormonal implants and contraceptive injections. The action is aimed at blocking the process of ovulation (the release of an egg from the ovary) and delaying the development of the uterine mucosa, thereby complicating the implantation of the fertilized egg.

Efficiency of the method.
The Mirena spiral is a reliable and effective means of protection against unwanted pregnancy, with a long period of use. For every thousand women who started using this hormonal IUD, there were only two cases of unplanned pregnancy during the first year.

Fertility is restored literally immediately after the IUD is removed. Very rarely, the ability to become pregnant is restored in women over a longer period after stopping use of the product (within three to six months).

It should be noted that, like any other means of hormonal contraception, the Mirena spiral is not able to protect a woman from sexually transmitted diseases (STDs).

Side effects.
Usually, the side effects of the Mirena hormonal device appear in the first months after its introduction. Gradually they all disappear and do not require additional treatment. Most often, after starting to use it, women notice the following side effects:

• reduction in the duration of menstrual bleeding (may be completely absent), as well as a decrease in its intensity;
• the occurrence of acne;
• headache;
• nausea;
• weight gain;
• dizziness;
• frequent mood changes;
• ovarian cysts;
• increased sensitivity of the mammary glands.

Regarding the duration of menstruation, it should be noted that everything will fall into place after stopping the use of this contraceptive.

The impact of the intrauterine system on women's health.
The Mirena spiral is an excellent means of preventing pelvic diseases of an inflammatory nature, iron deficiency anemia, in addition, its use significantly reduces the risk of developing endometriosis, alleviates painful menstruation (algomenorrhea), and can also reduce the size of myomatous nodes.

The cost of the Mirena hormonal device varies between nine and eleven thousand rubles, depending on the region. When compared with birth control pills, on which you will have to spend an average of seven hundred to a thousand rubles monthly (for five years), its use is more profitable from an economic point of view.

Contraindications.
In the presence of severe diseases, chronic infections or malignant neoplasms, the use of the Mirena intrauterine device should be agreed with specialists.
Other contraindications to the use of this method of contraception are:

• hypersensitivity to the components of the drug;
• history of deep vein thrombosis of the lower extremities;
• malignant neoplasms of the uterus or cervix;
• previous treatment for breast cancer;
• diseases that occur with increased susceptibility to infections;
• the presence of inflammatory diseases of the pelvic organs;
• uterine anomalies (congenital and acquired);
• pregnancy or suspicion of it;
• presence of urinary tract infections;
• postpartum endometritis;
• cervical dysplasia;
• septic abortion within the last three months (serious uterine infection during or shortly before or after the abortion);
• uterine bleeding of unknown cause;
• cervicitis;
• acute liver diseases (severe cirrhosis, jaundice, hepatitis) and liver tumors.

Conditions for introducing a hormonal IUD into the uterine cavity.
Only an experienced doctor who has performed this procedure more than once should install intrauterine devices. For women of childbearing age, the Mirena spiral as a means of contraception is introduced into the uterine cavity no later than within seven days from the start of the menstrual cycle. The introduction of a contraceptive at a later date is carried out only after confirmation that the woman is not pregnant, and she is recommended to additionally use barrier methods of contraception (condom) for a week. After the expiration date, the coil can be replaced with another one on any day of the cycle.

The installation of an intrauterine device after childbirth is carried out no earlier than six weeks, this is exactly the time required for the involution of the uterus. If there is a decrease in the rate of uterine contraction after childbirth or subinvolution, it is necessary to exclude the development of postpartum endometritis and postpone the insertion of the IUD until the uterus is completely restored.

It is recommended to install the IUD into the uterine cavity after an artificial or spontaneous abortion in the first and second trimester after seven days, if there are no signs of infection.

If the installation of an intrauterine contraceptive is difficult, or very severe pain or bleeding is observed during or after the procedure, then in this case a physical and ultrasound examination is necessary to exclude perforation (mechanical damage) of the uterus.

Removing Mirena.
The specialist removes the intrauterine device from the uterine cavity (after its expiration date) on any day of menstruation (subject to a regular cycle), by grasping its threads with forceps and gently pulling. If further contraception is necessary, the woman is given a new IUD on the same day; there is no need to use additional contraceptives. If the IUD is not removed during menstruation, then a week before this procedure the woman should use additional contraception. If amenorrhea is present, a woman should use barrier contraception a week before removal of the intrauterine device and before the onset of menstruation.

After removing the Mirena intrauterine system, the doctor must make sure of its integrity, since if difficulties arise during its removal, there have been cases of the hormonal-elastomer core slipping onto the horizontal arms of the T-shaped body, as a result of which they “sank” inside the core. After confirming the integrity of the spiral, no additional examinations or interventions are required. Restrictors located on the horizontal arms usually prevent the core from being completely separated from the T-shaped body.

Today it has been scientifically proven that it is possible to safely use two or more intrauterine systems in a row.

Use of Mirena during pregnancy and breastfeeding.
Hormonal contraceptives, including the Mirena intrauterine device, should not be used during pregnancy or if pregnancy is suspected. If pregnancy occurs while using the intrauterine system (which is possible if the syralium falls out), the system should be removed, as it significantly increases the risk of spontaneous abortion and premature birth.

Careless removal of the IUD or probing of the uterus can also cause spontaneous abortion. If it is not possible to remove the contraceptive carefully, the question arises about the advisability of artificial termination of pregnancy. If the woman does not want to have an abortion in this case, she is informed about the risks and likely consequences of premature birth for the child. In the future, such a pregnancy will require careful monitoring. The patient will also need to inform doctors if symptoms appear that may complicate pregnancy (including colicky abdominal pain combined with fever).

It is believed that the use of Mirena six weeks after birth does not affect the growth and development of the child. Monotherapy with gestagens does not affect the quality and quantity of breast milk.

Complications.
The use of this intrauterine contraceptive very rarely leads to problems and complications. If you experience any unusual symptoms, it is important to contact your doctor immediately to avoid further complications.

When using the Mirena hormonal device, complications may arise in the form of intrauterine system prolapse, uterine perforation, infection, and ectopic pregnancy.

Loss (expulsion).
The IUD may partially or completely fall out of the uterine cavity. The risk of this phenomenon is very high in nulliparous women using this method of contraception during the first few months of use. However, there are cases of system rejection at a later stage of use. In order to notice the loss in time, you need to check them every menstruation when changing pads or tampons.

If you notice prolapse, you must additionally use a condom and immediately contact your gynecologist. In case of partial prolapse, the intrauterine system is completely removed.

Perforation.
It is very rare, but there are still cases when the spiral pierces the wall of the uterus during insertion. Usually this fact is identified immediately and corrected. If this was not noticed, the spiral may enter other parts of the pelvis and damage internal organs. In this case, surgical intervention is required to remove it.

Infection.
The use of intrauterine contraceptive devices is accompanied by some risk of pelvic infection, but the risk of this decreases significantly twenty days after its insertion into the uterine cavity. Pelvic infections can be caused by bacteria that enter the uterus during insertion of the IUD. The development of infection usually occurs within three weeks after installation. If infection is observed after the specified time, then infection is more likely to have occurred through contact with a sick partner.

Scientific studies have proven that the Mirena coil does not contribute to the development of the pelvic organs or infertility.

The Mirena intrauterine therapeutic system is a white or almost white hormonal-elastomer core located on a T-shaped body and covered with an opaque membrane, which serves as a kind of regulator for the release of the active ingredient. The T-shaped body has a loop at one end with an attached thread to remove the coil and two arms. The Mirena system is placed in a guide tube and is free of visible impurities. The drug is supplied in sterile blisters made of polyester or TYVEK material in the amount of 1 piece.

pharmachologic effect

The intrauterine system, or simply the Mirena IUD, is a pharmaceutical drug based on levonorgestrel , which, gradually released into the uterine cavity, has local gestagenic effect . Thanks to the active component of the therapeutic agent, the sensitivity of estrogen and progesterone receptors of the endometrium is reduced, which is manifested in a strong antiproliferative effect.

There are morphological changes in the inner lining of the uterus and a weak local reaction to a foreign body in its cavity. The mucous membrane of the cervical canal becomes significantly denser, which prevents the penetration of sperm into the uterus and inhibits the motor abilities of individual sperm. In some cases, suppression of ovulation is also noted.

The use of Mirena gradually changes the character menstrual bleeding . In the first months of using an intrauterine device, due to inhibition of endometrial proliferation, an increase in spotting and bloody discharge from the vagina may be observed. As the pharmacological effect of the therapeutic agent develops, when the pronounced suppression of proliferative processes reaches a maximum, a period of scanty bleeding begins, which often transforms into oligo- And amenorrhea .

3 months after starting to use Mirena, menstrual blood loss in women is reduced by 62-94%, and after 6 months - by 71-95%. This pharmacological ability to change the nature of uterine bleeding is used to treat idiopathic menorrhagia in the absence of hyperplastic processes in the membranes of the female genital organs or extra genital conditions, an integral part of the pathogenesis of which is a pronounced hypocoagulation , since the effectiveness of the drug is comparable to surgical treatment methods.

Pharmacodynamics and pharmacokinetics

Once the intrauterine system is installed, the pharmaceutical drug begins to act immediately, which is manifested in the gradual release levonorgestrel and its active absorption, which can be judged by changes in its concentration in the blood plasma. Speed The release of the active component is initially 20 mcg per day and gradually decreases, reaching 10 mcg per day after 5 years. Hormonal IUD Mirena installs high local exposure , which provides a concentration gradient of the active substance in the direction from the endometrium to the myometrium (the concentration in the walls of the uterus varies more than 100 times).

Entering the systemic circulation, levonorgestrel contacts whey proteins blood: 40-60% of the active component nonspecifically combines with , and 42-62% of the active component – ​​specifically with selective sex hormone carrier SHBG . About 1-2% of the dosage is present in the circulating blood as free steroid. During use of a therapeutic agent, the concentration of SHBG decreases and the free fraction increases, which indicates the nonlinearity of the pharmacokinetic ability of the drug.

After insertion of the Mirena IUD into the uterine cavity, levonorgestrel in blood plasma is detected after 1 hour, and the maximum concentration is reached after 2 weeks. Clinical studies have proven that the concentration of the active component depends on the woman’s body weight - with low weight and/or with a high concentration of SHBG, the amount of the main component in the plasma is higher.

Levonorgestrel metabolized with the participation isoenzyme CYP3A4 to the final metabolic products in the form of conjugated and non-conjugated 3-alpha and 5-beta tetrahydrolevonorgestrel , after which it is excreted through the intestines and through the kidneys with an excretion coefficient of 1.77. In its unchanged form, the active component is eliminated only in trace amounts. The total clearance of the biological substance Mirena from blood plasma is 1 ml per minute per kilogram of weight. The half-life is about 1 day.

Indications for use

• contraception;
• idiopathic menorrhagia;
• preventive treatment endometrial hyperplasia during hormone replacement therapy.

Mirena spiral - contraindications

Absolute contraindications for the use of hormonal IUDs:

• pregnancy ;
• inflammatory diseases of the pelvic organs;
• postpartum ;
• infectious process in the lower parts of the genitourinary system;
• history of septic abortion over the past three months;
• malignant neoplasms uterus or cervix;
• female reproductive system;
• uterine bleeding of unknown origin;
• hormone-dependent tumor neoplasms;
• congenital or acquired anomalies of the anatomical and histological structure of the uterus;
• acute liver diseases;
• increased sensitivity to the pharmacological components of the intrauterine device.

Pathological conditions that may complicate the use of an intrauterine device with levonorgestrel :

• postpartum period from 48 hours to 4 weeks;
• deep vein thrombosis;
• benign trophoblastic disease ;
• breast cancer present or in history within the last 5 years;
• high probability of sexually transmitted infectious diseases;
• active liver disease (eg spicy , decompensated and so on).

Side effects of Mirena

Menstrual cycle changes

Side effects of the IUD should start with changes in the nature and cyclicity of menstrual bleeding , because they occur much more often than other adverse effects of therapeutic measures. Thus, the duration of bleeding increases in 22% of women, and irregular uterine hemorrhages observed in 67%, when considering the first 90 days after installation of the Mirena drug. The frequency of these phenomena gradually decreases, since the hormonal spiral releases less biologically active substance over time and by the end of the first year it is 3% and 19%, respectively. However, the number of manifestations of other menstrual cycle disorders increases - by the end of the first year develops in 16%, and rare bleeding in 57% of patients.

Other side effects

• From the outside immune system: skin rash and , , .
• From the outside nervous system: headache, , depressed mood up to .
• Side effects from the reproductive system and mammary glands: vulvovaginitis , discharge from the genital tract, pelvic infections, , pain in the mammary glands, expulsion intrauterine device, , perforation of the uterus.
• From the outside gastrointestinal tract: abdominal pain, nausea.
• Dermatological disorders: , , .
• From the outside of cardio-vascular system: increased blood pressure.

Mirena intrauterine device: instructions for use (Method and dosage)

General provisions for using the drug

The contraceptive Mirena is injected directly into the uterine cavity, where it exerts its pharmacological effects for 5 years. Release speed the active hormonal component is 20 mcg per day at the beginning of the use of the intrauterine device and gradually decreases to a level of 10 mcg per day after 5 years. Average elimination rate levonorgestrel throughout the entire therapeutic course is about 14 mcg per day.

There is a special contraceptive effectiveness indicator , which reflects the number of pregnancies in 100 women while using a contraceptive. If installed correctly and all rules for using the intrauterine device are followed, Pearl index for Mirena is about 0.2% for 1 year, and the same figure for 5 years is 0.7%, which expresses the incredibly high effectiveness of this method of contraception (for comparison: condoms have a Pearl index of 3.5% to 11 %, and for chemicals such as spermicides - from 5% to 11%).

Installation and removal of the intrauterine system may be accompanied by pain in the lower abdomen and moderate bleeding. Also, manipulation can cause fainting due to a vascular-vagal reaction or a convulsive seizure in patients , therefore, the use of local anesthesia of the female genital organs may be required.

Before installing the drug

It is recommended that the IUD be placed only doctor , who has experience with this type of contraception, since mandatory aseptic conditions and appropriate medical knowledge of female anatomy and the operation of the pharmaceutical drug are required. Immediately before installation it is necessary to carry out general and gynecological examination , in order to eliminate the risks of further use of contraception, the presence pregnancy and diseases that act as contraindications.

The doctor must determine the position of the uterus and the size of its cavity, since the correct location of the Mirena system ensures a uniform influence of the active component on endometrium , which creates conditions for its maximum efficiency.

Instructions for Mirena for medical personnel

Visualize the cervix using gynecological mirrors, treat it and the vagina with antiseptic solutions. Grasp the upper lip of the cervix with forceps and, using gentle traction, straighten the cervical canal, secure this position of the medical instruments until the end of the procedure for installing the intrauterine device. Slowly moving the uterine probe through the organ cavity to the fundus of the uterus, determine the direction of the cervical canal and the exact depth of the cavity, in parallel, excluding possible anatomical septa, synechiae, submucosal fibroma or other obstacles. If the cervical canal is narrow, it is recommended to use local or conduction anesthesia to widen it.

Check the sterile packaging with the drug for integrity, then open it and remove the intrauterine device. Move the slider to the farthest position so that the system is pulled inside the conductor tube and takes on the appearance of a small stick. Holding the slider in the same position, set the upper edge of the index ring in accordance with the previously measured distance to the fundus of the uterus. Carefully advance the guidewire through the cervical canal until the ring is approximately 1.5-2 cm from the cervix.

After reaching the required position of the spiral, slowly move the slider until the horizontal arms are fully opened and wait 5-10 seconds until the system acquires a T-shape. Advance the guidewire to the fundal position, as evidenced by complete contact of the index ring with the cervix. While holding the conductor in this position, release the drug using the lowest position of the slider. Carefully remove the conductor. Cut the threads to a length of 2-3 cm, starting from the external os of the uterus.

It is recommended to confirm the correct position of the intrauterine device using ultrasound immediately after the procedure for installing Mirena. Repeated examination is performed after 4-12 weeks, and then once a year. If there are clinical indications, a gynecological examination and verification of the correct position of the spiral using functional laboratory diagnostic methods should be carried out regularly.

Removing the intrauterine device

Mirena should be removed after 5 years after installation, since the effectiveness of the therapeutic agent is significantly reduced after this period. The medical literature even describes cases of the adverse effects of an intrauterine device not removed in a timely manner with the development of inflammatory diseases of the pelvic organs and some other pathological conditions.

To extract the drug requires strict adherence to aseptic conditions. Removing Mirena involves carefully pulling the threads grasped with special gynecological forceps. If the threads are not visible and the intrauterine device is located deep in the organ cavity, then a traction hook can be used. It may also be necessary to dilate the cervical canal.

After removal Mirena preparation should inspect the system for its integrity, since in some situations the hormonal-elastomer core may separate or slip onto the shoulders of the T-shaped body. Pathological cases have been described in which such complications of intrauterine device removal required additional gynecological intervention.

Overdose

When used correctly and following all the rules for placing an intrauterine device, an overdose of a pharmaceutical drug impossible .

Interaction

Pharmaceutical enzyme inducers, especially biological catalysts from the system cytochrome P 450 , which are involved in the metabolic degeneration of drugs such as anticonvulsants ( , Phenytoin , ) And ( and others), enhance biochemical transformation gestagens . However, their influence on the effectiveness of Mirena is insignificant, since the main point of application of the therapeutic abilities of the intrauterine device is the local effect on the endometrium.

Terms of sale

Available in pharmacy kiosks with a prescription.

Storage conditions

The intrauterine hormonal device should be stored in sterile packaging out of the reach of young children and protected from direct sunlight. The proper temperature should not exceed 30 degrees Celsius.

Best before date

special instructions

Mirena hormonal device for uterine fibroids

(other names - fibroids or leiomyoma ) is a benign tumor that grows from the muscular layer of the uterus (myometrium) and is one of the most common gynecological diseases. Pathological focus is a knot of chaotically woven smooth muscle fibers from several millimeters to several centimeters. To treat this nosological entity, surgical intervention is usually used, but a conservative therapy regimen has now been developed.

The drug of choice is hormonal agents with a preferred local type of interaction, therefore the Mirena intrauterine device is a kind of gold standard for the sanitation of uterine fibroids.

Antiestrogenic effect is implemented in reducing the size of pathological nodes, preventing possible complications and reducing the volume of surgical intervention in order to preserve the maximum physiological structure of the uterus and make future pregnancies possible.

Mirena spiral for endometriosis

– a pathological condition when the cells of the inner layer of the uterus grow outside it. Histological structures have receptors for female sex hormones, which causes the same changes as in the normal endometrium, manifested by monthly bleeding, in response to which an inflammatory reaction develops.

Gynecological disease is common in women of reproductive age and, in addition to painful sensations, can lead to a frequent complication of endometriosis, which is why it is so important to diagnose the pathological condition in a timely manner and correctly approach it. Of course, treatment for endometriosis can be a surgical intervention with minimally invasive access and a small number of side effects, but it is much preferable to choose conservative treatment methods.

The Mirena intrauterine device is an effective remedy for eliminating endometriosis for several reasons:

• the effect of the drug, proven by practical research, is manifested by inhibition of the growth of pathological foci, a decrease in their size and gradual resorption;
• fewer side effects compared to other pharmaceuticals;
• relief of pain that inherently accompanies the problem of endometriosis;
• there is no need to take daily oral tablets or injections;
• normalization of the menstrual cycle;
• there is no need for contraception.

Intrauterine device for endometrial hyperplasia

Endometrial hyperplasia – this pathological condition is extremely similar to endometriosis, as it represents excessive growth and thickening of the mucous membrane of the female genital organs. The difference lies in the correct anatomical location of the histological structures, which only changes the symptoms and possible complications, but does not eliminate them.

The nosological unit can be recognized by heavy and prolonged bleeding during menstruation or uterine hemorrhages not related to the cycle, absent ovulation and the inability to implant an embryo into the altered endometrium, which is a manifestation of an increased level of estrogen in the body. The etiological treatment of this problem, aimed at eliminating the immediate cause, is hormonal agents with a pronounced antiestrogenic effect.

Most gynecologists prefer to use the Mirena intrauterine system because of the reliability of its pharmacological action, ease of daily use, which does not require additional medical knowledge and relative cheapness compared to other therapeutic agents, because the use of Mirena does not involve everyday expenses for oral tablets or injections.

Pregnancy after using the Mirena intrauterine device

Since the contraceptive has predominantly local pharmacological effects, complete restoration of all physiological indicators after removal of the drug it occurs quite quickly. Within a year after the evacuation of the system, the frequency of planned pregnancies reaches 79.1-96.4%. The histological state of the endometrium is restored after 1-3 months, and the menstrual cycle is completely rebuilt and normalized within 30 days.

Analogs

There are several pharmaceutical drugs with the same ATC code and a similar composition of active ingredients: Jaydess , , Evadir , however, only Jaydess can rightfully be called an analogue, since the drug is represented by an intrauterine system based on levonorgestrel with a lower dosage, and therefore designed for only three years of constant use.

With alcohol

The pharmaceutical drug has a pronounced local therapeutic effect and enters the systemic bloodstream of the female body in small quantities, therefore it does not interact with the components of alcoholic beverages, however, their dosed use is recommended so as not to cause other side effects or adverse consequences.

During pregnancy and lactation

The use of the Mirena intrauterine device is contraindicated in pregnancy or suspicion of it, since any intrauterine contraceptive increases the risk spontaneous abortion And premature birth. Removal or probing of the system can also lead to unplanned evacuation of the fetus from the uterine cavity. If careful removal of the contraceptive is not possible, the appropriateness of medical abortion should be discussed if indicated.

If a woman wants to continue her pregnancy, then, first of all, the patient should be fully informed about the possible risks and adverse consequences for both her body and the child. In the future, you should carefully monitor the course of pregnancy and be sure to exclude ectopic implantation using reliable diagnostic methods.

Due to topical use of hormonal contraceptives, there is a possibility virilizing effect on the fetus However, due to the high effectiveness of the pharmaceutical drug Mirena, clinical experience regarding pregnancy outcomes with simultaneous use of an intrauterine device is very limited. A woman who wishes to continue her pregnancy should also be informed about this.

Breast-feeding is not a contraindication for the use of the intrauterine system, although small amounts of the active component (about 0.1% of the dose) may pass into milk during lactation. It is unlikely that such minute amounts of levonorgestrel will have any pharmacological effects on the child. The medical community overwhelmingly agrees that the use of the drug in 6 weeks after childbirth it does not have adverse effects on the growth and development of the young body.

Intrauterine contraceptive

Active substance

Levonorgestrel (micronized)

Release form, composition and packaging

Intrauterine therapy 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: polydimethylsiloxane elastomer core; 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 brown polyethylene, colored with iron oxide black ≤1 wt.%.
Delivery device: conductor - 1 pc.

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

pharmachologic effect

The drug Mirena is an intrauterine therapeutic system (IUD) that releases levonorgestrel and has a mainly local gestagenic effect. Progestin (levonorgestrel) is released directly into the uterine cavity, which allows it to be used in an extremely low daily dose. High concentrations of levonorgestrel in the endometrium help to reduce the sensitivity of its estrogen and progesterone receptors, making the endometrium resistant to estradiol and having a strong antiproliferative effect. When using the drug Mirena, morphological changes in the endometrium and a weak local reaction to the presence of a foreign body in the uterus are observed. An increase in the viscosity of the cervical secretion prevents the penetration of sperm into the 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 suppressing endometrial proliferation, an initial increase in spotting and spotting from the vagina may be observed. Following this, a pronounced suppression of endometrial proliferation leads to a decrease in the duration and volume of menstrual bleeding in women using Mirena. Scanty bleeding often transforms into oligo- or amenorrhea. At the same time, ovarian function and the concentration of estradiol in the blood remain normal.

Mirena can be used to treat idiopathic menorrhagia, i.e. menorrhagia in the absence of hyperplastic processes in the endometrium (endometrial cancer, metastatic lesions of the uterus, submucous or large interstitial node of uterine fibroids leading to deformation of the uterine cavity, adenomyosis), endometritis, extragenital diseases and conditions accompanied by severe hypocoagulation (for example, von Willebrand disease, severe thrombocytopenia ), the symptoms of which are menorrhagia.

After 3 months of using Mirena, menstrual blood loss in women with menorrhagia is reduced by 62-94% and by 71-95% after 6 months of use. When using Mirena for 2 years, the effectiveness of the drug (reduction of menstrual blood loss) is comparable to surgical treatment methods (ablation or resection of the endometrium). A less favorable response to treatment is possible with menorrhagia caused by submucous uterine fibroids. Reducing menstrual blood loss reduces the risk of iron deficiency anemia. Mirena reduces the severity of dysmenorrhea symptoms.

The effectiveness of Mirena in preventing endometrial hyperplasia during chronic estrogen therapy was equally high with both oral and transdermal estrogen use.

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. Consistent with the decreasing release rate, the median plasma concentration of levonorgestrel in women of reproductive age with body weight above 55 kg decreases from 206 pg/ml (25th-75th percentile: 151 pg/ml-264 pg/ml) determined after 6 months, up to 194 pg/ml (146 pg/ml-266 pg/ml) after 12 months and up to 131 pg/ml (113 pg/ml-161 pg/ml) after 60 months.

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 SHBG concentrations, levonorgestrel concentrations are higher. In women of reproductive age with low body weight (37-55 kg), the median concentration of levonorgestrel in blood plasma is approximately 1.5 times higher.

In postmenopausal women using Mirena simultaneously with the use of estrogens intravaginally or transdermally, the median concentration of levonorgestrel in 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 of the uterus or cervix;

- progestogen-dependent tumors, incl. ;

- uterine bleeding of 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);

- hypersensitivity to the components of the drug.

Carefully and only after consultation with a specialist should the drug be used for the conditions listed below:

- congenital heart defects or heart valve diseases (due to the risk of developing septic endocarditis);

- diabetes.

The advisability of removing the system should be discussed if any of the following conditions are present or first occur:

- migraine, focal migraine with asymmetric vision loss or other symptoms indicating transient cerebral ischemia;

- unusually severe headache;

- jaundice;

- severe arterial hypertension;

- severe circulatory disorders, 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 hormone replacement therapy (HRT) containing estrogen only.

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 a contraceptive 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 of this IUD. It is necessary to conduct a general and gynecological examination, including examination of the pelvic organs and mammary glands, as well as a smear examination from the cervix. Pregnancy and sexually transmitted diseases should be excluded, and inflammatory diseases of the genital organs should be completely cured. The position of the uterus and the size of its cavity are determined. If it is necessary to visualize the uterus, a pelvic ultrasound should be performed before inserting the Mirena IUD. After a gynecological examination, a special instrument, the so-called vaginal speculum, is inserted into the vagina and the cervix is ​​treated with an antiseptic solution. Mirena is then injected into the uterus through a thin, flexible plastic tube. The correct location of the Mirena drug in the fundus of the uterus is especially important, which ensures a uniform effect of the gestagen on the endometrium, prevents expulsion of the IUD and creates conditions for its maximum effectiveness. Therefore, you should carefully follow the instructions for installing Mirena. Since the technique for installing different IUDs in the uterus is different, special attention should be paid to practicing the correct technique for installing a specific system. The woman may feel the insertion of the system, but it should not cause her severe pain. Before insertion, if necessary, local anesthesia of the cervix can be applied.

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

Sometimes after insertion of the IUD, pain, dizziness, sweating and pale skin are noted. 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 carrying out HRT with drugs containing only estrogen, in women with amenorrhea, Mirena can be installed at any time; in women with continued menstruation, installation is performed in the last days of menstrual bleeding or withdrawal bleeding.

Delete Mirena by carefully pulling the threads grasped with forceps. If the threads are not visible and the system is in the uterine cavity, it can be removed using a traction hook to remove the IUD. This may require dilation of the cervical canal.

The system should be removed 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 the IUD may be accompanied by some pain and bleeding. The procedure may cause syncope due to a vasovagal reaction, bradycardia, or seizures in patients with epilepsy, especially in patients with a predisposition to these conditions or in cases of cervical stenosis.

After removing Mirena, the system should be checked for integrity. When it was difficult to remove the IUD, there were isolated cases of the hormonal-elastomer core slipping onto the horizontal arms of the T-shaped body, as a result of which they were hidden inside the core. Once the integrity of the IUD is confirmed, this situation does not require additional intervention. Stoppers on the horizontal arms usually prevent the core from completely separating from the T-body.

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 the age of 65 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. Using gentle traction with forceps, straighten the cervical canal. The forceps should be in this position throughout the entire administration of Mirena to ensure gentle traction of the cervix towards the inserted instrument.

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 conductor 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 install a new Mirena system 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 estrogen replacement therapy, most women gradually stop cyclic bleeding during the first year of use.

Below are data on the frequency of adverse drug reactions reported with the use of Mirena. Determination of the frequency of 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 (*, **).

Often	Often	Infrequently	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
	Backache**
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 plasma concentration 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 only be used 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 injection 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) may 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 serious infection that must be treated immediately. Even in cases where only individual symptoms indicate the possibility of infection, bacteriological examination and monitoring are indicated.

Expulsion

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

If the position in the uterine cavity is incorrect, the IUD must be removed. A new system may be installed at this time.

It is necessary to explain to the woman how to check the 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 began to have constant bleeding or pain, or your periods became excessively heavy).

You have other medical problems, such as migraine headaches or severe recurring headaches, sudden changes in vision, jaundice, increased blood pressure, or any other diseases or conditions listed in the Contraindications 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,” 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 the system was installed, 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 slipped 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, consult a 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 advised 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 uterus 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.

The Mirena intrauterine device is made of plastic and contains progesterones. During the day, on average, it releases about 20 mcg of active substance into a woman’s body, which provides contraceptive and therapeutic effects.

An intrauterine device (IUD) consists of a core filled with a hormonally active substance, which provides the main effect on the body, and a special body shaped like the letter “T”. To prevent the drug from being released too quickly, the body is covered with a special membrane.

The body of the spiral is additionally equipped with threads that allow it to be removed after use. The entire structure is placed in a special tube, allowing for trouble-free installation.

The main active ingredient in the core is levonorgestrel. It begins to be actively released into the body as soon as the contraceptive is installed in the uterus. The average release rate is up to 20 mcg in the first few years. Normally, by the fifth year the figure drops to 10 mcg. In total, one spiral contains 52 mg of active substance.

The hormonal component of the drug is distributed in such a way that it produces only a local effect. During the operation of the IUD, most of the active substance remains in the endometrial layer covering the uterus. In the myometrium (muscle layer), the concentration of the drug is about 1% of that in the endometrium, and in the blood levonorgestrel is in such insignificant quantities that it is not able to produce any effects.

When choosing Mirena, it is important to remember that the concentration of the active substance in the blood is significantly influenced by body weight. In women with low weight (36-54 kg), the indicators can exceed the norm by 1.5-2 times.

Action

The Mirena hormonal system produces its main effect not due to the release of a biologically active substance into the uterine cavity, but due to the body’s reaction to the presence of a foreign body in it. That is, when an IUD is inserted, a local inflammatory reaction develops, which makes the endometrium unsuitable for implantation of a fertilized egg.

This is achieved through the following effects:

• inhibition of normal growth processes in the endometrium;
• decreased activity of glands located in the uterus;
• active transformations of the submucosal layer.

The effects of levonorgestrel also contribute to changes occurring in the endometrium.

Additionally, due to the Mirena intrauterine device, the mucous secretion secreted in the cervix thickens, as well as a significant narrowing of the lumen of the cervical canal. Such an effect makes it difficult for sperm to penetrate into the uterine cavity with their further advancement to the egg for fertilization.

The main active ingredient of the spiral also affects sperm entering the uterus. Under its influence, there is a significant decrease in their mobility; most sperm simply lose their ability to reach the egg.

The main mechanism of therapeutic action is the reaction of the endometrium to levonorgestrel. Its effect on the mucous layer leads to the gradual loss of sensitivity of the sex receptors to estrogens and gestagens. The result is simple: sensitivity to estradiol, which promotes the growth of the endometrium, greatly decreases, and the mucous layer becomes thinner and is rejected less actively.

Indications

The hormonal system is used in the following cases:

• method of protection against;
• menorrhagia of an idiopathic nature;
• prevention and prevention of pathological growth of the endometrium during treatment with estrogen drugs;

Basically, in modern gynecology, the Mirena coil is used to control menorrhagia, which is characterized by heavy bleeding in the absence of endometrial proliferation. A similar condition can occur in various pathologies of both the reproductive and circulatory systems (uterine cancer, thrombocytopenia, adenomyosis, etc.). The effectiveness of the spiral has been proven; within six months of use, the intensity of blood loss is reduced by at least half, and over time the effect can be compared even with complete removal of the uterus.

Contraindications

Like any therapeutic agent, the IUD has a number of contraindications in which its use is prohibited.

These include:

• pregnancy or lack of confidence that it has not occurred;
• infectious processes in the genitourinary tract;
• precancerous changes in the cervix and its damage by malignant tumors;
• uterine bleeding of unknown etiology;
• severe deformation of the uterus due to a large myomatous or tumor node;
• various severe liver diseases (cancer, hepatitis, cirrhosis);
• age over 65 years;
• allergy to components used in the drug;
• thromboembolism of any organs, thrombophlebitis, systemic lupus erythematosus or suspicion of it.

There are also a number of conditions in which the spiral is used with increased caution:

• transient ischemic attacks;
• migraines and headaches of unknown origin;
• hypertension;
• severe circulatory failure;
• history of myocardial infarction;
• various valvular pathologies of the heart (due to the high risk of developing infectious endocarditis);
• diabetes mellitus of both types.

Women with diseases from this list should more closely monitor changes in their own health after installing the Mirena hormonal intrauterine device. If any negative dynamics occur, you should immediately consult a doctor.

Peculiarities

After installing the IUD, women are often concerned about a significant decrease in the intensity of menstruation or their complete disappearance. When using the Mirena spiral, this is a normal reaction of the body, since the hormone contained in the core of the product stops the proliferation processes in the endometrium. This means that its rejection is either significantly reduced or completely stopped.

It is important for women to remember that in the first few months after having an IUD inserted, your periods may become heavier. There is no reason to worry - this is also a normal reaction of the body.

How does the installation work?

The instructions for the Mirena intrauterine device state that only a gynecologist can install it.

Before the procedure, the woman undergoes a number of mandatory tests that confirm the absence of contraindications to the use of contraception:

• general blood and urine tests;
• level analysis to exclude pregnancy;
• full examination by a gynecologist with two-hand examination;
• assessment of the condition of the mammary glands;
• analysis confirming the absence of sexually transmitted infections;
• Ultrasound of the uterus and appendages;
• extended type.

As a contraceptive, it is recommended to install the Mirena spiral within the first 7 days from the start of a new pregnancy. To achieve therapeutic goals, this recommendation can be neglected. The introduction of an IUD after pregnancy is allowed only after 3-4 weeks, when the uterus has gone through the process.

The procedure begins with the gynecologist inserting a vaginal speculum into the uterine cavity. Then the cervix is ​​treated with an antiseptic using a special tampon. Under the control of a speculum, a special conductor tube is installed into the uterine cavity, inside of which there is a spiral. The doctor, after checking the correct installation of the “shoulders” of the IUD, removes the guide tube, and then the speculum. The spiral is considered installed, and the woman is given time to rest for 20-30 minutes.

Side effects

The instructions state that the side effects that develop as a result of using Mirena do not require additional treatment and generally disappear after a few months from the start of use.

The main adverse reactions are associated with changes in the duration of menstruation. 10% of patients reported complaints of uterine bleeding, prolonged spotting, and amenorrhea.

Side effects from the central nervous system may occur. The most common complaints are headaches, nervousness, irritability, mood changes (sometimes even depressive states).

In the first days after installation of the IUD, undesirable effects from the gastrointestinal tract may develop. These are mainly nausea, vomiting, loss of appetite, and abdominal pain.

If there is excessive sensitivity to levonorgestrel, systemic changes are possible, such as weight gain and the appearance of acne.

It is recommended to consult a doctor after installing the IUD if the following symptoms appear:

• menstruation is completely absent for 1.5-2 months (pregnancy must be excluded);
• pain in the lower abdomen bothers you for a long time;
• chills and fever, heavy sweats at night appeared;
• discomfort during sexual intercourse;
• the volume, color or smell of discharge from the genital tract has changed;
• During menstruation, more blood began to be released.

Advantages and disadvantages

The IUD, like any therapeutic agent, has its advantages and disadvantages.

The advantages of Mirena include:

• effectiveness and duration of the contraceptive effect;
• local effect of the components of the spiral - this means that systemic changes in the body occur in minimal quantities or do not occur at all, depending on the patient’s susceptibility;
• rapid restoration of the ability to conceive after removal of the IUD (within 1-2 cycles on average);
• quick installation;
• low cost, for example, when compared with within 5 years of use;
• prevention of a number of gynecological diseases.

Disadvantages of Mirena:

• the need to spend a large sum of money on its purchase at a time - the average price for a spiral today is from 12,000 rubles or more;
• there is a risk of developing menorrhagia;
• the risk of developing inflammatory processes increases with frequent changes of sexual partners;
• if the IUD is installed incorrectly, its presence in the uterine cavity causes pain and provokes bleeding;
• During the first months, heavy menstruation causes inconvenience;
• is not a means of protection against sexually transmitted infections.

Possible complications

The Mirena hormonal system is introduced into the uterine cavity, which is an invasive procedure. This carries the risk of developing a number of complications that need to be taken into account.

Expulsion

Loss of the product from the uterine cavity. The complication is considered common. To control it, it is recommended to check the IUD threads in the vagina after each menstrual cycle.

Most often, unnoticeable expulsion occurs during menstruation. Because of this, women are advised to inspect their hygiene products so as not to miss the process of hair loss.

Expulsion in the middle of the cycle rarely goes unnoticed. It is accompanied by pain and early bleeding.

After leaving the uterine cavity, the device ceases to have a contraceptive effect on the body, which means pregnancy may occur.

Perforation

Perforation of the uterine wall is extremely rare as a complication when using Mirena. Basically, this pathology accompanies the process of installing an IUD in the uterine cavity.

Recent birth, high lactation, and atypical position of the uterus or its structure predispose to the development of complications. In some cases, perforation is facilitated by the inexperience of the gynecologist performing the installation procedure.

In this case, the system is urgently removed from the body, as it not only loses its effectiveness, but also becomes dangerous.

Infections

In terms of frequency of occurrence, infectious inflammation can be placed between perforation and expulsion. The greatest likelihood of encountering this complication occurs in the first month after installation of the IUD. The main risk factor is the constant change of sexual partners.

Mirena is not installed if a woman already has an acute infectious process in the genitourinary system. Moreover, acute infections are a strict contraindication to the installation of an IUD. The product must be removed if an infection has developed that is not amenable to therapeutic intervention within the first few days.

Additional possible complications can be considered (very rare, less than 0.1% of cases per year), amenorrhea (one of the most common), development of a functional type. The decision regarding the treatment of certain complications is made by the doctor, based on the general condition of the patient and her individual characteristics.

Removal

The IUD must be removed after 5 years of use. It is recommended to carry out the procedure in the first days of the cycle if the woman intends to continue to protect herself from pregnancy. You can ignore this recommendation if, after removing the current Mirena, you immediately plan to install a new one.

The spiral is removed using threads, which the doctor grabs with forceps. If for some reason there are no threads for removal, artificial dilatation of the cervical canal is necessary, followed by removal of the spiral using a hook.

If you remove the IUD in the middle of the cycle without installing a new IUD, pregnancy is possible. Before removing the product, sexual intercourse with fertilization could well have occurred, and after the procedure, nothing will prevent the egg from being implanted into the uterine cavity.

When removing a contraceptive, a woman may experience discomfort, and the pain can sometimes be acute. It is also possible to develop bleeding, fainting, and convulsive seizures with a tendency to epilepsy, which the doctor must take into account when carrying out the procedure.

Mirena and pregnancy

Mirena is a drug with high efficacy rates, but the occurrence of an unwanted pregnancy cannot be ruled out. If this happens, the first thing the attending physician should do is to make sure that the pregnancy is not ectopic. If it is confirmed that the egg has been implanted in the uterine cavity, then the issue is resolved with each woman individually.

In some cases, careful removal of the coil is not possible. Then the question of . If refused, the woman is informed of all possible risks and consequences for her own health and the health of the unborn child.

If it is decided to continue the pregnancy, it is necessary to warn the woman about the need to carefully monitor her condition. If any suspicious symptoms appear (stabbing pain in the abdomen, fever, etc.), she should immediately consult a doctor.

The woman is also informed about the possibility of a virilizing effect on the fetus (the appearance of secondary male sexual characteristics), but such an effect is rare. Today, due to the high contraceptive effectiveness of Mirena, there are not many birth outcomes with its use, but so far there have been no recorded cases of the development of birth defects. This is due to the fact that the child is protected from the action of the spiral.

Use after childbirth and during lactation

It has been reliably established that the use of Mirena 6 weeks after birth does not have a negative effect on the child. His growth and development do not deviate from age norms. Monotherapy with gestagens can affect the quantity and quality of milk during lactation.

Levonorgestrel enters the child's body during breastfeeding at a dosage of 0.1%. Such an amount of biologically active substance is not capable of causing harm to the baby’s health.

Mirena is a good method of contraception for women who can boast of good tolerance to progestogen-type drugs. The use of the IUD will also be useful for those who have heavy and painful periods, a high risk of developing fibroids and myomas, and active endometriosis. However, the IUD, like any medicine, has its drawbacks, which is why the advisability of its use is best discussed with your doctor. The specialist will be able to correctly assess the balance of risks and benefits and, if the Mirena spiral is not suitable for the patient as a therapeutic or contraceptive agent, offer her an alternative.

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