Brought to you by Bayer

Brought to you by

5 Years, 3 indications. For all the phases of her life

YOUR HEALTHCARE PROFESSIONAL HAS PRESCRIBED A MIRENA® FOR YOU

Mirena® is well researched and studied and available from a Gynaecologist or a General Practitioner trained in the Mirena® insertion technique.

LEARN MORE ABOUT A MIRENA®:1

  • As a Contraceptive
  • As treatment of Idiopathic Heavy Menstrual Bleeding (HMB)
  • As protection of the endometrium during Hormone Replacement Therapy (HRT)

 

ABOUT THE MIRENA®

  1. WHAT A MIRENA® CONTAINS1
    The active substance is levonorgestrel. Each sterile intrauterine system contains levonorgestrel 52 mg. The other ingredients are polydimethylsiloxane elastomer, polydimethylsiloxane tubing, polyethylene, barium sulphate, and iron oxide.
  2. WHAT IS A MIRENA® USED FOR?1
    A Mirena® is used for contraception (prevention of pregnancy), idiopathic menorrhagia (excessive menstrual bleeding) and for protection from endometrial hyperplasia (excessive growth of the lining of the womb) during estrogen replacement therapy.
  3. HOW TO USE A MIRENA®
    How effective is a Mirena®: In contraception, a Mirena® is 99.8 % effective, similar to female sterilisation.2 A Mirena® has a failure rate of approximately 0.1 % per year. In the treatment of excessive menstrual bleeding a Mirena® causes a major reduction of menstrual bleeding already after three months. Some users have no periods at all.1
    When should a Mirena® be inserted:
    You can have a Mirena® inserted within 7 days from the onset of the menstrual bleeding.  A Mirena® can also be inserted immediately after a first trimester abortion provided that there are no genital infections. A Mirena® should be inserted only after the womb has returned to its normal size after delivery, and not earlier than 6 weeks after delivery.1

 

 

Mirena® can be replaced by a new system at any time of the cycle. When a Mirena® is used to protect the lining of the womb during estrogen replacement therapy, it can be inserted at any time in an amenorrheic woman (a woman who has no monthly bleeding), or during the last days of menstruation or withdrawal bleeding.1

Mirena® should be inserted by a Healthcare Professional who is trained/experienced in a Mirena® insertion.1

How is a Mirena® inserted?1

  • Your Healthcare Professional will give you a normal pelvic (gynaecological) examination and find the particular position of your womb.
  • An instrument called a speculum is inserted into the vagina.
  • The cervix is cleansed with an antiseptic solution.
  • A Mirena® is then inserted into the womb via a thin, flexible plastic tube (the inserter). Local anaesthesia may be applied to the cervix prior to insertion, if appropriate.
  • The flexible plastic tube will be withdrawn from your body leaving the Mirena® in your womb.

Some women may experience pain and dizziness after insertion. If these do not pass within half an hour in the resting position, the Mirena® may not be correctly positioned. An examination should be carried out and the Mirena® removed if necessary.

WHEN SHOULD I SEE MY HEALTHCARE PROFESSIONAL?

You should have your Mirena® Intrauterine System (IUS) checked 4-12 weeks after insertion, and thereafter regularly, at least once a year. In addition, you should contact your Healthcare Professional if any of the following occurs:

  • You no longer feel the threads in your vagina.
  • You can feel the lower end of the system.
  • You think you may be pregnant.
  • You have persistent abdominal pain, fever, or unusual discharge from the vagina.
  • You or your partner feel pain or discomfort during sexual intercourse.
  • There are sudden changes in your menstrual periods (for example, if you have little or no menstrual bleeding, and then you start having persistent bleeding or pain, or you start bleeding heavily).
  • You have other medical problems, such as migraine headaches or intense headaches that recur, sudden problems with vision, jaundice, or high blood pressure.

 

FOR HOW LONG CAN A MIRENA® BE USED?

A Mirena® is effective for five years, after which it has to be removed. If you like, you may have a new Mirena® inserted when the old one is removed.

What if I want to become pregnant or have a Mirena® removed for another reason?1
The Intrauterine System (IUS) can be easily removed at any time by your Healthcare Professional, after which pregnancy is possible.

Once a Mirena® is removed, fertility returns to your fertility level at your current age.

If pregnancy is not desired, a Mirena® should not be removed after the seventh day of the menstrual cycle unless contraception is covered with other methods (e.g. condoms) for at least seven days before the removal. When the woman has no menses, she should use barrier methods of contraception for seven days before removal until her menstruation reappears. A new Mirena® can also be inserted immediately after removal, in which case no additional protection is needed.

Can I become pregnant after stopping use of a Mirena®?1
Yes. After a Mirena® is removed, it does not interfere with your normal fertility. You may become pregnant during the first menstrual cycle after a Mirena® is removed.

Can a Mirena® affect my menstrual periods?1
A Mirena® does affect your menstrual cycle. It can change your menstrual periods so that you have spotting (a small amount of blood loss), shorter or longer periods, lighter or heavier bleeding, or no bleeding at all.

Many women have frequent spotting or light bleeding in addition to their periods for the first 3-6 months after they have a Mirena® inserted. Some women may have heavy or prolonged bleeding during this time. Please inform your Healthcare Professional, especially if this persists.

Overall, you are likely to have a gradual reduction in the number of bleeding days and in the amount of blood lost each month. Some women eventually find that periods stop altogether. As the amount of menstrual bleeding is usually reduced with the use of a Mirena®, most women experience an increase in their blood haemoglobin value. When the system is removed, periods return to normal.

Is it abnormal to have no periods?1,3
Menstrual bleeding can become less or stop completely in 20 % of women. If no menstrual bleeding occurs for 6 weeks after a previous bleed, a pregnancy test is recommended. If you find that you are not having periods with a Mirena®, it is because of the effect of the hormone on the lining of the womb. The monthly thickening of the lining does not occur, therefore there is nothing to come away as a period. It does not necessarily mean that you have reached menopause or are pregnant. Your own hormone levels remain normal.

How will I know if I’m pregnant?1
Pregnancy is unlikely in women using a Mirena®, even if they do not have periods.
If you have not had a period for 6 weeks and are concerned, then consider having a pregnancy test. If this is negative, there is no need to carry out another test unless you have other signs of pregnancy, e.g. morning sickness, tiredness or breast tenderness.

Can a Mirena® cause pain or discomfort?1
Some women feel pain (like menstrual cramps) in the first few weeks after insertion. You should return to your Healthcare Professional or clinic if you have severe pain or if the pain continues for more than three weeks after you have had a Mirena® inserted.

Will a Mirena® interfere with sexual intercourse?1
Neither you nor your partner should feel a Mirena® Intrauterine System (IUS) during intercourse. If you do, intercourse should be avoided until your Healthcare Professional has checked that the Mirena® Intrauterine System (IUS) is still in the correct position.

 

How long should I wait to have sexual intercourse after the insertion?1
It is best to wait about 24 hours after having a Mirena® inserted before having sexual intercourse. However, as soon as it is inserted, a Mirena® prevents pregnancy if inserted within the first 7 days of menses.

Can tampons be used?1
Use of sanitary pads is recommended. If tampons are used, you should change them with care so as not to pull the threads of the Mirena®.

What happens if the Mirena® comes out by itself?1
It is possible that a Mirena® may dislodge or fall out. Should the system come out either completely or partially, there may be some signs to alert you i.e. an unusual increase in bleeding, the return of your normal periods and/or you or your partner can feel the lower end of the system itself, during intercourse.

If the Mirena® comes out completely or partially, you will not be protected against pregnancy. Contact your Healthcare Professional as soon as possible and use another reliable contraceptive method until you see your Healthcare Professional.

How can I tell whether the Mirena® is in place?1
At the end of the Mirena® are tiny, thin threads – so small that you will not feel them unless you specifically insert a finger into your vagina to feel for them. They will be at the end of the vagina near the opening of your womb. Do not pull the threads because you may accidentally pull the Mirena® out.9

 

CONTRACEPTION

1. HOW DOES MIRENA® PREVENT PREGNANCY?4

A Mirena® contains a hormone called levonorgestrel, which is a progestogen. This hormone prevents pregnancy by:

  • Reducing the monthly growth of the lining of the uterus.4
  • Thickening of the cervical mucus, so that it is difficult for the sperm to get through to the egg.4
  • Inhibition of binding of the sperm to the egg.4

2. HOW EFFECTIVE IS MIRENA®?

In contraception, a Mirena® is 99.8 % effective, similar to female sterilisation.2 Once a Mirena® is removed, fertility rapidly returns to your fertility level at your current age.1

In the treatment of excessive menstrual bleeding, a strong reduction of menstrual bleeding will occur within the first 3 months of fitting a Mirena®. Bleeding patterns vary based on the patient. Some users have no periods at all.1

3.  DOES MIRENA® REMAIN EFFECTIVE THROUGHOUT THE 5-YEAR PERIOD?

Yes. The efficacy of a Mirena® in contraception is similar throughout the 5-year lifespan of the system.1,3,5

4.  WHY IS A MIRENA® A PARTICULARLY GOOD CONTRACEPTIVE CHOICE?

Because of a Mirena®’s long wearing time, there is no need for daily attention.1 The long-term nature and reversibility of a Mirena®’s contraceptive action meets the needs of most women – even young women who may want to be protected from unplanned pregnancies until they are ready for motherhood.6

5. HOW SOON AFTER I REMOVE A MIRENA® WILL I BE ABLE TO FALL PREGNANT?

Once a Mirena® is removed, fertility rapidly returns to your fertility level at your current age.1

In fact, unless a pregnancy is desired, a Mirena® should not be removed after the seventh day of the menstrual cycle in a sexually active woman.1 If a Mirena® is removed in mid-cycle and you have had intercourse within the previous week, you may become pregnant unless a new system is inserted immediately.1

 

HEAVY MENSTRUAL BLEEDING (HMB)

AND HOW DOES A MIRENA® COMPARE TO HYSTERECTOMY?
A Mirena® is effective in the treatment of idiopathic Heavy Menstrual Bleeding (HMB) and is a good alternative to hysterectomy.7 Studies specifically comparing a Mirena® to hysterectomy showed that surgery and the associated risks were avoided in 58% of the women who participated in the study.7

Medical treatment e.g. with a Mirena® is recommended as first-line treatment for idiopathic Heavy Menstrual Bleeding (HMB). Hysterectomy is not a first choice treatment in this context.8

Although a Mirena® is a proven alternative to hysterectomy, many surgical procedures are still performed without first evaluating a Mirena® or other medical treatments.7

A Mirena® is indicated for the treatment of idiopathic Heavy Menstrual Bleeding (HMB)1 and has been found to reduce menstrual blood loss with comparatively few side effects.9

As a contraceptive, a Mirena® is 99.8 % effective, similar to female sterilisation.2

Recent treatment guidelines from the National Institute of Health and Clinical Excellence (NICE) recommend that a Mirena® be considered as first-line treatment – particularly where long-term use (at least 12 months) is anticipated.10

 

ENDOMETRIAL PROTECTION DURING ESTROGEN REPLACEMENT THERAPY

1. WHY WOULD IT MAKE SENSE TO PRESCRIBE A MIRENA® FOR WOMEN WHO ARE TAKING ESTROGEN AS THEIR HORMONE REPLACEMENT THERAPY (HRT)?

Estrogen can alleviate the symptoms associated with menopause. But, when estrogen is administered without a progesterone as “counter-balance”, the lining of the womb may be stimulated to grow “unchecked”.9  The rationale for adding in a progesterone (as you would do with the use of a Mirena®) is to prevent estrogen induced endometrial growth which can lead to cancer.9

A Mirena® contains only progesterone – and this progesterone is delivered directly into the womb.1

The use of a Mirena® versus Oral Hormone Replacement Therapy (HRT) allows the adverse effects caused by the systemic administration of progesterone (such as when Hormone Replacement Therapy (HRT) is taken by mouth) to be minimised3 – and also allows the free choice of estrogen with regard to type, dose and administration i.e. whether by mouth or by skin patch.3

2.  CAN I SIMPLY CONTINUE WITH MY MIRENA® WHEN STARTING HORMONE REPLACEMENT THERAPY?

Yes! That is the beauty of a Mirena®. The system has to be replaced every 5 years.1 So if you wish to continue with a Mirena® during your Hormone Replacement Therapy (HRT) you can insert a new one when the old one is removed.1

3.  WHAT IF I HAVE NEVER USED A MIRENA® BEFORE?

You can start using it as part of your Hormone Replacement Therapy (HRT) at the time estrogen is first prescribed for you.1

 

4.  WHEN CAN A MIRENA® BE INSERTED IF I CHOOSE TO USE IT AS PART OF MY HORMONE REPLACEMENT THERAPY (HRT)?
If you are already not having periods, then a Mirena® can be inserted at any time.1 If you are still menstruating then a Mirena® can be inserted during the last days of menstruation.1

5. CAN A MIRENA® STOP ME FROM HAVING MY PERIODS?
Yes! One of the advantages of a Mirena® is that when used in combination with estrogen replacement therapy a non-bleeding pattern gradually develops in most women during the first year.1

Some bleeding and spotting may occur in the first few months of use before bleeding patterns settle down. It is comforting to know that the average number of spotting days decreases gradually and after the first 3 months there are usually only few days of bleeding, if any at all.1

 

POST-PARTUM

1.  CAN A MIRENA® BE USED DURING BREASTFEEDING?

The Mirena® may be used in breastfeeding women if indicated by your Healthcare Professional. Levonorgestrel, the active ingredient of the Mirena®, has been identified in small quantities in the breast milk of nursing women. However, there appears to be no negative effects on infant growth or development when using any progestogen-only method, starting six weeks after delivery.1  A study conducted to assess the possible effects of a Mirena® on breastfeeding performance, infant growth and infant development during the first year after birth compared to a copper Intrauterine Device (IUD) showed that 89% of women using a Mirena® were still breastfeeding at 1 year, and that there were no significant differences in breastfeeding performance, or any of the infant growth or development parameters between a Mirena® and a copper containing intrauterine device.11

2.  HOW SOON AFTER DELIVERY CAN A MIRENA® BE INSERTED?

The Mirena® should be inserted only after the womb has returned to its normal size after delivery. If it has still not returned to its normal size after 6 weeks, consider waiting 12 weeks post-partum.1

3. WHAT IF I WANT TO BECOME PREGNANT AGAIN?

The Mirena® can be removed at any time by your Healthcare Professional, after which pregnancy is possible based on your fertility level at that time of your life.

Removal usually is a painless procedure. After the Mirena® is removed, it does not interfere with your normal fertility. You may become pregnant during the first menstrual cycle after a Mirena® is removed.1

POST-ABORTION

1.  WHY DO I NEED CONTRACEPTION AS SOON AS POSSIBLE AFTER AN ABORTION?

The World Health Organization reported 43.8 million induced abortions globally in 2008.12 A large proportion of abortions are repeat abortions.13 Ovulation may return as early as 8 – 10 days after an induced abortion with no difference between medical and surgical abortion and 83 % of women have ovulation during the first cycle after abortion. More than 50 % of women have been found to reinitiate sexual activity within two weeks after the induced abortion.13 Women who have their intrauterine contraceptive inserted during the first trimester post-abortion have a highly effective contraceptive method already at the first post-abortion ovulation.13
Furthermore, it is possible that early insertion of an intrauterine contraceptive after medical abortion could be technically less complicated and less painful, due to the dilated cervix found immediately after a medical termination of pregnancy.13

2. WHY IS A MIRENA® SUITABLE AS POSTABORTION CONTRACEPTIVE?

A Mirena® is 99.8 % effective as a contraceptive,2 and is generally recommended as a category 1 contraceptive in the World Health Organization medical eligibility criteria for contraception.14 A Mirena® can be inserted immediately after a first trimester abortion provided that there are no genital infections, and it remains effective for 5 years, after which it needs to be replaced.1 The contraceptive effect of a Mirena® is fully reversible, and fertility rapidly returns to your fertility level at your current age once a Mirena® is removed.1

 

 

 

BONE HEALTH

1.  WILL A MIRENA HAVE AN EFFECT ON MY MENSTRUATION AND AFFECT MY BONE HEALTH?19-22
No, because a Mirena®’s effect is mainly localised in the uterus, most women will ovulate regularly even though they may not be menstruating. The studies show the same estrogen concentrations for women menstruating and those who are not.

MENOPAUSE

1.  HOW WILL I KNOW IF I’VE REACHED MENOPAUSE?15
Menopause is the term for the last period you will ever have.

Apart from changes in bleeding pattern, the majority of women have noticeable signs when they reach this period of their lives, e.g. hot flushes, mood changes, unusual sweating and other symptoms. If you feel that this applies to you, your Healthcare Professional can do tests to check.

2.  I HAVE REACHED PERIMENOPAUSE*. MUST I HAVE A MIRENA® REMOVED?15
No, unless you are going to use another form of contraception. You could still fall pregnant in this time.

If you decide to use estrogen replacement therapy to alleviate the symptoms you are experiencing, a Mirena® is indicated for the protection of your womb from the effect of the estrogen component of the hormone replacement.1 Your Healthcare Professional will advise you on which form of estrogen to take.

* Perimenopause means “around menopause” and refers to the time during which your body makes the natural transition to menopause, marking the end of the reproductive years. Perimenopause is also called the menopausal transition. Women start perimenopause at different ages.

 

I DO NOT NEED CONTRACEPTION ANYMORE BUT HAVE HEAVY PERIODS. CAN I USE A MIRENA®?1
Yes. Your Healthcare Professional will first exclude other causes of Heavy Menstrual Bleeding (HMB) before a Mirena® is considered.
A Mirena® has been prescribed to you for one of the following uses:1
1) Contraception.
2) Treatment of idiopathic Heavy Menstrual Bleeding (HMB) (Heavy Menstrual Bleeding of
unknown cause).
3) Protection of the uterus against the effect of estrogen during Hormone Replacement Therapy (HRT).

FREQUENTLY ASKED QUESTIONS AND ANSWERS

  1. WHAT DOES IT MEAN THAT A MIRENA® IS AN INTRAUTERINE SYSTEM (IUS) AND NOT AN INTRAUTERINE DEVICE (IUD)?
    An Intrauterine Device (IUD) is a contraceptive device, e.g. like a ‘coil’, that exerts its contraceptive effect mechanically and not via a hormone.16 Often a major problem with this is that it tends to make your periods heavier, longer and sometimes more painful.16
    A Mirena® is an IUS (Intrauterine System). In addition to having a mechanical effect it secretes levonorgestrel, hormone, which reduces the monthly growth of the lining of the uterus, thickens the cervical mucus so that it is difficult for the sperm to get through to the egg, and inhibits binding of the sperm to the egg.4
  2. WHAT DOES A MIRENA® LOOK LIKE? It’s not much longer than a match, and is more or less T-shaped. It has a couple of short threads hanging from the foot of the ‘T’.1,4,22 Most importantly, the stem of the ‘T’ contains a reservoir of female hormone, of the type known as a ‘progestogen’.1,4,22 This hormone is steadily released into your womb,4 day after day, for up to five years, making it 99.8 % effective as a contraceptive, similar to female sterilisation.2
  3. SO WHAT ARE THE ADVANTAGES OF THE INTRAUTERINE SYSTEM (IUS)?
  • It doesn’t interfere with sex.1
  • It’s effective.2
  • You can keep it in for 5 years.1
  • You can decide to remove it before 5 years.1
  • Once removed you can fall pregnant – it does not compromise your fertility.1
  • Once removed, fertility rapidly returns to your fertility level at your current age. You may fall pregnant during the first menstrual cycle after removal.1,22
  • Once inserted you don’t have to worry about taking a daily contraceptive

99.8 % Effective!2

More effective than most other contraceptive methods.2

100 % Flexible!
Use it for up to 5 years… remove it before that, if you want to fall pregnant.1

Anyway you look at it – you’re in control!

4. HOW DOES A MIRENA® WORK?
The vertical part of the “T” contains a progestogen, called levonorgestrel, which is similar to one of the hormones that is made in your body.4,22 The system releases levonorgestrel into your uterus at a constant rate. The amount of hormone released is 20 micrograms/24 hours – which is a very low dose – but because this release occurs constantly,4 a Mirena® is one of the most effective contraceptives available.5

 

 

5. HOW DOES A MIRENA® PREVENT A PREGNANCY?4
A Mirena® contains a hormone called levonorgestrel, which is a progestogen. This hormone prevents pregnancy by:

  • Reducing the monthly growth of the lining of the uterus.4
  • Thickening of the cervical mucus, inhibiting the binding of the sperm to the egg.4
  • Inhibition of binding of the sperm to the egg.4

6. HOW EFFECTIVE IS MIRENA®?
In contraception, a Mirena® is 99.8 % effective, similar to female sterilisation.2 Once a Mirena® is removed, fertility returns at the age when the Mirena is removed.1

In the treatment of excessive menstrual bleeding, a strong reduction of menstrual bleeding will occur within the first three months of fitting a Mirena®.
Bleeding patterns vary between individuals. Some users will have no periods at all.

7. DO I NEED TO USE ADDITIONAL CONTRACEPTION AFTER INSERTING A
MIRENA®?1,4
If a Mirena® is fitted during the first 7 days of your menstruation, or if you are using another reliable contraceptive method at the time of insertion, there is no need for extra precaution.

8. WHAT IS A MIRENA® USED FOR?
A Mirena® can be used for contraception and to treat idiopathic Heavy Menstrual Bleeding (HMB) (of unknown origin).1,4 It prevents excessive growth of the lining of the womb during estrogen replacement therapy.1

9. CAN I BREASTFEED WHILE USING A MIRENA®?
Non-hormonal contraceptive methods/devices are methods of choice during breastfeeding.4 Levonorgestrel has been identified in small quantities in the breast milk of nursing women, but the quality and quantity of the milk is not affected.4

10. FOR HOW LONG CAN A MIRENA® BE USED?
A Mirena® provides protection against pregnancy for up to 5 years, after which it has to be removed. If you like, you may have a new Mirena® inserted when the old one is removed.1

 

11. HOW IS A MIRENA® FITTED?1
Only a Healthcare Professional trained on the Mirena® insertion techniques can fit a Mirena®. After a gynaecological examination, an instrument called a speculum is inserted into the vagina, and the cervix (opening of the womb) is cleaned with an antiseptic solution. Your Healthcare Professional will use a thin instrument called a “sound” to measure the depth of your womb for correct positioning of a Mirena®.
A Mirena® is fitted into the womb via a thin, flexible plastic tube. The threads pass from the system through the cervix and into the vagina. The threads are then cut to about 2-3 cm in length, outside the cervix.

12. WHEN SHOULD A MIRENA® BE FITTED?1
You can have a Mirena® inserted within 7 days from the onset of the menstrual bleeding. A Mirena® can also be inserted immediately after a first trimester miscarriage or termination of pregnancy, provided there are no genital infections. A Mirena® should not be inserted earlier than 6 weeks after delivery. If the womb has still not returned to its normal size after 6 weeks, consider waiting 12 weeks post-partum. A Mirena® can be replaced by a new system at any time of the cycle.

13. IS IT PAINFUL TO FIT?1
You can feel the insertion but it should not cause much pain. Some women may experience pain and dizziness after insertion, and pain intensity may differ among individuals. This is a normal physiological response and should pass within half an hour in the resting position.

14. DO I NEED TO HAVE A MIRENA® CHECKED REGULARLY?1,4
You should have your Mirena® checked twice during the first year, firstly 4-12 weeks after insertion, and again after 12 months. Thereafter, you should have your Mirena® checked once a year unless your Healthcare Professional advises otherwise.

15. CAN I FALL PREGNANT WITH A MIRENA® IN PLACE?

No contraceptive method is 100% effective.  Clinical studies have demonstrated that a Mirena® is 99.8% effective in preventing pregnancy.2

It is therefore rare for women to fall pregnant with a Mirena® in place.1

However, if a Mirena® comes out, you are no longer protected and must use another form of contraception until you see your Healthcare Professional. Some women may not have their periods while using a Mirena®. Not having a period is not necessarily a sign of pregnancy. If you do not have your period and have other symptoms of pregnancy (for example nausea, tiredness, breast tenderness) you should see your Healthcare Professional for an examination and have a pregnancy test.1

16. WHAT IF I WANT TO BECOME PREGNANT OR WANT TO REMOVE A MIRENA® FOR OTHER REASONS?1
A Mirena® can be removed at any time by your Healthcare Professional, after which pregnancy is possible.

Removal usually is a painless procedure. Fertility rapidly returns to your fertility level at your current age after removal of a Mirena®.

If pregnancy is not desired, a Mirena® should not be removed after the seventh day of the menstrual cycle unless contraception is covered with other methods (e.g. condoms) for at least seven days before the removal. If you have no menses, you should use barrier methods of contraception for 7 days before removal until your menstruation reappears. A new Mirena® can also be inserted immediately after removal, in which case no additional protection is needed.

17. CAN A MIRENA® BECOME DISLODGED OR FALL OUT?1,4
It is possible that a Mirena® may dislodge or fall out. Should the system come out either completely or partially, there will be some signs to alert you i.e. an unusual increase in bleeding, the return of your normal periods and/or you or your partner can feel the lower end of the system itself.

If a Mirena® comes out completely or partially, you will not be protected against pregnancy. Contact your Healthcare Professional as soon as possible and use another reliable contraceptive method until you see your Healthcare Professional.

18. DO I HAVE TO CHECK WHETHER MY MIRENA® IS IN PLACE?1
It is recommended that you check – it is a very simple procedure. At the end of the Mirena® are tiny, thin threads – so small that you will not feel them unless you specifically insert a finger into your vagina to feel for them. They will be at the end of the vagina near the opening of your womb. Do not pull the threads because you may accidentally pull the Mirena® out.

 

 

19. WILL A MIRENA® INTERFERE WITH SEXUAL INTERCOURSE?1
Neither you nor your partner should feel the Mirena® during intercourse. If you do, intercourse should be avoided until your Healthcare Professional has checked that the Mirena® is still in the correct position.

20. HOW LONG SHOULD I WAIT TO HAVE SEXUAL INTERCOURSE AFTER THE INSERTION?1
It is best to wait about 24 hours after having a Mirena® inserted before having sexual intercourse. However, as soon as it is inserted, a Mirena® will prevent pregnancy if inserted within the first 7 days of menses.

21. IS THERE A SETTLING-IN PERIOD WITH REGARDS TO MY PERIODS?1
A Mirena® does affect your menstrual cycle. Many women have frequent spotting or light bleeding in addition to their periods for the first 3-6 months after they have a Mirena® inserted. This is a normal part of the settling–in phase and will regulate with time.

22. ISN’T IT ABNORMAL NOT TO HAVE A PERIOD?1
Menstrual bleeding can become less or stop completely in 20 % of women. If no menstrual bleeding occurs for 6 weeks after a previous bleed, a pregnancy test is recommended. If you find that you are not having periods with a Mirena®, it is because of the effect of the hormone on the lining of the womb. The monthly thickening of the lining does not occur, therefore there is nothing to come away as a period. It does not necessarily mean that you have reached menopause or are pregnant.

23. IS THERE ANY MEDICATION MY HEALTHCARE PROFESSIONAL CAN PRESCRIBE TO SHORTEN THE SPOTTING PERIOD?
There is no proof that medication will have an effect on the bleeding pattern.

24. CAN I USE TAMPONS?1
Use of sanitary pads is recommended. If you use tampons, remove them with care, to ensure that you do not pull the threads of the Mirena®.

25. IS IT GUARANTEED THAT MY PERIODS WILL DISAPPEAR COMPLETELY?1
No. This happens for about 20 % of users after a year of a Mirena® use. Others may still have a short, light bleed every month or merely a scanty discharge. If you suddenly have a heavy bleed after a long period of not having any bleeding, it is best to contact your Healthcare Professional.

26. I HAVE A SKIN PROBLEM AND AM USING A HORMONAL CONTRACEPTIVE TO CONTROL IT. IS A MIRENA® A GOOD CHOICE FOR ME?
The hormone in a Mirena® does not contain any properties to treat acne. There are contraceptives that are specifically indicated for acne and most oral contraceptives will have some effect on your skin due to the estrogen (a Mirena® does not contain any estrogen).4,23 Unless there is a specific medical reason, a Mirena® is not ideal if you need hormonal acne treatment as well as a contraceptive.

Some women will develop acne in their adulthood with no prior history of acne. This is called “late onset acne”.17

27. WILL A MIRENA® CAUSE ME TO GAIN WEIGHT?6
It should not. 5 year follow-up studies with a Mirena® compared to copper Intrauterine Devices (IUDs) (loop) showed the same gradual increase in weight as women become older.

28. SHOULD I EXPERIENCE ADVERSE EFFECTS ON A MIRENA®, WILL IT GET BETTER OVERTIME?
During the first few months after insertion of a Mirena®, you may experience transient hormonal side effects including water retention, headache, breast tenderness and acne or other skin problems. However, the incidence decreases over time. Only 3-4 % of women reported acne as a side effect 3 months after a Mirena® was inserted, and this decreased to just over 1 % at 5 years.3

29. WILL A MIRENA® CAUSE AN ECTOPIC PREGNANCY (A PREGNANCY IN THE FALLOPIAN TUBE)?4,6
The rate of ectopic pregnancies in users of a Mirena® is significantly low at 5 per 10,000 women-years.  Furthermore, the risk of an ectopic pregnancy with a Mirena® is lower than in someone who is not using any contraception at all.6 However, should a woman fall pregnant with a Mirena® in place, her risk of ectopic pregnancy is about 1 in 20, and she should seek medical advice to exclude an ectopic pregnancy.4,6
Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy.1 The highest number of ectopic pregnancies occurs in sexually active women not using any contraception.6

30. WILL A MIRENA® CAUSE INFECTIONS?1,6
The risk is low. The Mirena® inserter tube has been designed to minimise the risk of infection and to prevent contamination with micro-organisms during insertion. But, the risk of infection is increased if you or your partner has several sexual partners and is increased in the presence of sexually transmitted diseases. The risk of infection may be increased immediately and during the first month after insertion. Your doctor should screen you for existing infections and provide treatment to clear up any pre-existing infections prior to insertion.1,6

31. DOES A MIRENA® CAUSE CYSTS ON MY OVARIES?1,4
Since the contraceptive effect of a Mirena® is mainly due to its local effect inside the womb, women of fertile age will keep ovulating even though they are using a Mirena® as a contraceptive. Sometimes the release of the egg is delayed and the follicle keeps
on growing. These enlarged follicles cannot be distinguished from ovarian cysts on sonar. Enlarged follicles have been diagnosed in about 12 % of women using a Mirena®. These are mostly symptom free but some may be accompanied by pelvic pain, or painful intercourse. In most cases, these follicles disappear spontaneously after two to three months’ observation.

32. WILL ANY OF THE HORMONES IN A MIRENA® BE ABSORBED INTO MY BODY?4
Although the effect of the hormone in a Mirena® is mainly local (inside the womb), a small amount of the hormone will be absorbed into your blood circulation and enter your body. Most women will still ovulate because the amount absorbed into the bloodstream is not enough to suppress ovulation.

 

33. WHAT SIDE EFFECTS CAN I EXPECT?3,4
Changes in bleeding patterns are the most frequently reported side-effects (adverse events) but subside during prolonged use.

  • During the first 90 days, prolonged bleeding is experienced by 22 % and irregular bleeding by 67 % of women after post-menstrual insertion of a Mirena®.
  • This incidence decreases to 3 % and 19 % at the end of the first year of use, respectively.
  • Amenorrhoea increases from 0 % to 16 % and infrequent bleeding increases from 11 % to 57 % from the first 90 days until the end of the first year of use respectively.

When a Mirena® is used in combination with continuous estrogen replacement therapy, a non-bleeding pattern gradually develops in most women during the first year.

Expulsion:
Symptoms of the partial or complete expulsion of a Mirena® may include bleeding or pain. However, the system can be expelled from the uterine cavity without the woman noticing it, leading to loss of contraceptive protection. Partial expulsion may decrease the effectiveness of a Mirena®. As a Mirena® decreases menstrual flow, increase of menstrual flow may be indicative of an expulsion.

A displaced Mirena® should be removed. A new system can be inserted at that time.

Perforation:
Perforation or penetration of the uterine corpus or cervix by a Mirena® rarely occurs, and if this does occur the Mirena® must be removed.

Ectopic pregnancy:
Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy. In clinical trials, the ectopic pregnancy rate with a Mirena® was approximately 0.02 % to 0.1 % per year – a lower rate than in women not using any contraception.

Ovarian cysts:
Ovarian cysts have been reported as adverse drug reactions in approximately 7 % of women using a Mirena®. Most of these cysts are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases, the cysts disappear
spontaneously during two to three months of observation.

Other common side-effects include:

  • Dysmenorrhoea, Spotting, Ovarian Cyst, Upper Genital Track infection
  • Headache, Migraine
  • Depressed mood / Depression
  • Nausea, abdominal/pelvic pain
  • Acne, Hirsutism

Uncommon and Rare side-effects may include:

  • Alopecia
  • Hypersensitivity including rash, urticaria and angioedema
  • Increased blood pressure

 

How to report side effects.
If you experience any side effects, Bayer’s web-based tool, SafeTrack makes it quick
and easy to report. SafeTrack can be accessed from:
www.safetrack-public.bayer.com

ADDITIONAL INFORMATION

Your Healthcare Professional will examine you and ask you about your medical history in order to decide whether you can use a Mirena®.

Do not use a Mirena®:1

  • If you are hypersensitive (allergic) to a Mirena® or any of the other ingredients of a Mirena®.
  • If you are pregnant or suspect that you may be pregnant.

If you have any of the following conditions:

  • Known or suspected pregnancy.
  • Current or recurrent infection of the female reproduction organs.
  • Lower genital tract infection.
  • Infection of the womb after delivery.
  • Infection of the womb after abortion during the past 3 months.
  • Infection of the cervix (neck of womb).
  • Cell abnormalities in the cervix.
  • Cancer or suspected cancer of the cervix or womb.
  • Tumours which depend on progestogen hormone to grow.
  • Unexplained abnormal vaginal bleeding.
  • Abnormality of the cervix or womb including fibroids if they distort the cavity of the womb.
  • Conditions associated with increased susceptibility to infections.
  • Active liver disease or liver tumour.

Take special care with a Mirena®:1
If any of the conditions mentioned below exist or appears for the first time while using a Mirena®, consult your Healthcare Professional immediately.

The conditions are:

  • Migraine, asymmetrical visual loss or other symptoms which may be signs of a transient cerebral ischemia (temporary blockage of the blood supply to the brain).
  • Exceptionally severe headache.
  • Jaundice (a yellowing of the skin, white of the eyes and/or nails).
  • Marked increase in blood pressure.
  • Severe disease of arteries such as stroke or heart attack.

A Mirena® may be used with caution in women who have congenital heart disease or valvular heart disease whom are at risk of infective inflammation of the heart muscle.
Antibiotic preventive medication should be administered to these patients when inserting or removing a Mirena®.

In diabetic users of a Mirena®, the blood glucose concentration should be monitored.

Irregular bleeding may mask some symptoms and signs of endometrial polyps or cancer, and in these cases diagnostic measures have to be considered.

A Mirena® is not the method of first choice for young women who have never been pregnant, nor for postmenopausal women with shrinking of the womb.

Medical examination/consultation1

Examination before insertion may include a cervical smear test (Pap smear), examination of the breasts and other tests, e.g. for infections, including sexually transmitted diseases. A gynaecological examination should be performed to determine the position and size of the womb.

A Mirena® may not be suitable for use as a post-coital contraceptive (used after intercourse).

What you should be aware of with the use of a Mirena®?

Infections:

The insertion tube helps to prevent a Mirena® from contamination with microorganisms during the insertion, and the Mirena® inserter has been designed to minimise the risk of infections. Despite this, there is an increased risk of pelvic infection immediately and during the first month after insertion. Pelvic infections in Intrauterine System (IUS) users are often related to sexually transmitted diseases. The risk of infection is increased if the woman or her partner has several sexual partners. Pelvic infections must be treated promptly. Pelvic infection may impair fertility and increase the risk of a future extrauterine pregnancy (pregnancy outside the womb). A Mirena® must be removed if there are recurrent pelvic infections or infections of the lining of the womb, or if an acute infection is severe or does not respond to treatment within a few days.1

Consult a Healthcare Professional without delay if you have persistent lower abdominal pain, fever, pain in conjunction with sexual intercourse or abnormal bleeding.1

Expulsion:

The muscular contractions of the womb during menstruation may sometimes push the Intrauterine System (IUS) out of place or expel it. Possible symptoms are pain and abnormal bleeding. If the Intrauterine System (IUS) is displaced, the effectiveness may be reduced. The Mirena® decreases menstrual flow, therefore an increase of menstrual flow may be an indicator of an expulsion of the device.1

Perforations:

In very rare cases, during insertion of a Mirena®, part of the Mirena® or the entire system penetrates the inside wall of the womb or pierces the womb and becomes lodged outside the womb. The Mirena® becomes ineffective and must be removed as soon as possible. The risk of perforation may be increased if a Mirena® is inserted shortly after delivery, in lactating women, or in women with uterus fixed and leaning backwards (towards the bowel).1

 

Extrauterine pregnancy:

It is very rare to become pregnant while using a Mirena®. The overall risk of an ectopic pregnancy when using a Mirena® is very low, at about 1 in 1000 in 5 years.6 It is very rare to become pregnant with a Mirena®. However, if you become pregnant with a Mirena® in place, the risk of ectopic pregnancy is about 1 in 20.6 Women who have already had an extrauterine pregnancy, surgery of the tubes from the ovaries to the womb or a pelvic infection carry a higher risk. An extrauterine pregnancy is a serious condition which calls for immediate medical attention. The following symptoms could mean that you may have an extrauterine pregnancy and you should see your Healthcare Professional immediately:

  • Your menstrual periods have ceased and then you start having persistent bleeding or pain.
  • You have vague or very bad pain in your lower abdomen.
  • You have normal signs of pregnancy, but you also have bleeding and feel dizzy.1

Faintness:

Some women feel dizzy or faint due to a drop in blood pressure after a Mirena® is inserted. This is a normal physical response. Your Healthcare Professional will tell you to rest for a while after you have had a Mirena® inserted.1

Enlarged ovarian follicle (cells that surround a maturing egg in the ovary):

Since the contraceptive effect of a Mirena® is mainly due to its local effect inside the womb, women of fertile age will keep ovulating even though they are using a Mirena® as a contraceptive. Sometimes the release of the egg is delayed and the follicle keeps on growing. These enlarged follicles cannot be distinguished from ovarian cysts on sonar. Enlarged follicles have been diagnosed in about 12 % of women using a Mirena®. These are mostly symptom free but some may be accompanied by pelvic pain, or painful intercourse. In most cases, these follicles disappear spontaneously after 2 to 3 months of observation.

Pregnancy and Breastfeeding:

It is very rare for a woman to become pregnant with a Mirena® in place. But if a Mirena® comes out, you are no longer protected and must use another form of contraception until you see your Healthcare Professional.1

Some women may not have their periods while using a Mirena®. Not having a period is not necessarily a sign of pregnancy. If you do not have your period and have other symptoms of pregnancy (for example nausea, tiredness, and breast tenderness) you should see your Healthcare Professional for an examination and have a pregnancy test.1

If you become pregnant with a Mirena® in place, you should have the Mirena® removed as soon as possible. If you leave a Mirena® in place during pregnancy, the risk of having a miscarriage, infection or preterm labour will be increased. The hormone in a Mirena® is released into the womb. This means that the foetus is exposed to a relatively high concentration of hormone locally, although the amount of the hormone received through the blood and placenta is little. The effect of such an amount of hormone on the foetus cannot be completely ruled out, but to date, there is no evidence of birth defects caused by a Mirena®.

A Mirena® can be used during breastfeeding. Levonorgestrel, the active ingredient of the Mirena®, has been identified in small quantities (about 0.1 %) in the breast milk of nursing women. However, there appears to be no negative effects on infant growth or development when using any progestogen-only method starting six weeks after delivery.1 A study conducted to assess the possible effects of a Mirena® on breastfeeding performance, infant growth and infant development during the first year after birth compared to a copper intrauterine device showed that 89.3 % of women using a Mirena® were still breastfeeding at 1 year, and that there were no significant differences in breastfeeding performance, or any of the infant growth or development parameters between a Mirena® and a copper containing intrauterine device.11

Important information about the Mirena® device:

Besides containing the active ingredient, levonorgestrel, a Mirena® contains the following inactive ingredients: barium sulphate, colloidal anhydrous, iron oxide, polydimethylsiloxane elastomer, silica and polyethylene. The barium sulphate makes it visible on X-rays.

The Mirena® contains retrieval threads which are transparent.

Using other medicines with a Mirena®:

Please tell your Healthcare Professional if you are taking other medicines on a regular basis, including complementary or traditional medicines, and medicines obtained without a prescription. The metabolism of levonorgestrel may be increased by concomitant use of other medicines, such as epilepsy medication (e.g. phenobarbital, phenytoin, carbamazepine) and antibiotics (e.g. rifampicin, rifabutin, nevirapine, efavirenz). Since the mechanism of action of a Mirena® is mainly local, this is not believed to have major importance for the contraceptive efficacy of a Mirena®.1

How long has the Mirena® been available?

For more than 20 years.

Research commenced in 1970. The Mirena® became available to the general public for the first time in Finland in 1990 and it has been available in South Africa since June 1999.

Where can I buy a Mirena®?

You can purchase a Mirena® from most pharmacies on presentation of a prescription from a registered healthcare professional. While most leading pharmacies will carry stock, it is advisable to contact your pharmacy and check.

The Mirena® is also available from certain healthcare professionals’ practices.

Does medical aid pay for a Mirena®?
Reimbursement for a Mirena® is dependent on the indication for which it’s being used and varies from scheme to scheme.  Contact your medical aid to establish if they offer any medical cover for contraception.

For the indication for idiopathic Heavy Menstrual Bleeding (HMB) certain schemes may pay a portion of the consultation, insertion procedure and device. It’s advisable to contact your medical aid prior to insertion and discuss whether pre-authorization is required and from which benefit it will be covered.

 

 

INSERTION PROCEDURE

YOUR HEALTHCARE PROFESSIONAL WILL INSERT A MIRENA® IN 5 STEPS4,18 

  1. Measure uterus with the sound
  2. PUSH to load and position Mirena®
  3. Advance inserter until flange is 1,5-2 cm from cervix
  4. Pull slider to the mark, insert until flange touches cervix
  5. Pull slider all the way back, remove inserter and cut the threads 2-3 cm

 

WHEN IS A MIRENA® DUE FOR REPLACEMENT?

A MIRENA® IS DUE FOR REPLACEMENT FIVE YEARS AFTER INSERTION.1

To make it easier to remind yourself when your Mirena® should be removed or replaced please make a note of the following information and place the provided card somewhere safe. You can also record the information on this page in the area under the card:

REMINDER CARD

 

Brought to you by Bayer, in the interest of women’s health


  1. Mirena® patient information leaflet. February 2019.
  2. Centers for Disease Control and Prevention. U.S. Selected Practice Recommendations for Contraceptive Use, 2013.
    Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition. Morbidity
    and Mortality Weekly Report Early Release 2013;62:1-60.
  3. Varila E, Wahlström T, Rauramo I. A 5-year follow-up study on the use of a levonorgestrel intrauterine system in women receiving
    hormone replacement therapy. Fertil Steril 2001;76:969–73
  4. Mirena® approved package insert. February 2019.
  5. Luukainen T. Levonorgestrel-Releasing Intrauterine Device. Ann New York Acad Sci 1991:43-49.
  6. National Institute for Health and Clinical Excellence Guideline CG30. Long-acting reversible contraception: the effective and
    appropriate use of long-acting reversible contraception. [online] October 2005 [cited] 30 June 2016. Available from URL: https://
    www.nice.org.uk/Guidance/CG30.
  7. The ESHRE Capri Workshop Group. Intrauterine devices and intrauterine systems. Human Reproduction Update 2008;14(3):197-208.
  8. Marret H, Fauconnier A, Chabbert-Buffet N, et al, on behalf of the CNGOF. Clinical practice guidelines on menorrhagia: Management of abnormal uterine bleeding before menopause. Eur J Obstet Gynecol Reprod Biol 2010;152:133–7.
  9. Sitruk-Ware R, Inki P. The levonorgestrel intrauterine system: long-term contraception and therapeutic effects. Women’s Health
    2005;1(2):171-182.
  10. National Collaborating Centre for Women’s and Children’s Health. Heavy Menstrual Bleeding Clinical Guideline. London: RCOG
    Press for NICE; 2007.
  11. Shaamash AH, Sayed GH, Hussien MM, et al. A comparative study of the levonorgestrel-releasing intrauterine system Mirena® versus
    the Copper T380A intrauterine device during lactation: breastfeeding performance, infant growth and infant development.
    Contraception 2005;72:346-351.
  12. Guttmacher Institute. Facts on Induced Abortion Worldwide. [online] January 2012. Available from URL: http://www.guttmacher.org.
  13. Sääv I, Stephansson O, Gemzell-Danielsson K. Early versus Delayed Insertion of Intrauterine Contraception after Medical
    Abortion — A Randomized Controlled Trial. PLoS ONE 2012;7(11):e48948.
  14. WHO Medical eligibility criteria for contraceptive use. Part II. Using the recommendations. Available from URL: www.who.int/ reproductivehealth/publications/family_planning/MEC-5.
  15. Wildemeersch D, Schacht E, Wildemeersch P. Contraception and treatment in the perimenopause with a novel “frameless”
    intrauterine levonorgestrel-releasing drug delivery system: an extended pilot study. Contraception 2002;66:93-99.
  16. Delvin D. The IUS (Mirena, Levosert and Jaydess) [online] February 2016 [cited] 14 July 2016. Available from URL: http://www.netdoctor.co.uk/conditions/sexualhealth/a2214/the-ius-mirenaand-jaydess.
  17. Post-adolescent acne: a review of clinical features. British Journal of Dermatology. 1997;136(1): 66-70.
  18. Mirena® insertion instructions. Dated 1999.
  19. Bahamondes MV, Monteiro I, Castro S et al. Prospective study of the forearm bone mineral density of long-term users of the levonorgestrel-releasing intrauterine system. Human Reproduction 2010;25(5): 1158–1164.
  20. WHO – Department of Reproductive Health and Research. Provider brief (2007): Hormonal Contraception and Bone Health. www.who.int/reproductive-health.
  21. Lopez LM, Grimes DA, Schulz KF, Curtis KM, Chen M. Steroidal contraceptives: effect on bone fractures in women. Cochrane Database of Systematic Reviews 2014, Issue 6. Art. No.: CD006033. DOI: 10.1002/14651858.CD006033.pub5.
  22. Mansour, D. The benefits and risks of using a levonorgestrelreleasing intrauterine system for contraception. Contraception 85 (2012) 224–234.
  23. Ebede, TL, Arch EL, Berson D. Hormonal Treatment of Acne in Women. J Clin Aesthetic Dermatol. 2009;2(12):16–22.
  24. Andersson K, Odlind V, Rybo G. Levonorgestrelreleasing and copper-releasing (Nova T) IUDs during five years of use: a randomised comparative trial. Contraception 1994;49:56–72.

Approval number : PP-MIR-ZA-0059-1

For more health information

Click on the body area you want to know more about. Select a related health topic from the menu

Select a body area
Head
Chest
Abdomen
Pelvis
Legs
Feet
Mental Health
Skin
General
Infant Health
HIV 11 – HIV and Opportunistic infections
HIV 11 – HIV and Opportunistic infections
Doctors were first alerted to the existence of AIDS when patients clinically presented with opportunistic ....
Acne
Acne
What is acne? Acne is a common skin condition that causes pimples on the face, neck, shoulders, chest and back.1a Acne can be emotionally stressful ....