Side effects of hormonal IUS

Very common side-effects (10 or more in every 100 women)

• headache
• abdominal/pelvic pain
• acne/greasy skin*
• bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent periods and absence of bleeding (see also following section on irregular and infrequent bleeding)
• ovarian cyst*
• inflammation of the external genital organs and vagina (vulvovaginitis)
• genital discharge*

Common side-effects (between 1 and 10 every 100 women)

• depressed mood/depression
• migraine
• feeling sick (nausea)
• upper genital tract infection
• painful menstruation (dysmenorrhea)
• breast pain/discomfort
• device expulsion (complete and partial) - (see the following section on expulsion)
• hair loss*
• genital discharge
• excessive body hair (hirsutism)
• vaginal discharge
• intrauterine contraceptive expelled (complete and partial)
• back pain**

Uncommon side-effects (between 1 and 10 in every 1,000 women)

• excessive body hair
• Hair Loss (Alopecia)

Rare side-effects (between 1 and 10 in every 10,000)

• perforation of the womb (uterine perforation)

* Frequency may vary between products

** Back pain is not observed with all products available to the public.

Description of selected possible side effects
Allergic reactions

Allergic reactions including rash, hives (urticaria), angioedema (characterized by sudden swelling of e.g. the eyes, mouth, throat) and blood pressure increase have been reported with similar products. The risk of perforation is increased in breast-feeding women. Cases of sepsis (very severe systemic infection, which may be fatal) have been reported following IUD insertion.

Procedural pain, procedural bleeding, insertion-related vasovagal reactions with dizziness or syncope (fainting) and seizure (fit) in epileptic patients in connection with insertion or removal procedures have been reported with similar products as well.

Extrauterine pregnancy (pregnancy outside the womb)

It is uncommon to become pregnant while using an IUS. However, if you become pregnant while using it, the risk that the pregnancy could develop outside the womb (have an extrauterine or ectopic pregnancy) is increased. Women who have already had an extrauterine pregnancy, surgery of the fallopian tubes or a pelvic infection carry a higher risk for this type of pregnancy. An extrauterine pregnancy is a serious condition, which calls for immediate medical attention (see section 2, “Warnings and precautions for signs and symptoms) and may impact future fertility.

The following signs and symptoms could mean that you may have an extrauterine pregnancy and you should see your doctor immediately (see also section “Pregnancy, breast feeding and fertility”):

• Your menstrual periods have stopped and then you start having persistent bleeding or pain
• You have pain in your lower abdomen that is severe or persistent
• You have normal signs of pregnancy, but you also have bleeding and feel dizzy.
• You have a positive pregnancy test

Irregular or infrequent bleeding

An IUS is likely to affect your menstrual cycle. It can change your menstrual periods so that you have spotting (a small amount of bleeding), shorter or longer periods, lighter or heavier bleeding, or no bleeding at all.

You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first.

Overall, you are likely to have a gradual reduction in the amount and number of days of bleeding each month. Some women eventually find that periods stop altogether.

The monthly thickening of the lining of the womb may not happen due to the effect of the hormone and therefore there is nothing to come or shed away as a menstrual period. It does not necessarily mean that you have reached menopause or are pregnant. Your own hormone levels usually remain normal.

When the system is removed, your period should soon return to normal.

Pelvic Infection

The IUS inserter and the IUS itself are sterile. Despite this, there is an increased risk of pelvic infection (infections in the lining of the womb or the fallopian tubes) at the time of placement and during the first 3 weeks after the placement.

Pelvic infections in IUS users are often related to the presence of sexually transmitted diseases. The risk of infection is increased if you or your partner has multiple sexual partners or if you have had pelvic inflammatory disease (PID) before.

Pelvic infections must be treated promptly.

Pelvic infections such as PID may have serious consequences and it may impair fertility and increase the risk of a future extrauterine pregnancy (pregnancy outside the womb). The IUS must be removed if you experience recurring PID or if an infection is severe or does not respond to treatment.

Expulsion

The muscular contractions of the womb during menstruation may sometimes push the IUS out of place or expel it. It is rare but possible for an IUS to come out during your menstrual period without you noticing.

It is also possible for your IUS to partially expel from your womb, meaning that it is displaced but not completely expelled (you and your partner may notice this during sexual intercourse). If the IUS is completely or partially expelled, you will not be protected from pregnancy.

Perforation

Penetration or perforation of the wall of the womb may occur rarely during placement of an IUS, although the perforation may not be detected until some time later. If an IUS becomes lodged outside the cavity of the womb, it is not effective at preventing pregnancy. You may need surgery to have the IUS removed.

The risk of perforation may be increased:

• if the IUS is placed shortly after giving birth
• in a women with the womb leaning backwards (fixed retroverted womb)
• in lactating (breast-feeding) women.

Ovarian cyst

Since the contraceptive effect of the IUS is mainly due to its local effect in the womb, ovulation (release of the egg) usually continues while using an IUS. Sometimes an ovarian cyst may develop. In most cases there are no symptoms.

An ovarian cyst may require medical attention, or more rarely surgery, but it usually disappears on its own. If you get any side effects, talk to your doctor or nurse.

Note: If any of the side-effects become serious or if you notice any side-effects not listed here, contact your doctor.

References

1. Long-acting reversible contraception - the effective and appropriate use of long-acting reversible contraception. National Collaborative Centre for Women’s and Children’s health. Commissioned by the National Institute for Health and Clinic Excellence, October 2005. Published by RCOG Press. ISBN 1-904752-18-7
2. Jaydess Singapore Patient Information Leaflet. 27 Apr 2016
3. Mirena Singapore Patient Information leaflet. 5 Mar 2014