Faq's

SMB Cu 375 is an IUD, an intra uterine device, used for contraception. It is a small plastic rod, called stem, with two small flexible side-arms with spurs. The plastic is a mixture of LDPE and barium sulphate in a weight ratio of 80 + 20. A copper wire is wound around the stem. A nylon thread with two ends is attached to the bottom end of the stem

SMB Cu 375 is intended for single use only.

SMB-Cu 375 has a thicker copper wire, with a surface area of 375 square millimeters. It works for five years.

SMB Cu 375 is an IUD. IUD stands for 'intra-uterine (contraceptive) device': an object in the womb. An IUD does not guarantee absolute protection against pregnancy, but it is very effective. It works as soon as it is fitted.

The IUD your doctor advised you to use is Cu 375

In order to explain how it works we first would like to point out a few things.

The womb or uterus is located in the lower part of the abdomen ('tummy'), just above the pubic bone. The womb is a pear-shaped, muscular organ, slightly smaller than your fist.
The womb is joined to the cervix , and the vagina . The fallopian tubes extend from both sides of the upper part of the womb to the ovaries .
Together the ovaries, fallopian tubes, womb and vagina form the female sex organs. They are not functional until puberty.

When a woman starts having periods (menstruating) she is sexually mature. Around every four weeks a tiny egg cell (which is smaller than this . dot) ripens in one of the ovaries.
This egg cell (a) travels through the fallopian tube where it may be fertilized by a male seed cell (sperm, b in Figure 3). While the egg cell travels through the fallopian tube, the womb prepares to receive a fertilized egg. The inside of the womb is lined with mucous membrane (c) (just like the inside of your mouth). At about the time when an egg cell is ready to be fertilized, this membrane - the endometrium - becomes twice as thick as normal, and tiny blood vessels supply it with an extra quantity of blood.
If the egg cell is not fertilized, a part of the endometrium is shed after fourteen days, together with a quantity of blood: menstruation (d) takes place.
If the egg is fertilized, it travels from the fallopian tube into the womb. Here, it attaches to the mucous membrane (e), usually high up in the womb. If this happens, the mucous membrane is not shed: no menstruation takes place.


An age old method rediscovered
For more than 2000 years it has been known that pregnancy can be prevented by inserting objects into the womb, such as a pebble, a ring or a wire.
Doctors have developed a modern and reliable way of contraception based on this age-old method. An important discovery was that the reliability of IUDs is greatly improved by adding copper.
How an IUD prevents pregnancy is not exactly known yet, but it is generally believed that an IUD prevents the sperm meeting and fertilizing an egg cell.

Your doctor will take a thorough look at your medical records to find out if there is any reason why you should not use an IUD. In addition, you must tell your doctor all about your state of health.

You should not use SMB Cu 375 if any of the following applies to you :

• tumors of the womb or cervix.
• vaginal bleeding with an unknown cause.
• pregnancy or suspected pregnancy.
• an increased risk of extra-uterine (or 'ectopic') pregnancy. (That is a pregnancy in which a fertilized egg does not implant in the womb, but for instance in a fallopian tube.).
  The risk is higher if you have had an ectopic pregnancy before, or if you have ever had an infection of the womb or the fallopian tubes (pelvic inflammatory disease, PID).
• abnormalities of the womb or the cervix; many or large fibroids (benign growths of the uterine wall) together with very heavy menstrual periods. endometriosis (growth of uterine tissue outside the womb or fallopian tubes).
• an infection of the reproductive organs, with the exception of candidiasis (the latter is an infection caused by the skin fungus Candida albicans).
• a sexually transmitted disease during the past 12 months (with the exception of vaginal infections caused by bacteria, candidiasis, or infections caused by the herpes virus, the hepatitis B virus, or the cytomegalovirus).
• an infected miscarriage or abortion in the past 3 months.
• PID (pelvic inflammatory disease, infection of the womb or the fallopian tubes), or if you suffer repeatedly from PID.
• an allergy to copper.

IUDs DO NOT protect against HIV infection (AIDS) or any other sexually transmitted disease.

General notes
You should be informed by your doctor on all aspects of SMB Cu 375 including those concerning your health and future fertility.
Your doctor should arrange regular check-ups for you.
Contact your doctor about any changes in your state of health, which you think may be due to the use of SMB Cu 375
Tell any doctor you consult that you are using an IUD.

SMB Cu 375 and other medicines
Some medicines may prevent Cu 375 from working properly. This can lead to decrease in contraceptive efficacy. This is the case for medicines that suppress the immune system (for instance given to prevent rejection of a graft after transplantation), corticosteroids, and 'nonsteroidal anti-inflammatory drugs' (NSAIDs) including painkillers such as aspirin. If you need longlasting intensive treatment with any of these medicines, another method of contraception might be more appropriate.
If you have to undergo intensive treatment with any of these medicines on occasion, during these periods you should take additional protective measures (for example by using a condom).
There are also indications that tetracycline antibiotics may hinder the working of an IUD.
Always tell your doctor or dentist who prescribes another medicine that you use SMB Cu 375. He/she can tell you if need to take additional contraceptive precautions and ifso, for how long.

SMB Cu 375 and other treatments
When you have microwave, shortwave or diathermy treatment of the lower abdomen or back, inform your (physio)therapist that you use a copper-bearing IUD.

SMB Cu 375 and breast feeding
SMB Cu 375 may be used while you are breast feeding. However, as there may be an increased risk that Cu 375 may pass the uterine wall during breast feeding, particular care should be taken. Therefore, if you wish to use SMB Cu 375 while breastfeeding, please seek the advice of your doctor.

SMB Cu 375 and pregnancy
Even when using an IUD, there is still a very slight chance that you become pregnant. If this happens, pregnancy could lead to serious complications. So you should contact your doctor if your period is two weeks or more late. The IUD should be removed as soon as pregnancy is established. Sometimes, removing the IUD leads to a miscarriage.
If you insist on continuing the pregnancy without removal of the IUD, you ought to be referred to a gynaecologist. This because such a pregnancy requires a good medical support. You must tell your doctor immediately if you have complaints such as flu, fever, cramping or pain in your tummy, pain during intercourse and vaginal bleeding or discharge.
If you do get pregnant with the IUD in place, there is a chance of having an extra-uterine pregnancy (a fertilized egg not implanting in the womb, but for instance in a fallopian tube). Although a copper loaded IUD protects also against extra-uterine (ectopic) pregnancies, it protects better against a normal pregnancy. An extrauterine pregnancy is a serious condition, which needs urgent medical attention
Some signs of an ectopic pregnancy are:

• your period is two or more weeks late.
• severe one-sided lower abdominal pain with or without vaginal bleeding.
• shoulder tip pain
• dizziness or fainting.

You must tell your doctor immediately if you have any of these signs.

SMB Cu 375 and the ability to drive and use machines
It is unlikely that SMB Cu 375 affects the ability to drive and the capability to use machines.

You should have extra check-ups by your doctor if any of the following apply to you:

• Valvular heart disease. The use of an IUD may increase the risk of a bacterial inflammation of the inside lining of the heart (endocarditis). To prevent this, treatment with antibiotics should be given on inserting or removing the IUD.
• Anaemia, or a history of severe uterine bleeding;
• if you have a blood clotting disorder, or if you are using medicines that interfere with blood clotting (anti-coagulants);
• painful or irregular menstruation;
• uterine scars from perforation, or from surgery (other than caesarean section);
• small fibroids (benign growths of the uterine wall), polyps (benign growths of the uterine mucous membrane), or endometriosis (growth of uterine tissue outside the womb or fallopian tubes);
• a disorder of the copper metabolism (that is the way in which your body takes up and excretes copper), for instance Wilson's disease;
• an infection of the lower genital tract (cervix and vagina), or if you suffer from that repeatedly;
• sexual contact with multiple partners and unsafe sexual habits do increase the risk of PID. So tell your doctor if you or your partner have other sexual partners.

How should SMB Cu 375 be inserted
SMB Cu 375 has to be inserted by a doctor. After examining your womb to determine its position, size and condition, an instrument called 'speculum' is inserted into your vagina (as for a smear test) and the cervix and vagina are cleaned with antiseptic lotion.

The womb is held steady while its length is measured.
Your doctor uses a thin plastic tube to insert Cu 375 into your womb. After insertion , the two threads reach into the top of the vagina (see Figures 4 and 5) so that you can check if it is still in place. Your doctor will show you how to do this.

These pictures show how SMB Cu 375 is inserted

• The flexibility of SMB Cu 375 allows it to go through the cervix easily.
• This picture shows Cu 375 when completely inserted into the womb.
• After the removal of the insertion tube SMB Cu 375 is left high in the womb.

How can you check whether SMB Cu 375 is still in place
Neither you nor your partner should feel Cu 375 during intercourse. If you do, tell your doctor.
Sometimes an IUD is pushed out of the womb into the vagina ('expulsion'). Your womb remains slightly open during your menstrual period, so the chance of expulsion is somewhat higher during these days. Always check your sanitary towel or tampon before disposing of it. (Menstrual tampons can be freely used.)

Make sure after each period and at any time you have an unusual pain in your abdomen during your period, that you do feel the threads deep down in the vagina, and that you do not feel the rod sticking out of the cervix. Always wash your hands carefully before and after this examination.

If you do not feel the threads, or if you do feel the firm part of Cu 375, you should contact your doctor. Until you have been examined, use an additional form of contraception such as a condom.

How long may SMB Cu 375 be left in place
SMB Cu 375 should be replaced every five years.

To help you remember when SMB Cu 375 was inserted, and when Cu 375 must be removed at the latest, your doctor will give you a User Card that shows these data. Keep this card carefully. This card is also important in case you want to report any complaints about SMB Cu 375

If you want to become pregnant, ask your doctor to remove Cu 375

Possible complications in the beginning
Soon after Cu 375 has been fitted, you may have lower abdominal pain or cramps, but these usually get better quickly. If you have serious or persistent abdominal complaints or heavy bleeding you must tell your doctor.

Your heart rate and/or blood pressure may change during, or after insertion or removal of an IUD.

Your first, and sometimes your second menstruation may come slightly earlier than expected. These periods may last longer and be a bit more painful than usual.

In the beginning some bleeding may occur between menstrual periods. This is nothing to worry about, but mention it to your doctor during your next visit.

After two or three months everything should be back to normal again.

Occasionally complaints are reported, such as; pain in the back or legs, pain during intercourse, or itching eruptions of the skin as a result of an allergic reaction. If you notice such signs, contact your doctor immediately.

Infections of the sex organs or urinary tract
During the first weeks to months after insertion of an IUD, there is a slightly higher chance of infection of the womb and the fallopian tubes (pelvic inflammatory disease, PID). The chances of getting an infection are greater if you or your partner have other sexual partners.

Having PID can seriously affect your fertility in the future. An infection should be treated until it is completely cured. Sometimes the IUD has to be removed to ensure complete healing of the infection.

Signs of an infection of the sex organs or urinary tract are:

• flu-like complaints with a high temperature (over 38°C/100°F);
• persistent lower abdominal tenderness or pain.
• pain during or after sexual intercourse.
• prolonged or heavy menstrual bleeding.
• unpleasant-smelling vaginal discharge.

You must tell your doctor immediately if you have any of these signs.

Breakage
There have been occasional reports of the thread breaking when removing Cu 375. Very occasionally the plastic body broke. This mostly happened when Cu 375 got stuck (embedded) in the wall of the womb. Breakage or embedding may require an operation (curettage) to remove the device or pieces of it.

A shifting IUD
In rare occasions an IUD may pass the uterine wall. If this occurs an operation is required to remove the IUD and repair the uterine wall.

Don't open or damage the pouch.

in an intact package SMB Cu 375 may be stored for five years, if kept dry and below 30°C in the original carton box.

SMB Cu 375 may be inserted until the expiry date printed on the package.