Here you will find all answers to frequently asked questions about the IUB™ Ballerine®. The following information does not replace the patient information leaflet, which entails important details about what to consider when using this medical device, in what circumstances it must not be used and which side effects can occur.
What is the hormone-free IUB Ballerine?
Hormone-free high-tech-contraception for 5 years. The IUB™ Ballerine® is a birth control method that requires no hormones and is effective for up to 5 years. The IUB™ Ballerine® works locally along the same principle as other intrauterine devices and prevents pregnancy. The contraceptive effect comes mainly from the copper.
How does the IUB Ballerine work?
As soon as the IUB™ Ballerine® is inserted in your uterus, it starts releasing small amounts of copper to provide continuous birth control for up to 5 years. The method of action is similar to standard copper intrauterine devices.
It is believed that copper IUDs achieve their primary contraceptive effect by interference with sperm motility and fertilization of an egg, and possibly prevention of implantation.
How reliable is the IUB Ballerine?
The efficacy of the IUB™ Ballerine® is over 99%2 in pregnancy prevention.
Can you feel the IUB Ballerine during intercourse?
During sexual intercourse you and your partner should not feel the IUB™ Ballerine® when inserted correctly. If you or your partner can feel the strings, your health care provider can shorten them.
When & where is the IUB Ballerine inserted?
The hormone-free IUB™ Ballerine® is inserted in your uterus during an office visit after an individual consultation by your doctor. Your doctor first examines you to find the position of your uterus.
After measuring your uterus, the IUB™ Ballerine® is carefully inserted through a thin tube. The tube is removed and the IUB™ Ballerine® remains inside your uterus where it finds its ideal position and becomes active immediately. Two threads extend into your vagina. The threads are trimmed to minimize discomfort.
The best time for the placement is during your menstruation when the cervix is more open and the possibility of being pregnant is low. Two months after the placement, a check up examination should be done. After that, a yearly check-up with your health care provider is recommended.
Does the insertion hurt?
The placement of the IUB™ Ballerine® can be painful especially if the cervix is very tight. You can ask your doctor to use pain medication 1 hour prior to the insertion.
Immediately after insertion, cramping or menstrual type bleeding can occur. Some women feel faint, nauseated, or dizzy for a few minutes afterwards. No grounds for worry – the uterus needs time to adapt to the new situation. Any pain usually subsides quickly. Should pain continue, please consult your health care provider.
What side effects can occur?
After placement of the IUB™ Ballerine® heavier, longer periods and spotting between periods can occur – most of these side effects diminish after 2-3 months. Once your uterus gets used to the IUB™ Ballerine® these side effects should occur less frequently.
Rarely, the IUB™ Ballerine® goes through the wall of the uterus, especially during placement. This is called perforation. If the IUB™ Ballerine® perforates the uterus, it should be removed. Surgery may be needed. If the IUB™ Ballerine® perforates the uterus, you are notprotected from pregnancy.
The IUB™ Ballerine® may partially or completely fall out of the uterus. This is called expulsion. Women who have never been pregnant may be more likely to expel the IUB™ Ballerine® than women who have been pregnant before.
Please refer to the patient information leaflet for the full list of possible side effects that can occur.
Who should not use the IUB Ballerine?
You should not use the IUB™ Ballerine® if you:
- might be pregnant.
- have an abnormally shaped uterus.
- have a pelvic infection called pelvic inflammatory disease (PID) or have current behavior that puts you at high risk of PID (for example, because you or your partner are having sexual intercourse with multiple partners).
- have had an infection in your uterus after a pregnancy or abortion in the past 3 months.
- have cancer of the uterus or cervix.
- have unexplained bleeding from your vagina.
- have an infection in your cervix.
- have Wilson’s disease (a disorder in how the body handles copper).
- are allergic to any of the IUB™ Ballerine®’s materials (copper, nickel, titanium, PET and polypropylene).
- already have an intrauterine contraceptive in your uterus.
Important information
Contact your doctor if you:
- think you are pregnant
- have pelvic pain or you or your partner feel pain during sexual intercourse
- have unusual vaginal discharge or genital sores
- have unexplained fever
- might have been exposed to sexually transmitted diseases (STDs)
- can feel any other part of the IUB™ Ballerine® besides the threads
- become HIV positive or your partner becomes HIV positive
- have severe or prolonged vaginal bleeding
- miss a menstrual period
- The IUB™ Ballerine® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reference:
1. IUB(TM) Ballerine(R) Patient Information leaflet.
2. Real world safety & performance data for IUB™ Ballerine, OCON Medical Ltd.