Frequently Asked Questions
Image of IUB Ballerine Composition
Frequently Asked Questions
The IUB™ Ballerine® is a trusted birth control method that requires no hormones and is effective for up to 5 years.
It works locally in line with the same principle as other intrauterine devices and prevents pregnancy.
The IUB™ is intended for use by women at least 15 years of age. Contraception begins immediately after insertion.
The IUB™ is a copper-releasing device that is placed in your uterus to prevent pregnancy for up to 5 years.
It is made of a shape memory alloy (nickel and titanium) frame shaped as a 15 mm in diameter sphere. The frame is coated with polyethylene terephthalate (PET shrink tubing). Copper is placed on the frame.
Two threads made of Polypropylene are attached to the end of the frame. The threads are the only part of the IUB™ that you may feel when the IUB™ is in your uterus.
Side note: The IUB™ and its components do not contain latex.
As soon as the IUB™ Ballerine® is inserted into 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.
The IUB™ Ballerine® does not stop your ovaries from making an egg(ovulation) each month.
The efficacy of the IUB™ Ballerine® is over 99% in pregnancy prevention.
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. The correct position of the IUB™ Ballerine® can be checked with an ultrasound examination. Two threads extend into your vagina. The threads are trimmed to minimize discomfort.
The best time for the placement is during the last days of 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.
The placement of the IUB™ Ballerine® can be painful, especially if the cervix is very tight. You can ask your healthcare provider to use a local anaesthetic or a preventive pain-reducing treatment.
Immediately after insertion, cramping or menstrual type bleeding can occur. Some women feel faint, nauseated, or dizzy for a few minutes afterwards. No cause for concern – the uterus needs time to adapt to the new situation. Any pain usually subsides quickly. Should the pain continue, please consult your healthcare provider,
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 healthcare provider can shorten them.
After the 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 not protected 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.
Some web-based sources indicate expulsion rates from studies carried out with a product, the SCu380A, which has never been introduced to the market. The single study conducted using this model would not be a performance indicator of the currently marketed IUB™ as it differs in design and was subjected to lacking or substandard patient selection and insertion practices: 60% of participants had baseline heavy dysmenorrhea, menorrhagia or were post-abortion.
The IUB™ MINI (12mm IUB™ – not available in S.A) was first introduced in Austria in 2014. The MINI has a 20% smaller frame diameter at 12mm with a softer nitinol frame. Experience has demonstrated that expulsion occurred in approximately 9% of users. This figure is estimated to be the result of the smaller framed variant to be less appropriate for those with higher risk of expulsion such as those under 20y/o, prior expulsions, women with heavier menses et cetera, as well as teething effects related to insertion training. In the measured period of 1 year, the 9% expulsion rate (internal survey, including dislocated IUBs) corresponds to a rate comparable to that of other IUDs as shown in published studies, e.g. Rowe 2016, Sivin 1990 and Madden 2014, the latter found a strong relationship between higher IUD expulsion rates in users under 20y/o, at a rate of 10.5% after 12 months and 16.4% after 24 months.
The IUB™ MIDI (15mm IUB™ – available in S.A) through its larger and stiffer frame coupled with proper training specifying the importance of near-fundal deployment resulted in reduced expulsion rates, comparable or under those of current T-IUDs; the expulsion rate after 12 months is 3.7% according to real-world data. Both the MINI and MIDI are approved and available, however, OCON recommends gaining experience with the MIDI variant before using the MINI in women who could benefit from a smaller frame, primarily those with a lower expulsion risk who have experienced heavier pain and bleeding with prior IUDs.
Significant research suggests that the relative risk of pelvic inflammatory disease (PID) increases only during the first 20 days after IUD insertion and then returns to its baseline, while the absolute risk remains low. The probable cause of infections is a bacterial contamination associated with the insertion and not the IUD itself. The risk of PID in the IUD insertion is 0-2% when there is no cervical infection, and 0-5% when the infection is performed with an unrecognized infection.
For this reason, we recommend that you do not use tampons, menstrual cups and sexual intercourse in the first week after the insertion, in order to keep the risk of infection as low as possible.
The germicidal effect of copper is known since ancient times. Therefore copper is also used in door knobs for example. Also drinking water pipes are made out of copper due to its antibacterial effect.
Copper has in its pure form – and in the IUB™ only 99.99% medical copper is used – an extremely low allergy potential, very few cases of copper allergy have been reported. The presence of true copper allergies should be within a range of 1 to several hundred thousand. Another reason to not use copper IUDs is a copper storage disease, the so-called Wilson’s disease, which occurs in a frequency of 1: 200,000.
The daily intake of copper, which is an important nutrient, is far higher than that absorbed by the IUB™.
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 behaviour 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 device in your uterus.
Contact your healthcare provider 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.
Are you looking to get the IUB™ Ballerine® but would like to claim back from medical aid? No problem.The best way to claim back from your medical aid will be to purchase the IUB™ Ballerine® directly from your gynaecologist or from a pharmacy. Please do keep in mind that claiming back depends on your plan and benefits.
The following list of medical aids are one’s that can cover the IUB™ Ballerine®:
- AECI Medical Aid Society
- Barloworld Medical Scheme
- Government Employees Medical Scheme (GEMS)
- Horizon Medical Scheme
- Hosmed Medical Scheme
- MBMed Medical Aid Fund
- Medshield Namibia Health Plan
- Nedgroup Medical Aid Scheme
- Old Mutual Staff Medical Aid Fund
- Parmed Medical Aid Scheme
- SABC Medical Scheme
- South African Police Service (POLMED)
- Swaziland Medical Aid Fund (Swazimed)