SAFE AND HORMONE FREE BIRTH CONTROL IUB COPPER PEARLS OCON

Transcription

1 SAFE AND HORMONE FREE BIRTH CONTROL IUB COPPER PEARLS OCON

2 LONG TERM CONTRACEPTION FOR 5 YEARS Your health care provider prescribed the IUB (Intra Uterine Ball) copper pearls. In this brochure you will find answers to frequently asked questions about the hormone free contraception IUB. This brochure does not replace an individual consultation with your health care provider but serves as additional information. The following information also 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. The patient information leaflet can be downloaded at The IUB is not approved for sale in the US.

3 Comparable with standard copper intrauterine devices the IUB : is a hormone free contraceptive prevents pregnancy locally - within the uterus is effective for up to 5 years does not effect the libido and bone metabolism has no influence on the ovulation THE IUB COPPER PEARLS AT A GLANCE does not cause weight increase offers high efficacy* is an alternative to permanent sterilization an operation that can be avoided The IUB is expected to be an effective contraceptive also suitable for young women, who have not been pregnant yet. Fertility will be restored immediately after removal. Your health care provider will advice you on what birth control method is best suited for you. *comparable with oral contraceptives (pill). However, no birth control method is 100% effective.

4 Hormone free high-tech-contraception for 5 years The IUB copper pearls are a birth control method that requires no hormones and is effective for up to 5 years. The IUB works along the same principle as other intrauterine devices and prevents pregnancy locally - within the uterus. The contraceptive effect comes mainly from the copper. WHAT ARE THE HORMONE FREE COPPER PEARLS? The IUB copper pearls consist of a special shape memory alloy, which has been successfully used in medicine for a long time, e.g. in implants and stents. Several copper pearls are strung on a uterus friendly frame, coated with polymer. The spherical shaped IUB moves freely in the uterus, without sharp edges and corners. Once the flexible thread is released from the leading-in tube in the uterus it remembers its 3-dimensional past and rebuilds its round and smooth shape.

5 The uterus friendly & flexible IUB consists of the special shape memory alloy Nitinol, coated with polymer and several copper pearls. Due to this special form and material the IUB constantly finds its ideal position in the uterus. Damages and irritations will be avoided due to the high-tech design. copper pearls HIGH-TECH CONTRACEPTION FOR HER At the end of the shape there are two removal strings that serve to remove the IUB copper pearls. Worldwide unique: The use of the shape memory alloy Nitinol as carrier material in the intrauterine contraception. For many years this alloy has been successfully used in medical implants for many years. The IUB lasts for up to 5 years. shape memory alloy Nitinol removal strings vagina uterus For detailed information about the IUB please download the patient information leaflet at

6 THE 3-DIMENSIONAL IUB IUB SCu300A Intrauterine Device 12 mm IUB SCu300B Intrauterine Device 15 mm IUB SCu300C Intrauterine Device 18 mm Since the IUB is one third to a half of the size of traditional intrauterine devices, it can be inserted almost painlessly without local anesthesia. Once the IUB is placed in the uterus it forms a 3- dimensional spherical shape. The IUB is available in 3 different sizes ranging from 12 mm to 18 mm in diameter. Your doctor will advise you which size is most suitable for you. illustrations in actual size

7 As soon as the IUB is placed in your uterus, it starts releasing small amounts of copper into your uterus to provide continuous birth control for up to 5 years. HOW DO THE COPPER PEARLS WORK? The method of action is similar to standard copper intrauterine devices. The copper ions released: interfere repeatedly with the process of fertilization in the uterus limit the sperm mobility prevent sperm from fertilizing the egg prevent the egg from attaching (implanting) in the uterus The amount of copper released from the copper pearls is minimal - the average quantity of copper ingested with a normal diet is much higher than the quantity inserted to the body through the copper pearls.

8 The efficacy of the IUB copper pearls is comparable with oral contraceptives, the pill, when used correctly.* HOW SECURE ARE THE IUB COPPER PEARLS? CAN YOU FEEL THE IUB COPPER PEARLS DURING INTERCOURSE? During sexual intercourse you and your partner cannot feel the IUB when inserted correctly. From time to time the removal strings may be considered to be disturbing - your health care provider can shorten them. *however, no birth control method is 100% effective.

9 The hormone free IUB is placed in your uterus during an office visit after an individual consultation by your health care provider. Your health care provider first examines you to find the position of your uterus. After measuring your uterus, the IUB can be carefully inserted with a tube containing the IUB copper pearls. If women have not been pregnant yet, it can happen that the cervix needs to be stretched a little bit before inserting the IUB copper pearls. WHEN & WHERE IS THE IUB INSERTED? The tube is removed, leaving the IUB inside your uterus where it finds its ideal position and becomes active immediately. The correct position of the IUB can be checked with ultrasound examination. Two threads extend into your vagina. The best time for the placement is the last days of your menstruation where the cervix is open wide enough and the possibility of a pregnancy is the lowest weeks after the placement a check up examination should be done. After that a yearly check-up with your health care provider is recommended.

10 The placement of the IUB can be painful when the cervix is very tight. In this case a local anesthetic or the use of medicine that relax the muscles of the cervix are recommended. If you are pain sensitive, you can ask your health care provider for a local anaesthesia or a preventive pain-killing treatment. DOES THE INSERTION HURT? Immediately after the insertion menstruational complaints can occur. No grounds for worry - the uterus needs time to adapt to the new situation. The pain usually subsides quickly. Should the pain continue, please consult your doctor or contact him/her immediately to clarify the situation.

11 After placement of the IUB heavier, longer periods and spotting between periods can occur - most of these side effects diminish after 2-3 months. After your uterus gets used to the IUB copper pearls these side effects occur less frequently. Very occasionally the placement can cause a short fainting like it can happen when giving blood - without any further serious complications. WHAT SIDE EFFECTS CAN OCCUR? Rarely, the IUB goes through the wall of the uterus, especially during placement. This is called perforation. If the IUB perforates the uterus, it should be removed. Surgery may be needed. If the IUB perforates the uterus, you are not protected from pregnancy. The IUB 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 than women who have been pregnant before. If you can feel the threads outside of your vagina visit your doctor for a check-up. If you have questions about a side effect, check with your health care provider.

12 You should not use the IUB if you: WHO SHOULD NOT USE THE COPPER PEARLS? 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 (e.g. frequently changing sex 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 vaginal bleeding have an infection in your cervix have Wilson s disease (a disorder in how the body handles copper) are allergic to any material that is used in the IUB already have an intrauterine contraceptive in your uterus Please refer to the patient information leaflet for additional information. For detailed information about the IUB please downloaded the patient information leaflet at

13 To make sure the IUB is placed correctly it is best advised to avoid sexual intercourse or the use of vaginal tampons or menstrual cups 5 days after placement. IMPORTANT INFORMATION Contact your health care 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 be exposed to sexually transmitted diseases (STDs) cannot feel the IUB s threads or can feel the threads are much longer can feel any other part of the IUB besides the threads become HIV positive or your partner becomes HIV positive have severe or prolonged vaginal bleeding miss a menstrual period The IUB copper pearls do not protect against HIV infection (AIDS) and other sexually transmitted diseases. It is recommended to use a condom when changing sex partners frequently weeks after placement a check-up by your health care provider is recommended. The IUB should be removed after 5 years. It can be replaced with a new IUB.

14 Name and address of the patient: Decision of consent Please tick the box where appropriate and complete: O After careful consideration I wish to have the IUB copper pearls placed in the uterus. Please tick the box where appropriate and complete: Replacing of the IUB O I have read the information that has been handed to me. I will respect the rules of behavior. O In my consultation with key issues were discussed including: Choice of method, advantages and disadvantages compared with other methods, possible complications, factors that pose increased risks, behavior, check-ups, additional measures until the first check-up, as well as: O I agree with changing the IUB and do not need further information or time to consider. I know about the use of the hormone free IUB, its efficacy and possible complications that can occur. Place, Date Signature of the patient ADDITIONAL INFORMATION CAN BE FOUND AT OCON Medical Ltd. 15 Hashdera Hamerkazit, POB 552, Modiin , Israel Tel. (972) My questions were answered fully and comprehensible. I do not need any additional time for consideration. Signature of the health care provider

15 PB/EN/090215/4 OCON name and address of health care provider