Summary of Contents for Melbea MelbeaGold
- Page 1 T-shaped gold-copper alloy intrauterine contraceptive medical device INFORMATION FOR THE USER: Information for Women...
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Page 2: Table Of Contents
INFORMATION FOR WOMEN CONTENTS 0. PRELIMINARY INFORMATION 1. WHAT KIND OF PRODUCT IS MELBEAGOLD? 2. WHAT IS MELBEAGOLD COMPOSED OF? WHAT DOES IT LOOK LIKE? 3. HOW DOES THE MELBEAGOLD PRODUCT ACHIEVE ITS EFFECT? 3.1. What is the mechanism of action of the MelbeaGold product? 3.2. How effective is the MelbeaGold product? 4. IN WHAT SIZES IS MELBEAGOLD AVAILABLE? FOR WHAT UTERINE SIZES IS THE PRODUCT AVAILABLE? 5. HOW LONG CAN MELBEAGOLD BE USED AFTER INSERTION? 5.1. What is the maximum lifetime in situ of the MelbeaGold product? 5.2. What to do if you wish to continue the use of MelbeaGold products for contraceptive purposes? 5.3. What to do if you wish to stop using your MelbeaGold product before the end of its lifetime? 6. WHAT ARE THE INDICATIONS AND COUNTERINDICATIONS OF USING MELBEAGOLD? 6.1. Who and in what cases should use MelbeaGold products? 6.2. Absolute contraindications... - Page 3 9. HOW TO INSERT AND REMOVE THE MELBEAGOLD PRODUCT? 9.1. When is it recommended to insert the MelbeaGold product? 9.2. Description of the insertion technique 9.3. Description of the removal technique 10. WHAT EFFECTS CAN THE USE OF MELBEAGOLD HAVE ON THE MENSTRUATION CYCLE? 11. HOW TO VERIFY THAT THE MELBEAGOLD PRODUCT IS IN AN APPROPRIATE POSITION DURING ITS USE? 12. WHEN IS IT RECOMMENDED TO SEE A GYNAECOLOGIST FOR ROUTINE CHECK-UPS? 13. WHAT SIGNS AND SYMPTOMS INDICATE THAT YOU SHOULD UNDERGO A GYNAECOLOGICAL EXAMINATION? 14. WHAT ARE THE POSSIBLE SIDE EFFECTS THAT MAY ARISE DURING THE USE OF MELBEAGOLD? 15. MISCELLANEOUS INFORMATION 15.1. Manufacturer’s declarations 15.2. Details and contact information of the manufacturer 15.3. Version number and issue date of the document 15.4. Issue date of the first licence 15.5. CE identification number of the certification body 15.6. Description of the symbols used on the label 15.6.1. Meaning of the symbols and pictograms used by the manufacturer on the label 15.6.2. Meaning of the symbols and pictograms used by the manufacturer on the patient card...
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Page 4: Preliminary Information
1. WHAT KIND OF PRODUCT IS MELBEAGOLD? The MelbeaGold product is what is commonly known as a hormone-free copper coil, which is inserted by a gynaecologist into your uterine cavity to provide long-term protection against unwanted pregnancies. In technical language, MelbeaGold is a copper-containing medical device, which falls into the category of Intrauterine Contraceptive Devices abbreviated as IUD or IUCD). MelbeaGold does not protect against HIV infections (AIDS) or any other sexually transmitted infections (STIs)! 2. WHAT IS MELBEAGOLD COMPOSED OF? WHAT DOES IT LOOK... -
Page 5: How Effective Is The Melbeagold Product
The most effective methods can be found at the end/bottom of the table. The square found at the beginning/top of the table shows the chance of pregnancy in the case of women who do not use contraceptive methods/ devices and are actively trying to become pregnant. The Pearl Index value of intercourse without protection is 85 ( that is out of 100 women, 85 becomes pregnant ). In comparison, in the case of the typical use of copper-containing IUDs ( such as the MelbeaGold product ), which fall in the category of methods, the Pearl Index value is 0.8. This means that in the first year, out of 100 women, less than 1 become pregnant. Table No. 1 – Effectiveness of various contraceptive methods and the associated risk of pregnancy Percentage of cases where pregnancy occurs Over the course of 1 year *... -
Page 6: In What Sizes Is Melbeagold Available? For What Uterine Sizes Is The Product Available
Since the Pearl Index value of copper-containing IUDs is between 0.2 and 0.8, the possibility of pregnancy must be taken into account even when using such contraceptive devices. 4. IN WHAT SIZES IS MELBEAGOLD AVAILABLE? FOR WHAT UTERINE SIZES IS THE PRODUCT AVAILABLE? Based on the size of the uterus, your gynaecologist or your health care service provider can easily select the one most suitable for you from the mini, short, and standard size variations of the MelbeaGold coil (see: Figure No. 1). Figure No. 1 - the shapes, sizes, and ratios of the 3 size variations of the MelbeaGold product 32 mm 32 mm 24 mm 33 mm 26 mm... -
Page 7: Absolute Contraindications
• you are looking for a contraceptive method that does not contain hormones, • your current health conditions do not preclude the use of such a product (see the contraindications under Sections 6.2 and 6.3). There are health conditions in the case of which the use of copper-containing coils is contraindicated. Either because it would not be safe or because there is currently insufficient information about how safe it would be. In the case of the presence or suspected presence of certain medical conditions, the use of a copper-containing IUD, such as MelbeaGold, is contraindicated (see absolute contraindications ). In the case of the presence of certain other conditions, your gynaecologist or health care service provider may decide, having consulted you whether MelbeaGold can be used and the insertion implemented, after which you may agree to the insertion of the device at your own responsibility in spite of the heightened risks (see relative contraindications ). 6.2. Absolute contraindications The MelbeaGold product must not be inserted in the following cases: »... -
Page 8: Relative Contraindications
» Conditions associated with increased susceptibility to pelvic infections, » Women of childbearing potential who have not yet given birth (including virgin women). Taking the above into account, please inform your gynaecologist or healthcare service provider if any one of the above health conditions applies to you and if you have recently given birth or you are currently breastfeeding. 7. WHAT WARNINGS SHOULD BE TAKEN INTO ACCOUNT WHILE USING MELBEAGOLD? – Your gynaecologist or health care service provider will give you a guide titled “Information for women”. Please carefully read and understand this guide. – Please retain the “Information for women” guide and the “Patient Card” filled out by your gynaecologist or health care service provider. After you are given this card, please verify that all fields have been filled out before leaving the medical facility. – Medical devices are sometimes used for purposes not listed on the information leaflet among the indications of the manufacturer or used in spite of the existence of a relative contraindicated condition. Please request further information from your gynaecologist or healthcare service provider regarding the product details included in the user instructions intended for medical professionals. – MelbeaGold is a single-use device which comes in a sterile packaging; the device must not be reused! – The insertion and removal procedures may cause slight pain or bleeding. The procedures may trigger fainting in the case of patients suffering from circulatory disorders and seizures in the case of patients suffering from epilepsy. -
Page 9: What Potential Interactions And Incompatibilities Are Known Between Melbeagold And Other Medical Treatments And Medications
Before insertion, it is recommended to perform a test to confirm that you are not allergic to copper, nickel, or plastics. – You may use tampons while wearing the MelbeaGold device. – The warnings related to the use of medications, other devices, and medical treatments while wearing the MelbeaGold device are included in Section 8. – Your doctor will inform you how you can check the presence of the indicator string in your vagina; further details are included in Section 11. – The warnings related to the possible side effects you may experience while wearing the MelbeaGold device are included in Section 14. 8. WHAT POTENTIAL INTERACTIONS AND INCOMPATIBILITIES ARE KNOWN BETWEEN MELBEAGOLD AND OTHER MEDICAL TREATMENTS AND MEDICATIONS? 8.1. Interactions with medications and other devices The MelbeaGold device and the equivalent Goldlily device have not undergone an interaction study to identify possible interactions between the medical devices and other treatments, medications, and devices. Experience and the relevant scientific literature have shown that a reduction in the effectiveness of copper-containing IUDs as a result of the use of medication is unlikely. However, notices contain information about a reduction in the effectiveness of copper-containing IUDs as a result of the long-term use of non-steroidal anti-inflammatory drugs (acetylsalicylic acid in particular) as well as corticosteroids. -
Page 10: How To Insert And Remove The Melbeagold Product
Make sure to inform your health care service provider that you have a copper-containing intrauterine device (MelbeaGold) inserted if they are planning to perform a short-wave treatment of the pelvic region, such as diathermy, on you. Do not consent to such thermotherapy procedures while the MelbeaGold device is within your uterus. – The use of the MelbeaGold product in an MR environment may pose a risk! The MelbeaGold device and the equivalent Goldlily device have not undergone testing to establish whether a magnetic resonance (MR) environment may cause such devices to heat up or become dislodged and it has not been tested to what extent the assessment of the data obtained during the imaging process may be affected by such devices. However, based on data from scientific literature and non-clinical studies, IUDs with copper-gold alloy wires are safe to use at specific MR values, their shape and materials are not damaged or distorted, the devices do not become dislodged, they do not heat up, or damage their environment. Before undergoing an MRI procedure, please inform your health care service provider that a copper-containing intrauterine device (MelbeaGold) is within your uterus. If the MRI system does not generate more than 3.0 T and the process does not take more than 15 minutes, the removal of IUDs containing copper or a copper-gold alloy is not required. In the case of other MR imaging parameters, you must consult with the physician conducting the examination and decide whether to remove the device prior to the procedure, to use a different imaging method, or to perform the imaging procedure with great care, under supervision, and at your own risk. 9. HOW TO INSERT AND REMOVE THE MELBEAGOLD PRODUCT? Before insertion, you must become familiar with the mechanism of action of the MelbeaGold device, the risk posed by its use, the possible side effects and their frequency, the possible time of their onset, and the relevant symptoms and consequences. You must undergo a gynaecological examination which includes abdominal ultrasound and a cervical smear test as well. The possibility of pregnancy, lower body infections, and sexually transmitted diseases must be excluded. It must be established whether you have any conditions which may fall within the scope of contraindications. Please inform your gynaecologist or health care service provider whether you use any other contraceptive methods or devices ( e.g. whether you already... -
Page 11: Description Of The Insertion Technique
9.2. Description of the insertion technique Your gynaecologist or health care service provider will use an antiseptic solution to clean your vagina and cervix then measures the length of your uterus. After this, the medical professional will slide a plastic tube containing the MelbeaGold product into your uterus via the vagina and the cervix. Due to the small diameter of the insertion tube, cervical dilation is not required. When the MelbeaGold device enters your uterus, you might experience cramps or a stinging sensation. Bleeding is also possible. Your gynaecologist or health care service provider will remove the insertion tube, leaving the MelbeaGold device in your uterus. Two threads of the blue indicator string will extend into your vagina. The threads will be cut so that they will be just long enough to allow you to feel them with your fingers during a self-check. If the device is pulled into the insertion tube and inserted in accordance with the steps specified in the user instructions for medical professionals, the correctly positioned T-shaped MelbeaGold device will be located in your uterine cavity near the fundus. The two arms of the product will be fully open on both sides, extending toward the uterine horns. The body of the IUD, together with the indicator string exiting via the cervix, will extend into the lower portion of the uterine cavity to a smaller extent. DEVICE (IUD) Figure No. 2 – The position of the MelbeaGold product in the uterine cavity (not to scale) -
Page 12: Description Of The Removal Technique
9.3. Description of the removal technique – The most suitable time for the removal of a MelbeaGold product is during menstruation. – The MelbeaGold product is removed by gently pulling on the body of the device while holding both threads of the indicator string. The indicator string has to be held with a suitable tool ( e.g. sponge forceps ) and carefully pulled out in the direction of the longitudinal axis of the uterus. As soon as the IUD appears in the cervix, grip the device with the sponge forceps and continue pulling it until the entirety of the MelbeaGold product has been removed. Do not continue pulling the device by the indicator string until it is completely removed since the string can snap and the end of the device body may cause injury to the walls of the reproductive organs if it is being pulled at an angle. – If the strings are not visible but the MelbeaGold device is still in the uterus, the removal must be postponed until the next menstruation. When bleeding has ceased, the double threads of the indicator string generally become visible again. If the indicator string is still not visible and the MelbeaGold device is still in the uterus, the device can be removed using a pair of thin forceps. – Following the inspection of the removed MelbeaGold device by the gynaecologist and if required, the taking of photographs or the recording of video footage, the gynaecologist must ensure that the device, which is considered infectious hazardous waste after removal, is placed in a marked container, and disposed of as required. 10. W HAT EFFECTS CAN THE USE OF MELBEAGOLD HAVE ON THE MENSTRUATION CYCLE? The first menstrual cycles following insertion generally differ from previous cycles. The menses might be more abundant, heavier and might last longer; you might also experience intermenstrual bleeding or abdominal cramps. -
Page 13: When Is It Recommended To See A Gynaecologist For Routine Check-Ups
), you will be informed of this by your gynaecologist or healthcare service provider. 13. W HAT SIGNS AND SYMPTOMS INDICATE THAT YOU SHOULD UNDERGO A GYNAECOLOGICAL EXAMINATION? Always contact your gynaecologist or healthcare service provider if • you believe that you are pregnant, • you are experiencing pelvic pain or you experience pain during intercourse, • you are noticing unusual vaginal discharge or genital sores, • you are experiencing unexplained fever, flu-like symptoms, or body chills, • you might be exposed to sexually transmitted infections, • you are concerned that the MelbeaGold was rejected ( “came out ”), or became broken (part of it was expelled), • you cannot feel the indicator strings of the MelbeaGold device or you feel them to be significantly longer than usual, • you can feel any part of the MelbeaGold device in the vagina beside the indicator string, • you or your partner are found to be HIV positive, • you are experiencing prolonged or heavy bleeding or any kind of bleeding that worries you, • you missed a menstrual cycle. With respect to the background of the clinical symptoms and disorders listed here, further clarification is provided in other chapters and sections of the information leaflet. - Page 14 – Visit your doctor if your menstrual cycle is delayed since it is rare but possible to develop both intrauterine and ectopic pregnancy even in spite of using the MelbeaGold device. In the event of pregnancy, the MelbeaGold product must be removed by the end of the third month if the indicator string is visible. The removal of the MelbeaGold device during pregnancy may lead to abortion. Your gynaecologist or health care service provider will offer to abort the pregnancy due to the increased risk of pelvic inflammatory disease and other severe complications in such cases, including labour pains, miscarriage, sepsis, and death. If you decide to carry the pregnancy to term or the MelbeaGold device can no longer be removed ( your pregnancy is in an advanced stage ), you have to be informed in detail of the risks caused by the presence of a MelbeaGold device which was not removed. The risk of miscarriage is significantly higher in such cases than when the coil is removed and you will require especially extensive prenatal care. If you decide to carry the pregnancy to term, visit your doctor regularly. Immediately contact or visit your gynaecologist or healthcare service provider if you are experiencing any of the following symptoms: – you experience flu-like symptoms, fever, body chills, cramps, pain, bleeding, vaginal discharge, or fluid seeping from the vagina during pregnancy. These could be signs of an infection. – If the entirety of the MelbeaGold device is expelled from your uterus, the device ceases to provide contraceptive protection. The risk of pregnancy is present even in the case of a partial expulsion. Visit your doctor immediately. If the rejected device or a part of it is available, present it to your doctor for inspection. The MelbeaGold device so removed must be considered potentially infectious material; accordingly, you must ensure that it is taken to your gynaecologist or healthcare service provider in appropriately sealed, leakage-free packaging. Following the inspection of the removed MelbeaGold device by the gynaecologist and if required, the taking of photographs or the recording...
- Page 15 – After the removal or spontaneous expulsion of the product, check the MelbeaGold device to verify that neither of its arms remained in the uterine cavity, the wire is not damaged or fractured, and the device as a whole is undamaged. If the MelbeaGold device was damaged ( became broken ) in the uterus, its position has to be established using hysteroscopy, ultrasound, or X-ray imaging; surgical intervention might be necessary. – Call your gynaecologist or health care service provider if the heavier bleeding typical after the insertion becomes more severe or prolonged or the spotting bleeding continues. – Visit your doctor if you or your partner experience pain during intercourse. Neither you nor your partner is supposed to feel the MelbeaGold product during intercourse. The MelbeaGold product is inserted into the uterine cavity, not the vagina. It is possible for your partner to feel the double ends of the indicator string during intercourse. – Please inform your gynaecologist or health care service provider of any side effects that bother you as well as of any persistent side effects. Ask your doctor about side effects. You or your doctor may report side effects to the manufacturer directly or using the dedicated medical device vigilance system. In such cases, the device should be retained by your gynaecologist or healthcare service provider in the manner required in the case of infectious materials or at least take photographs or record video footage in order to facilitate a successful investigation by the manufacturer and/or the certification body or the competent authorities. Experiencing a known side effect does not mean that the product is faulty. – Immediately notify your gynaecologist or healthcare service provider if you are experiencing any of the following symptoms: – lower abdominal or pelvic pain, odourless discharge, unusual...
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Page 16: What Are The Possible Side Effects That May Arise During The Use Of Melbeagold
– Redness, itching, swelling, flaky, dehydrated skin. Over a longer period, the skin may become thicker and may develop cracks and keratosis. Other symptoms may also occur, such as respiratory problems. These might be caused by the copper released by the MelbeaGold product. If you did not experience these symptoms before insertion, you should definitely have yourself tested for copper allergy. If you are allergic to copper, the product must be removed ( contraindication ). The risk of developing a copper allergy is low since pure copper is typically non-allergenic. The alloy used in the MelbeaGold device consists of high purity copper and gold. – If you have any questions beside the above or you are uncertain about any symptoms, please contact your gynaecologist or health care service provider. 14. WHAT ARE THE POSSIBLE SIDE EFFECTS THAT MAY ARISE DURING THE USE OF MELBEAGOLD? The known side effects caused by the MelbeaGold product are the followings: – pregnancy, – rejection (complete or partial), – uterine perforation (complete or partial perforation or implantation), – breakage of the device, – anaemia (low red blood cell count), – pain during intercourse, – spotting or heavy bleeding, bloodstains, – prolonged menstrual periods, – painful menstrual periods, including cramps, – vaginal irritation or discharge, –... - Page 17 It is possible to develop a life-threatening infection in the first few days following the insertion of the MelbeaGold device, the symptoms of which may be fever, body chills, and pain. – Acute pelvic inflammatory disease (PID), endometritis, and actinomycosis In the case of some IUD users, a serious pelvic inflammatory disease (PID) or endometritis may develop, which are usually sexually transmitted. PID is an infection of the uterus, the fallopian tubes, and the adjacent organs. Among the types of human actinomycosis, pelvic actinomycosis is a very rare disease, which is known to be associated with intrauterine, including copper-containing, contraceptive devices and involves an infection that spreads downward from the uterus. In the case of MelbeaGold, it is most likely to occur in the first week following insertion, accompanied by fever, pain, and bleeding. It is hypothesised that the disease is caused by microorganisms entering the uterine cavity during the insertion process and causing an infection. During insertion, your gynaecologist or health care service provider must strictly follow the steps of the aseptic insertion technique in order to prevent and avoid infection. Women who have suffered from PID or endometritis are exposed to a higher risk of reinfection. The probability of developing PID or endometritis is also higher if you or your partner have multiple sexual partners. PID, endometritis, and actinomycosis are treated with antibiotics; in the case of more serious cases, surgery, or the removal of the womb (hysterectomy) might be necessary. In the case of such infections, the MelbeaGold product must be removed. PID might cause serious problems such as infertility, an ectopic pregnancy, and chronic pelvic pain. PID may also develop without symptoms! In rare cases, PID might cause death. – Rejection The MelbeaGold device may spontaneously become dislodged and fully or partially exit the uterus by itself. You are not protected against pregnancy if the MelbeaGold device was rejected. Rejection occurs in 1-2 cases out of 100 women. A significant precursor to rejection is the device becoming dislodged due to the strong cramps or low-intensity but frequent contractions of the uterus. In addition to rejection, these uterine contractions may also cause the spontaneous breaking of the device or lead to the device becoming dislodged and being ejected through the breaking of the product.
- Page 18 In the case of perforation, the MelbeaGold device may cause internal scarring, infection, damage to other organs, pain, infertility, and even death. In addition to pharmacotherapy, surgery is required to remove the MelbeaGold device and treat any damaged organs. In the case of breastfeeding women, women who have not given birth, and women who have recently given birth, the risk of perforation is higher when inserting the MelbeaGold device. If the device size is selected incorrectly, this may also cause perforation. The probability of perforation is higher in the case of women with abnormal ( retroverted ) uteri or immobile uteri due to adhesions ( e.g. caused by endometriosis ). The uterine wall may be perforated by the physician during the insertion or removal of the device (iatrogenic perforation) or at any time during or after insertion due to forces caused by sudden and strong or weaker but repeated uterine contractions (spontaneous perforation). Id diagnosed early, the complications of perforation may be treated with medication or surgery; fertility generally remains unaffected in such cases. The MelbeaGold product must be removed. – Implantation In rare cases, the implantation of the device into the uterine wall may make removal more difficult. In such cases, surgery might be required. – Breaking of the product In rare cases, the breaking of the MelbeaGold and pieces remaining in the uterine cavity may make removal more difficult. In such cases, surgery might be required. It is also possible that surgery will not be required since all pieces of the product are rejected either at the time of breaking or sometime afterwards. – Changes to the menstrual cycle You might experience heavier or longer menstrual cycles or spotting during your period. Bleeding occasionally becomes heavier after insertion. In abnormal cases, this bleeding may become even heavier and prolonged; the number of bloodstains may increase. – Unique arousal symptoms during the insertion or removal of the device...
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Page 19: Miscellaneous Information
15. M ISCELLANEOUS INFORMATION 15.1. Manufacturer’s Declarations The manufacturer declares that MelbeaGold ( device and accessories ) do not contain the following: – materials, tissues, products of animal origin, – human blood derivatives or products containing human blood derivatives, – carcinogenic, mutagenic, teratogenic materials, including phthalates, and products containing such materials, – radioactive materials, GMOs, or products containing such materials, – natural latex rubber or materials containing natural latex rubber. The manufacturer declares that the packaging of MelbeaGold does not contain the following: radioactive material. 15.2. Data and contact details of the manufacturer MELBEA Innovations Kft. H-6600 Szentes, Bese László u. 8. (Hungary) www.melbea.com 15.3. Version number and issue date of the document vMG-26.11.2020-EN, v03 15.4. Issue date of the first licence 18.07.2014 15.5. CE identification number of the certification body 2409 15.6. Description of the symbols used on the label 15.6.1 Meaning of the symbols and pictograms used by the... -
Page 20: Meaning Of The Symbols And Pictograms Used By The Manufacturer On The Patient Card
Do not use product if damaged. Fragile. handle with care. Manufacturer Contact details of the manufacturer MR conditional The label contains the identification number of the label (see: LS-xxx ), its version number (see: vMG-xx.yy.zzzz ), a code indicating the size variation of the device, as well as the country code of the language used ( e.g.: HU-ST refers to the Hungarian version and the standard size variation of the product ). 15.6.2 Meaning of the symbols and pictograms used by the manufacturer on the patient card MANUFACTURER CONTACT DETAILS OF THE MANUFACTURER PATIENT NAME PRODUCT NAME TIME AND DATE OF INSERTION NAME OF INSERTING PHYSICIAN/INSTITUTION...
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