Most gynaecological hospitals and practices work with Ballerine IUB. The IUB™ Ballerine® group has 240 women. An intrauterine device (IUD), also known as intrauterine contraceptive device (IUCD or ICD) or coil, is a small, often T-shaped birth control device that is inserted into the uterus to prevent pregnancy.IUDs are one form of long-acting reversible birth control (LARC). Made by OCON Medical in Modi’in, Ballerine is the first product based on the trademarked IUB (Intra Uterine Ball) invented by senior gynecologist Dr. Ilan Baram, medical director of the company. buy Lyrica in dubai OCON Healthcare — IUB Ballerine® first ever 3D spherical copper intrauterine contraceptive. Indikuje se k zabránění nechtěného početí (antikoncepce) až … What are the diamerers of the applicator for Mirena, Kyleena and Jaydess? Ballerine IUB is the most innovative non-hormonal intrauterine medical device developed by the Israeli gynaecologist Dr. Ilan Baram after many years of work and research. Pregnancy rate should be measured on much larger study cohort. The amount of copper released per day is very low and is within the microgarm/day range. The IUB™ Ballerine® enters pre-loaded in a tube into the uterine cavity and takes a spherical shape which is small and optimally adapted to uterine cavity. Some web based sources indicate expulsion rates from studies carried out with a product, the SCu380A, which has never been introduced to the market. They are larger than the intrauterine space and therefore cause more discomfort to users. Gynaecology Services. However, they should be changed with care so as not to pull the threads of the IUB™ Ballerine® when removing the tampon or menstrual cup. This surface area has been shown to provide equivalent contraceptive efficacy as 380mm2 and can therefore be considered the lowest effective dose (Mansour D, 2010). Price/Book: A financial ratio used to compare a company's current market price to its book value. If it slides into the cervix, there is no longer any protection against pregnancy and the IUB™ Ballerine® should be replaced. The hormone-free Ballerine is shaped like a ball, as opposed to the standard T-shape coil in common use, and it is said to reduce the risk of complications in the uterus. In our study of the IUB™ Ballerine® MINI conducted in Romania and Bulgaria, we found that women in the IUB™ Ballerine® group reported less pain and less bleeding in comparison to women in the IUD group. Contrary to common belief that the IUB™ Ballerine® MINI would be a good fit for young women the Madden study shows that women younger than 20 years old are prone to a higher expulsion rate with T-shaped IUDs. IUB, OCON and the OCON and IUB logos are trademarks of OCON Medical Ltd.Ballerine and Sphera are registered trademarks of OCON Medical Ltd.OCON products are not yet approved for sale in the United States.IUB Ballerine MAXI: CE mark pending. In 2 separate recent studies of the IUB™ Ballerine® MIDI conducted in Israel and Switzerland, we found that women reported high satisfaction rates regarding bleeding and pain during use. What requirements do you have to fulfill to give out a Pearl Index on a product? Can the IUB™ Ballerine® get stuck in the uterine wall / tissue? The manufacturer of a new contraceptive copper IUD, which was launched on the Dutch market in 2019, claims: “IUB™ Ballerine® is a new, reliable, hormone-free intrauterine device (IUD). First interim results of an EU study of the IUB™ Ballerine® compared to a standard IUD TCu380 show both a superiority of the IUB™ Ballerine® regarding menstrual pain and bleeding as well as increased user satisfaction, which is probably due to the small size, flexibility and modern, 3-dimensional shape. All Copper IUDs in general slowly release copper ions into the surrounding tissue at a rate that decreases over time. Our IUB™ Ballerine® Guarantee program policy is as follows: The IUB™ Ballerine® shall not replace IUDs or IUS. Since the IUB™ Ballerine® is only 15mm in size it is more suitable for the average uterine width of 24 – 26mm than 32mm wide T-shaped IUDs. Rhia Ventures Invests in OCON Healthcare's Ballerine®, ... the first and only 3D spherical copper IUB (Intrauterine Ball). This is a force greater than is expected to be applied in normal conditions. In addition, the IUB™ Ballerine® has the thinnest inserter currently on the market with a diameter of only 3.2mm which ensures a less painful insertion. The only problem with it is the price because MAP is expensive. With the IUB™ Ballerine®, this distance is less important as it moves and always finds its optimal position in the uterus. Since pregnancy rates are in general very low and a pregnancy occurs in very rare cases, this difference on a country basis is not unusual and will settle with time and the more women who are using the IUB™ Ballerine®. When removed, women immediately recover their ability to become pregnant. It is a safer product, offers greater user satisfaction and is simpler to use. We believe that the smaller and more flexible frame of the IUB™ Ballerine® together with lack of sharp edges to irritate the uterine wall, influence to reduce bleeding amount and menstrual pain. Results to demonstrate this? Israel’s OCON Healthcare Develops Futuristic Contraceptive Devices. 1989 г. The IUB™ Ballerine® MIDI, 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. – the medicine Mifegyne (mifepristone) was registered in France with an indication – medical abortion up to 49 day of amenorrhea . Gynaecology; Overview; How much is absorbed to the organism and how much is cleared out of the body? Are there any special guidelines to reduce chances of expulsion? Beyond this, early 1970’s work has demonstrated the positive correlation between surface area and efficacy. Mirena- 4.4 mm, Jaydess- 3.8 mm, Kyleena- 3.8 mm. The obvious solution is to reduce the arm lengths but then there is a problem of expulsion since the uterus can squeeze it to the cervical canal’s diameter and malposition due to the frequent uterine contractions. Ballerine®'s unique shape reduces irritation to the endometrium with fewer malpositions and perforations, which are significant drawbacks associated with current T-shaped IUDs. Analogy – Contraceptive effect comes from amount of copper / foreign body in the uterus. Current IUDs are T-shaped. If an IUD stays within the uterus during pregnancy septic abortion or preterm delivery can occur and this can lead to serious health issues, even death. With very small percentage rates it depends on pure luck where and when these pregnancies occur. IUB Ballerine®'s unique shape reduces irritation to the endometrium with fewer malpositions and perforations, which are significant drawbacks associated with current T-shaped IUDs. By the new European regulatory guidelines, study cohort of minimum 800 women of ages 17-35, for a few years, is needed for Pearl index or pregnancy rate measurements. What is the daily amount of copper released from the IUB™ Ballerine® . esemény után is megbízhatóan alkalmazható! The presence of true copper allergies should be within a range of 1 to several hundred thousand. It is more accurate than using a standard rate as it considers length of use. The IUB™ Ballerine® is more patient- and uterus-friendly. It has been established that one of the key aspects in reducing expulsions is training on the insertion method, with particular attention to pushing the push rod rather than pulling the insertion tube during deployment, which should be conducted near the fundus. Only then, after carefully removing the violet rod, remove the insertion tube. Far better to go with something that has been tested millions of times over and you know all the bad things that can go wrong with it. Ballerine IUB is applied similarly to standard coils through a thin application tube, 3.2 mm (the thinnest on the market) into the uterus, without requiring dilatation of the cervix, after which it recovers its spherical shape adapting itself to the uterine cavity contour. Harmony Antenatal Screening £700 Consultation and review. See IFU. Ballerine IUB is an efficient form of contraception with 99% efficiency for a period of 5 years. 118. preg0041050 £6.98 new lower price. Manufacturer Appliance Order No Qty Price (p) Convatec Ltd. Ileodress Small 19mm starter hole Opaque S851 10 2753 25mm starter hole Opaque S852 10 2753 32mm starter hole Opaque S853 10 2753 ... IUB Ballerine MIDI 2500 . Distinct from current IUDs that make use of copper collars, wires or a combination thereof, the IUB™ makes use of 2.1mm in diameter beads that are generally more robust than the copper wire used in standard IUDs. Therefore, unlike conventional IUDs, it is not allowed to retract 1-2cm but just a couple of mm. The MINI could be a good choice for women with low risk of expulsion – like eg. However the general consensus is that the contraceptive effect is mainly due to the release of copper ions into the uterus, interfering with sperm motility and survival to prevent fertilization. Can the copper balls detach from the frame? What explains the Pregnancy rates difference between countries? 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 inpublished studies, e.g. The Ballerine IUB is a hormone-free IUB coil that’s inserted into your uterus. Can the IUB™ Ballerine® be used with menstrual cups or vaginal tampons? In general ectopic pregnancies are not higher in women with IUDs than women without an IUD. OCON Healthcare Our mission is to introduce innovative, high-quality an intrauterine drug-delivery technology to improve women’s health and quality of life Our Products This Is What We Do OUR PRODUCTS IUB™ Ballerine®, a safer1, more comfortable, hormone-free next generation “smart” IUD (long acting reversible contraceptive) with memory effect. The T-IUD group has 122 women. Nevertheless, the physician should consult the ICD instructions for use for information about possible adverse interaction. Accordingly, it is also cheaper in terms of price and is paid for by statutory health insurance until the age of 21. Women with heavy menstruation were also more frequently affected. Az Rézgyöngy IUB™ intrauterin fogamzásgátló több mint 99%-os. The beads of the IUB™ Ballerine® have an average weight of 645mg. It uses as the denominator the total months or cycles of exposure from the initiation of the product to the end of the study or the discontinuation of the product. Indikuje se k zabránění nechtěného početí (antikoncepce) až … It has been shown that low lying IUB’s can migrate back to a fundal position, as long as the IUB™ Ballerine® is entirely located within the intrauterine cavity. the result is that when short term studies or studies with small amount of participants will tend to show higher Pearl index values. It's more than 99% effective. 120 likes. It works in a similar way to other copper IUDs and is effective for 5 years. If it is a very mild arcuate heart shape an IUB may work, however if it is very severe and actually separates the uterus into two, the IUB™ Ballerine® will not be efficient. Different measurments then expected are for the doctors discretion to decide wheather to use the IUB™ Ballerine®. Nitroděložní kulička IUB TM (Intra Uterine Ball) Ballerine ® je nehormonální nitroděložní tělísko kulovitého tvaru s měděnými perlami. How can one handle those claiming no expulsion of T-shaped IUDs at their practice? www.mifegyne.bg. Past IUD use with older IUDs could mildly elevate the risk of ectopic pregnancy. Nitroděložní kulička IUB TM (Intra Uterine Ball) Ballerine ® je nehormonální nitroděložní tělísko kulovitého tvaru s měděnými perlami. Pearl index is a time dependant parameter. Nitinol coronary stents have been used for over 15 years. Nitroděložní tělísko - jejich typy, aplikace a funkce We have learned that with T-shaped IUDs the distance of 0.5cm to the fundus is very important for pregnancy prevention. Yes, this is the purpose of the IUB™ Ballerine® MIDI and IUB™ Ballerine® MAXI (in development) versions that should cater better to those with greater risk of expulsion. Over the years we have received very few reports of such cases. Harmony Antenatal Screening £700 Consultation and review. The addition of copper with a surface area of ≥200mm2 reduced this rate to under 2% (Mansour D, 2010). This together with the figures being not significantly different statistically means that it can be said that efficacy is comparable. This is why they use the pearl index to show efficacy, since it is measured in 100 women’s years and decreases after more years. Who said that we can use other studies done on pearl index on our product? The germicidal effect of copper is known since ancient times. Hypermenorrhea or endometriosis. The Essure Sterilization Device is also made of Nitinol however as far as we know the side effects didn’t come from the Nitinol. The daily intake of copper, which is an important nutrient, is far higher than that absorbed by the IUB™ Ballerine®. Ball The Intra Uterine Ball (Ballerine) – IUB™ The IUB™ Ballerine® is also made of nitinol of the same type as stents. Ballerine IUB is a last generation intrauterine contraceptive device which is the result of many years of development in an area which HAS HAD NOTHING NEW TO OFFER for more than 25 years, namely copper T-shaped coils. Private Gynaecology & Antenatal Prices. Menstrual bleeding in the next 2 cycles is generally heavier than usual, however reported as non-painful and from the 3rd period and on – menstruation gradually returns back to normal. Over 70 000 women worldwide have used Ballerine IUB, 95% of whom would recommend the device to their female friends and would use it again as a reliable and safe method of contraception. Companies with negative earnings receive an "NE." Please see ultrasound guide. Access is easy (UK) although you do sometimes have to put up with the provider being a bit embarrassed, judgey or asking you confidential questions on the shop floor . OCON’s IUB Ballerine® is the first ever 3D spherical copper intrauterine contraceptive with a superior safety profile pe UT 380 Short As UT 380 Standard (above), but now even smaller. Your GP or local contraception clinic can provide more information. The IUB™ Ballerine® MIDI is the default variant we recommend. There is nothing like it. The closer to the fundus the better, as the Nitinol wire turns 180° away from the fundus and would otherwise sit too low. The most common implantable nitinol alloy is composed of 50/50% elemental nickel/titanium. Ours is too. This can often only be seen in hysteroscopy – in the ultrasound they look okay, but may cause pain and bleeding. Veronika Jičínská je na Facebooku. Therefore copper is also used in door knobs for example. The thinnest profile – 3.2 mm for insertion makes the application easy to perform – no dilatation and minimal pain. In general abnormally shaped uteri are not ideal for any IUD. Price Dimension (L) tient Threads (Col.) Threads (No.) They are also more prone to perforating the uterus during insertion (at least 0.1% of cases), malposition (~7%) and expulsion (6-10%). The difference between the IUB™ Ballerine® and the T-shaped IUD are 30% in the first few months with the IUB being better than the T-shape. Protection is maintained as long as the IUB™ Ballerine® is in the uterus. Copper is therefore a significant contributor to IUD pregnancy efficacy. This is where the three dimensional IUB™ Ballerine® provides an answer as it has no sharp ends, has a maximal diameter of 15mm and cannot be squeezed to under 12/15mm in diameter (depending on variant). 1. – the medicine Mifegyne (mifepristone) was registered in France with an indication – medical abortion up to 49 day of amenorrhea . Лекарства за спешна контрацепция след необезопасен полов акт за предотвратяване на нежелана бременност Вземи онлайн от 366bg! The dual aim of the measurement by the hysteroscope is to define the right place to release the IUB™ Ballerine® in the uterus together with verifying uterine anterior or posterior position. Mifegyne – the only mifepristone with four indications: a libidóra sem. Current IUD design has been set in the early 1970’s and has not changed since. The length (cervical outer oss to the fundus) of a normally shaped uterus is 5-9 cm. Copper has in its pure form – and in the IUB™ Ballerine® only 99.99% medical copper is used – an extremely low allergy potential, very few cases of copper allergy have been reported. Rhia Ventures invested in Israeli-based OCON Healthcare to assist the US launch of Ballerine®, the first and only 3D spherical copper IUBTM (Intrauterine Ball). So the IUB™ Ballerine® MIDI is definetly the better fit for young women with higher risk of expulsion. Pearl-Indexe 0,2. Copper surface area and purity references:ISO 7439:20155.3.2: The nominal active surface area of copper shall be at least 200 mm2 but shall not be larger than 380 mm2.6: The purity of the copper shall be at least 99,9 %, which shall be certified. What is the nickel content of the IUB™ Ballerine®? In OCON’s experience as well as published clinical data – higher expulsion rate is age related rather then parity related – so that multi parity would not create a greater risk for expulsion. 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. One study found that female family planning providers choose LARC methods more often (41.7%) than the general public (12.1%). The use of IUB™ Ballerine® MIDI demonstrates a reduced expulsion rate. What is difference between the technology than current devices in the IUD market place? Provides 380mm² copper suitable for minimum uterine length of 5cm. , /PRNewswire/ -- Rhia Ventures invested in Israeli-based OCON Healthcare to assist the US launch of Ballerine®, the first and only 3D spherical copper IUB (Intrauterine Ball). Gynaecology Services. Price/Cash Flow: Latest closing price divided by the last 12 months revenue/cash flow per share. Attached is a study on Nickel sensitivity with Essure. What is the mode of action of the IUB™ Ballerine®? What are the instructions for low lying IUB™ Ballerine, Is the risk of expulsion of the IUB™ Ballerine. Yes, in general the insertion tube diameter is the same for IUB™ Ballerine® MINI and MIDI. Studies in animals and humans showed no change in the blood copper levels between woman/animals carrying a copper based IUD and the general population. The nominal copper surface area of the IUB™ Ballerine® is 304.4mm2. The procedure is much more complicated and aggressive. a day support until 20 weeks of pregnancy. Лекарства за спешна контрацепция след необезопасен полов акт за предотвратяване на нежелана бременност Вземи онлайн от 366bg! Results are being prepared for submission for publication. Benefits, that the standard copper IUDs cannot guarantee due to their shape and size. Before use the patient information should be read. Far better the devil you know. The probable cause of infections is a bacterial contamination associated with the insertion and not the IUD itself. , /PRNewswire/ -- Rhia Ventures invested in Israeli-based OCON Healthcare to assist the US launch of Ballerine®, the first and only 3D spherical copper IUB (Intrauterine Ball). The placement of the IUB can be painful when the cervix is very tight. Ectopic pregnancies are not higher with the IUB™ Ballerine® than with any other IUDs. Mode of action:https://www.ncbi.nlm.nih.gov/pubmed/12501086 https://www.ncbi.nlm.nih.gov/pubmed/9807692, Copper surface area:Tatum https://www.ncbi.nlm.nih.gov/pubmed/4557644Mansour https://www.ncbi.nlm.nih.gov/pubmed/20136566Paragard https://hcp.paragard.com/Pdf/ParaGard-PI.pdf, Expulsion:Rowe https://www.ncbi.nlm.nih.gov/pubmed/26916172 Sivin https://www.ncbi.nlm.nih.gov/pubmed/2124179 Madden https://www.ncbi.nlm.nih.gov/pubmed/25198262, Pearl index:Pearl https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(01)18648-4/fulltext https://www.ncbi.nlm.nih.gov/pubmed/2199875, Low lying IUDs:https://www.contraceptionjournal.org/article/S0010-7824(00)00167-0/fulltexthttps://www.contraceptionjournal.org/article/S0010-7824(05)00263-5/fulltext, Nickel sensitivity:essure https://www.jmig.org/article/S1553-4650(11)00235-4/fulltext https://www.ncbi.nlm.nih.gov/pubmed/19571342?dopt=Abstract(this is for permanent coronary stents, for the uterus with its tissue contact the criticality would be reduced), PID:https://www.contraceptionjournal.org/article/S0010-7824(17)30164-6/fulltexthttps://www.ncbi.nlm.nih.gov/pubmed/1347812, Post cesarian:https://www.ncbi.nlm.nih.gov/pmc/artic. Is this different with the IUB™ Ballerine®? After 5 years, the IUB is removed again in the gynecologist's office. Rowe 2016, Sivin 1990 and Madden 2014, the latter found a strong relation 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. Gynaecology; Ballerine IUB consists of 17 copper pearls which are strung on a thin fibre of high-technology alloy – Nitinol (used in the production of coronary stents and artificial valves), which after insertion into the uterine cavity recovers its round three-dimensional shape and adapts itself to the uterine cavity. What kind of nickel and titanium are used in the IUB™ Ballerine®? Banded? The IUB Ballerine is a hormone-free contraceptive solution that could represent the … Source: Jerusalem Post - Neutral Published on Sep 19, 2020 Due to the high safety rates and good tolerability of Ballerine IUB, it is recommended for younger women (over 18 years of age) as well, unlike older coils recommended for women who have given birth and at an older age. Copyright OCON Medical Ltd., d/b/a OCON Healthcare. Nitinol is a combination of 50% nickel and 50% titanium. Also drinking water pipes are made out of copper due to its antibacterial effect. What is the total copper surface area and weight of the IUB™ Ballerine®? Prior to the addition of copper to intrauterine devices (IUDs) the pregnancy rate was 18% (Tatum, 1972). However, it has been found that the average uterine width in Europe is 24-26 mm. Since a ball cannot be malpositioned this issue is solved altogether. However, a pregnancy with an IUD in situ is more often an ectopic one than a pregnancy with no IUD. Generally any IUD should be removed if a pregnancy occurs. An internationally recognized study – by Madden published in 2014, with a data pool of over 4,000 Mirena and over 1,000 CuT380 (Nova-T) patients, shows expulsion rates of 6.2% after 12 months, 8.5% after 24 months and 10.2% after 36 months. Fewer malpositions and perforations, which are significant drawbacks associated with current T-shaped IUDs guidelines... Are significant drawbacks associated with current T-shaped IUDs according to OCON ’ s Territory product Manager women it... Be removed if a pregnancy with an indication – medical abortion up to 49 day amenorrhea. Advisable to avoid using it in women with cardiac implantable devices ( defibrillator ) experience using copper IUDs general! The next generation IUD IUB™ Ballerine® is also cheaper in terms of price and is simpler to the! Insurance until the age of 21 with older IUDs could mildly elevate the risk of copper which! 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