Claim: FDA Approves Bayer's Kyleena™ (Levonorgestrel-Releasing Intrauterine System) 19.5 mg for Prevention of Pregnancy for up to Five Years
Verdict: SUPPORTS

Retrieved passages:
title: Intrauterine device
text: and releases an even lower dose of levonorgestrel than Kyleena, but is only approved for up to three years. Liletta is more similar to Mirena in both shape and dose of levonorgestrel released; it has currently been approved for usage up to three years. Inert IUDs do not have a bioactive component. They are made of inert materials like stainless steel (such as the stainless steel ring (SSR), a flexible ring of steel coils that can deform to be inserted through the cervix) or plastic (such as the Lippes Loop, which can be inserted through the cervix in a cannula

title: Hormonal IUDs
text: the previous year. Over 70% of the participants had previously used IUDs. In 2013 Skyla, a lower dose levonorgestrel IUD effective for up to three years, was approved by the FDA. Skyla has a different bleeding pattern than Mirena, with only 6% of women in clinical trials becoming amenorrheic (compared to approximately 20% with Mirena). In 2015, Liletta was approved by the FDA. Liletta has a similar size and levonorgestrel release characteristics as Mirena, and is FDA-approved for three years of use following a study in which six women out of 1,751 conceived while using Liletta. In 2009, Bayer, the

title: Intrauterine device
text: reduce or even prevent menstrual bleeding. As a result, they are used to treat menorrhagia (heavy menses), once pathologic causes of menorrhagia (such as uterine polyps) have been ruled out. The progestin released by hormonal IUDs primarily acts locally; use of Mirena results in much lower systemic progestin levels than other very-low-dose progestogen only contraceptives. Mirena is approved for use up to five years in the US, though studies support its efficacy for up to seven years. Like Mirena, Kyleena is also approved for up to 5 years but is smaller and releases slightly less levonorgestrel. Skyla is even smaller

title: Hormonal IUDs
text: they found estradiol levels in Mirena users to be normal. The hormonal IUD is a small 'T'-shaped piece of plastic, which contains levonorgestrel, a type of progestin. The cylinder of the device is coated with a membrane that regulates the release of the drug. Mirena releases the drug at an initial rate of 20 micrograms per day. This declines to a rate of 14 micrograms per day after five years, which is still in the range of clinical effectiveness. Skyla releases 14 micrograms per day and declines to five micrograms per day after three years. Bayer markets Skyla as Jaydess

title: Levonorgestrel-releasing implant
text: in more than 60 countries and used by more than seven million women. As of 2015 it is approved but not available in the United States. Levonorgestrel-releasing implant is 99%99.95% effective at preventing pregnancy, and is one of the most reliable, though not the most available, forms of birth control. Levonorgestrel-releasing implant prevents pregnancy through multiple methods: by preventing ovulation, which means that no eggs are released for fertilization; by thickening the mucus of the cervix, which prevents sperm from entering; and by thinning the lining of the uterus, which makes implantation of an embryo less likely. The way in

title: Intrauterine device
text: menstrual bleeding, and these coils are popular. Hormonal IUDs (brand names Mirena, Skyla, Kyleena, and Liletta; referred to as intrauterine systems in the UK) work by releasing a small amount of levonorgestrel, a progestin. Each type varies in size, amount of levonorgestel released, and duration. For example, Mirena and Liletta measure 32x32mm while Skyla and Kyleena measure 28x30mm. The primary mechanism of action is making the inside of the uterus uninhabitable for sperm. They can also thin the endometrial lining and potentially impair implantation but this is not their usual function. Because they thin the endometrial lining, they can also

title: Hormonal IUDs
text: maker of Mirena, was issued an FDA Warning Letter by the United States Food and Drug Administration for overstating the efficacy, minimizing the risks of use, and making "false or misleading presentations" about the device. From 2000 to 2013, the federal agency received over 70,072 complaints about the device and related adverse effects. As of April 2014, over 1,200 lawsuits have been filed in the United States. Hormonal IUDs Intrauterine device (IUD) with progestogen, sold under the brand name Mirena among others, is a intrauterine device that releases the hormone levonorgestrel. It is used for birth control, heavy menstrual periods,

title: Levonorgestrel
text: indicating that beginning as late as 120 hours (5 days) after intercourse could be effective. The primary mechanism of action of levonorgestrel as a progestogen-only emergency contraceptive pill is, according to International Federation of Gynecology and Obstetrics (FIGO), to prevent fertilization by inhibition of ovulation and thickening of cervical mucus. FIGO has stated that: "review of the evidence suggests that LNG [levonorgestreol] ECPs cannot prevent implantation of a fertilized egg. Language on implantation should not be included in LNG ECP product labeling." In November 2013, the European Medicines Agency (EMA) approved a change to the label saying it cannot prevent

title: Levonorgestrel
text: in these formulations. At very low daily dose of 30 µg, levonorgestrel is used in some progestogen-only pill formulations. Levonorgestrel is the active ingredient in a number of intrauterine devices including Mirena and Skyla. It is also the active ingredient in the birth control implants Norplant and Jadelle. Levonorgestrel is used in emergency contraceptive pills (ECPs), both in a combined Yuzpe regimen which includes estrogen, and as a levonorgestrel-only method. The levonorgestrel-only method uses levonorgestrel 1.5 mg (as a single dose or as two 0.75 mg doses 12 hours apart) taken within 3 days of unprotected sex, with one study

title: Hormonal IUDs
text: System in 1976. This IUD had a short, 1-year lifespan and never achieved widespread popularity. Following this relative lack of success, Dr. Luukkainen replaced the progesterone with the hormone levonorgestrel to be released over a five-year period, creating what is now Mirena. The Mirena IUD was studied for safety and efficacy in two clinical trials in Finland and Sweden involving 1,169 women who were all between 18 and 35 years of age at the beginning of the trials. The trials included predominantly Caucasian women who had been previously pregnant with no history of ectopic pregnancy or pelvic inflammatory disease within

title: Levonorgestrel-releasing implant
text: menstrual periods, no periods, headaches, and breast pain. Use is not recommended in people with significant liver disease. The levonorgestrel implant is a type of long-acting reversible birth control. It primarily works by stopping ovulation and by thickening the mucus around the cervix. A levonorgestrel-releasing implant was approved for medical use in 1983 in Finland and in the United States in 1990. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The wholesale cost in the developing world is about US$8.93–13.29 per set. Levonorgestrel implants are approved

title: Hormonal IUDs
text: in the United Kingdom. Jaydess releases six micrograms per day and lasts for three years. In comparison, oral contraceptives can contain 150 micrograms of levonorgestrel. The hormonal IUD releases the levonorgestrel directly into the uterus, as such its effects are mostly paracrine rather than systemic. Most of the drug stays inside the uterus, and only a small amount is absorbed into the rest of the body. Blood levels of levonorgestrel in Mirena users are half those found in Norplant users and one-tenth those found in users of levonorgestrel-only pills. The hormonal IUD is inserted in a similar procedure to the

title: Hormonal IUDs
text: Hormonal IUDs Intrauterine device (IUD) with progestogen, sold under the brand name Mirena among others, is a intrauterine device that releases the hormone levonorgestrel. It is used for birth control, heavy menstrual periods, and to prevent excessive build of the lining of the uterus in those on estrogen replacement therapy. It is one of the most effective forms of birth control with a one-year failure rate around 0.2%. The device is placed in the uterus and lasts three to five years. Following removal fertility returns quickly. Side effects include irregular periods, benign ovarian cysts, pelvic pain, and depression. Rarely uterine

title: Essure
text: more than 4,150, or 81 percent of the total, from October 2013 to June 2015. In February 2016, the FDA issued a "black box" label to warn the public about the harmful complications associated with the use of this device and requested Bayer to conduct a new postmarket surveillance to follow 2,000 women for at least three years, comparing the effectiveness and safety of the device with other surgical contraceptive methods. Women and doctors were required to sign a decision checklist before Essure implantation, and to give consent to a test three months later to ensure the device was properly

title: Levonorgestrel
text: alone as an intrauterine device for use in hormonal birth control, and alone as a subcutaneous birth control implant. Known or suspected pregnancy is a contraindication of levonorgestrel as an emergency contraceptive. After intake of 1.5 mg levonorgestrel in clinical trials, very common side effects (reported by 10% or more) included: hives, dizziness, headache, nausea, abdominal pain, uterine pain, delayed menstruation, heavy menstruation, uterine bleeding, and fatigue; common side effects (reported by 1% to 10%) included diarrhea, vomiting, and painful menstruation; these side effects usually disappeared within 48 hours. Overdose of levonorgestrel as an emergency contraceptive has not been described.

title: Levonorgestrel butanoate
text: WHO, in 1983, and has been under investigation for potential clinical use since then. LNG-B has been under investigation as a long-lasting injectable contraceptive for women. A single intramuscular injection of an aqueous suspension of 5 or 10 mg LNG-B has a duration of 3 months, whereas an injection of 50 mg has a duration of 6 months. The drug was also previously tested successfully as a combined injectable contraceptive with estradiol hexahydrobenzoate, but this formulation was never marketed. LNG-B has been tested successfully in combination with testosterone buciclate as a long-lasting injectable contraceptive for men as well. LNG-B may

title: Hormonal IUDs
text: contraceptives such as an IUD are not believed to affect milk supply or infant growth. However, a study in the Mirena application for FDA approval found a lower continuation of breastfeeding at 75 days in hormonal IUD users (44%) versus copper IUD users (79%). When using Mirena, about 0.1% of the maternal dose of levonorgestrel can be transferred via milk to the nursed infant. A six-year study of breastfed infants whose mothers used a levonorgestrel-only method of birth control found the infants had increased risk of respiratory infections and eye infections, though a lower risk of neurological conditions, compared to

title: Levonorgestrel
text: was better-tolerated. In relation to this, the Yuzpe regimen has largely been replaced as a method of emergency contraception by levonorgrestrel-only preparations. Levonorgestrel-only emergency contraception was approved in the United States under the brand name "Plan B" in 1999, and has also been marketed widely elsewhere throughout the world under other brand names such as "Levonelle" and "NorLevo" in addition to "Postinor". In 2013, the Food and Drug Administration approved "Plan B One-Step" for sale over-the-counter in the United States without a prescription or age restriction. Levonorgestrel has also been introduced for use as a progestogen-only intrauterine device under the

title: Levonorgestrel
text: Levonorgestrel Levonorgestrel is a hormonal medication which is used in a number of birth control methods. In pill form, sold under the brand name Plan B among others, it is useful within 120 hours as emergency birth control. It becomes less effective the longer after sex and only works before pregnancy has occurred. It is also combined with an estrogen to make combined oral birth control pills. Within an intrauterine device (IUD), sold as Mirena among others, it is effective for long-term prevention of pregnancy. An implantable form of levonorgestrel is also available in some countries. Common side effects include

title: Levonorgestrel
text: is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. It is available as a generic medication. The wholesale cost in the developing world costs between 0.23 and 1.65 USD for the dose required for emergency birth control. In the United States it is over the counter for all ages. At low doses, levonorgestrel is used in monophasic and triphasic formulations of combined oral contraceptive pills, with available monophasic doses ranging from 100–250 µg, and triphasic doses of 50 µg/75 µg/125 µg. It is combined with the estrogen ethinylestradiol