Product Brief: Caucus on New and Underused Reproductive Health Technologies- Levornorgestrel intrauterine system
Publication date: 2011
PRODUC T BRIEF Caucus on New and Underused Reproductive Health Technologies Levonorgestrel intrauterine system Description !e levonorgestrel intrauterine system (LNG IUS) is a T-shaped, plastic, contraceptive intrauterine system (IUS) that releases the progestin hormone levonorgestrel into the uterus at a dose of 20 µg per day for up to "ve years. LNG IUS prevents pregnancy by thickening cervical mucus, inhibiting sperm motility, and suppressing the growth of the uterine wall.1,2,3 !e LNG IUS must be inserted and removed by a quali"ed medical or health care practitioner using aseptic techniques. A gynaecological examination is advised before device insertion (to screen for infections and exclude pregnancy) and again four to twelve weeks a#er insertion. !erea#er, annual check-ups are recommended to ensure that the device remains in place and is functioning properly. !ere are no age or parity restrictions on its use, and women can use an LNG IUS throughout their reproductive life if it is replaced at the recommended intervals. Removal of an LNG IUS can be done at any time by a quali"ed medical or health care practitioner. Upon removal, fertility will return rapidly. LNG IUS is best suited for women who desire a long- term, reliable contraceptive method for birth spacing and limiting; and, women who have access to a quali"ed medical or health care practitioner for counselling, examination, insertion, and check-ups. !e LNG IUS does not provide protection from sexually transmitted infections (STIs). Efficacy, safety, and benefits !e LNG IUS is one of the most e$ective and long-lasting contraceptive methods available. Over the "rst year of use, the pregnancy rate is 2 per 1,000 women using an LNG IUS—in other words, 0.2 percent. A#er the "rst year, there is a lower risk of pregnancy— cumulatively only 5 to 8 pregnancies per 1,000 women over "ve years of use.4,5 Complications from LNG IUS use are rare, but may include uterine perforations at the time of insertion, expulsion due to inappropriate device location, and pelvic in%ammatory disease.6 Side e$ects associated with use of the LNG IUS include possible change in bleeding patterns (in frequency, duration, and amount), absence of bleeding, and benign ovarian cysts. In addition to the protection against pregnancy associated with use of LNG IUS, there are a number of signi"cant health bene"ts related to the product’s additional indication for the treatment of heavy menstrual bleeding.7 !ese include the reduction of iron-de"ciency anaemia, reduced volume of menstrual bleeding, and the lessening of menstrual cramps.8 For more information on LNG IUS, its health bene"ts, and contraceptive dynamics, see the Special Issue on IUS/intrauterine devices of Contraception.9 Current programme/sector use IUSs are now being introduced in both developed and developing countries and are gaining popularity in a number of countries in South Asia, Africa, and Latin America.10 Mirena®, an IUS produced by Bayer Schering Pharma, is provided commercially through gynaecologists in the countries where it is registered. During 2009, approximately 3.03 million units were sold globally, with the largest sales reported in the United States and Europe. Since its introduction into the market, more than 18 million women have selected Mirena® as their method of choice.11 !e International Contraceptive Access (ICA) Foundation, founded by the Population Council and Bayer Schering Pharma, provides a bioequivalent LNG IUS that is now available in 13 countries through the public and non-pro"t sector via donations. Speci"cally, the ICA Foundation is currently providing one form of LNG IUS for projects in Brazil, Curacao, Dominican Republic, Ecuador, El Salvador, Ethiopia, Ghana, Indonesia, Kenya, Nigeria, Paraguay, Saint Lucia, and South Africa. Despite the increasing popularity of the LNG IUS, there are several obstacles to its expanded use, including the upfront cost of the product in the private sector. In terms of costs over time, the LNG IUS is among the least expensive contraceptive method because of its long-term e$ectiveness, yet the initial cost of the product in the private sector is high.12 Availability of the product is also a current constraint. !e LNG IUS is generally not available in developing countries except through the ICA Foundation. !e prevailing policies in many countries are also challenging access, as only certi"ed nurses and medical practitioners are permitted to insert C A U C U S O N N EW A N D U N D ER U S ED R EP R O D U C TI V E H EA LT H T EC H N O LO G IE S P R O D U C T B R IE F This brief was last updated January 2011. For more information on the Caucus on New and Underused RH Technologies, please visit our web page at http://www.rhsupplies.org/working-groups/caucus-on-newunderused-rh-technologies.html. This publication forms part of a series of technical briefs, written by members of the Caucus on New and Underused Reproductive Health Technologies, a thematic group established under the auspices of the Reproductive Health Technologies Coalition. The Caucus’ aim is to broaden the discussion within the Coalition of reproductive health technologies that are not well integrated into the public or commercial health sectors. Responsibility for the selection and contents of the product briefs rests solely with the Caucus and does not imply endorsement by the Coalition or its wider membership. For additional information, please contact firstname.lastname@example.org. IUSs. Authorizing trained allied health workers to carry out this procedure has been shown to be e$ective and cost-saving in a number of settings. Eliminating unnecessary follow-up visits may be another way to reduce costs and increase patient acceptability of the IUS. Requiring a clinic follow-up soon a#er insertion to ensure proper placement and absence of infection is important; therea#er, clinic visits only in response to negative signs and symptoms, or a woman’s desire for removal, have been shown to be su'cient in treating complications and meeting patients’ needs.13 Manufacturer LNG IUS are manufactured in Turku, Finland by Bayer Schering Pharma Oy. !e LNG IUS available in the private market as Mirena® is marketed internationally by Bayer Schering Pharma, and by Bayer Healthcare Pharmaceuticals in the United States. Registration status/suppliers !e Mirena® IUS is registered in more than 120 countries worldwide, distributed commercially by Bayer Schering Pharma, and donated to public-sector organizations in the United States by the Arch Foundation. !e LNG IUS provided by the ICA Foundation is registered in three countries (Ghana, Kenya, and Nigeria). !is LNG IUS uses a di$erent inserter than is used for Mirena® and o#en requires a di$erent registration. Public-sector price agreements !e ICA Foundation donates LNG IUSs to international development agencies and public-health organizations (both governmental and nongovernmental a'liates) who then o$er the LNG IUS at reduced- or no-cost to poor women and families.14 As of October 2010, more than 35,000 LNG IUS units have been donated by the ICA Foundation. !e Arch Foundation provides donations to individuals meeting poverty criteria through quali"ed public-sector organizations in the United States.15 References 1 World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP). Family Planning: A Global Handbook for Providers. Baltimore and Geneva: CCP and WHO, 2007. 2 Association of Reproductive Health Professionals (ARHP) website. Available at www.arhp.org. Accessed January 6, 2011. 3 International Contraceptive Access (ICA) Foundation website. Available at www.ica-foundation.org. Accessed October 28, 2010. 4 WHO/JHU/CCP, 2007. 5 Salem, R. New Attention to the IUD: Expanding women’s contraceptive options to meet their needs. Population Reports. 2006; B(7). Available at: www.populationreports.org/b7/. Accessed January 6, 2011. 6 WHO, 2007. 7 Mirena® Signi"cantly Reduced Heavy Menstrual Bleeding website. Available at http://www.mirena-us.com/hmb/ mirena-reduces-heavy-menstrual-bleeding.jsp. Accessed October 28, 2010. 8 Fraser, IA. 2010. Non-contraceptive health bene"ts to intrauterine hormonal systems. Contraception 82: 396–403. 9 Special Issue on IUD/IUS of Contraception. 2007; 75(6S). Available at: www.contraceptionjournal.org. 10 Salem, 2006 11 Bayer AG 2009 annual report. Available at: http://www. annualreport2009.bayer.com/en/Bayer-Annual-Report-2009. pdfx. Accessed January 6, 2011. 12 Salem, 2006. 13 Ibid. 14 ICA Foundation, 2010 15 !e Arch Foundation website. Available at: www.archfoundation.com. Accessed January 6, 2011.