PRODUCT BRIEF

Caucus on New and Underused Reproductive Health Technologies

Levonorgestrel intrauterine system

Description Complications from LNG IUS use are rare, but may
include uterine perforations at the time of insertion,
The levonorgestrel intrauterine system (LNG IUS) expulsion due to inappropriate device location, and
is a T-shaped, plastic, contraceptive intrauterine pelvic inflammatory disease.7 Side effects associated
system (IUS) that releases the progestin hormone with use of the LNG IUS include possible change
levonorgestrel into the uterus at a dose of 20 μg in bleeding patterns (in frequency, duration,
per day for up to five years. The LNG IUS prevents and amount), absence of bleeding, and benign
pregnancy by thickening cervical mucus, inhibiting ovarian cysts.
sperm motility, and suppressing the growth of the
In addition to the protection against pregnancy
uterine wall.1,2,3
associated with the use of LNG IUS, there are a
The LNG IUS must be inserted and removed by a number of significant health benefits related to the
qualified medical or health care practitioner using product’s additional indication for the treatment
aseptic techniques. A gynecological examination of heavy menstrual bleeding.8 These include the
is advised before device insertion (to screen for reduction of iron-deficiency anemia, reduced volume
infections and exclude pregnancy) and again four of menstrual bleeding, and the lessening of menstrual
to twelve weeks after insertion. Thereafter, annual cramps.9 The reduction of menstrual bleeding enabled
check-ups are recommended to ensure that the device by LNG IUS is attributable to the product’s gradual
remains in place and to ensure that the user’s needs are reduction of the thickness and vascularity of the
being met. There are no age or parity restrictions on its endometrium over the first three to six months of use.
use, and women can use an LNG IUS throughout their As a result, women who had previously experienced
reproductive life if it is replaced at the recommended heavy menstrual bleeding noticed a significant
intervals. Removal of an LNG IUS can be done at any reduction in blood loss of between 79 and 98
time by a qualified medical or health care practitioner. percent.9 Practically speaking, women using LNG IUS
Upon removal, fertility will return rapidly. The gradually experience lighter menstrual bleeding for
LNG IUS is best suited for women who desire a fewer days. Because of this additional effect of LNG
long-term, reliable contraceptive method for birth IUS, a provider may recommend it to women with
spacing or limiting, and also have access to a qualified menorrhagia or who seek to lessen heavy periods.8
medical or health care practitioner for counseling, For more information on LNG IUS, its health benefits,
examination, insertion, and check-ups. The LNG IUS and contraceptive dynamics, see the special issue
does not provide protection from sexually transmitted of the journal Contraception on IUS/intrauterine
infections, including HIV. contraception devices.10

Efficacy Current program/sector use

The LNG IUS is one of the most effective and long- IUSs are now being introduced in both developed
lasting contraceptive methods available. Over the and developing countries and are gaining popularity
first year of use, the pregnancy rate is 2 per 1,000 in a number of countries in South Asia, Africa,
women using an LNG IUS—in other words, 0.2 and Latin America.11 Mirena®, an IUS produced by
percent. After the first year, there is an even lower risk Bayer Pharma, is provided commercially through
of pregnancy—cumulatively only 5 to 8 pregnancies gynecologists and other qualified providers in the
per 1,000 women over five years of use.4,5 The LNG countries where it is registered. Millions of units have
IUS is an extensively studied method; clinical data is been sold globally, with the largest sales reported in
available for over 13,000 woman-years of use, and has the United States and Europe. Since its introduction
demonstrated high efficacy and acceptability.6 into the market, more than 18 million women have
 selected Mirena® as their method of choice.12 The Registration status/suppliers
C A U C U S O N N E W A N D U N D E R U SE D R E P R O D U C T I V E H E A LT H T EC H N O LO G I ES  P R O D U C T B R I E F

International Contraceptive Access (ICA) Foundation,

founded by the Population Council and Bayer The Mirena® IUS is registered in more than 120
Pharma, provides a bioequivalent LNG IUS that is countries worldwide, distributed commercially
now available in 15 countries through the public by Bayer Pharma, and donated to public-sector
and nonprofit sector via donations. Specifically, the organizations in the United States by the Arch
ICA Foundation is currently providing the LNG Foundation (http://www.archfoundation.com).
IUS for projects in Brazil, Curacao, Dominican
The LNG IUS provided by the ICA Foundation is
Republic, Ecuador, El Salvador, Ethiopia, Ghana,
registered in three countries (Ghana, Kenya, and
India, Indonesia, Kenya, Mexico, Nigeria, Paraguay,
Nigeria), but is available through public-sector
Saint Lucia, and South Africa. International recipients
donations with approval by national medical
include Marie Stopes International, the International
authorities such as the Ministry of Health or National
Planned Parenthood Federation, Pathfinder,
Drug Controller. The LNG IUS uses a different
AmeriCares, and Rotary International.
inserter than is used for Mirena® and thus often
Despite the increasing popularity of the LNG IUS, requires a different registration.
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 Public-sector price agreements
IUS is among the least expensive contraceptive
The ICA Foundation donates LNG IUSs to
methods because of its long-term effectiveness, yet
international development agencies and public
the initial cost of the product in the private sector is
health organizations (both governmental and
high.13 Availability of the product is also a current
nongovernmental affiliates) who then offer the
constraint; the LNG IUS is generally not available
LNG IUS at reduced or no cost to poor women and
in developing countries except through the ICA
families.17 As of December 2012, nearly 50,000 LNG
Foundation. The prevailing policies in many countries
IUS units have been donated by the ICA Foundation.18
are also challenging access, as only certified nurses
Institutions seeking additional information about the
and medical practitioners are permitted to insert
availability of donations of LNG IUS for developing
intrauterine devices (IUDs) and IUSs. Authorizing
country service programs should consult the ICA
trained allied health workers to carry out this
Foundation website at www.ica-foundation.org.
procedure has been shown to be effective and cost
saving in a number of settings.14,15 Eliminating
unnecessary follow-up visits may be another way
to reduce costs and increase patient acceptability References
of the IUS. Requiring a clinic follow-up soon after 1. World Health Organization Department of Reproductive
insertion to ensure proper placement and absence Health and Research (WHO/RHR) and Johns Hopkins
of infection is important; thereafter, clinic visits are Bloomberg School of Public Health/Center for
only recommended in response to negative signs Communication Programs (CCP). Family Planning: A Global
Handbook for Providers. Baltimore and Geneva: CCP
and symptoms, or a woman’s desire for removal. This
and WHO, 2007.
guidance has been shown to be sufficient in treating
2. Association of Reproductive Health Professionals (ARHP)
complications and meeting patients’ needs.16 website. Available at: www.arhp.org. Accessed January 6, 2011.
3. International Contraceptive Access (ICA) Foundation
website. Available at: www.ica-foundation.org.
Manufacturer Accessed February 27, 2013.
4. WHO/JHU/CCP, 2007.
LNG IUSs are manufactured in Turku, Finland, by
5. Salem R. New Attention to the IUD: Expanding women’s
Bayer Pharma. The LNG IUS available in the private
contraceptive options to meet their needs. Population Reports.
market as Mirena® is also marketed by Bayer Pharma. 2006; B(7). Available at: www.populationreports.org/b7/.
Accessed February 27, 2013.

2
 6. ICA Foundation, 2013. 14. Wright NH, Sujpluem C, Rosenfield AG, Varakamin S. Nurse-
C A U C U S O N N E W A N D U N D E R U SE D R E P R O D U C T I V E H E A LT H T EC H N O LO G I ES  P R O D U C T B R I E F

7. WHO, 2007. Midwife Insertion of the Copper T in Thailand: Performance,

Acceptance, and Programmatic Effects. Studies in Family
8. Mirena® Significantly Reduced Heavy Menstrual Bleeding
Planning. September 1977;8(9)237–243.
website. Available at: http://www.mirena-us.com/what-it-does/
what-does-mirena-mean-for-you.jsp. Accessed February 27, 15. Liambila W, Obare F, Undie C, Birungi H, Kuria SN, Muia
2013. RW, Matekwa A. Strengthening the Delivery of Comprehensive
Reproductive Health Services through the Community Midwifery
9. Fraser IA. Non-contraceptive health benefits to intrauterine
Model in Kenya. APHIA II OR Project in Kenya. Nairobi,
hormonal systems. Contraception. 2010;82:396–403.
Kenya: Population Council; 2012.
10. Special Issue on IUD/IUS of Contraception. 2007;75(6S).
16. Salem, 2006.
Available at: www.contraceptionjournal.org.
17. ICA Foundation, 2013.
11. Salem, 2006.
18. ICA Foundation, 2013.
12. Bayer AG 2010 annual report. Available at: http://www.
annualreport2010.bayer.com/en/bayer-annual-report-2010.
pdfx. Accessed January 20, 2012.
13. Salem, 2006.

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 Supplies 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 secretariat@rhsupplies.org.

This brief was last updated May 2013