The Levonorgestrel Intrauterine System: Reasons to Expand Access to the Public Sector of Africa

1. Recently Placed on WHO’s Essential Medicines List

WHO recently placed the LNG IUS on the Essential Medicines List.⁹ Thus, in the eyes of WHO, the LNG IUS is now considered one of the most “efficacious, safe, and cost-effective medicines for priority conditions.”⁹ Priority conditions are “selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment.” Now, according to WHO, a health care system is not meeting basic needs without the LNG IUS on the formulary.

2. Well Accepted Worldwide

Worldwide, user satisfaction with the LNG IUS is consistently high. A study in 18 different countries in Asia and Europe found that 95% of LNG IUS users were satisfied with the product.¹⁰ Compared with the subdermal implant, the LNG IUS is often better tolerated. For example, in Australia, 3-year continuation rates of the LNG IUS and the etonogestrel subdermal implant were 73% and 53%, respectively.¹¹ In the United States, the LNG IUS continuation rate at 24 months was found to be significantly higher than that of the subdermal implant (79% versus 69%, respectively).¹² In the only head-to-head comparison of the levonorgestrel subdermal implant and the LNG IUS, the subdermal implant had a removal rate for irregular bleeding of 26.8% at 36 months compared with 3.3% for the LNG IUS.¹³ Prolonged bleeding consistently affected 20% to 40% of implant users at different follow-up times, but the problem did not exceed 10% for LNG IUS users.

Research in Africa also shows good prospects for the LNG IUS. In Kenya, 16% of family planning clients chose the LNG IUS when given the opportunity; only 3% wanted the copper IUD.¹⁴ Kenyan providers cited non-contraceptive benefits (reduction of menstrual blood loss, alleviation of anemia) as important reasons for recommending the LNG IUS to clients.¹⁵ In a prospective cohort study, approximately 90% of women in Kenya were still using the LNG IUS after 12 months.¹⁶ A survey in South Africa found that 75% of respondents were positive toward a product such as the LNG IUS if it would reduce menstrual bleeding.¹⁷ In Ghana, LNG IUS users and providers had similar high opinions of the product.¹⁸ In Ghana and 8 other countries in sub-Saharan Africa, the International Contraceptive Access (ICA) Foundation has donated thousands of LNG IUS products since 2003.^19,20

3. Unique/Advantageous Delivery System and Important Non-Contraceptive Benefits

No other hormonal method releases progestin directly into the uterus; this results in a predominately local effect with highly efficacious triple-action mechanisms on the cervix, endometrium, and ovaries to prevent pregnancy. Moreover, the level of levonorgestrel released from the LNG IUS is steady and slow, which minimizes side effects. In contrast, short-acting hormonal methods have abrupt dosing effects and higher levels of circulating hormones that create peaks and troughs of systemic levels; for many users, this causes intolerable side effects, leading to high discontinuation rates.

Non-contraceptive benefits also make the LNG IUS unique; the benefits are linked to how the LNG IUS shrinks the endometrium and minimizes uterine bleeding. The LNG IUS is a proven treatment for heavy menstrual blood loss and is more effective than all other non-hysterectomy approaches.²¹ The LNG IUS also decreases bleeding among women with uterine fibroids.²² Finally, the LNG IUS has very promising prevention actions against a number of conditions, including endometriosis, uterine fibroids, endometrial hyperplasia, endometrial cancer, and peri-menopausal menstrual disturbances.²³

The LNG IUS may help anemic women; this is probably the most important potential non-contraceptive benefit for women in resource-poor countries. Through the mechanism of reducing menstrual blood loss, the LNG IUS can help anemic women retain up to 19 grams of iron each month.²⁴ This amount, when accumulated over many months, might increase iron stores and prepare women for healthy pregnancy when the time comes. Anemia affects approximately 46% of women of reproductive age in sub-Saharan Africa and Southeast Asia,²⁵ and it contributes to 20% of all maternal deaths.²⁶ Prolonged anemia after pregnancy, short birth intervals, and even poor nutritional status prior to a first pregnancy increase the risks of poor health outcomes.

Because of these unique attributes, the LNG IUS is not interchangeable with the copper IUD. In Kenya, nearly a third of LNG IUS acceptors said they would have chosen a short-acting method if the LNG IUS were not available, and only 21% would have chosen the copper IUD.¹⁴ In the United States, approximately 80% of intrauterine contraceptive use is attributable to the LNG IUS and 20% to the copper IUD; the CHOICE study demonstrated that women overwhelmingly wanted the LNG IUS in a 4 to 1 ratio over the current copper IUD product.²⁷

4. Opportunity to Activate Some Countries

The best example of rapid uptake of the LNG IUS is from the United States. In this mature contraceptive market, the LNG IUS quickly reinvigorated interest in intrauterine contraception.²⁸ Between 1995 and 2013, the proportion of all contraceptive users using intrauterine contraception in the United States rose from less than 1% to over 10%.²⁹ Today intrauterine contraception is more popular in the United States than any new delivery system introduced since 1992, including the injectable DMPA (1992), the vaginal ring (2001), the patch (2002), and the etonogestrel subdermal implant (2006).^30,31 The general rise in intrauterine contraceptive use was also seen in federally funded family planning programs, in which provision increased from 48,000 intrauterine contraceptive services in 1999 to more than 270,000 in 2011.³²

Ministries of Health recognize the importance of expanding access to long-acting reversible contraception, particularly since sterilization services are more difficult to provide. In the 1980s, many countries put the newly available copper IUD at the center of their family planning programs. Egypt, Mexico, Turkey, and Vietnam experienced tremendous fertility transition in one generation by making the IUD widely accessible. Today, Ethiopia’s Ministry of Health is using health extension workers to make subdermal implants widely available; this may result in similar patterns of uptake that were observed in countries where the copper IUD became popular. Other countries will focus on the LNG IUS when it becomes available. No one can predict which countries will launch the LNG IUS and make it successful, just as nobody predicted which countries would succeed with copper IUDs and implants.

The international family planning community is ready to support the LNG IUS. At the biennial International Conference on Family Planning in Ethiopia in 2013, a small survey of 30 conference participants found that 100% of respondents with knowledge of the LNG IUS supported the idea of making the product available in public-sector clinics worldwide (personal communication with Heather Vahdat, FHI 360, November 11, 2014). When asked why they would support the introduction of an LNG IUS, responses fell primarily into 2 categories: benefits offered by the method (e.g., long-acting, fewer side effects, reduced bleeding) and to support expansion of the method mix/choice for women.

5. Many Women in sub-Saharan Africa Want to Use Intrauterine Contraception

NGOs consistently show high uptake of IUDs in the same public-sector clientele where ministries fail. The difference is that NGO providers have the knowledge, skills, job expectations, and proper support to make IUD services available. For example, between 2008 and 2012 Marie Stopes International more than tripled the number of IUDs it provided in sub-Saharan Africa, from 69,087 insertions to more than 215,000.^33,34 The interest in long-acting methods overall is growing.³⁵

Introduction of the LNG IUS is a new opportunity for Ministries of Health and providers in the public sector to establish successful, demand-driven intrauterine contraception services. As demonstrated in the United States, a single intrauterine product with a proven track record and high acceptability can stimulate provision of services, even in the public sector. With a new product such as the LNG IUS, public-sector providers can develop the skills and confidence to insert IUDs and serve the clientele who currently have latent demand for services. Thus, the LNG IUS may be the easiest route to establish consistent access to the copper IUD.

6. Need for More Highly Effective Options

WHO lists IUDs (copper IUDs and the LNG IUS) and subdermal implants as the most effective reversible forms of contraception.³⁶ Only subdermal implants and intrauterine contraception can compensate for lack of access to sterilization services. For spacing births, implants and intrauterine contraception eliminate the risks of unintended short birth intervals. In public-sector facilities throughout sub-Saharan Africa, the current array of contraceptive choices is imbalanced in favor of the least effective, short-acting options. Thus, women who need permanent or long-term protection face difficult challenges over many years. For many countries, the copper IUD has not contributed much toward reducing national levels of unintended pregnancy and fertility. New products such as the LNG IUS are needed to attract new users to highly effective, long-acting contraception.

Adolescents also need more effective options like the LNG IUS. Preventing unintended pregnancy in this population (especially first pregnancies) can help young women achieve other goals they may have (e.g., education, employment). Consensus is building that long-acting reversible contraceptives should be easily available to sexually active young women.^37,38

Summary

The LNG IUS is not just another, interchangeable contraceptive. This fact should help justify taking procurement and program action for the public sector in sub-Saharan Africa. For many decades, the obstacles to procurement appeared insurmountable. Today, however, international donors have better information and more opportunities to make large-scale procurement a reality. With renewed emphasis and funding for family planning, the timing couldn’t be better. Women in resource-poor countries will benefit tremendously from the LNG IUS; worldwide equity in access to the technology is needed.