Long-Acting and Permanent Contraception: An International Development, Service Delivery Perspective Roy Jacobstein, MPH, MD

Recent scientific findings about long-acting and permanent methods of contraception underscore their safety, effectiveness, and wide eligibility for individuals who desire them. This has led to new guidance from the World Health Organization to inform national policies, guidelines, and standards for service delivery. Although developing countries have made much progress in expanding the availability and use of family planning services, the need for effective contraception in general (and long-acting and permanent methods in particular) is large and growing because the largest cohorts in human history are entering their reproductive years. More than half a billion people will use contraception in developing countries (excluding China) by 2015, an increase of 200 million over levels of use in 2000. The health, development, and equity rationales that historically have underpinned and energized the international family planning effort remain valid and relevant today. Despite the other compelling challenges faced by the international health community, the need to make family planning services more widely available is pressing and should remain a priority. J Midwifery Womens Health 2007;52:361–367 © 2007 by the American College of Nurse- Midwives. keywords: contraception, female sterilization, implants, international family planning, IUDs, reproductive health, vasectomy, WHO Medical Eligibility Criteria

INTRODUCTION of maternal mortality and an even greater risk of maternal morbidity. By contrast, women in developed countries Over the past four decades, the organized international face a lifetime risk of maternal death of one in 2800 family planning effort has made great progress in ex- 2 panding the availability and use of voluntary reproduc- (.035%). tive health and family planning services. Access to Recent scientific findings and new understanding modern contraception has become recognized by the about long-acting and permanent methods of contracep- international community as a basic human right; how- tion underscore their safety and effectiveness. This has ever, obstacles and challenges remain. led to new guidance from the World Health Organization 3 Meeting the current needs for family planning is (WHO), as well as continuing strong support by the US difficult. An even greater challenge will be to meet the Agency for International Development (USAID) for contraceptive needs of the largest cohorts in human family planning in general and for long-acting and history to enter their reproductive years. There will be permanent methods of contraception in particular. The more than half a billion contraceptive users in developing methods considered “long-acting” in this context are countries (excluding China) by 2015, an increase of 200 intrauterine devices (IUDs) and implants; vasectomy and million people over the number of people using contra- female sterilization are considered “permanent.” In- ception in 2000. Whereas the rates of modern contracep- jectables, such as Depo-Provera (Pfizer U. S. Pharma- tive use in North America and Western Europe are over ceuticals, New York, NY), are considered “short-acting” 70%, such use is still very low in East Africa (17%), because their lengths of action are only from 1 to Middle Africa (5%), and West Africa (6%). 3 months. Related to these levels of contraceptive use, maternal WHO’s guidance documents are available to inform mortality is a great rarity in the developed world (e.g., national policies, guidelines, and standards for delivery two deaths per 100,000 live births in Sweden), whereas of family planning services, which in turn should help in the developing world, maternal morbidity and mortal- foster wider access to family planning services. Wider ity is much more common. For example, there are one or access to and use of family planning, especially of more maternal deaths for every 100 births in 17 of the 36 long-acting and permanent methods of contraception, countries in West, Middle, and East Africa.1 Women in which are the most effective contraceptives available, sub-Saharan Africa face a one in 16 (6.25%) lifetime risk can substantially reduce the high levels of maternal mortality and morbidity in developing countries, as well as unwanted pregnancies and abortion. Address correspondence to Roy Jacobstein, MPH, MD, Clinical Director, In recognition of the pressing need to make quality, the ACQUIRE Project, EngenderHealth, 440 Ninth Avenue, New York, voluntary family planning services more widely avail- NY 10001. E-mail: [email protected] able, the Office of Population at USAID designed the The author’s views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development or the Access, Quality, and Use in Reproductive Health (AC- United States Government. QUIRE) Project, a 5-year, $150 million project that

Journal of Midwifery & Women’s Health • www.jmwh.org 361 © 2007 by the American College of Nurse-Midwives 1526-9523/07/$32.00 • doi:10.1016/j.jmwh.2007.01.001 Issued by Elsevier Inc. focuses on facility-based services and clinical contracep- Table 1. WHO Medical Eligibility Criteria, Classification Categories tion, especially long-acting and permanent contraception. Provider With Classification Provider With Clinical Limited Clinical WHO GUIDANCE FOR FAMILY PLANNING USE Category Judgment Judgment WHO has developed evidence-based tools that help 1 Use method in any Yes, use the method circumstances providers and clients choose an appropriate contraceptive 2 Generally use the method Yes, use the method method. These tools include a family planning handbook 3 Use of method not usually No, do not use the for frontline providers, a counseling tool, and two guid- recommended unless other method ance documents: Medical Eligibility Criteria for Contra- more appropriate methods ceptive Use3 and Selected Practice Recommendations for are not available or not 4 acceptable Contraceptive Use. The eligibility criteria and practice 4 Method not to be used No, do not use the recommendations are based on systematic reviews of the method latest clinical and epidemiological research. They are 3 meant to inform and rationalize national service delivery From the World Health Organization. guidelines, policies, standards, and practices, leading to improved access, quality, and use of the range of modern family planning methods. Updated guidelines and poli- THE COPPER INTRAUTERINE DEVICE cies also can help reduce or eliminate unjustified medical The copper IUD (CuT 380A) has an effectiveness profile 5 policy and practice barriers. comparable to that of female sterilization, vasectomy, The Medical Eligibility Criteria gives guidance on the and implants. Three to eight women per 1,000 using the safety and appropriate use of modern methods of contra- CuT 380A IUD become pregnant in the first year of use.6 ception. The question addressed is, “In the presence of a A long-term international study sponsored by WHO given medical condition or client characteristic, can a found an average annual failure rate of 0.4% or less, and particular family planning method be used, and with a cumulative failure rate after 12 years of use of 2.2%,7 what degree of caution or restriction, as reflected in four which is comparable to that of female sterilization. classification categories?” These classification categories Copper-bearing IUDs have been shown to be very safe represent gradations based on likely benefits and risks. The Medical Eligibility Criteria’s schema also distin- for most women (Category 1 or Category 2). This guishes among providers “with clinical judgment” and includes women who are: postpartum, postabortion, and “with limited clinical judgment” (Table 1). For providers farther from pregnancy or birth (i.e., “interval” IUD with limited clinical judgment, Categories 1 and 2 insertion); breastfeeding; HIV-infected; young and/or become “Yes, use the method,” while Categories 3 and 4 nulliparous; and unable to use hormonal methods. IUDs become “No, do not use the method.” These distinctions are highly protective against ectopic pregnancy via their and simplifications are helpful, particularly in the coun- high efficacy in preventing any pregnancy. Women who tries of sub-Saharan Africa and South Asia, where human use copper-bearing IUDs have a 91% lower absolute risk resources for health care are scarce, and thus much of of ectopic pregnancy than do women using no contra- family planning service delivery must be provided by ception.8 However, among women who do become providers with relatively limited training. pregnant while using an IUD, the relative risk of ectopic The Selected Practice Recommendations functions as pregnancy is higher than in non-users, with an estimated a set of frequently asked questions. Practice recommen- 6% to 8% being ectopic.9 Still, this means that 92% to dations address common clinical issues that arise in the 94% of the rare pregnancies in IUD users will not be provision of modern contraceptive methods. Based on ectopic. While some women report increases in men- systematic review of available scientific evidence but- strual bleeding with copper IUD use, no significant tressed by expert consensus, the Selected Practice Rec- changes in hemoglobin levels have been found.10 WHO ommendations addresses 33 common questions providers thus advises that the CuT 380A can generally be used by are likely to have about various modern contraceptives women with iron deficiency anemia (Category 2). and advises on their safe and effective use. For example, Despite the findings that confirm the IUD’s high “When can a woman have a copper-bearing IUD in- degree of safety and effectiveness, as well as its suitabil- serted?” or, “When can a man rely on his vasectomy for ity for most women, efforts to ‘revitalize’ IUD use in contraception?” developing countries family planning programs have many challenges. Providers tend to overestimate the IUD’s association with negative side effects and condi- Roy Jacobstein, MPH, MD, is Clinical Director of the ACQUIRE Project tions. In addition, myths and misconceptions at the client 11 at EngenderHealth. and community levels remain widespread.

362 Volume 52, No. 4, July/August 2007 PROVIDER CONCERNS ABOUT IUDS doing” but often don’t fully consider the “harm of not doing.” Providers typically have three primary concerns about IUDs. Usually, these are that the IUD may: 1) cause pelvic inflammatory disease (PID); 2) cause infertility; Infertility 12 and/or 3) be unsuitable for HIV-infected women. The second related provider concern is that the IUD might be associated with infertility, a personal tragedy everywhere, and in social context, highly disadvanta- Pelvic Inflammatory Disease geous to most women in developing countries. A well- Rates of clinical PID are very low among IUD users, designed study compared nulligravid, infertile women between 0.6 and 1.6 cases/1000 woman-years of use after with primigravid women and found similar patterns of the first 20 days of use.13 That is, roughly 999 of 1000 previous copper IUD use. Tubal infertility was not women receiving an IUD do not get PID. When PID does associated with IUD use per se, or with duration of use, occur in a woman who has an existing IUD, it is caused reason for removal, or gynecologic symptoms during use. Rather, presence of antibodies to C trachomatis was by Chlamydia trachomatis and Neisseria gonorrhoeae 17 (or other sexually-transmitted organisms), not by the associated with infertility. IUD itself.14 A large WHO study of 23,000 IUD inser- tions with 51,000 woman-years of follow-up found HIV/AIDS modest increased short-term risk of PID in IUD users: 7 Recent evidence suggests that IUDs are generally safe in cases/1000 women in the first 3 to 6 weeks post- women with HIV/AIDS. Two cohort studies in Kenya insertion. After this time, PID risk appeared comparable 15 found comparably low overall and infectious complica- to that of women not using an IUD. These findings are tion rates (7%–10% and 0.2%–2% respectively) follow- the basis for WHO’s practice recommendation that only ing IUD insertion in HIV-infected women. The studies one routine follow-up visit need be conducted, after the conclude that HIV does not appear to increase the risk of first menses or 3 to 6 weeks after IUD insertion, but that IUD-related adverse events, including PID.18,19 An an- subsequent routine follow-up visits are not needed. cillary study found cervical shedding of HIV, a proxy for Providers working in countries with higher prevalence increased infectivity to the male partner, is not increased of sexually-transmitted infection (STI) and fewer re- with IUD use, and concluded that IUD use by HIV- sources for STI testing and treatment may wonder if positive women does not appear to increase the risk of these findings apply to their setting. No prospective acquiring HIV among their HIV-negative male part- studies exist, so inferences must be drawn from modeling ners.20 In response to this evidence, WHO has changed studies. One such study using conservative estimates of its guidance for IUD use by women with HIV and AIDS. each relevant variable found that even where STI prev- Previously, for theoretical reasons only, IUD use by alence is high (10%), in the absence of screening of any HIV-infected women had been Category 3. The concern type, about one case of PID would occur in every 333 had been that the PID risk might be increased because of IUD insertions. This risk could be halved to one case in the overall immunosuppressive effects of HIV. Now, use 667 insertions by simple screening for STI risk prior to of an IUD in women who are HIV-infected or have AIDS IUD insertion. Even if these estimates are off by a factor is Category 2, except for the situation of IUD initiation in of six, the study notes, estimated risk of PID from IUD a woman with AIDS who is ill and/or on antiretroviral use would still be less than 1% in high-risk settings. In therapy, which is Category 3 (Table 2). One practice addition, this risk should not be compared to zero, but implication of these new classifications is that if a rather should be weighed against the other sizeable risks woman who has an IUD in place develops AIDS, the a woman in such settings faces. The modeling study IUD may remain in place. offers an additional view of these risks: if 25% of the IUD-associated PID causes infertility (twice the level PROGRAMMATIC CONSIDERATIONS ABOUT THE IUD: ACCESS associated with a single PID event15), then without any screening, for every 2700 IUD insertions, one case of Access to the IUD could potentially be greater than IUD-associated infertility would occur. In settings with a access to female sterilization or vasectomy, because high prevalence of STIs, the consequences of denying more service cadres can provide the IUD because it is a IUDs to 2700 women would be 2160 pregnancies, at non-surgical method. Also, unlike sterilization, the IUD least 400 serious obstetrical complications, one to two is a method quite suitable for women wishing to space deaths from pregnancy and childbirth, and unknown births as well as those who have completed child- mortality and morbidity from unsafe abortion.16 bearing. From the standpoint of economic access, the These considerations are often not borne in mind by IUD is the most cost-effective method after 1 to 5 years family planning providers who, like medical practitioners of use, depending on the study.21–23 Finally, IUD use for everywhere, tend to be very fearful of the “harm of women who are HIV-positive is likely to become even

Journal of Midwifery & Women’s Health • www.jmwh.org 363 as for copper-bearing IUDs, except for clinical consider- Table 2. Overview: Current (2004) Medical Eligibility Criteria for IUD 3,4 Use in Clients with STIs or HIV/AIDS ations related to the hormone the IUD contains. The hormonally-induced decreased menstrual bleed- Category ing from levonorgestrel-containing IUDs may be an advantage in settings of high iron-deficiency anemia, Condition Initiation Continuation such as in much of the developing world. Sociocultural Increased general risk of STI (high 2* 2 aspects of menstrual bleeding and spotting might pose prevalent setting) acceptability issues and underscore the need for good † High individual risk of STI 3 2 anticipatory counseling. However, the greatest impedi- Current chlamydial or GC infection, or 4‡ 2 purulent cervicitis ment to current and likely future widespread program- HIV-positive 2 2 matic use of the LNG-IUS in developing countries AIDS 3 2 (where per capita income for all needs may be a dollar or AIDS and clinically well on ARV 2 2 less per day) is that the device is 30 to 80 times more ARV ϭ anti-retroviral therapy; GC ϭ gonorrhea; STI ϭ sexually-transmitted costly (approximately $40) to developing country pro- 6 infection. grams than is the CuT 380A ($0.50–$1.50). From the World Health Organization.3 *Category 2: A condition where the advantages of using the method generally PROGESTIN-CONTAINING SUBDERMAL IMPLANTS outweigh the theoretical or proven risks. †Category 3: A condition where the theoretical or proven risks generally outweigh the There are three progestin-containing subdermal implants. advantages of using the method. The first implant to be developed was Norplant, which ‡Category 4: A condition that represents an unacceptable health risk of the is no longer being manufactured. Norplant had six contraceptive method is used. levonorgestrel-containing capsules, and was used for up to 7 years. The two implants currently available interna- tionally are Jadelle (Schering Oy, Pharmaceuticals, more programmatically important in the next few years, Turku, Finland) and Implanon (Organon USA Inc., as antiretroviral therapy continues to become more Roseland, NJ). Jadelle contains two flexible, silicone- widely available in developing countries, and HIV- based polymer rods that are 43 mm in length and 2.5 mm infected women of reproductive age live longer and in diameter; each rod contains 75 mg levonorgestrel, low healthier lives. levels of which are continuously released into the blood over Jadelle’s period of use, approved by the U. S. Food and Drug Administration (FDA) for up to 5 years. THE LEVONORGESTREL-CONTAINING IUD Implanon has one rod that contains 68 mg of etono- Levonorgestrel-containing (or “levonorgestrel-releasing”) gestrel, and is used for up to 3 years. While both implants IUDs release 20 micrograms of the progestin levonorg- have been approved by the FDA, only Implanon is estrel into the uterus daily. (Developers of this IUD refer available in the United States. to it as an intrauterine “system”: the LNG-IUS, helpful The effectiveness of these three implants are compa- terminology which will be used here.) The LNG-IUS rably high, with failure rates of 0.1% to 0.2% or lower in prevents pregnancy mainly via local hormonal effects in the first year of use.25 the uterine cavity: prevention of endometrial growth, Because they have fewer elements to be implanted thickening of cervical mucus, and inhibition of sperm than Norplant, Jadelle and Implanon offer faster and motility and function. After an initial increase in spotting easier insertion and removal. In mid-2006, USAID en- during the first few months, the LNG-IUS brings about a tered into a 5-year procurement contract with the manu- highly significant reduction in bleeding and/or spotting. facturer Schering Oy for the provision of Jadelle. In women with normal menstruation, the LNG-IUS USAID’s cost will be $21 per set, with delivery from the reduces blood loss by 75% at 3 months and reduces the manufacturer beginning in January 2007. number of bleeding days. After the first year of use, 70% to 90% of women using the LNG-IUS experience a FEMALE STERILIZATION reduction in monthly bleeding, and 20% to 30% of women experience no bleeding at all.24 Female sterilization is the most widely-used modern The LNG-IUS is effective for 5 years and has a method of contraception in the world, in both developing somewhat lower failure rate than that of copper-bearing and developed countries.26 Female sterilization can be IUDs (0.1%–0.3% in the first year of use).8 Unlike performed postpartum, after spontaneous or therapeutic copper-bearing IUDs, the LNG-IUS cannot be used to abortion, or as an interval procedure (unrelated in time to provide emergency contraception.24 WHO’s medical el- a pregnancy). The timing of the procedure influences igibility classification categories and practice recommen- both the surgical approach and the method of tubal dations for levonorgestrel-containing IUDs are the same occlusion.

364 Volume 52, No. 4, July/August 2007 There is no new evidence about the effectiveness of the micro-inserts remain anchored, tubal occlusion re- female sterilization, but some aspects of its effectiveness sults from stimulation of tissue in-growth by the PET bear mention, as they may seem “new.” Although female fibers during the first few months post-placement. sterilization is intended to be permanent, and its effec- Backup contraception is needed for 3 months, after tiveness, like other long-acting and permanent methods which time a hysterosalpingogram is performed to con- of contraception, is very high, the risk of failure contin- firm occlusion.29 Essure is not available in family plan- ues for years after the procedure and does not diminish ning programs in developing countries, nor is it likely to with time. The Centers for Disease Control and Preven- become available, because of considerations of cost, tion reported cumulative pregnancy rates in the United practicality, and (the lack of) comparative advantage. States of 5.5 pregnancies/1000 women at 1 year, 13/1000 at 5 years, and 18.5/1000 at 10 years.27 That is, there VASECTOMY were almost two pregnancies per 100 women by 10 The effectiveness of vasectomy is comparable to the years, though this risk varied by method and timing of other long-acting and permanent methods. It is important sterilization, age, race, and ethnicity. to remember that vasectomy is not effective immediately Female sterilization, like the IUD, is highly protective after it is performed. Failure (pregnancy) rates with against ectopic pregnancy because it is so effective at vasectomy are commonly quoted in the range of 0.2% to preventing pregnancy. However, among women who do 0.4%, but failure rates as high as 3% to 5% have been become pregnant after female sterilization, the relative reported from some countries.30 Failure may be caused risk of ectopic pregnancy is higher than it is in non-users, by client behavior (incorrect use of backup contraception although risk varies substantially by method and timing after the vasectomy for the recommended timeframe of of sterilization. In the aggregate, the 10-year cumulative 12 weeks), or may be because of a failed technique itself. probability of ectopic pregnancy after female steriliza- This underscores the importance of good preoperative tion by any method was found to be 7.3 per 1000 counseling, so men know that vasectomy failure does not procedures. This means approximately one-third of fe- equate to spousal infidelity. male sterilization failures resulted in ectopic pregnancy, Vasectomy is a very safe and simple surgical form of two-thirds in intrauterine pregnancy.28 contraception with few restrictions. Major morbidity and mortality with vasectomy is rare and there are generally WHO ELIGIBILITY CRITERIA FOR FEMALE STERILIZATION no adverse long-term effects. Minor complications, such According to WHO, there is no medical condition that as postoperative pain, infection and bleeding, and absolutely restricts eligibility for female sterilization, but chronic pain, occur at levels of 5% to 10%. There are some conditions and circumstances require additional fewer complications with the “no-scalpel” vasectomy considerations. For female sterilization (and vasectomy) technique, which entails a small puncture in the scrotum only, the Medical Eligibility Criteria thus uses a different rather than an incision.31 classification scheme, which also has four classification In developing countries reproductive health and family categories: A (Accept: “no medical reason to deny planning programs, vasectomy is typically provided un- sterilization to a person with this condition”); C (Cau- der local anesthesia in an outpatient setting. Although tion: “the procedure is normally conducted in a routine vasectomy is safer, simpler, less expensive, and compa- setting, but with extra preparation and precautions”); D rably effective compared to female sterilization, it re- (Delay: “the procedure is delayed until the condition is mains the least known and least used modern contracep- evaluated and/or corrected”); and S (Special: “the proce- tive method in developing countries.32 dure should be undertaken in a setting with an experi- There is one new WHO recommendation with respect enced surgeon and staff, equipment needed to provide to vasectomy: a man should wait 12 weeks before relying general anesthesia, and other back-up medical sup- on his vasectomy for contraception. WHO no longer port . . . ”). High risk of HIV and being HIV-infected are recommends the alternative of waiting until after 20 both classified A; AIDS is classified S, with a clarifica- ejaculations. tion that the presence of an AIDS-related illness may require a delay in the procedure. THE ACQUIRE PROJECT To help meet the challenge of “keeping family planning New Method of Transcervical Sterilization on the radar screen,” USAID’s Office of Population In 2002, the FDA approved the use of a new transcervical designed the ACQUIRE Project. ACQUIRE is a 5-year, sterilization device, Essure (Conceptus Inc., Mountain $150 million project, the aim of which is to increase the View, CA). Essure consists of two micro-inserts, which use of reproductive health and family planning services, have a stainless steel inner coil, a nitinol outer coil, and with a focus on facility-based services and clinical polyethylene (PET) fibers. After hysteroscopic place- contraception, especially long-acting and permanent con- ment into the uterine end of each fallopian tube, where traception.

Journal of Midwifery & Women’s Health • www.jmwh.org 365 In 2003, USAID awarded ACQUIRE to a partnership long-acting and permanent contraception as perceived headed by EngenderHealth that includes: the Adventist by the potential user, not by the service system or Development and Relief Agency International; CARE; ACQUIRE; and the design of initial/pilot efforts with IntraHealth International; Meridian Group International; scale-up (diffusion) in mind, planned from the start. This and the Society for Women and AIDS in Africa. The consideration of change also leads to more realistic partners have complementary expertise and experience program goals and timeframes, as it underscores the that addresses reproductive health and family planning reality that “change takes time,” especially in medical/ service delivery needs from the perspectives of health clinical settings, which are often conservative and systems, providers, clients, and communities. change-resistant. ACQUIRE operationalizes its mandate into three pro- grammatic priorities: 1) expand contraceptive services CONCLUSION and choices; 2) increase participation of clients, provid- ers, and communities; and, 3) expand the number of Recent findings and new understandings about various service sites offering a range of reproductive health and contraceptive methods, including long-acting and perma- family planning services. That is, “more methods and nent methods, have led to new evidence-based guidance services to more people in more places.” ACQUIRE does from WHO. There is a large and growing need in this by providing service-oriented technical assistance to developing countries for effective contraception in gen- reproductive health and family planning programs in eral and for longer-acting and permanent methods in sub-Saharan Africa, Asia, and Latin America. In program particular, because the largest cohorts in history are implementation, ACQUIRE’s guiding principles empha- entering their reproductive years. The USAID-designed size: 1) The fundamentals of care (informed decision- and funded ACQUIRE Project is working to increase making, clinical safety, and quality assurance and man- access to and use of good quality, voluntary reproductive agement)33; 2) Identification, adaptation, and use of health and family planning services in developing coun- proven, or “best” practices; 3) Taking a holistic, systems tries in Africa, Asia, and Latin America. The health, approach that pays attention to program elements on both development, and equity rationales that historically have the “supply side” (e.g., service site readiness and capac- underpinned and energized the international reproductive ity, training needs, and security of contraceptive logistics health and family planning effort remain relevant and and supplies) and the “demand side” (e.g., mass media valid today. and interpersonal communication, community involve- ment, and other behavior change interventions); 4) Use I would like to thank to Kate Curtis of the Centers for Disease Control and of data for decision making, especially locally-generated Prevention, Herbert Peterson, MD, of the University of North Carolina School of Public Health, and Patricia MacDonald of the US Agency for data; and 5) Participatory programming to foster owner- International Development for reviewing this paper and providing useful ship and sustainability. feedback. 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