Series K, Number 7
Injectables and Implants

CONTENTS

Home (Key Points)

New Implants Can Expand Access
Table 1. Comparing Implants
Table 2. Continuation Rates for New Implants
Table 3. Estimated Worldwide Use of Implants

Box: Which New Implant to Introduce?

Spotlight: From Norplant to Jadelle: Smooth Transition in a Dominican Republic Clinic

Preparing to Offer New Implants

Spotlight: Training Nurses Increases Implant Use in Ghana

Box: Information and Communication Technology Supports Implant Programs

Meeting Demand for New Implants Requires Supply and Access
Table 4. Key Resources for Program Managers and Providers of Implants

Bibliography

Credits

• Box: What Clients Should Know About Insertion and Removal
• INFO Reports: “Implants: Tools for Providers”

• Table 1: Comparing Implants
• Table 4: Key Resources for Program Managers and Providers of Implants

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"Implants: Tools for Providers"
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New Implants Can Expand Access

Family planning programs around the world are introducing the new one- or two-rod implant systems Implanon®, Jadelle®, and in some countries Sino-Implant (II)®. By 2008 Norplant®, the six-capsule implant system, first introduced in mid-1980s, will no longer be available. Like Norplant, the new implants are highly effective, and like Norplant, they alter bleeding patterns. Their most important improvement over Norplant is easier and quicker insertion and removal. Sino-Implant (II) may also cost much less than other implants.

The new implants are recommended for as much as three to five years of use, depending on the make. Thus they are particularly suitable for women who want to space births. Indeed, for many women implants are a convenient method. Once inserted into a woman’s arm, the implants do not require any action by the user. Since implants do not contain estrogen, they do not decrease production of breast milk and thus are suitable for breastfeeding women. They are also a good choice for women who do not want more children but are not ready to opt for sterilization, which is permanent.

With new implants making the method easier to provide, more programs may want to begin offering implants. Programs currently offering Norplant will need to consider how to make the transition to the newer implants and to meet possibly greater demand.

What Is New About Implants?

The new contraceptive implants are small, thin, flexible plastic rods, each about the size of a matchstick, that release a progestin hormone, either levonorgestrel (Jadelle, Sino- Implant (II)) or etonogestrel (Implanon), into the body. The hormone prevents pregnancy by thickening the cervical mucus, which blocks sperm from meeting an egg, and by disrupting the menstrual cycle, including preventing ovulation—the release of an egg from an ovary. With Implanon the primary mechanism of action is the prevention of ovulation in most cycles. With Jadelle ovulation is prevented in about half of cycles. Implants do not interrupt an existing pregnancy (18, 19, 31, 46, 47, 55, 60, 69, 124).

© 2006 David Alexander, Courtesy of Photoshare

Jadelle and Sino-Implant (II) improve on Norplant for delivery of levonorgestrel. Jadelle, developed by the Population Council and produced by Bayer Schering Pharma, shares many features with its predecessor Norplant. Randomized comparative trials show that the two implants are almost identical in clinical performance (96, 97, 100, 125). Jadelle is a two-rod system, however, compared with Norplant’s six capsules. Each rod contains 75 mg of levonorgestrel. Jadelle improves on Norplant by offering the same performance but also easier insertion and removal, and fewer complications associated with insertion and removal (94, 96). Clients currently using Norplant can continue to use the method until it is time to get the capsules removed. Norplant is labeled for five years of use, but large studies have found that it is effective for seven years (32, 98). Jadelle is labeled for up to five years of continuous use.

The new implants can be inserted and removed very quickly —more quickly than Norplant—but the length of time needed depends on the skill of the provider as well as the number of rods (18, 19, 31, 46, 47, 55, 60). For experienced providers in comparative trials, inserting Jadelle took about an average of 2.5 minutes, compared with 4.8 minutes for Norplant. Removing Jadelle took 5 to 7.5 minutes, compared with 10 to 15 minutes for Norplant (17, 96) (see Table 1).

The World Health Organization’s (WHO) Model List of Essential Medicines, as published in March 2007, includes a two-rod levonorgestrel-releasing implant (123). This inclusion is likely to create greater awareness of implants at the country level. Many countries base their national essential drugs list on WHO’s Model List. (For more information, see http://www.who.int/medicines/publications/EML15.pdf.)

The Chinese two-rod implant system Sino-Implant (II), manufactured by Shanghai Dahua Pharmaceutical, has been available in China since the mid-1990s and has been registered for use in Indonesia since 2002. Like Jadelle, each rod contains 75 mg of levonorgestrel. Its clinical performance in terms of effectiveness and safety is comparable to that of Norplant (25, 57). Insertion and removal times for Sino-Implant (II) are not available at this time. Sino-Implant (II) is labeled for up to four years of continuous use.

© 2006 David Alexander, Courtesy of Photoshare

Implanon provides a one-rod option. Implanon, a single-rod contraceptive implant developed by Organon, contains 68 mg of the progestin etonogestrel. Safety and effectiveness studies have demonstrated that Implanon is highly effective and that insertion and removal are usually fast and uncomplicated (28, 53). Compared with Norplant, Implanon was significantly quicker to insert and remove (82). Although complications are rare with both systems, fewer occurred with Implanon removals (67). Experienced providers inserted Implanon in an average of 1.5 minutes and removed the rod in about 2.7 minutes (see Table 1). As the insertion procedure for Implanon is different from the other implants, training providers in proper insertion is essential (69).

Implanon is currently labeled for up to three years of continuous use. WHO is conducting a randomized clinical trial in seven countries to assess the clinical performance and contraceptive efficacy of Jadelle and Implanon. This will be the first large-scale study comparing the second generation of implants (75).

Implant Characteristics Important to Women

Contraceptive implants offer women many advantages that can suit their reproductive intentions and that make continued use easy (18, 19, 31, 46, 47, 55, 60, 113, 124):

• Implants offer many advantages that can suit women and that make continued use easy.

  Highly-effective. Implants are one of the most effective methods, comparable to intrauterine devices (IUDs), female sterilization, and vasectomy. Far fewer than one pregnancy per 100 users (five per 10,000) is expected during the first year of using levonorgestrel implants. A small risk of pregnancy remains beyond the first year of use and continues as long as the woman is using implants. Overall, in five years of Jadelle use, one pregnancy per 100 users can be expected. Similar rates have been found for Sino-Implant (II) (25). In three years of Implanon use, less than one pregnancy per 100 users can be expected (46, 113, 124).
• Convenient. Once the implants are in place, no routine follow-up is required, and no action is required of the client until the implants need to be replaced (122, 124).
• Immediate return to fertility. Once implants are removed, women can become pregnant as quickly as women who stop using nonhormonal methods.
• Any side effects resolve immediately after removal. In contrast with injectable contraceptives, the hormone does not remain in the body once the implants are removed. Therefore, any associated side effects will resolve shortly after removal.
• Complications are few. Few complications occur as a result of the insertion procedure. Rarely, infections occur at the insertion site. Most of these infections occur within the first two months after insertion. Expulsion of an implant is extremely rare. It most often occurs within the first four months after insertion and is often related either to infection or to incorrect insertion. Removal can sometimes be difficult, but this is rarely a problem if the implant was properly inserted and the provider is skilled at removal (124).
• Suitable for nearly all women. Nearly all women can use implants, including women who have or have not had children; are not married; are of any age, including adolescents; have just had an abortion, miscarriage, or ectopic pregnancy; are breastfeeding (starting as soon as six weeks after childbirth); have anemia; smoke cigarettes (regardless of age); or are infected with HIV or have AIDS, whether or not on antiretroviral (ARV) therapy. It is not certain whether ARV medications reduce the effectiveness of implants, but they are thought not to. Use of condoms would make up for any such reduction in the effectiveness of the implants. Usually, women who should not use implants include those who are breastfeeding and are less than six weeks since giving birth; have a current blood clot in deep veins of legs or lungs; have unexplained vaginal bleeding that requires evaluation; have breast cancer (currently or in the past); have severe liver disease, infection, or tumor; and currently use antiseizure drugs or rifampicin (121, 124).

(For more information on the clinical characteristics of implants, see the companion INFO Reports, “Implants: Tools for Providers”).

Continuation rates are high. Women who use implants tend to be satisfied, and continuation rates are high. A recent Cochrane Review found that the majority of women using contraceptive implants continued with the method longterm. Over 80% of women were still using their implant at two years (82). In clinical trials and observational studies in a number of countries, continuation rates for implants range between 78% and 96% at one year, and between 50% and about 86% at three years (15, 25, 26, 28, 53, 57, 95, 96) (see Table 2). Continuation rates for Norplant and Jadelle are not significantly different (82). While there have been concerns that continuation may sometimes reflect difficulty finding removal services, the majority of implant users have had no problems getting their implants removed and acceptability studies find that women using the method over many years have been satisfied with the implants (96).

Use Could Increase if Barriers Overcome

Worldwide, the level of implant use is low (see Table 3). In spite of over 25 years of development, refinement, and introduction in family planning programs around the world, contraceptive implants have failed to gain wide use. The largest barrier to implant use is the high cost of the method. As a result, few programs and clinics are able to offer the method and, among those who do, stock-outs are frequent (36, 42, 60, 74).

The costs of contraceptive implants, however, have fallen in the past few years and are likely to continue falling. Wholesale prices for bulk orders of Jadelle, Implanon and Sino-Implant (II) have been as low as US$21, US$19, and US$4.50 respectively. Continued support from donors and subsidized prices can make it easier for programs to provide implants. (For more information on cost issues, see Meeting Demand for New Implants Requires Supply and Access.)

There is concern that overall costs of a family planning program will rise if it introduces implants. The cost of implants could be weighed against their potential to reduce unintended pregnancies, however (47). In a recent assessment using data from Kenya, researchers used a previously published simulation model to estimate the annual number of unintended pregnancies with implant use compared with the number of unintended pregnancies with oral contraceptive use. The simple exercise estimated that, if 100,000 users of oral contraceptives switched to implants, an estimated 26,000 unintended pregnancies would be prevented over a five-year period (42).

Providing implants requires planning. Because implants are a “provider-dependent” method, introducing or expanding implant services requires that programs have the capacity to deliver the method appropriately. This includes having the equipment and facilities needed to provide implants, staff trained to perform insertions and removals and to counsel both new and continuing clients, as well as a well-functioning logistics system to maintain the supply of implants and other contraceptive methods (60) (see Preparing to Offer New Implants).

Because the new implants are easier to insert and remove than the six-capsule Norplant system, family planning programs that have provided Norplant should be able to switch quickly to providing the new implants. There may be a period of unavoidable overlap as a program continues offering Norplant while introducing newer implants. This overlap could complicate training and counseling. In addition, providing implants with different durations of action requires attention to appropriate counseling for each method and keeping careful records of which implant a woman has. Programs need to take these and other factors into account when deciding which implants they are going to offer and when (see Which New Implant to Introduce?). A clinic in the Dominican Republic serves as an example of switching successfully from Norplant to Jadelle (see Spotlight: From Norplant to Jadelle: Smooth Transition in a Dominican Republic Clinic).