Product Brief: Caucus on New and Underused Reproductive Health Technologies- Contraceptive Implants
Publication date: 2011
PRODUC T BRIEF Caucus on New and Underused Reproductive Health Technologies Contraceptive Implants Description Introduced more than 25 years ago, contraceptive implants are one of the most e!ective family planning methods available when used in accordance with approved prescribing information. Implants are thin, "exible rods that are inserted just under the skin of a woman’s upper arm and provide sustained contraception ranging generally from three to #ve years. $e Population Council developed the #rst contraceptive implant—Norplant—which was approved in Finland, the country of manufacture, in 1983. Norplant consisted of six rods (2.4 mm × 34 mm), each containing 36 mg of levonorgestrel (a progestin). $e second-generation system, Jadelle, was subsequently developed and approved by the U.S. Food and Drug Administration (USFDA) in 1996; Jadelle consists of two rods (2.5 mm × 43 mm), each containing 75 mg of levonorgestrel. In 1994, Sino-implant (II), a similar two-rod implant with the same amount of active ingredient as Jadelle, was introduced in China. $is was followed by Implanon in 1997 and approved by USFDA in 2006, a single-rod contraceptive implant (2 mm × 40 mm) containing 68 mg etonogestrel, a synthetic female hormone resembling progesterone, which was developed in the Netherlands. Production of Norplant was discontinued in 2008.1 Contraceptive implants provide long-lasting contraception by suppressing ovulation, impeding sperm transit by thickening the cervical mucus, and altering the endometrial structure.2 $e duration of contraceptive protection varies by brand: Jadelle is registered to provide contraception for #ve years, Sino-implant (II) for four years, and Implanon for three years. Doctors may advise women who are overweight to replace the implant earlier. Insertion and removal of an implant must be conducted by a well-trained health care provider, and both insertion and removal are generally short, non-complicated procedures. A'er removal, return to fertility is usually rapid as the synthetic hormones in implants have a short half life, and there is no delayed return to fertility for implant users, as compared to women who do not use contraception.3 A new implant can be inserted at the time of removal if continued contraception is desired. Contraceptive implants can be used by almost all women. Implants are best suited for women who desire a user-independent contraceptive method for birth spacing and limiting. Implants should not be inserted in women during the #rst six weeks a'er childbirth if they are exclusively or partially breastfeeding; those with serious liver disease, problems with blood clots, or unusual vaginal bleeding; and women that have or have had breast cancer.3 Contraceptive implants do not provide protection from sexually transmitted infections. Efficacy Contraceptive implants are one of the most e!ective contraceptive methods available. Annual pregnancy rates are less than 1 percent with all implants.4,5 Continuation rates are o'en better than those for other hormonal contraceptives or intrauterine devices.6 No signi#cant di!erences are found in contraceptive e!ectiveness or continuation rates among users of various contraceptive implants.4 $e major side e!ects associated with the use of contraceptive implants are changes in bleeding patterns (frequency, duration, and amount).3,7 Other potential side e!ects include weight gain, headaches, abdominal pain, acne, dizziness, nausea, breast tenderness, and mood changes. Rarely, infection at the site of the implant will occur.3 Ovarian cysts may also occur, but usually do not require treatment.8 Current programme/sector use Because of implants’ e!ectiveness and convenience, they are popular and in high demand when available in family planning programmes. However, the high upfront commodity cost can be a barrier to access especially in resource-constrained settings. Still, because they are e!ective for a number of years (i.e., three to #ve years), are independent of user’s compliance, and do not require frequent resupply, implants are more reliable and more cost-e!ective compared to other shorter-acting contraceptive methods.9 Although use of implants—as a percent of the method mix—remains low worldwide, demand o'en exceeds supply. In many settings, potential implant users go on waiting lists or choose another method. $is has led analysts to conclude that the true demand for implants is unknown because there are not enough supplies and services available to meet demand.10 Signi#cant increases in procurement of contraceptive implants have been 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 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. This brief was last updated January 2011. reported worldwide over the last four years. Data gathered by the RH Interchange show that in 2005 fewer than 100,000 implants were donated in sub-Saharan Africa. By 2010, donations rose 19-fold to more than 1.8 million.11 Contraceptive implants are a practical method for use in all settings as their insertion requires a short in-o(ce procedure for a one-rod implant and a minor surgical intervention for the two-rod implant. An essential element of implant provision is ensuring excellent counselling before insertion so that women know what potential side e!ects to expect and how to reliably access removal services.1 Guidance for e!ective implant introduction and scale-up is available for providers and managers. An online toolkit on contraceptive implants provides up-to-date and accurate information on training, guidance on best practices, and resources and tools to help improve access to and quality of services: http://www.k4health.org/ toolkits/implants. Manufacturers Jadelle is manufactured by Bayer Schering Pharma. Sino-implant (II) is manufactured by Shanghai Dahua Pharmaceuticals Co., Ltd. Implanon is manufactured by Merck/MSD. Registration status/suppliers Jadelle: Available with a disposable trocar, prequali#ed by the World Health Organization, and has been registered in more than 47 counties worldwide. $is product is distributed commercially by Bayer Schering Pharma. Sino-implant (II): Available with a disposable trocar, has been registered in 13 countries in Africa and Asia, and is under active review in ten additional countries as of January 2011. In addition to the manufacturer’s name for the product (Sino-implant (II)), the product is marketed under a variety of names by distributors in di!erent countries: as Zarin by Pharm Access Africa, Ltd., as TRUST by DKT Ethiopia, and as Femplant by Marie Stopes International. Implanon: Available in a preloaded, disposable, sterile trocar; is prequali#ed by the World Health Organization; and has been registered in 80 countries. $e product is distributed commercially by Merck/MSD. Public-sector price agreements Jadelle: Public-sector price agreements with organizations such as the US Agency for International Development (USAID), the United Nations Population Fund (UNFPA), PSI, and others have been established. Sino-implant (II): Public-sector price agreements are established with distribution partners. Implanon: Public-sector price agreements have been made through contracts with individual ministries of health, UNFPA, USAID, and nongovernmental organizations engaged in family planning. References 1 Ramchandran D, Upadhyay UD. Implants: $e Next Generation. Population Reports. Series K: Injectables and Implants 2007;7:1–19. 2 Croxatto HB. Mechanisms that explain the contraceptive action of progestin implants for women. Contraception. 2002;65(1):21–27. 3 World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. Family Planning: A Global Handbook for Providers. Baltimore and Geneva: CCP and WHO, 2007. 4 Glasier A. Implantable contraceptives for women: e!ectiveness, discontinuation rates, return to fertility, and outcome of pregnancies. Contraception. 2002;65(1):29–37. 5 Steiner M, Lopez M, Grimes D, et al. Sino-implant (II)—a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials. Contraception. 2010; 81(3)197–201. 6 Power J, French R, Cowan F. Subdermal implantable contraceptives versus other forms of reversible contraceptives or other implants as e!ective methods for preventing pregnancy. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.:CD001326. DOI:10.1002/14651858.CD001326.pub2. 7 Sivin I. Risks and bene#ts, advantages and disadvantages of levonorgestrel-releasing contraceptive implants. Drug Safety. 2003;26(5):303–35. 8 Hohmann H, Creinin MD. $e contraceptive implant. Clin Obstet Gynecol. 2007;50(4):907–17. 9 Mavranezouli I. Health economics of contraception. Best Pract Res Clin Obstet Gynaecol. 2009;23(2):187–98. 10 Hubacher D, Kimani J, Steiner MJ, Solomon M, Ndugga MD. Contraceptive implants in Kenya: Current status and future prospects. Contraception. 2007;75(6):468–473. 11 Tumlinson K, Steiner M, Rademacher K, et al. $e promise of a!ordable implants: is cost recovery possible in Kenya? Contraception. In press.