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Implants

Product Profile 

ImplantsWoman with new implant
via FHI360/M. Steiner 2012
Potential Lives Saved/Year:


If unmet need for modern methods were fully satisfied, an estimated 53 million unintended pregnancies would be avoided, ~ 90,000 women’s lives would be saved and ~590,000 newborn deaths would be averted ¹

 

 

 


 

 


>> Read the full case study (PDF)

Problem and Proposed Intervention


Sexually-active women of reproductive age in developing countries experience high rates of unintended pregnancy. According to the Guttmacher Institute, nearly 90 percent of the estimated 208 million pregnancies in 2008 occurred in the developing world.  Globally, 86 million pregnancies were unintended; of these, 41 million ended in abortions, 33 million in unplanned birth, and 11 million in miscarriage.  When women and couples can access a wide range of contraceptive methods, they are more likely to find a method they like and can use over a period of time, to switch methods when life circumstances change, and to meet their contraceptive intentions. Even among those who currently use contraception, many who would like to have no more children have no access to long-acting and permanent methods. Similarly those who are at risk of HIV/AIDS or other sexually transmitted infections (STIs) too often do not have access to the means for prevention of both infection and pregnancy. Youth, in particular, must overcome significant barriers to access contraception that meets their needs and vulnerability to unprotected sex.  Among investments in public health, those made to ensure access to contraceptive supplies and services are proven to result in significant improvements in the health of women and children. The 603 million women who currently use modern contraception in developing countries, combined with the 215 million women with an unmet need for modern contraception, attest to the need and desire for contraceptive services and related commodities overall.  Three main reproductive health products have long been classified by the Coalition’s Caucus on New Underutilized Methods as being “underutilized:” emergency contraception, female condoms and contraceptive implants.  As a group, the three serve as a bellwether for identifying opportunities for improving access, use and effectiveness of family planning and for meeting Millennium Development Goal 5b—universal access to reproductive health.


  Contraceptive implants product characteristics:


Drug/Product:

contraceptive implants

Proposed Indication:

reproductive health

Formulation:

2‐rod levonorgestrel‐releasing implant, each rod containing 75 mg of levonorgestrel (150 mg total)

Avg. Cost:

~$8-$18 per unit


Read more below.



Initial Findings from Product Case Study Working Paper

 

* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product.  The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.

 

 

Strengths

Challenges

Policy and Regulation

 

 

Global

* Two rod implants are included in the WHO EML[1] 17 (2011).2

* One rod implants are still not included in the WHO EML.

National, Regional

* Service delivery policies and protocols are in place in many countries for both two-rod and one-rod presentations.

 

Product specification & characteristics

* They are safe, highly effective, and quickly reversible long-acting progestin-only contraceptives that require little attention after insertion.

* No regular action by the user and no routine clinical follow-up are required.

* Implants are one of the most effective contraceptive methods. The contraceptive effect of implants ends immediately after removal and fertility returns rapidly.

* Long-acting methods, including implants, are more effective in practice than shorter acting methods, including oral contraceptives and injectables, because compliance and continuation rates are higher.

* Complications during insertion and removal of implants are rare.

* Innovation: Traditionally, reusable stainless steel trocars have been used to insert implants. Disposable trocars may make implant insertion more feasible in developing countries, enable a more decentralized provision of the method, and reduce the risk that improperly cleaned equipment could lead to transmission.

* The majority of implant users experience menstrual disturbances (not as severe as those experienced by DMPA users).

* Other side effects may include weight gain, vaginitis, acne, breast pain, headache, abdominal pain, ovarian cysts, mood changes.

Financing, Procurement & Supply

* Implants are available from three main manufacturers, Bayer Pharma AG, Merck/MSD Inc, and Shanghai Dahua Pharmaceuticals Co., Ltd.  Each manufacturer has the capacity to significantly expand production, if demand sufficient and financing available.

* Jadelle is prequalified by WHO. It is registered in more than 47 counties and under review in 10 others.

* Implanon (one-rod) is prequalified by WHO and registered in approximately 80 countries.

* Implants are more cost-effective in the long term than repeated use of short-acting methods.

* Increases in procurement of contraceptive implants have been reported over the last few years.

* There are different public-sector price agreements in place with the different manufacturers. 

* Quality assurance efforts are integrated within each manufacturer’s production plans & marketing strategy.

* Given the diversity in implant products, technical requirements for competent training in counseling, insertion and removal of each product as well as related procurement processes is required.

* Relative high commodity costs and a lack of supplies at the country level, due to lack of procurement or distribution networks within the country, contribute to unsatisfied demand for implants.

* Commonly reported stock-outs of either the method or other needed instruments and supplies means that implant services are often unavailable.

* Implants are often combined in information systems and on procurement lists leading to challenges in supply management.

* Upfront commodity cost can be a barrier to both procurement and client access.

Service Provision (Rational Use)

* In some settings, policies allow task-shifting which permit lower cadres of health care providers to insert and/or remove implants.

 

Demand

* Despite a high incidence of adverse menstrual events, overall levels of user satisfaction are high. Furthermore, implants have higher continuation rates than most other reversible methods. 3

* Evidence indicates that thorough pre-insertion counseling can help women accept side effects and reduce their early discontinuation of the method.

* Client satisfaction because convenient to use, long-lasting, and highly effective. 

* Although use of implants, as a percent of the method mix, remains low worldwide, demand often exceeds supply.




[1] Guttmacher Institute, International Planned Parenthood Federation, Facts on Satisfying the Need for Contraception in Developing Countries, November 2010. Original source:  World Health Organization (WHO) et al., Trends in Maternal Mortality:1990 to 2008,           Geneva: WHO, 2010.
[2] WHO. WHO Model List of Essential Medicines (March 2011), 17th edition.  Available at:  http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf.  Accessed March 26,2011
[3] Power J, French R, and Cowan F. Subdermal Implantable Contraceptives Versus Other Forms of Reversible Contraceptives or Other Implants As Effective Methods of Preventing Pregnancy (Review). Cochrane Database of Systematic Reviews 2007;3(3):1-31.