Contraceptive Implants Session II: Who Can and Cannot Use Implants Photo credits: © 2006 David Alexander/CCP, Courtesy of Photoshare

Characteristics of Implants Why might these women be interested in using implants? Breastfeeding mother Adolescent Infected with HIV Has little to no access to a health care facility Desires no more children Ask participants for reasons why these women might prefer or avoid implants. Then, click the mouse to reveal the next example. <Move through each case quickly and mention the following points>

Implants Are Safe for Nearly All Women Almost all women can use implants safely, including women who: Have just had an abortion, miscarriage or ectopic pregnancy Are breastfeeding Have anemia now or in the past Have varicose veins Smoke cigarettes, regardless of woman’s age or number of cigarettes smoked Have or have not had children Are married or not married Are of any age including adolescents and women over 40 years old Are infected with HIV This slide represents the international consensus on the initiation of implants and breastfeeding as reflected in the WHO MEC. For further information on the initiation of implants and breastfeeding, see slide 10.  This consideration should be more fully discussed at that time.   Most health conditions do not affect safe and effective use of implants. Many women who cannot use methods that contain estrogen can safely use implants.

Who Can and Cannot Use Implants (part 1) Most women can safely use implants But usually cannot use implants if: Adapted from WHO’s Decision-making tool for family planning clients and providers. This slide represents the international consensus on the initiation of implants and breastfeeding as reflected in the WHO MEC. For further information on the initiation of implants and breastfeeding, see slide 10.  This consideration should be more fully discussed at that time.   Explain that most women can safely use implants as mentioned in the previous slide. Show the slides and discuss which women should not use implants. Ask several participants to share one thing that they know about the Medical Eligibility Criteria (MEC) in their national FP/RH guidelines (if they exist) or the WHO MEC. May be pregnant Some other serious health conditions

Who Can and Cannot Use Implants (part 2) Most women can safely use implants. But usually cannot use implants if: May be pregnant If in doubt, use pregnancy checklist or perform pregnancy test. Some other serious health conditions Has blood clot in lungs or deep in legs now and is not on anticoagulant therapy. Women with superficial clots (including varicose veins) CAN use implants. Ever had breast cancer. Unexplained vaginal bleeding. If the bleeding suggests a serious condition, help her choose a method without hormones to use until unusual bleeding is assessed. Serious liver disease or jaundice (yellow skin or eyes). Adapted from WHO’s Decision-making tool for family planning clients and providers. This slide represents the international consensus on the initiation of implants and breastfeeding as reflected in the WHO MEC. For further information on the initiation of implants and breastfeeding, see slide 10.  This consideration should be more fully discussed at that time.  

Medical Eligibility Criteria What are medical eligibility criteria? Define the categories. Review the job aid. Demonstrate how to use the WHO MEC Wheel or the Quick Reference Chart. Explain that implants are safe for the overwhelming majority of women. Use slides 7-8 to provide an overview of the medical eligibility criteria for implants.

With clinical judgment WHO’s Medical Eligibility Criteria Categories for IUDs, Hormonal and Barrier Methods Category Description With clinical judgment 1 No restriction for use Use the method under any circumstances 2 Benefits generally outweigh risks Generally use the method 3 Risks usually outweigh benefits Use of method not usually recommended, unless other methods are not available/acceptable 4 Unacceptable health risk Method not to be used Category 1: For women with these conditions or characteristics, the method presents no risk and can be used without restrictions. According to the MEC, implants can be used without any restrictions by women with category 1 conditions. For example, progestin-only implants can be used freely by women of any age, including those who are less than 18 years old; women who are breastfeeding a baby older than six weeks (to be discussed on page 10); women who are heavy smokers; or women who have complicated valvular heart disease, endometriosis, endometrial or ovarian cancer, or thyroid disease. Category 2: For women with these conditions or characteristics, the benefits of using the method generally outweigh the theoretical or proven risks. Women with Category 2 conditions generally can use the method, but careful follow-up may be required. For women with category 2 conditions, the advantages of using this method outweigh the theoretical or proven risks. Progestin-only implants can generally be used by women with category 2 conditions, but careful follow-up may be required in some cases. Examples of such conditions include blood pressure above 160/100 mm Hg, a history of deep venous thrombosis/pulmonary embolism (DVT/PE), diabetes with vascular complications, heavy or prolonged vaginal bleeding patterns, or multiple risk factors for cardiovascular disease. Category 3: For women with these conditions or characteristics, the theoretical or proven risks of using the method usually outweigh the benefits. Women with Category 3 conditions generally should not use the method. However, if no better options for contraception are available or acceptable, the provider may judge that the method is appropriate, depending on the severity of the condition. In such cases, ongoing access to clinical services and careful follow-up will be required. Category 4: For women with these conditions or characteristics, the method presents an unacceptable health risk and should not be used. Source: WHO, 2015.

When clinical judgment is limited WHO’s Medical Eligibility Criteria Categories for IUDs, Hormonal and Barrier Methods Category When clinical judgment is limited 1 Use the method 2 3 Do not use the method 4 According to WHO, in settings where clinical judgment is limited, category 2 conditions should be treated in the same manner as category 1 conditions. This means that women with category 1 and category 2 conditions should be able to obtain and use progestin-only implants without restrictions. Source: WHO, 2015.

Implants are safe for nearly all women. Conditions (selected examples) Category 1 and 2 Examples (not inclusive): Who Can Start Implants Implants are safe for nearly all women. WHO Category Conditions (selected examples) Category 1 Adolescents, post-abortion, postpartum in non-breastfeeding women, heavy smokers, women being treated for high blood pressure, valvular heart disease, endometriosis, endometrial or ovarian cancer, thyroid disorders Category 2 Breastfeeding <6 weeks postpartum, multiple risk factors for cardiovascular disease, blood pressure ≥160/100, history of blood clots in legs or lungs, diabetes with vascular complications, heavy or prolonged vaginal bleeding patterns Discuss conditions included in categories 1 and 2. Remind participants that implants are safe for most women Source: WHO, 2015.

Category 3 and 4 Who Should Not Start Implants A small number of women may not be able to use implants. WHO Category Conditions (selected examples) Category 3 Acute blood clots in deep veins of legs or lungs; unexplained vaginal bleeding; history of breast cancer; severe liver disease, infection or tumors; and certain cases of systemic lupus. Continuation only: ischemic heart disease, stroke, migraine with aura. Category 4 Current breast cancer Although progestin-only implants are safe for most women, there are some exceptions. According to the WHO MEC, progestin-only implants are not generally recommended for women with category 3 conditions. In these situations, the risks of using this method usually outweigh the advantages. Category 3 conditions include: Acute blood clot in deep veins of legs or lungs, unexplained vaginal bleeding, history of breast cancer, severe liver disease and most liver tumors, certain cases of systemic lupus and breastfeeding before 6 weeks postpartum. The condition of breastfeeding before 6 weeks postpartum is a special case that merits further consideration. Based on theoretical (i.e. not proven) reasons having to do with the concern that progestogens may negatively affect the neonatal liver or brain, the WHO MEC has classified breastfeeding before 6 weeks postpartum as a category 3. WHO also notes that “in many settings pregnancy morbidity and mortality are high, and access to services is limited. Progestin-only contraceptives may be one of the few types of methods widely available and accessible to breastfeeding women immediately postpartum.”  Reflecting this consideration, after careful evaluation of the evidence and their own health systems and settings, some countries have made different classifications.  The United States Center for Disease control (CDC) gives the condition of breastfeeding at 0-4 weeks a Category 2 and from 4-6 weeks a Category 1. The United Kingdom’s Royal College of Obstetricians and Gynaecologists: Faculty of Sexual and Reproductive Health Care give it a Category 1 from birth onward. The materials in this training package reflect the WHO classification. Women who develop ischemic heart disease, have a stroke, or develop migraine headaches with an aura while using implants should generally not continue using progestin-only implants. Women with category 4 conditions should not use implants. Current breast cancer is the only category 4 condition. Source: WHO, 2015.

Implant Use by Women with HIV WHO Eligibility Criteria Condition Category Asymptomatic or mild HIV clinical disease 1 Severe or advanced HIV clinical disease ARV therapy with NRTIs and integrase inhibitors ARV therapy with NNRTIs and PIs 2 Women with HIV or AIDS can use without restrictions Some ARV drugs reduce blood progestin level Efficacy is not affected because implants provide consistent dose of hormone over time Dual method use should be encouraged for women taking Efavirenz Ask participants: What advice should you give to clients with HIV who choose implants? <accept responses from several participants; click the mouse to reveal the next bullet> Source: WHO, 2015

Implant Use by Postpartum Women WHO Eligibility Criteria Condition Category Non-breastfeeding 1 Breastfeeding<6 weeks 2 Breastfeeding≥6 weeks Breastfeeding and non- breastfeeding women can initiate anytime starting immediately postpartum Ask participants: Let us take a closer look at the conditions and categories pertaining to postpartum clients. Use slide to present the following: Non-breastfeeding women can initiate implants immediately postpartum. We have also discussed the different recommendations adopted by WHO and countries such as the US and UK regarding the use of implants earlier than 6 weeks postpartum based on theoretical concerns about possible negative effects of progestins on the fetal liver and brain.  WHO has classified use at 0-6 weeks postpartum a classification of 3, while others have given it a lower classification (1 or 2).  Unlike Combined Oral Contraceptives (COCs), implants do not have an effect on breast milk production. Ask participants about what they encounter with postpartum women. Is it easy or difficult for them to come back for insertion at 6 weeks postpartum? Source: WHO, 2015.

Understanding the Implant Checklist Read questions 1–6 in the checklist and match them with the conditions and categories on the MEC quick reference chart. This set of questions identifies women who should not use implants. This set of questions identifies women who are not pregnant. Distribute an implant checklist to each participant. When introducing the checklist, mention that it should be used by providers to determine whether a client is medically eligible to use the method that she selected during an informed decision-making process. The questions on the checklist identify women who have health conditions—WHO category 3 or 4—that make it unsafe for them to use progestin-only implants. The checklist also incorporates questions that allow a provider to determine with reasonable certainty that a client is not pregnant. To use the checklist, providers ask the questions on the checklist and follow the instructions based on the client’s responses. Explain that the medical eligibility questions, questions 1–6, are at the top of the checklist. Ask participants: After examining the checklist and the MEC chart, are you confident that the checklist questions address the conditions that prohibit safe use of progestin-only implants? Explain why. How have you determined a client’s medical eligibility for implants in the past and how might the checklist facilitate that process? The checklist also gives instructions about initiating implants.

When to Start Implants (part 1) Anytime a provider is reasonably certain a woman is not pregnant. Pregnancy can be ruled out if any of these situations apply: Is fully breastfeeding, has no menses, and baby is between 6 weeks and 6 months old Abstained from intercourse since last menses or delivery Had a baby in the past 4 weeks (if not breastfeeding) Started monthly bleeding within the past 7 days Had a miscarriage or abortion in the past 7 days Is using a reliable contraceptive method consistently and correctly If none of the above apply, pregnancy can be ruled out by pregnancy test, pelvic exam, or by waiting till next menses. Ask participants: If a woman is medically eligible and wants to use implants, when can she initiate them? <participants brainstorm; accept responses from several participants> Let us compare your responses with the information on the next several slides. <click the mouse to reveal each bullet on the slide> Source: WHO, 2016

When to Start Implants (part 2) First 7 days of menstrual cycle, no backup method needed After 7th day of menstrual cycle, rule out pregnancy and use backup method for 7 days Postpartum Menses has not returned Fully breastfeeding and <6 months postpartum OR not breastfeeding and <4 weeks postpartum: Insert anytime, no backup needed Fully breastfeeding and >6 months postpartum OR partially breastfeeding OR not breastfeeding and >4 weeks postpartum: Rule out pregnancy and use backup method for 7 days Menses has returned (breastfeeding AND non-breastfeeding): As advised for women having menstrual cycles Remind participants that the instruction boxes below the questions on the Checklist for Screening Clients Who Want to Initiate Contraceptive Implants also provide guidance about when to initiate implants for women who are eligible. If implants are initiated during the first seven days of the menstrual cycle—where day one is the first day of bleeding—no backup contraceptive method is necessary. If progestin-only implants are initiated more than seven days after the start of woman’s monthly bleeding (more than five days for Implanon), she should be counseled to use a backup contraceptive method such as condoms for the first seven days following insertion. Breastfeeding and non-breastfeeding women may have implants inserted immediately after delivery. If a woman who is not breastfeeding wants to start using implants more than four weeks after she has given birth, it is necessary to rule out pregnancy before they can be inserted. Source: WHO, 2016

When to Start Implants (part 3) Postabortion or miscarriage: immediately; without backup if within 7 days. If more than 7 days, rule out pregnancy and use a backup method for 7 days after insertion. Switching from a hormonal method: immediately if it was used consistently and correctly Injectable users can have implants inserted within the reinjection window; without backup No need to wait for next menses After using emergency contraceptive pills: Insert within 7 days after start of next menstrual period (5 days for Implanon); provide with backup method during interim Source: WHO, 2016.

When to Start Implants (part 4) After using emergency contraceptive pills (ECPs): Progestin-only or combined ECPs Implants can be inserted on same day ECPs taken, use a backup method for first 7 days Ulipristal acetate ECPs (UPA-ECPs) Interaction between UPA-ECPs and implants that may make one or both less effective Implants can be inserted on the 6th day after taking UPA-ECPs Use a backup method from the time she takes UPA-ECPs until 7 days after implant inserted