Norplant Implants

1. 1 Norplant� Implants Norplant� is the registered trademark of the Population Council for six-capsule subdermal levonorgestrel implants.

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3. 3 Norplant Implants Six thin, flexible capsules filled with levonorgestrel (LNG) that are inserted just under the skin of a woman�s upper arm

4. 4 Norplant Implants: Pharmacodynamics Amount of diffusion (serum concentration) is related to surface area of the silastic tubing Rate of diffusion is related to various characteristics of the tubing (density and thickness) Duration of action is related to amount of steroid (LNG) contained within the silastic tubing (capsules)

5. 5 Norplant Implants: Mechanisms of Action

6. 6 Levonorgestrel Serum Levels in Norplant Users The mean level of LNG in the blood stream drops rapidly during the first few weeks after insertion. By 6 months, it reaches 0.25B0.4 ng/ml and decreases only slightly during the next 4.5 years.The mean level of LNG in the blood stream drops rapidly during the first few weeks after insertion. By 6 months, it reaches 0.25B0.4 ng/ml and decreases only slightly during the next 4.5 years.

7. 7 Norplant Implants: Contraceptive Benefits Highly effective (0.05�11 pregnancies per 100 women during the first year of use) Rapidly effective (< 24 hours) Long-term method (up to 5 years protection) Pelvic examination not required prior to use Do not interfere with intercourse Do not affect breastfeeding

8. 8 Norplant Implants: Contraceptive Benefits continued Immediate return of fertility on removal Few side effects Client needs to return to clinic only if problems No supplies needed by client Can be provided by trained nonphysician (nurse or midwife) Contain no estrogen

9. 9 Norplant Implants: Noncontraceptive Benefits Decrease ectopic pregnancy May decrease menstrual cramps May decrease menstrual bleeding May improve anemia Protect against endometrial cancer Decrease benign breast disease Protect against some causes of PID

10. 10 Norplant Implants: Limitations Cause changes in menstrual bleeding pattern (irregular bleeding/spotting initially) in most women Require trained provider for insertion and removal Woman must return to healthcare provider or clinic for insertion of another set of capsules or removal

11. 11 Norplant Implants: Limitations continued Woman cannot stop whenever she wants (provider dependent) Effectiveness may be lowered when certain drugs for epilepsy (phenytoin and barbiturates) or tuberculosis (rifampin) are taken Cost-effectiveness dependent on length of use Do not protect against STDs (e.g., HBV, HIV/AIDS)

12. 12 Who Can Use Norplant Implants Women: Of any reproductive age Of any parity including nulliparous women Who want highly effective, long-term protection against pregnancy Who are breastfeeding (6 weeks or more postpartum) and need contraception Who are postpartum and not breastfeeding Who are postabortion

13. 13 Who Can Use Norplant Implants continued Women: With desired family size who do not want voluntary sterilization With histories of ectopic pregnancy Who have blood pressure < 180/110, blood clotting problems or sickle cell disease With moderate to severe menstrual cramping Who smoke (any age, any amount) Who prefer not to or should not use estrogen Who cannot remember to take a pill every day

14. 14 Norplant Implants Use in Breastfeeding Women May increase quantity of breastmilk Has no effect on: Initiation or duration of breastfeeding Quality of breastmilk Long-term growth and development of infants

15. 15 Norplant Implants: Who Should Not Use(WHO Class 4) Norplant implants should not be used if woman: Is pregnant (known or suspected) Has unexplained vaginal bleeding until the cause is determined and any serious problems are treated Has breast cancer

16. 16 Norplant Implants: Conditions Requiring Precaution (WHO Class 3) Norplant implants are not recommended unless other methods are not available or acceptable if woman: Is jaundiced (active, symptomatic) Has ischemic heart disease (past or current) Has had breast cancer Has liver neoplasia (hypothetical concern only) Is taking drugs for epilepsy (phenytoin and barbiturates) or tuberculosis (rifampin)

17. 17 Norplant Implants: Conditions No Longer Requiring Precaution for Use Norplant implants can be used safely in clients who: Have diabetes mellitus (uncomplicated or < 20 years duration) Have hepatitis (asymptomatic and carriers) Have high blood pressure (< 180/110) Have pre-eclampsia (history of) Smoke (any age, any amount) Will have surgery (with or without prolonged bed rest) Have valvular heart disease (including symptomatic) Have venous thromboembolic diseases (blood clotting)

18. 18 When to Insert Norplant Implants Anytime you can be reasonably sure the client is not pregnant Days 1B7 of the menstrual cycle Postpartum: after 6 months if using lactational amenorrhea method (LAM) after 6 weeks if breastfeeding but not using LAM immediately or within 6 weeks if not breastfeeding Postabortion (immediately or within the first 7 days)

19. 19 Norplant Implants: Infection Prevention Recommendations Wash client�s entire arm and hand with soap and water prior to antiseptic prep. Use sterile or high-level disinfected instruments, surgical gloves and other items. After use, decontaminate all items. Place disposables (needle and syringe) and waste items in a puncture-proof container prior to disposal. Clean and final process reusable items by sterilization (or high-level disinfection).

20. 20 Norplant Implants: Cumulative Pregnancy Rates The tubing used to make Norplant capsules was changed in 1992 to a less dense tubing. Studies of the older capsules with denser tubing demonstrated an increase in the gross cumulative pregnancy rate in women weighing more than 70 kg. This effect does not occur with the newer capsules. There is no reason to be concerned about the use of Norplant Implants by heavier women.The tubing used to make Norplant capsules was changed in 1992 to a less dense tubing. Studies of the older capsules with denser tubing demonstrated an increase in the gross cumulative pregnancy rate in women weighing more than 70 kg. This effect does not occur with the newer capsules. There is no reason to be concerned about the use of Norplant Implants by heavier women.

21. 21 Norplant Implants: Ectopic Pregnancy Facts: Progestins lead to lower tubal motility. Lower tubal motility may alter egg or zygote transport and lead to ectopic pregnancy. Findings: No increased rate of ectopic pregnancy during effective life (5 years). Ectopic pregnancy is more likely (about 13%) if pregnancy occurs in Norplant implants users.

22. 22 Norplant Implants: Comparison of Incidence Rates of Ectopic Pregnancy Because Norplant Implants are highly effective, the risk of ectopic pregnancy is very low. In fact, the ectopic pregnancy rate of 1.3 for women using Norplant Implants is lower than the rate of 2.7 per 1000 woman-years for noncontracepting women in the US. If a woman does become pregnant with Norplant Implants in place, there is a greater likelihood that the pregnancy will be ectopic.Because Norplant Implants are highly effective, the risk of ectopic pregnancy is very low. In fact, the ectopic pregnancy rate of 1.3 for women using Norplant Implants is lower than the rate of 2.7 per 1000 woman-years for noncontracepting women in the US. If a woman does become pregnant with Norplant Implants in place, there is a greater likelihood that the pregnancy will be ectopic.

23. 23 Norplant Implants: Ectopic Pregnancy Overall pregnancy rates: Highest: reproductive-age women using no method (2.7�3.0/1,000) Intermediate: reproductive-age women overall (1.4/1,000) Lower: Norplant implants users (1.3/1,000) Ratio of ectopic to intrauterine pregnancies increased in Norplant implants users (about 13 %)

24. 24 Norplant Implants: Changes in the Menstrual Bleeding Pattern

25. 25 Norplant Implants: Ten Most Frequently Reported Conditions

26. 26 Norplant Implants: Treatment of Common Side Effects Although nearly all users will experience side effects during 5 years of use, serious problems are rare and most can be alleviated with simple treatments. If side effects are not treated, however, they may prompt users to stop using implants. It is especially important to treat menstrual bleeding changesCwhich occur in most usersCbecause these changes are a common reason for discontinuation. This table shows treatments for the most common side effects.Although nearly all users will experience side effects during 5 years of use, serious problems are rare and most can be alleviated with simple treatments. If side effects are not treated, however, they may prompt users to stop using implants. It is especially important to treat menstrual bleeding changesCwhich occur in most usersCbecause these changes are a common reason for discontinuation. This table shows treatments for the most common side effects.

27. 27 Norplant Implants: Drug Interactions Most interactions relate to increased liver metabolism of levonorgestrel: Rifampin (tuberculosis) Anti-epilepsy (seizures): Barbiturates, phenytoin, carbamzepine (but not valproic acid) Griseofulvin (long-term use only)

28. 28 Norplant Implants: Insertion Site Problems

29. 29 Norplant Implants: Client Instructions Keep incision area dry for 48 hours. Keep pressure bandage on for 48 hours and leave Band-Aid7 on until incision heals (3�5 days). Bruising, swelling and tenderness at insertion site are common. Routine work can be done immediately. Avoid bumping the area, carrying heavy loads or applying unusual pressure to incision site. After healing, area can be touched and washed with normal pressure.

30. 30 Norplant Implants: General Information Contraceptive effectiveness begins 24 hours after insertion and stops soon after removal. Changes in menstrual bleeding patterns are common. Certain drugs may reduce effectiveness of implants. Tell your provider if you start any new drugs. Removal of implants is necessary 5 years after insertion. After removal, the fibrous sheath may be felt. Use a condom if at risk for STDs (e.g., HBV, HIV/AIDS).

31. 31 Norplant Implants: Warning Signs Return to clinic if any of the following occur: Delayed menstrual period after several months of regular cycles (may be sign of pregnancy) Severe lower abdominal pain Heavy bleeding Pus or bleeding at insertion site Infection at insertion site Expulsion Migraine headaches

32. 32 Comparison of Nurse-Midwives vs. Physicians: Insertion of Norplant Implants in Indonesia