Rationale: Risk of pregnancy during lactational amenorrhea is very low: less than 2% in the first 6 months postpartum if fully breastfeeding; less than or equal to 7% in the first 12 months. If the fully or nearly fully breastfeeding woman remains amenorrheic, her risk of pregnancy is about the same as her risk with other modern contraceptive methods (22, 147, 214).

* In breastfeeding women, bleeding in the first 56 days (8 weeks) postpartum is NOT considered "menstrual" bleeding because it is not preceded by ovulation.

Recommendation: If the woman is fully breastfeeding but does not want to rely on LAM, ideally wait until at least 6 weeks postpartum to initiate Norplant implants. If she is only partially breastfeeding and does not want to rely on LAM, it is still advisable to wait at least until 6 weeks postpartum before initiating Norplant implants.

Rationale: Based on animal studies and observed fluctuations of human sex hormones in the first 6 weeks of life, plus the immaturity of the neonatalliver for the metabolism of exogenous steroids, it is considered prudent to wait to initiate progestin-only contraceptives until a breastfeeding woman is at least 6 weeks postpartum (112, 289).

Most studies (2, 63, 242, 309, 311) have not detected clinically measurable effects on the health or growth of breastfed babies of women who begin using Norplant implants after 6 weeks postpartum, although not all studies report consistent findings (62, 241). Based on current literature including studies with other progestin-only methods (135, 187, 309, 311), it is unlikely that there is a significant effect on growth of breastfeeding infants whose mothers initiate Norplant implants after the sixth postpartum week.

Recommendation: Programs that wish to give clients the option of Norplant implant insertion immediately postpartum should also give clients the option of returning after 6 weeks to receive Norplant implants.

Rationale: In some service delivery settings, access to Norplant implant insertion may be difficult for clients to obtain outside of immediate postpartum services.

Rationale: While there may be a theoretical concern of increased thrombogenic effect with COC use in the first week postpartum, there is no known clinical thrombogenic effect of progestin-only contraceptives; therefore Norplant implants can be safely inserted immediately postpartum, for nonbreastfeeding women (36, 86, 306).

Rationale: See Progestin-Only Injectables, Question 4, for considerations applicable to progestin-only methods.

• If possible, handle all counseling and screening on the same day as the insertion.
• A routine system of pre-exam visits is not necessary.

A visit within the first 1 to 3 months may be advised if additional counseling is necessary or to check the insertion site.

Inform the woman when removal will be necessary (in 5 years, or sooner if she desires) and provide her with a means of remembering this date.

Visits are encouraged for other preventive reproductive health care as available, including provision of condoms, when appropriate.

Rationale: The client should be encouraged to return to the clinic if she has any problems or questions, after 5 years, or when she desires removal, and for general reproductive health care. If women have no complaints, there is no need for routine contraceptive clinic visits before the end of the 5 years (72, 219, 332).

For prolonged spotting or moderate bleeding (equivalent to normal menstruation but longer in duration), the first approach should be counseling and reassurance. It should be explained that in the absence of evidence for other diseases, irregular bleeding commonly occurs with Norplant implants.

If counseling and reassurance are not sufficient for the woman and the woman wishes to continue Norplant use, the following management approaches may be tried:

• Short-term (for 7 to 21 days) COCs or estrogen or
• Ibuprofen (or similar nonsteroidal anti-inflammatories other than aspirin).

Rationale: Norplant implants may cause increased bleeding in some women and decreased bleeding in others. Changes in bleeding patterns tend to decrease over time (48, 219, 288).

Bleeding is managed by rebuilding the endometrium with COCs, or by taking ibuprofen* which blocks prostaglandin synthesis and thus decreases uterine contractions (COCs are preferred over estrogen because Norplant implants deliver such a low dose of progesterone that the contraceptive effect on the cervical mucus may be reduced by the addition of estrogen only) (61, 303).

* Nonsteroidal anti-inflammatory drugs (e.g. ibuprofen) should be used instead of aspirin because of aspirin's stronger and longer-lasting inhibitory effects on platelet aggregation (aspirin promotes bleeding) (5,83).

Recommendation: If suspected, abnormal conditions that cause prolonged or heavy bleeding should be evaluated and treated as appropriate.

Some prolonged or heavy bleeding may fail to be corrected. Some women will require removal of Norplant implants due to medical reasons for excessive bleeding or due to client's preference.

Evaluate and address anemia, as appropriate. Give nutritional advice on the need to increase the intake of iron-containing foods.

Do not perform uterine evacuation unless another medical condition is suspected. (Vacuum aspiration is generally the preferred method of uterine evacuation.)

Rationale: Any specially trained doctor, nurse, midwife, or other health worker can perform Norplant insertions and removals (219).

• Appropriate handwashing by the provider and thorough cleaning of the insertion site,
• Proper decontamination of reusable sharps and other instruments,
• Sterilization (or, at a minimum, high-level disinfection) of all equipment, and
• Safe disposal of contaminated sharps and other disposables.

Another concern is the increasing problem of transmission of hepatitis B and AIDS viruses to clients, health care providers, and clinic staff, especially cleaning personnel. To minimize this risk, blood-contaminated waste must be properly disposed of, and soiled instruments, gloves, and other items must be decontaminated, then thoroughly cleaned, and then sterilized or high-level disinfected after every use.

Sterilization (the destruction of all microorganisms, including endospores) is the preferred practice for processing instruments and other items that come in contact with the blood stream or touch tissue beneath the skin. When sterilization is not possible, high-level disinfection (which destroys all microorganisms except some endospores) is acceptable.

Regardless of which method (sterilization or high-level disinfection) is used for instruments and other items, thorough cleaning of the client's arm and hand to remove soil and organic material is also necessary to prevent infection. Appropriate dressing and instruction to clients on hygiene of the insertion site are also important (272).

Some women may refuse to have their Norplant implants removed after 5 years. In such cases, women should be counseled on the potential risks (including ectopic pregnancy) and benefits. If she still refuses to have the removal, she should be encouraged to use an additional method of contraception.

Rationale: Norplant implants are a very highly effective method of protection against pregnancies for up to 5 years after placement. The risk of ectopic pregnancy is also reduced (compared with use of no method). The blood levels of the hormone released by the implants decrease with time. Thus, it is assumed that pregnancy and ectopic pregnancy rates both will rise after 5 years. For these reasons, it is recommended that Norplant implants be removed after 5 years of use.

Recent data from a very large Chinese study clarify some of the issues. Women who weighed less than 60 kg and women over age 30 at implant insertion did not experience marked increases in pregnancy rates in years 6 and 7 of use as compared with rates in year 5, and the pregnancy rates were still quite low. A second, much smaller study in Chile found that the pregnancy rate during implant use increased to 4 per 100 woman years in years 6 through 8, but that no ectopic pregnancies occurred after the fifth year. These data perhaps suggest that although the blood levels of the drug are reduced after 5 years of use, this reduction is somewhat offset by the aging of the women, a fact or that may principally affect women over the age of 30, who participated in the study.

Although the general recommendation to remove Norplant implants after 5 years pertains to all women, the Chinese and Chilean data suggest some leeway to organize and implement removal services at 5 years for populations where a large proportion of women weigh less than 60 kg or are over 35 years of age at the end of 5 years of implant use.

High priority should be placed on linking women who desire removal with providers trained with the skills necessary to perform such removals. However, if a woman does not want her Norplant implants removed, she should be informed of the risks and benefits associated with use of Norplant implants beyond 5 years, including decreasing effectiveness and the possibility of ectopic pregnancy. If she makes an informed decision to keep the Norplant implants, she should be encouraged to use an additional method of contraception and be advised about the signs and symptoms that occur with pregnancy or with ectopic pregnancy. She should further be advised to return to the clinic or facility at any time that she experiences signs or symptoms of a pregnancy or ectopic pregnancy (219, 331, 338, 354).

Rationale: Because Norplant contraceptive implants provide a high level of protection against all pregnancies during the first 5 years, the number of ectopic pregnancies is reduced when compared with no contraceptive use. Data suggest that the ectopic pregnancy rate with Norplant implants is similar to the ectopic pregnancy rates for some very effective alternative methods such as female sterilization. However, the percentage of any pregnancies that do occur that are ectopic when using Norplant implants is somewhat higher than the percentage of pregnancies that are ectopic when using any other contraceptive method (219, 349, 357).

Rationale: Heavy women using hard-tubing Norplant implants experience a higher pregnancy risk than women using soft tubing because less hormone diffuses out through the hard tubing. Norplant implants made with hard tubing demonstrated a cumulative 5-year failure rate of 4.5% in women who weighed 60 to 69 kg. In contrast, Norplant implants made with soft tubing demonstrated a cumulative 5-year failure rate of 1.5% in women who weighed 60 to 69 kg. This difference between hard and soft tubing is more pronounced for heavier women. Women who weighed more than 70 kg had a 5-year cumulative failure rate of 9.3% for hard-tubing Norplant implants and 2.4% for soft tubing use.

Although recent data from China reported cumulative 5-year failure rates for hard tubing use that were lower than the failure rates reported above, an increased number of pregnancies was still associated with increasing weight—1.46 pregnancies (over 5 years) per 100 women weighing 50-59 kg, 2.08 pregnancies (over 5 years) per 100 women weighing 60-69 kg, and 4.58 pregnancies (over 5 years) for women weighing 70 kg or more.

Cumulative 5-Year Failure Rates for Norplant Implants
	Pooled Data from Clinical Trials, 1988 (254)		Data from China, 1995 (338)
User's Weight	Soft Tubing	Hard Tubing	Hard Tubing
60-69 kg	1.5%	4.5%	2.08%
70 kg or more	2.4%	9.3%	4.58%

• Counseling of potential acceptors (including the fact that some removals may be difficult and may require more than one removal procedure),
• Counseling that removal should be entirely voluntary and at the option of the client,
• Infection-prevention measures, and
• Techniques for inserting and removing implants (with an emphasis on removal training).

Rationale: Training in counseling is just as important as technical training for providers who supply Norplant implants. Counseling training should help providers to communicate effectively the advantages and disadvantages of the method, possible side effects, the length of protection provided, the procedures for insertion and removal, reasons to return to the clinic, and information on follow-up care.

Insertion and removal of Norplant implants are minor surgical procedures. Therefore, all centers inserting and removing Norplant implants need to follow basic infection prevention measures. Insertion and removal are relatively easy to learn, but formal training is needed to minimize the potential for difficult removals that may result from poor insertion techniques. An emphasis on removal training allows providers to understand the relationship between good insertion placement and ease of implant removal. Providers who have mastered insertion and removal skills on models before working with clients achieve competency in a shorter time.

Recommendation: Doctors, nurses, midwives, paramedics, and other health workers can perform insertion and removal procedures provided they are properly trained.

Rationale: Studies demonstrate that, with proper training, other health workers can insert and remove Norplant implants as well as physicians (219, 342,346).