| There is no risk from the
NORPLANT® Implants themselves after five years. However, since the hormone levels
released by NORPLANT® Implants decrease with time, after five years of use NORPLANT®
Implants do not prevent pregnancy as well as during the first five years of use. Available
evidence suggests that, as the rate of pregnancy increases, so will the rate of ectopic
pregnancy. Because of the increased risk of pregnancy, current recommendations (which
apply to all women regardless of weight or age) is that these implants be removed at the
end of five years. Providers and women should be aware, however, that recent data suggest
that for women who weigh less than 60 kg and/or are over 30 years of age at implant
insertion, good protection still exists in years six and seven after placement, although
the protection is somewhat less than that provided in the first five years. As stated
above, there may be an increasing risk of intrauterine and ectopic pregnancy, but this
risk tends to fall with age. A woman may refuse to
have her NORPLANT® Implants removed after five years. In such cases, the woman should be
counseled on the potential risks (including pregnancy) and contraceptive benefits. If the
woman still refuses to have the removal, she should be encouraged to use an additional
method of contraception. |
NORPLANT® Implants are a very
highly effective method of protection against pregnancies for up to five years after
placement. Also, in the first five years of use, the risk of ectopic pregnancy is also
reduced (compared to 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 will both rise after five years. For these reasons, it is recommended that
NORPLANT® Implants be removed after five 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 six and seven of use as
compared with rates in year five, 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
four per 100 woman years in years six through eight, 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 five years of use, this reduction is somewhat offset by the
aging of the women, a factor that may principally affect women over the age of 30 who
participated in the study.
Although the general recommendation to remove NORPLANT®
Implants after five years pertains to all women, the Chinese and Chilean data suggest some
leeway to organize and implement removal services at five 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
five 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
contraceptive benefits) associated with use of NORPLANT® Implants beyond five years,
particularly decreasing effectiveness and the possibility of ectopic pregnancy.
In 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.
- NORPLANT® Levonorgestrel Implants: a
summary of scientific data. New York: The Population Council, 1990.
- Gu S, Sivin I, Du M, Zhang L, Ying L,
Meng F, et al. Effectiveness of Norplant Implants through seven years: a large-scale study
in China. Contraception 1995;52(2):99-103.
- Diaz S, Pavez M, Miranda P, Johansson
ED, Croxatto HB. Long-term follow-up of women treated with Norplant Implants.
Contraception 1987;35(6):551-67.
- Meeting Report: NORPLANT® Implants
issues related to removal and quality of care. Washington, DC: USAID, June 6, 1995.
1 Currently NORPLANT®
Implants are approved for only five years; however, if approval is extended beyond five
years, the recommendations included here would have to be modified accordingly. |
