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Research

IUD Safety Can Be Appealing

In countries where IUDs are not widely used, unfounded health concerns can be a reason.

Network: Winter 1996, Vol. 16, No. 2

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Intrauterine devices (IUDs) have no systemic health effects or harmful side effects except an increased risk of anemia, making them among the most attractive of all contraceptive methods.

"Copper IUDs are popular in many countries because they are safe, in addition to being convenient and effective," says FHI's Gaston Farr, who has coordinated multicountry clinical trials involving the Copper T. In countries where the IUD is not widely used, misinformation about health concerns can be a significant barrier to use.

Copper-bearing IUDs are not a direct cause of pelvic inflammatory disease (PID), although users face some risk of PID when the device is inserted under unsterile conditions. Also, women at high risk of a sexually transmitted disease (STD) usually are not good candidates for IUD use because of a correlation between STDs and PID.

There is no evidence that IUDs increase the risk of cervical, uterine or endometrial cancer. However, women with known or suspected cancer of the uterus or endometrium, or undiagnosed vaginal bleeding, are not good candidates for the IUD.1 IUDs, like some uterine cancers, may cause uterine bleeding between menstrual periods. Bleeding abnormalities could be attributed to the IUD in error, and the real reason for bleeding overlooked.

Other health concerns usually are not serious or occur very infrequently. These include pregnancy during IUD use, intermenstrual bleeding or increased menstrual bleeding, perforation during insertion and expulsions.

Pregnancy

If a client with an IUD misses her period, providers should determine if she is pregnant, and whether the pregnancy is ectopic. If the egg is implanted in the uterus correctly, the client should choose whether to continue the pregnancy. There is no evidence of birth defects when conception occurs with a copper IUD in place.

If the IUD is still in place, it should be removed in order for the pregnancy to proceed safely. Removal should be done carefully. If the pregnancy is less than 13 weeks along and the strings are visible, removal can be done by a trained health care provider. If the strings are not visible, or if the pregnancy has advanced beyond 13 weeks, the client should be examined by a physician. If the IUD cannot be removed, the woman should be told she is at an increased risk of miscarriage, premature labor and uterine infection. If she still wishes to continue her pregnancy, she should be examined frequently for complications, such as infection.2

The high degree of contraceptive effectiveness from copper IUDs results in protection from all pregnancies, including tubal implantation or ectopic pregnancy. Irving Sivin of the Population Council, a leading expert on IUDs, analyzed 42 IUD studies published between 1970 and 1990. Ectopic pregnancies occurred in less than 0.02 percent of women using the Copper T 380 IUD, according to the pooled analysis.3

If an ectopic pregnancy does occur, immediate medical attention is needed since an ectopic pregnancy endangers the mother's life. The client should be referred to a hospital with surgical facilities. Ectopic pregnancy can be detected by ultrasound, hormonal tests, or by noticing symptoms, which include abdominal pain.

Bleeding

Irregular menstrual bleeding among IUD users is not usually a sign of a health problem. Bleeding can, in fact, be a sign that the IUD is working properly. The copper released by the IUD interrupts the normal reproductive cycle and causes the endometrium to shed more frequently than during a woman's normal menses.

However, due to the possibility of increased bleeding with IUD use, women should be carefully screened for risk of anemia prior to insertion. An Israeli study looked at 34 women using copper IUDs other than the Copper T 380: the Multiload 250 or the Nova T. Menstrual bleeding increased from 3.9 to 7.1 days after four months of use, and the ferritin levels - an indicator of anemia when levels are low - dropped by more than half (from 24 ng/ml to 9.3 ng/ml).4 Other indicators, hemoglobin and iron, remained the same. But since menstrual bleeding decreases over time, users may experience a slight increase in hemoglobin levels with extended IUD use.5

During the first year of FHI's multicountry trials, nearly half of all Copper T 380 users complained of bleeding and pain. However, only a small fraction of the women, 5.6 percent, had the device removed for this reason.6

Rarely was the removal medically necessary; for most of the women studied, the choice of removal was a personal preference. In addition, FHI's Farr found the acceptability of irregular bleeding varied from place to place. In Egypt, removals for bleeding were more common than elsewhere in Africa, at 17.3 per 100 users. By contrast, in Nigeria and Cameroon, irregular menses caused only 1.3 and 1.0 removals per 100 women using IUDs.7

Side effects of irregular bleeding, spotting, or heavy bleeding decrease with time. Once women are accustomed to IUD use, removal rates go down. A four-year study of two brand-name Copper T 380s, the Gyne T 380 and Slimline, conducted from 1988 to 1992, showed that women who had previously used IUDs were one-third as likely to have their IUDs removed because of bleeding or pain, compared with women without previous IUD experience.8

Insertion, perforation

Improper insertion can be harmful, since it can result in partial or total perforation of the uterine wall. However, this happens very infrequently. "Perforation is a very rare event in the hands of a skilled provider," says Dr. Barbara Rojnik of Slovenia, who chairs a World Health Organization steering committee on IUDs and is currently at FHI on a fellowship. The risk of uterine perforation by Copper T 380 IUDs is only 0.4 per 1,000 women and the risk of cervical perforation is 0.6 per 1,000, making a total perforation rate of approximately 1.0 per 1,000, or one woman in 1,000 insertions.9

When perforations do occur, the IUD may injure or puncture surrounding organs. A woman whose uterus has been perforated should have the IUD removed as soon as possible. If a client feels a sharp pain during insertion, the provider should terminate the procedure, provide an alternate contraceptive method, and wait at least a week before attempting another insertion. The cervix may also be perforated when an IUD is being expelled. Copper-bearing devices are made with a rounded tip at the bottom to reduce this risk.

Providers should always insert the IUD gently. A good time to insert is during menses when the cervix is dilated and irregular spotting will go unnoticed. However, IUDs can be inserted at any time in a woman's cycle, provided she is not already pregnant. The preference for menstrual insertion should not be used to refuse access to the method. The provider need not be a physician, but all providers should be well-trained to insert IUDs.

The sterilized IUD package should be opened just prior to insertion, not in advance. If left too long in the loading tube used for insertion, a Copper T IUD may lose its shape and become less effective. If a copper IUD has become tarnished in its sterile package (turns green or black), it is still safe to use and will be just as effective.

Expulsion, removal

Because IUDs require only one visit for insertion and few follow-up visits, correct use by the client is easy. She needs only to check for a marker string, also called the IUD's tail, to make sure the device has not been expelled.

While there is no health risk involved, a partially expelled device can leave a woman believing she is protected from pregnancy when she is not. Because expulsions are not always felt by the user, it is important for women to check routinely for the IUD string attached to the bottom of each device, to make sure the IUD is still in place.

Providers may use a syringe-like suction device to extract the IUD. A new IUD can be inserted if there are no complications from the removal, or if there are no indications that replacement would be problematic.

In the multicountry FHI study that compared the Copper T 380 with other IUDs, Copper T 380 IUDs had the lowest rate of expulsion. The risk of expulsion was greatest with the Lippes Loop, an inert IUD that does not contain copper. The Copper T 380 had an expulsion rate of 3.1 per 100 women for one year, compared with 6.4 per 100 for the Lippes Loop.10

Partial or complete expulsion usually occurs during the first few months after insertion, when the uterus is reacting to the presence of a new object. After the first three months, the risk decreases substantially. The provider's skill in insertion is the single most important factor in avoiding expulsion. Expulsions are also more common among young women who have not been pregnant.

The protection IUDs offer can be long-term. In the absence of complications, copper devices may be left in for 10 years or more. Those inserted after age 40 may be left in until menopause, unless a woman becomes pregnant. An IUD should be removed one year after menses stop, but no ill effects have been reported among women who have not had them removed more than a year after menopause.

-- Sarah Keller


Footnotes

  1. Guillebaud J. Contraception: Your Questions Answered. New York: Churchill Livingston, 1985. Program for International Training in Health (INTRAH). Guidelines for Clinical Procedures in Family Planning. (Chapel Hill: University of North Carolina, 1993) 166.
  2. Intrauterine Devices: Contraceptive Technology Update Series. Research Triangle Park: Family Health International, 1995.
  3. Schmidt F, Sivin I, Waldman S. The Copper T 380 IUD. Proceedings from the Fourth International Conference on IUDs. Eds. Bardin CW, Mishell DR. (Newton, MA: Butterworth-Heinemann, 1994), 303.
  4. Blum M, Ariel J, Zacharowitch D. Ferritin, a faithful reflection of iron deficiency in IUD wearers with mild vaginal spotting. Adv Contracept 1991;7(1):39-42.
  5. Sivin I, Díaz J, Alvarez F, et al. Four-year experience in a randomized study of the Gyne T 380 Slimline and the standard Gyne T 380 intrauterine copper devices. Contraception 1993; 47(1):17.
  6. Farr G, Amatya R. Contraceptive efficacy of the Copper T 380A and Copper T 200 intrauterine devices: Results from a comparative clinical trial in six developing countries. Contraception 1994;49(3):239.
  7. Amatya R, Farr G, Doh A, et al. Evaluation of the Copper-T 380A IUD's safety and efficacy at three African centers. Unpublished paper. Family Health International.
  8. Sivin, 37-42.
  9. Sivin I, Greenslade F, Schmidt F, et al. The Copper T 380 Intrauterine Device: A Summary of Scientific Data. (New York: The Population Council, 1992) 19.
  10. Rowe P. Clinical performance of Copper IUDs. Proceedings from the Fourth International Conference on IUDs. Eds. Bardin CW, Mishell DR. (Newton, MA: Butterworth-Heinemann, 1994) 13-31.
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