Int J Gynaecol Obstet 15: 153-156, 1977

Side Effects of Intrauterine Devices Elizabeth B. Connell Rockefeller Foundation, New York, New York, USA

ABSTRACT Connell, E. B. (Rockefeller Foundation, New York, New York, USA). Side effects of intrauterine devices. Int J Gynaecol Obstet 15: 153-156, 1977 Problems in determining and quantifying side effects of intrauterine device (IUD) use are reviewed. The types and incidences of major side effects are discussed, as well as methods of treatment. The author concludes that IUD use remains a safe and effective method of family planning.

INTRODUCTION Renewed interest in intrauterine contraception in the late 1950s brought with it the development of numerous new devices and an inevitable proliferation of reports (usually written by the inventor of the new device) extolling the virtues of each change in material or design (4, 11). It was quickly apparent, however, that the results obtained with any particular intrauterine device (IUD) varied considerably from one investigator to another and from one geographic region to another (2). To obtain statistically valid data, Dr. Christopher Tietze initiated the Cooperative Statistical Program (CSP) of the Population Council in the mid-1960s. By establishing a uniform method of collecting information and by developing and applying the life table technique of analysis, it has been possible to develop general concepts about intrauterine contraception as well as to more easily compare specific devices (14, 18). The variables analyzed in the CSP study include pregnancy, device expulsion, and device removal for pain and bleeding, for other medical or personal reasons, and for planned pregnancy. Results from this early work made it possible to make certain generalizations. Devices which have more surface area provide a higher degree of protection against pregnancy and expulsion, but they also produce higher rates of cramping and bleeding. Conversely, smaller devices are associated with less cramping and bleeding, but provide less protection against pregnancy and expulsion (19).

EVALUATING AND TREATING IUD EFFECTS

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Despite this new and vastly improved method of data collection, there remain several major and continuing problems: (a) how to evaluate what really constitutes a side effect, (b) how to determine the true incidence of side effects, and (c) how to treat patients with side effects. Evaluating side effects has always been extremely difficult because so many independent variables affect the data being collected. First, there is the physical nature of the device itself—its size and shape—and the material or materials from which it is made. Second, there is the instrument used to insert the device. Over the years it has been determined that the inserter is almost as important as the device itself, since both efficacy and rates of side effects vary directly with correct positioning of the IUD. Third, and for the same reason, the skill of the individual inserting the device also plays a major role (12). A fourth major factor to be considered is the attitude of physicians and clinic personnel responsible for patient care. The amount of information given to patients determines their future behavior. Furthermore, the attitudes of individuals seeing women complaining of side effects also have a major impact on the continuation rates; the rates increase or decrease whether physicians advise immediate removal or urge the patients in a concerned and supportive manner to continue using the IUD if possible. Finally, an absolutely critical factor, and one which often gets scant attention from physicians, is the patient's attitude toward this form of contraception and her willingness to continue IUD use in the face of mild to moderate symptoms. For example, older women who have greater numbers of children are likely to tolerate IUD side effects better than younger women with few or no children. Also, women who want no more children are more stoic about accepting problems related to the use of IUDs than women who merely wish to space their children. A whole host of psychological, cultural, and religious factors must also be considered in the final equation if one is to look at IUD use in its broadest perspectives (9).

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SIDE EFFECTS In 1968 the Food and Drug Administration published the Report on Intrauterine Contraceptive Devices (20). At that time the consensus of opinion was that this form of contraception was both safe and effective. In general, this continues to be the considered opinion of most individuals in the family planning field. However, side effects continue to occur, the most serious of which will now be briefly considered, along with the current concepts of management. Bleeding and cramping The side effects with the most important impact on continuation rates are cramping and bleeding. These two complications are responsible for more than half of all IUD removals (19). Both cramping and bleeding seem to be directly related to the size and shape of the IUD relative to the size and configuration of the uterine cavity. IUD-related bleeding may occur as increased menstrual bleeding or as intermenstrual bleeding. Numerous studies have been attempted to determine the causes of IUD-related bleeding. Theories include direct erosion of blood vessels, increased vascularity of the endometrium, and changes in coagulation patterns, as well as specific changes in the fibrinolytic activities of the endometrium itself. Bleeding rates for various IUDs range from 5 to 18%, with bleeding serious enough to require hospitalization occurring in roughly 1% of the users (10,19). Different materials produce different rates of cramping and bleeding. In general, softer devices tend to produce less bleeding than the more rigid ones. The older and larger plastic devices produce the most bleeding, the new and smaller copper devices somewhat less, and the progesteronebearing device is associated with a total blood loss that is actually less than the normal menstrual blood loss experienced by the same patient before IUD use. Numerous attempts have been made to find ways to treat this important problem. Treatments with hormones, antihistamines, antifibrinolytic agents, vitamins, coagulants and vasoconstrictors have all been tried without any consistent degree of success (3). Perforation Perforation is the second major side effect associated with all IUDs tested to date. Perforation may occur either at the time of insertion or any time after insertion. Perforation may be complete, i.e., with the IUD located entirely outside the uterus, or partial, i.e., with some part of the device retained within the uterine cavity or wall. The incidence of

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perforation ranges from 0.5 to 9.0 per 1000 insertions (19). It occurs most commonly at the time of insertion. However, there are now data suggesting that, on occasion, a partial perforation may become complete or a new perforation may take place from the endometrial cavity. This latter situation has been noted particularly with the Copper T IUD. These IUDs have been extruded through the wall of the cervix into the upper vagina at some point after the initial insertion (15). However, adding a small ball of plastic to the end of the vertical arm has decreased the incidence of this particular side effect. When perforation is suspected because the tail of the IUD cannot be visualized and the patient has not noted an expulsion, it is essential to follow up the problem very carefully (1). First of all, pregnancy must be ruled out. If the patient is not pregnant, one of several techniques may be used to locate the IUD. X-ray examinations with a sound or radioopaque dye in the uterine cavity may be carried out. Ultrasonography is also helpful in locating the displaced IUD. If the device is located in the abdominal cavity, it is usually advisable to remove it by the simplest method possible (1). Removals may be accomplished by culdotomy, culdoscopy, or laparoscopy. If dense adhesions are encountered, however, the safest procedure is laparotomy. Until recently, physicians thought that inert IUDs which were open could be left in the abdominal cavity; but because of the risk of intestinal strangulation and obstruction, it is now recommended that all devices be removed. It is essential that copper devices be removed, because copper induces a very intense reaction in the peritoneal cavity. Pregnancy Pregnancy, including ectopic pregnancy, must be considered as another major side effect of intrauterine contraception (1). Pregnancies have occurred with the device in situ or after unnoticed expulsion. Since IUDs protect against intrauterine pregnancy better than against extrauterine pregnancy, the possibility of tubal or ovarian pregnancy must always be considered, particularly if pregnancy is suspected and the symptoms are somewhat atypical. There are preliminary data which suggest that the IUD per se may induce ectopic pregnancies (17). Until the last few years, it was recommended that, if a woman wished to carry a pregnancy to term after conceiving with an IUD in situ, the IUD should be left alone. However, newer data suggest that removing the IUD reduces the risk of spontaneous abortion from 50 to 25%. Furthermore, the ominous syndrome of midtrimester septic

Side effects of IUD use

abortion has also been associated with leaving an IUD in place during pregnancy. Although this has occurred most frequently with the Dalkon Shield, probably because of its multifilament tail, it has also been noted with other devices (16). Therefore, it is essential that IUDs be removed if possible as soon as the diagnosis of pregnancy is made, regardless of whether the patient desires to continue her pregnancy to term (1). When the patient is pregnant and it is uncertain whether the IUD is still present, it is essential to determine its presence or absence, and if it is present, its exact location. If the patient plans to terminate her pregnancy, an x-ray may be used. If, however, she indicates that she wishes to continue her pregnancy, ultrasound diagnosis is preferred. If the IUD is still in situ, the patient should be informed of the increased risk of early spontaneous abortion or septic midtrimester abortion and what symptoms to report immediately (1). Infection The complication about which there is the most concern presently is that of infection. Several years ago it was shown that while bacteria identical to those found in the cervix and vagina are always introduced into the endometrial cavity during IUD insertion, this initial invasion clears rapidly: many cultures become negative within a few days and all are negative within 1 month (13). These early reports suggested that infection rates in users and nonusers were nearly identical and that most new infections were gonorrheal in origin (21). However, more recent studies have indicated that this somewhat simplistic view may not actually be the case. It has been shown, for example, that up to 15 days after insertion, the incidence of infection is higher among IUD users than among nonusers (19). It has also been demonstrated that a variety of organisms are responsible for the infections found among IUD users. Several clinical pictures are characteristic of these infections (1). The first is severe pelvic infection with acute pelvic pain, bleeding, and a generally septic picture. ' Organisms identified in this type of infection include gonorrhea as well as a variety of aerobes and anaerobes. After smears and cultures have been taken, treatment should begin immediately with a broad spectrum antibiotic, effective against gonorrhea. The IUD should be left in place. If there has not been improvement within 24 hours, the IUD should be removed. A second form of infection is a very mild, smoldering, and sometimes virtually asymptomatic type of pelvic infection, diagnosed most frequently at routine follow-up examinations when a tuboovarian abscess is found (1). This type of infection

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may produce the syndrome of progressive endometritis, usually noted 6-12 months after insertion. Patients frequently complain of vaginal spotting or bleeding and foul-smelling vaginal discharge. Parametrial and adnexal tenderness, with or without a distinct mass, are noted on examination. In these cases, cultures have revealed a wide variety of causative organisms. The IUD should be removed, cultures taken, and antibiotic treatment begun. Long-term sequelae There are two potential long-term problems of IUD use of major concern: infection as it relates to future pregnancy and cervical or endometrial cancer. The first issue, in particular, is beginning to affect the attitudes of many physicians about inserting IUDs in young women who have not yet had a pregnancy. Only continued studies can determine how important a factor this may be and whether intrauterine contraception is appropriate for this particular group of patients. While the second long-range concern—malignancy—is still being studied, there has been no evidence to suggest that there is any relationship between IUD use and the subsequent development of cervical or endometrial cancer (19, 20).

SUMMARY The IUD remains an effective and relatively safe contraceptive method with no single device being more or less free of side effects than any other (8, 9). More births have been averted by this method of family planning than by oral contraceptives, primarily because the continuation rate associated with IUD use remains higher than the rate associated with OC use. Approximately 75% of the women who accept an IUD continue to use it for 1 year after insertion. This continuation rate increases with succeeding years of use (5). The reported morbidity and mortality associated with long-term IUD use continues to remain low. Recent data estimate 1 to 10 deaths per 1000000 woman-years of use, with complications requiring hospitalization ranging from 0.3 to 1.0 per 100 woman-years of use (6). The mortality rate associated with IUD use is lower than for OC use; the morbidity rate is somewhat higher (7). Unless there are great and unforeseen technological advances in the immediate future, it appears that intrauterine contraception will continue to be one of the major methods of family planning in both domestic and international programs.

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REFERENCES 1. American College of Obstetricians and Gynecologists. The Intrauterine Device. Tech Bull No. 40, June 1976. 2. Bernard, R P (éd.): IUD Performance Patterns. Geographic Series, No. 4-5. The Pathfinder Fund, Chestnut Hill, Mass., 1970. 3. Burnhill, M S & Birnberg, C H: Improving the results obtained with current intrauterine contraceptive devices. Fértil Steril 20:232, 1969. 4. Davis, H J: The shield IUD. A superior modern contraceptive. Am J Obstet Gynecol Í0S.-455, 1970. 5. Huber, S C, Piotrow, P T & Orlans, F B: Intrauterine devices. Population Reports, Series B, No. 2, 1975. 6. Jennings, J: Report of safety and efficacy of the Dalkon shield and other IUDs. Prepared by the Ad Hoc Obstetric-Gynecology Advisory Committee to the U.S. Food and Drug Administration, October 29-30, 1974, p. 16 (mimeo). 7. Kahn, H S & Tyler, C W: IUD related hospitalizations. JAMA 254:53, 1975. 8. Kessel, E: Fielding of new IUDs in developing countries. In Intrauterine Devices—Development, Evaluation and Implementation (ed. R G Wheeler, G W Duncan & J J Speidel), p. 49. Academic Press, New York, 1974. 9. Korean Sociological Association: A study on the acceptability and effectiveness of intrauterine contraception in relation to sociomedical variables. In Sociological Evaluation of the Family Planning Programs and Research Activities in Korea, p. 198. Seoul, 1972. 10. Kushner, D H, Jaffurs, W J, Townsend, C E & Thomas, M A: Surgical and obstetrical complications of IUDs in a specialty hospital. Int J Fértil .74:48, 1969. 11. Lippes, J: A study of intrauterine contraception: development of a plastic loop. In Intrauterine Contraceptive Devices (ed. C Tietze & S Lewit), International Congress Series No. 54, p. 69. Exerpta Medica Foundation, Amsterdam, 1962. 12. Mishell, D R, Jr: The clinic factor in evaluating IUDs. In Program Abstracts of the Third International Conference of Intrauterine Contraception, p. 11. Cairo, Egypt, 1974.

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13. Mishell, D R, Jr, Bell, J H. Good, R G & Moyer, D L: The intrauterine device: a bactériologie study of the endometrial cavity. Am J Obstet Gynecol 96:119, 1966. 14. Potter, R G: Application of life table technique to measurement of contraceptive effectiveness. Demography 5:297, 1966. 15. Tatum, H J: Metallic Cu as an intrauterine contraceptive agent. Am J Obstet Gynecol 117:602, 1973. 16. Tatum, H J, Schmidt, F H, Phillips, D, McCarty, M & O'Leary, W M: The Dalkon shield controversy. JAMA 231:711, 1975. 17. Tatum, H J: Clinical aspects of intrauterine contraception: circumspection 1976. Fértil Steril 28:3, 1977. 18. Tietze, C & Lewit, S: Recommended procedures for the statistical evaluation of intrauterine contraception. Stud Fam Plann 4:35, 1973. 19. Tietze, C & Lewit, S: Evaluation of IUDs. Ninth Progress Report of the Cooperative Statistical Program. Stud Fam Plann 55:1, 1970. 20. United States Food and Drug Administration. Report on Intrauterine Contraceptive Devices. Advisory Committee on Obstetrics and Gynecology. Government Printing Office, Washington, D. C, 1968. 21. Westrom, L, Bengtsson, L P & Mandh, P A: The risk of pelvic inflammatory disease in women using intrauterine devices as compared to non-users. Lancet 2:221, 1976.

Address for reprints: Elizabeth B. Connell Rockefeller Foundation 1133 Avenue of the Americas New York, New York 10036 USA

Side effects of intrauterine devices.

Int J Gynaecol Obstet 15: 153-156, 1977 Side Effects of Intrauterine Devices Elizabeth B. Connell Rockefeller Foundation, New York, New York, USA AB...
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