Failure of Intrauterine Contraceptives: A Review

JOHN D. ALLINGHAM

SUMMARY Accidental pregnancies with intrauterine devices may in part be attributed to inappropriate patient selection, lack of insertion expertise by physicians, and downward migration of IUDs from initial placement position. Available research on these factors is reviewed and a clinical protocol using ultrasound is proposed to detect and correct malpositioned devices. (Can Fam Physician 25:617-618, 1979). Dr. Allingham, a certificant of the College, is on the staff of the Department of Family Medicine at the University of Calgary. Reprint requests to: Dept. of Family Medicine, Faculty of Medicine, University of Calgary, Calgary, AB. T2N 4J8.
CCEPTANCE OF THE IUCD by physicians and patients has been limited by several factors, among the more prominent being the incidence of dysmenorrhea, abnormal uterine bleeding, and contraceptive failure. Indeed, pregnancy rates, while quite variable in different series, have averaged about three per 100 'women years' of exposure.1 An understanding of contraceptive failure depends on accurate information about mechanism of action. With IUCDs such information is as yet imperfect. A generally accepted theory of action may be briefly summarized as follows: A sterile inflammatory reaction is induced by the contact between the device and the endometrium. The marked resultant leukocytosis which is triggered by the plastic or copper renders the endometrium less susceptible to implantation by a blastocyst. Copper ion appears to have a complicated series of effects, among them a possible inhibitory action on sperm mobility in the cervical mucus.2 Progestogen in the Progestasert device produces a decidual reaction in the endometrium which also appears to inhibit implantation. The above-mentioned effects of IUCDs tend to be localized and to be
A

devices, accurate placement and retention remain a concern. Indeed, as outlined below, one can postulate that IUDs are ideally designed only for women with particular uterine config-

urations.5
Patient Selection: Uterine Configuration
Hasson has shown that the best IUD performance is to be expected when the device is about 1.5 cm shorter than the true uterine cavity length. The worst record is found when the device equalled or exceeded the cavity length, or, in contrast, when the device was at least two cm shorter than the cavity.6 A more indirect but clinically practical approach to this issue was taken by Gibor,7 who documented higher failure rates among women whose uterine cavities sounded to less than 6.5 cm. If the above observations are correct, what percentage of patients can be expected to have uteri of inappropriate configurations? To answer this question, one must first note the dimensions of the devices in question. The Cu-7 and Cu-T are both 36 mm long. Hasson6 has demonstrated that the average length of the uterine cavity among nullipara is only 29 mm, and that in a study of over 300 women of all parities, 45% had cavities of less than 35 mm. The implication of these observations is that in a considerable proportion of women, a part of a copper device will be in the isthmus or
cervix. While such a fact would not preclude fundal placement of the horizontal arms, it would preclude full access by the copper to the uterine cavity. An additional problem concerns the horizontal dimensions. The Cu-T is 32 mm wide and the Cu-7 is 28 mm. Hysterographic studies have shown the range of fundal width in
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maximal in areas of direct contact of device with endometrium. As the uterine fundus is the area for most implantations, fundal placement and retention of devices is of considerable theoretical concern. Contraceptive failure of IUCDs appears to be related to many factors, among the more important of which appear to be patient selection, design of the device, insertion expertise, and post-insertion mobility of the device. Device Design An inverse relationship between the surface area of the uterine cavity covered by inert devices and pregnancy rates has been demonstrated.3 4 Unfortunately, maximum surface areas were generally achieved with devices producing relatively high incidences of patient discomfort, both on insertion and over time. Early efforts with smaller, more comfortable devices were hampered by high pregnancy rates. The addition of pharmacologically active agents to these smaller devices-copper in the Cu-7 and Cu-T and progestogen in the Progestasertbrought failure rates of small devices down to the range found for earlier large inert devices. Despite the more diffuse mode of action of these latter

CAN. FAM. PHYSICIAN Vol. 25: MAY 1979

normal females to be 21-50 mm.8 A device too wide for the fundus probably results in increased discomfort and risk of perforation. Since the devices apparently stay in position by anchoring one of the arms in the endometrium,9 a transverse diameter of the fundus considerably greater than that of the device would allow it to drift downward out of proper position. This observation might explain the apparent higher failure rates with devices inserted at under eight weeks postpartum and immediately post-abortion. 10 Other studies have suggested that acute flexion of the uterus reduces the likelihood of retention,11 and presumably proper positioning as well. Uterine anomalies, as expected, have also been shown to predispose to contraceptive failure.12

Insertion Expertise and Post-Insertion Dynamics

Several studies have suggested that accidental pregnancies are often associated with, and may be contributed by, lower uterine segment location of the device. 11-14 Inappropriate position can be the result of initial error in insertion, or later migration of the device. One study of initial placement showed nine percent initial malpositions. Using ultrasound, the authors showed that only 73 of 80 had initial fundal placement. A second study showed that 80% lacked architectural harmony between device and uterus. I . 12 Kamal12 showed on hysterography that only eight of 39 devices were in dimensional harmony. The wide range here no doubt reflects differences in examining technique used and variation in assigning particular placements as appropriate or not. Nevertheless, there is little doubt that badly inserted devices must account for a proportion of the observed accidental pregnancies. Downward displacement of initially well placed devices has been observed,11 but the numbers involved and the variable length of time considered make any estimate of frequency unwise. Reference was made above to disproportion between uterine fundal dimensions and those of IUDs as one explanation for the 'drift' phenomenon. Other factors involve the substantial changes in uterine configuration associated with the menstrual cycle.5

Cliniical Implications
In this paper, several factors have been noted which may account for a
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substantial percentage of contraceptive failures with IUDs. A variable percentage of the devices will not be satisfactorily positioned on insertion. Secondly, a percentage of the devices will move to inappropriate positions over time. Possible reasons for such movement have been alluded to. Finally, some women will have uteri with true uterine cavities too short to enclose completely a pharmacologically active device such as copper. A consideration of these observations, imperfect as they are, suggests the use of the following protocol for IUD management: 1. Encouragement of the patient to use a supplementary method of birth control for one complete cycle after IUD insertion. Correct positioning of the device should be confirmed by ultrasound before supplementary methods can reasonably be discontinued. 2. A second ultrasound exam should be done at a later date to pick up migration of initially well positioned devices. Until we know something about the 'natural history' of devices in utero, the timing of this second exam will have to be arbitrarily chosen. However, since most theoretically important factors would be expected to exert their effect relatively early, an examination after three completed cycles seems appropriate. 3. Until more is known about the implications of having a device longer than the true uterine cavity, women who would fall into this category should be discouraged from using the device. Since one cannot practically measure the true uterine cavity length for all candidates, an initial approximation might be to exclude all those whose uteri sound to less than 6.5 cm. If the hypotheses suggested above for IUD failure prove correct, following the above protocol should produce a substantial reduction in the failure rate. A study to test such a proposition is in the advanced planning stage. In the interim, how practical is the protocol? Two issues which bear on its utility are the cost of ultrasound examinations, and their availability. Physicians in many parts of the country do not have access to ultrasound diagnostics in their areas. For those who do have access, there is the issue of cost to the health care system, and the accuracy of the resultant reports. The latter problem can be solved by educating radiologists as to our precise needs. In

our own area, initial descriptions of IUDs as "in the uterus" have given way to more useful reports, locating devices in the fundus, mid-cavity or cervical portion of the uterus. Need for a second ultrasound exam after good initial placement has been documented, may be eliminated if manufacturers could be convinced to provide color coding on IUD strings or other markers to help us document accurately any migration of devices over time. There is unfortunately no other safe and effective way other than ultrasound to determine initial placement. While the issue of cost effectiveness will no doubt be debated, this review of failure mechanisms of IUDs will hopefully prompt all physicians to examine their own approach to the problem.
1. Hasson HM: Copper IUDs. J Reprod Med 20:139-154, 1978. 2. Zipper J, et al: An overview of IUD research and implications for the future. Int J Gynecol Obstet 15:73-78, 1977. 3. Andolsek L: The Ljubljana IUD Experience: 10 Years. Program Abstracts of the Third International Conference on Intrauterine Contraception, Cairo, 1974. 4. Keith L, et al: Experience with modern inert IUDs to date: A review and comments. J Reprod Med 20:125-131, 1978. 5. Hasson CM: Factors that affect IUD performance: A review and recommendations. J Reprod Med 21:137-145, 1978. 6. Hasson CM: Factors affecting the intrauterine contraceptive device: 1. Endometrial cavity length. Am J Obstet Gynecol 126:973-981, 1976. 7. Gibor Y, et al: Uterine length: A prognostic indicator for the successful use of the copper 7 intrauterine device. J Reprod Med 11:205-208, 1973. 8. Burnhill MS, Birnberg CH: The size and shape of the uterine cavity determined by hysterography and with an intrauterine contraceptive device as a marker. Int J Fertil 11:187-189, 1966. 9. Kamal 1, et al: The anchoring mechanism of retention of the copper T device. Fertil Steril 24:165-169, 1973. 10. Shire RM, Thompson JF: The in situ IUD & pregnancy outcome. Am J Obstet Gynecol 119:124-130, 1974. 11. Whittman BK, Chow 7TS: Diagnostic ultrasound in the management of patients using contraceptive devices. Br J Obstet Gynaecol 83:802-808, 1976. 12. Kamal I, et al: Pregnancies in the presence of copper intrauterine devices. Int J Gynecol Obstet 14:341-376, 1976. 13. Tsai WS, et al: Sonographic visualization of coexisting gestation sac and IUD in the uterus and a consideration of a causative factor of accidental pregnancy. Int J Fertil 18:85-92, 1973. 14. Sakurabayashi M, et al: Studies on the IUCDs. The position of JUD in the cavity of the uterus and nidation offertilized ova. Acta Obstet Gynaecol Jpn 16:275-277,

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CAN. FAM. PHYSICIAN Vol. 25: MAY 1979