The intrauterine device

The intrauterine device

Int J Gynecol Obstet, 1993, 41: 189-193 International Federation of Gynecology and Obstetrics The intrauterine 189 device ACOG Technical Bulletin ...

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Int J Gynecol Obstet, 1993, 41: 189-193 International Federation of Gynecology and Obstetrics

The intrauterine

189

device

ACOG Technical Bulletin Number 164 - February 1992 (Replaces No. 104, May 1987) Product liability and medical malpractice issues have had an impact on all contraceptive products, but none more so than the intrauterine device (IUD). In 1986, the sale of all IUDs except the steroid hormone-releasing IUD, Progestasert, was discontinued in the United States, although these devices were deemed safe and effective by the U.S. Food and Drug Administration (FDA). In 1988, a new copper IUD (Copper T380A; ParaGard) was approved for marketing by the FDA. Both the ParaGard and the Progestasert IUDs are highly effective and safe methods of fertility regulation when used appropriately. Failure rates of IUDs are only slightly higher than those of oral contraceptives, and about 80% of women who have an IUD inserted will continue to use the device through the first year (1). The FDA has approved continuous use of the ParaGard for 96 months and of the Progestasert for 12 months. The progesterone hormone in the Progestasert is completely absorbed in about 14 months, requiring annual replacement of the device. Although the incidence of side effects with IUD use is low, serious complications can occur. The physician must be cognizant of these potential adverse health effects.

Mechanisms of Action Three independent mechanisms have been suggested for the contraceptive action of IUDs (2) although none has been conclusively established: 1. Interference with sperm transport from the cervix to the fallopian tube 2. Inhibition

of sperm capacitation

3. Endometrial implantation

changes

IUD in the endometrial cavity alters the biochemical and cellular composition of cervical mucus, endometrial secretions, and tubal fluid. Significant increases in macrophages, lymphocytes, and plasmacells have been observed in both histologic sections of the endometrium and in endometrial fluid. Copper ions are detrimental to sperm capacitation and motility. Progesterone released in the endometrial cavity may alter tubal motility and sperm or egg viability in the tube. These changes are thought to impair fertilization (2). Studies detecting levels of human chorionic gonadotropin (hCG) reveal that this hormone is not present in IUD users during the luteal phase and implantation does not occur (3). As such, the IUD is not an abortifacient. There may be other mechanisms by which IUDs accomplish contraception.

Indications and Contraindications The IUD is especially suited for older, parous women who wish to prevent further pregnancies but who are not ready to choose a permanent method of family planning; who are in stable relationships in which neither partner has any other sexual partners; and who have no history of pelvic inflammatory disease (PID) or ectopic pregnancy. Physicians should be aware of the absolute and relative contraindications to IUD insertion. Any relative contraindication can become an absolute contraindication when it poses a life-threatening complication, and in all cases the risk of IUD use must be weighed against the benefits. Women must be screened carefully with history and pelvic examination for any of the contraindications to IUD use (see box on page 2).

or survival

that inhibit

the process

of

Progesterone- and copper-releasing IUDs do not interfere with ovulation or with menstrual cyclicity. An

Patient Counseling Women should be informed about the availability, effectiveness, and potential risks of each method of Int J Gvnecol Obstet 41

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ACOG Technical Bulletin

Absolute and Relative Contraindications to IUD Placement Absolute W Confirmed or suspected pregnancy ??Known or suspected pelvic malignancy ??Undiagnosed vaginal bleeding ??Known or suspected pelvic infection, acute or chronic, including sexually transmitted diseases and genital actinomycosis ??Reported behaviors placing an individual at high risk for sexually transmitted diseases ??Hyperbilirubinemia secondary to Wilson disease, which is relative only to devices containing copper Relative ??Uterine size or shape incompatible with effective IUD use ??Medical conditions (eg, corticosteroid therapy, valvular heart disease, and any incidence of immune suppression) increasing the risk of infection ??Nulligravidity ?? Abnormal Pap smear (until managed) ??History of ectopic pregnancy

contraception, particularly those that are appropriate for their age and parity. After considering these factors, if the patient indicates a preference for an IUD, the patient information brochure that is supplied by the manufacturer should be given to her. The patient should have the opportunity to review and discuss IUD use with the health care provider, who should fully explain the potential adverse health effects of the IUD. Women who decide to have an IUD inserted should be informed that about 20% of women discontinue use of the IUD during the first year because of bleeding, cramping pain, or spontaneous expulsion. Other patients report increased menstrual flow. Patients should be advised that the failure rate of the IUD is about 1% per year and should be acquainted with the symptoms of pregnancy and complications of an IUD. If amenorrhea Int J Gynecol Obstet 41

occurs, the patient must return promptly for evaluation. The patient should be made aware that when pregnancy occurs with IUD use, the relative likelihood of ectopic pregnancy and septic abortion is increased. The patient must be informed about the risks of pelvic infection and the factors (ie, having multiple sexual partners) that increase this risk. Patients with IUDs who develop flulike symptoms within 1 month of insertion should be evaluated. Theoretically, patients with immune suppression may be at special risk of IUD-associated infection. Clinical judgment should be exercised accordingly.

Physician liability Liability issues, mostly product related, have had a significant impact on IUD use in the United States. Because of these issues, many physicians have discouraged patients from considering IUDs. A select group of patients, however, are excellent IUD candidates. By following certain steps, the physician can minimize the risk of liability: ?? Inform the patient about the risks associated with IUD use. ?? Obtain a thorough history and perform a thorough pelvic examination. ?? Screen for gonococcus and chlamydia. ?? Take immediate steps to locate and remove a displaced IUD, if it is still present. ?? Inform the patient about the special risks associated with pregnancy when the IUD is in place. ?? Provide appropriate counseling if pregnancy occurs. ?? Instruct the patient to report any adverse effects associated with IUD use. H Provide appropriate treatment if adverse effects occur. ?? Document that counseling has occurred.

IUD Insertion and Removal The manufacturer’s physician information pamphlet should be read concerning the specifics of IUD insertion. The optimal time of insertion is during the latter part of the menstrual period, or 1 or 2 days after. Certain general recommendations can be made:

ACOG Technical Bulletin

1. Administration of an analgesic or antiprostaglandin prior to insertion has been found useful in some women. ?I. Antiseptic preparation of the cervix and vagina is imperative. 3. Paracervical block may be helpful insertional pain.

to minimize

4. The cervical angle should be straightened with the use of a tenaculum. The uterus must be sounded; if the uterus is found to be less than 6 cm or greater than 9 cm, IUD insertion is contraindicated. 5. The patient should be taught how to find the IUD string and promptly report its absence. 6. The patient should return for a check-up next menses.

after the

The use of an additional method of contraception during the first month of IUD use seems sensible. In addition, some patients use a second method each month at ovulation in order to gain even greater effectiveness. The administration of prophylactic antibiotics may be considered, as IUD insertion almost always introduces cervical bacteria and other organisms into the endometrial cavity. Suggested regimens include doxycycline, 200 mg orally 1 hour before insertion, or erythromycin, 500 mg orally 1 hour before insertion and 500 mg 6 hours after insertion. Removal of an IUD is accomplished by applying traction on the IUD tail string with forceps. When difficulty is encountered, removal may be facilitated by grasping the IUD itself after paracervical block. Should these measures prove unsuccessful, ultrasound or hysteroscopy should be performed. Occasionally, a device may have to be removed while the patient is under general anesthesia because of partial embedment in the uterine muscle.

Complications

191

genital tract at the time of insertion. After this period, the increased risk of PID is probably related to sexually transmitted disease (4. 5). If signs and symptoms of upper-tract pelvic infection occur, the physician should perform appropriate bacteriologic culture studies and begin antibiotic treatment. In the presence of salpingitis, tuboovarian abscess, or severe pelvic infection, the IUD should be removed. The timing of removal in relation to the administration of antibiotics depends on clinical evaluation of the severity of the disease. Displaced String The physician should determine the reason for a displaced IUD string. Intrauterine pregnancy can cause upward displacement of an IUD and its string. When pregnancy has been ruled out, the location of the IUD can be determined by one or more of the following methods:

?? Probing of the endocervical

canal and intrauterine cavity for the retracted string or palpating the IUD with a uterine sound

??Ultrasonography ??Anteroposterior and lateral X-rays of the pelvis and abdomen with the position of the uterine cavity indicated by a radiopaque instrument or dye

?? Hysteroscopic visualization

of the intrauterine cavity

Perforation Partial or complete perforation of the uterine wall by the IUD occurs in approximately l/l ,OoO-2.000 insertions (6). Probably, most perforations occur at the time of insertion; hence, the experience of the physician and the technique of insertion are important. Perforation is more likely to occur when insertions are done postpartum, ie, before complete involution of the uterus has occurred (7). Since all devices are capable of eliciting peritonitis, adhesions, and organ penetration, the IUD must be removed via laparoscopy, hysteroscopy. colpotomy, or laparotomy when IUD perforation is diagnosed.

Pelvic Infection Unlike some other contraceptive methods, the IUD offers no protection against sexually transmitted infections. During the first several months of IUD use, there is an increased risk of pelvic infection, probably because of the introduction of organisms into the upper

Actinomyces Infections Acfinom_vces,

an anaerobic, gram-positive bacterium, is occasionally detected on cervical cytology in IUD users (8). If this occurs in an asymptomatic patient who wishes to continue using the IUD. treatment with an

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ACOG Technical Bulletin

appropriate antibiotic (eg, ampicillin, 250 mg four times daily for 14 days) may be instituted and a repeat Pap test performed. If the results remain positive, or if the patient is symptomatic, she should have the IUD removed. When Actinornyces is found in a symptomatic patient, the IUD should be removed and antibiotic therapy initiated.

Pregnancy If a woman using an IUD becomes pregnant, there is a 2-3% chance that the pregnancy will be ectopic (9). Therefore, careful evaluation for this possibility is essential (10, 11). When intrauterine pregnancy is diagnosed in an IUD user and the patient elects to continue the pregnancy, the IUD should be removed as soon as possible if the string can be located. If the IUD is removed in the first trimester, the risk of a second- or third-trimester fetal loss is not increased. If the IUD remains in place, the woman should be advised of the increased risk of spontaneous abortion in the first trimester; of septic abortion, especially in the second trimester; and of premature birth in the third trimester (12). Because of these high risks of serious complications, she should be offered the option of pregnancy termination. If termination is elected, the IUD can be removed at the time of that procedure. Should the woman elect to carry the pregnancy to term, the IUD can be removed under ultrasound guidance if it is located inferiorly to the gestational sac. However, abortion may still result. If located superiorly, the IUD usually cannot be removed without abortion. In either case, the pregnant woman with an IUD should be more closely monitored during the entire pregnancy. Available data indicate no increased risk of congenital anomalies in IUD-associated pregnancies.

Fertility After IUD Discontinuation Pregnancy rates in women choosing to become pregnant after elective IUD removal are similar to those in women discontinuing the use of other methods of contraception (13-l 5). The relationship of past IUD use and tubal infertility secondary to salpingitis remains controversial. Pelvic infection due to sexually transmitted organisms occurs among IUD users and nonusers alike. Salpingitis may not be clinically apparent until the woman is trying to conceive. Limited data show little or no increased

risk of infertility

Int J Gynecol Obstet 41

among IUD users

who are in monogamous relationships (16). Following IUD discontinuation, the outcome of pregnancy appears to be no different than in women discontinuing use of other contraceptive methods.

Summanr The IUD is an excellent form of contraception for selected patients. As with all methods of contraception, the benefits and risks of the method and the needs of the patient must be considered. Counseling is an important part of the selection process and will identify those for whom the IUD is a suitable contraceptive choice.

REFERENCES 1. Sivin I, Tatum HJ. Four years of experience with the TCu 380A intrauterine contraceptive device. Fertil Steril 1981;36:159-163 2. Alvarez F, Brache V, Femandez E, Guerrero B, Guiloff E, Hess R, et al. New insights on the mode of action of intrauterinecontraceptive devices in women. Fertil Steril 1988;49:768-773 3. Segal SJ, Alvarez-Sanchez F, Adejuwon CA, Brache de Mejia V, Leon P, Faundes A. Absence of chorionic gonadotropin in sera of women who use intrauterine devices. Fertil Steril 1985;44:214-218 4.

Lee NC, Rubin GL, Borucki R. The intrauterine device and pelvic inflammatory disease revisited: new results from the Women’s Health Study. Obstet Gynecol 1988; 72:1-6 .

5.

Kessel E. Pelvic inflammatory disease with intrauterine device use: a reassessment. Fertil Steril 1989;5 1: l-l 1

6.

American College of Obstetricians Precis IV: an update in obstetricsand ington, DC: ACOG, 1990: 10

7.

Heartwell SF, Schlesselman S. Risk of uterine perforation among users of intrauterine devices. Obstet Gynecol 1983;61:31-36

and Gynecologists. gynecology. Wash-

8. Curtis EM, Pine L. Actinomyces in the vagina of women with and without intrauterine contraceptive devices. Am J Obstet Gynecol 198 1: 140:88&884 9. Tatum HJ, Schmidt FH, Jain AK. Management and outcome of pregnancies associated with the Copper T intrauterine contraceptive device. Am J Obstet Gynecol

1976; 126:869-879 IO. Sivin I. IUD-assoeiatedectopic pregnancies, 1974- 1984.

ACOG Technical Bulletin

In: Zatuchni GI, Goldsmith A, Sciarra JJ, eds. Intrauterine contraception: advances and future prospects. Philadelphia: Harper & Row, 1985:340-353 1 I. Ory HW. Ectopic pregnancy and intrauterine contraceptive devices: new perspective. The Women’s Health Study. Obstet Gynecol 198157: 137-144 12. Foreman H, Stadel BV. Schlesselman S. Intrauterine device usage and fetal loss. Obstet Gynecoll98 I ;58:669677 13. Hasson HM. Clinical experience

with intrauterine

de-

vices in a private practice. Adv Contracept 61

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1985; I :5 l-

14. Sandmire HF. Cavanaugh RA. Long-term use of intrauterine contraceptive devices in a private practice. Am J Obstet Gynecol 1985: 152: 169-l 75 15. Rioux JE. Cloutier D. DuPont P, Lamonde D. Pregnancy after IUD use. Adv Contracept 1986:2: 185-l 92 16. Cramer DW. Schiff I, Schoenbaum SC. Gibson M. Belisle S, Albrecht B. et al. Tubal infertility and the intrauterine device. N Engl J Med 19X5:3I2:94 l-947

Copyright 0 February 1992

THE AMERICAN COllE6E OF OBSIBS~~ Al&I 6YHECOl.OGlSlS Washington, DC’ 20024-2188 Int J Gvnecol Ohstet 41