Copper, intrauterine

Name: Copper, intrauterine

Warnings

  1. PREGNANCY
    Effects on the offspring when pregnancy occurs with the ParaGard T 380A in place are unknown.
    1. Septic Abortion
      Reports indicate an increased incidence of septic abortion with septicemia, septic shock, and death in patients becoming pregnant with an IUD in place. Most of these reports have been associated with, but are not limited to, the mid-trimester of pregnancy. In some cases, the initial symptoms have been insidious and not easily recognized. If pregnancy should occur with an IUD in situ , the IUD should be removed if the string is visible and removal is easily accomplished. Of course, manipulation may result in spontaneous abortion. If removal proves to be difficult, or if threads are not visible, interruption of the pregnancy should be considered and offered as an option. Rates of mortality with and without contraception are shown in Table I.
    2. Continuation of Pregnancy
      If the patient elects to maintain the pregnancy and the IUD remains in situ , she should be warned that there is an increased risk of spontaneous abortion and sepsis. In addition, she is at increased risk of premature labor and delivery. As a consequence of premature birth, the fetus is at increased risk of damage. She should be followed more closely than the usual obstetrical patient. The patient must be advised to report immediately all abnormal symptoms, such as flu-like syndrome, fever, abdominal cramping or pain, bleeding or vaginal discharge, because generalized symptoms of septicemia may be insidious.
  2. ECTOPIC PREGNANCY
    1. Patients with a history of ectopic pregnancy are at an increased risk of subsequent pregnancies being ectopic. Although current data indicate that there is no increased risk of ectopic pregnancy in patients using the ParaGard T 380A and some data suggest there may be a lower risk than the general population using no method of contraception, a pregnancy which occurs with the ParaGard T 380A in place is more likely to be ectopic than a pregnancy occurring without ParaGard T 380A. 2-4 Therefore, patients who become pregnant while using the ParaGard T 380A should be carefully evaluated for the possibility of an ectopic pregnancy.
    2. Special attention should be directed to patients with delayed menses, slight metrorrhagia and/or unilateral pelvic pain, and to those patients who wish to terminate a pregnancy because of IUD failure, to determine whether ectopic pregnancy has occurred.
  3. PELVIC INFECTION (PELVIC INFLAMMATORY DISEASE, PID)
    The ParaGard T 380A is contraindicated in the presence of PID or in women with a history of PID. Use of all IUDs, including the ParaGard T 380A, has been associated with an increased incidence of PID. Therefore, a decision to use the ParaGard T 380A must include consideration of the risks of PID. The highest rate of PID has been reported to occur after insertion and up to four months thereafter. A study suggests that the highest incidence occurs within 20 days postinsertion, then falls, remaining constant thereafter. 5 Administration of prophylactic antibiotics has been reported, although studies do not confirm the utility of this prophylactic measure in reducing PID. PID can necessitate hysterectomy and can also lead to tubo-ovarian abscesses, tubal occlusion and infertility, and tubal damage that can predispose to ectopic pregnancy. PID can result in peritonitis and, infrequently, in death. The effect of PID on fertility is especially important for women who may wish to have children at a later date.
    1. Women at special risk of PID
      The risk of PID appears to be greater for women who have multiple sexual partners and also for those women whose sexual partners have multiple sexual partners, as PID is most frequently caused by sexually transmitted diseases.
    2. PID warning to ParaGard T 380A users
      All women who choose the ParaGard T 380A must be informed prior to insertion that IUD use has been associated with an increased incidence of PID and that PID can necessitate hysterectomy, can cause tubal damage leading to ectopic pregnancy or infertility or, in infrequent cases, can cause death. Patients must be taught to recognize and report to their physician promptly any symptoms of pelvic inflammatory disease. These symptoms include development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever.
    3. Asymptomatic PID
      PID may be asymptomatic but still result in tubal damage and its sequelae. 6,7
    4. Treatment of PID
      Following diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained and antibiotic therapy should be initiated promptly. Removal of the ParaGard T 380A after initiation of antibiotic therapy is usually appropriate. Time should be allowed for therapeutic blood levels to be reached prior to removal. Guidelines for PID treatment are available from the Center for Disease Control (CDC), Atlanta, Georgia. A copy of the printed guidelines has been provided to you by Ortho-McNeil Pharmaceutical, Inc. The guidelines were established after deliberation by a group of experts and staff of the CDC, but they should not be construed as rules suitable for use in all patients. Adequate PID treatment requires the application of current standards of therapy prevailing at the time of occurrence of the infection with reference to the prescription labeling of the antibiotic selected.
      Genital actinomycosis has been associated primarily with long-term IUD use. If actinomycosis occurs, promptly institute appropriate antibiotic therapy and remove the ParaGard T 380A.
  4. EMBEDMENT
    Partial penetration or embedment of the ParaGard T 380A in the endometrium or myometrium can result in difficult removal. In some cases this can result in breakage of the IUD, necessitating surgical removal.
  5. PERFORATION
    Partial or total perforation of the uterine wall or cervix may occur with use of the ParaGard T 380A. The rate of perforation in randomized trials of the ParaGard T 380A has been 1 in 1,360. Insertions immediately after the expulsion of the placenta are not known to be associated with increased risks of perforation, but insertion later in the first postpartum month, particularly during lactation, has been associated with an increased risk of perforation. 8,9 Thus, unless performed immediately postpartum, insertion should be delayed to the second postpartum month. IUD insertion immediately postabortion in the first trimester is not known to be associated with increased risks of perforation, but insertion after second trimester abortion should be delayed until the second postabortion month.
    The possibility of perforation must be kept in mind during insertion and at the time of any subsequent examination. If perforation occurs, the ParaGard T 380A should be removed as soon as possible. A surgical procedure may be required. Abdominal adhesions, intestinal penetration, intestinal obstruction, and local inflammatory reaction with abscess formation and erosion of adjacent viscera may result if the ParaGard T 380A is left in the peritoneal cavity. There are reports of migration after insertion.
  6. MEDICAL DIATHERMY
    The use of medical diathermy (short-wave and microwave) in a patient with a metal-containing IUD may cause heat injury to the surrounding tissue. Therefore, medical diathermy to the abdominal and sacral areas should not be used on patients with a ParaGard T 380A in place.
  7. EFFECTS OF COPPER
    Additional amounts of copper available to the body from the ParaGard T 380A may precipitate symptoms in women with Wilson's disease. The incidence of Wilson's disease is approximately 1 in 200,000. The long term effects of intrauterine copper to a child conceived in the presence of an IUD are unknown.
  8. RISKS OF MORTALITY
    The available data from a variety of sources have been analyzed to estimate the risk of death associated with various methods of contraception. The estimates of risk of death include the combined risk of the contraceptive method plus the risk of pregnancy or abortion in the event of method failure. The findings of the analysis are shown in Table I. 10
TABLE I--Annual Number of Birth-Related or Method-Related Deaths
Associated with Control of Fertility per 100,000 Non-sterile Women,
by Fertility Control Method According to Age.
  Age Group  
Methods 15-19 20-24 25-29 30-34 35-39 40-44
No Birth Control Method/Term 4.7 5.4 4.8 6.3 11.7  20.6
No Birth Control Method/AB 2.1 2.0 1.6 1.9  2.8   5.3
IUD 0.2 0.3 0.2 0.1  0.3   0.6
Periodic Abstinence 1.4 1.3 0.7 1.0  1.0   1.9
Withdrawal 0.9 1.7 0.9 1.3  0.8   1.5
Condom 0.6 1.2 0.6 0.9  0.5   1.0
Diaphragm/Cap 0.6 1.1 0.6 0.9  1.6   3.1
Sponge 0.8 1.5 0.8 1.1  2.2   4.1
Spermicides 1.6 1.9 1.4 1.9  1.5   2.7
Oral Contraceptives 0.8 1.3 1.1 1.8  1.0   1.9
Implants/Injectables 0.2 0.6 0.5 0.8  0.5   0.6
Tubal Sterilization 1.3 1.2 1.1 1.1  1.2   1.3
Vasectomy 0.1 0.1 0.1 0.1  0.1   0.2

Adverse Reactions

These adverse reactions are not listed in any order of frequency or severity.

Reported adverse reactions with intrauterine contraceptives include: endometritis; spontaneous abortion; septic abortion; septicemia; perforation of the uterus and cervix; embedment; fragmentation of the IUD; pelvic infection; tubo-ovarian abscess; tubal damage; vaginitis; leukorrhea; cervical erosion; pregnancy; ectopic pregnancy; fetal damage; difficult removal; complete or partial expulsion of the IUD, particularly in those patients with uteri measuring less than 6.0 cm by sounding; menstrual spotting; prolongation of menstrual flow; anemia; amenorrhea or delayed menses; pain and cramping; dysmenorrhea; backaches; dyspareunia; neurovascular episodes, including bradycardia and syncope secondary to insertion. Uterine perforation and IUD displacement into the abdomen have been followed by peritonitis, abdominal adhesions, intestinal penetration, intestinal obstruction, and cystic masses in the pelvis. (Certain of these adverse reactions can lead to loss of fertility, partial or total removal of reproductive organs, hormonal imbalance, or death.) Urticarial allergic skin reaction may occur.

References

  1. Alvarez F et al: New insights on the mode of action on intrauterine contraceptives in women. Fertil Steril 1988; 49:768-773.
  2. World Health Organization's Special Programme of Research, Development and Research Training in Human Reproduction: A multinational case-control study of ectopic pregnancy. Clin Reprod Fertil 1985; 3:131-143.
  3. Ory HW, Women's Health Study: Ectopic pregnancy and intrauterine contraceptive devices: New perspectives. Obstet Gynecol 1981; 57:137-144.
  4. Marchbanks PA et al: Risk factors for ectopic pregnancy: A population-based study. JAMA 1988; 259:1823-1827.
  5. Farley TMM et al: Intrauterine devices and pelvic inflammatory disease: An international perspective. Lancet 1992; 339:785-788.
  6. Cramer DW et al: Tubal infertility and the intrauterine device. N Engl J Med 1985; 312:941-947.
  7. Daling JR et al: Primary tubal infertility in relation to the use of an intrauterine device. N Engl J Med 1985; 312:937-941.
  8. Heartwell SF, Schlesselman S: Risk of uterine perforation among users of intrauterine devices. Obstet Gynecol 1983; 61:31-36.
  9. Chi I-C, Kelly E: Is lactation a risk factor of IUD and sterilization-related uterine perforations? A hypothesis. Int J Gynaecol Obstet 1984; 22:315-317.
  10. Harlap S, Kost K, Forrest JD: Preventing pregnancy, protecting health: a new look at birth control choices in the United States. The Alan Guttmacher Institute 1991; 1-129.
  11. Chi I-C et al: Performance of the Copper T 380A Intrauterine device in breast feeding women. Contraception 1989; 39:603-618.
  12. Farr G, Rivera R: Interactions between intrauterine contraceptive device use and breast-feeding status at time of intrauterine contraceptive device insertion. Analysis of TCu-380A acceptors in developing countries. Am J Obstet Gynecol 1992; 167:144-151.
  13. Mark AS, Hricak H: Intrauterine contraceptive devices: MR imaging. Radiology 1987; 311-314.
  14. Sivin I, Stern J: Long-acting, more effective Copper T IUDs: A summary of US experience, 1970-1975. Stud Fam Plann 1979; 10:263-281.
  15. Sivin I, Schmidt F: Effectiveness of IUDs: A review. Contraception 1987; 36:55-84.
  16. Trussell J: The Essentials of Contraception, in R.A. Hatcher, et al: Contraceptive Technology , 16th Revised Ed., New York, Irvington, 1994, p. 113-114.
  17. World Health Organization (WHO): Mechanism of action, safety, and efficacy of intrauterine devices. Report of a WHO Scientific Group. Technical Report Series 753. Geneva; World Health Organization, 1987, p. 22.

Manufactured for

ORTHO-McNEIL PHARMACEUTICAL, INC.

Raritan, New Jersey 08869

by FEI Products, Inc.

N. Tonawanda, New York 14120

10U0732

©OMP 1998    Revised February 2002     631-40-410-6

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The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.
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