Copper IUDs (author's transl)

Following initial development of the Grafenberg ring in the 1920's, IUDs fell into disuse until the late 1950s, when plastic devices inserted using new technology began to gain worldwide acceptance. Further research indicated that copper had a significant antifertility effect which increased with increasing surface area, and several copper IUDs were developed and adapted, including the Copper T 200, the Copper T 220C, and the Copper T 380 A, probably the most effective yet. The Gravigard and Multiload are 2 other copper devices developed according to somewhat different principles. Copper devices are widely used not so much because of their great effectiveness as because of their suitability for nulliparous patients and their ease of insertion, which minimizes risk of uterine perforation. Records of 2584 women using Copper IUDs for 7190 women-years and 956 women using devices without copper for 6059 women-years suggest that the copper devices were associated with greater effectiveness and fewer removals for complications. Research suggests that the advantages of copper IUDs become more significant with increased duration of use. Contraindications to copper devices include allergy to copper and hepatolenticular degeneration. No carcinogenic or teratogenic effect of copper devices has been found, but further studies are needed to rule out other undesirable effects. Significant modifications of copper devices in recent years have been developed to increase their effectiveness, prolong their duration of usefulness, facilitate insertion and permit insertion during abortion or delivery. The upper limit of the surface area of copper associated with increased effectiveness appears to be between 200-300 sq mm, and at some point increases in copper exposure may provoke expulsion of the IUD. The duration of fertility inhibition of copper IUDs is usually estimated at 2-3 years, but recent research indicates that it may be 6-8 years, and some devices may retain copper surface for as long as 20 years. Shorter and smaller versions of standard copper IUDs have been tested as they permit easier insertion, but high rates of pregnancy, expulsion, and removal have prevented their wider use. The discovery that the size of the uterine cavity is more important than its length has prompted the development of some promising uterine measuring instruments. Attempts to develop a device appropriate for postpartum use have been disappointing, and expulsion rates remain high. A few promising new forms of copper IUDs have been developed but not yet tested clinically.     

Evaluation of combined multiload copper IUD (MLCu250 and MLCu375).

An improved IUD design has been developed, called the Combined Multiload Copper IUD, whose properties combine an easy insertion procedure with a high resistance to expulsion. The new design features an improved polyethylene skeleton which decreases the need to extend the uterine cavity and also decreases the medical removal rate. The Combined Multiload Copper IUD (MLCu) is available with 250 mm copper or 375 mm copper wiring around the vertical stem. 18 months of multicenter comparative testing among the MLCu device, the Lippes D, and 2 older-model copper T devices showed the MLCu device to have much lower expulsion and much higher continuation rates without sacrificing in pregnancy-prevention performance. Results with the MLCu375 show even lower pregnancy rates with no more medical removals or expulsions than with the MLCu250. The added advantage of the MLCu375 is that there is no need for replacement before 5 years. Clinical tests of postplacental insertion of the MLCu250 were carried out on 78 women in Ghent, Belgium, with promising results. Multicenter trials are continuing.     

Clinical performance of intrauterine devices in nulligravidae: is the length of the endometrial cavity of significance?

In a double-blind study 236 nulligravidae were randomized to insertion of standard models of two commonly used intrauterine devices, Multiload and Gravigard, or shorter versions of these devices. Before insertion the total axial uterine length and the length of the endometrial cavity were determined. After 12 months the total continuation rate was 57.2%. The clinical performance of Multiload models was not statistically different from that of the Gravigards, and the short IUD-types did not do better than the longer ones. Among the longer models a significant higher continuation rate was observed with the Multiload. The frequency of side effects was not increased when the total uterine cavity length was less than 7 cm. As the incidence of side effects was higher than normally reported after insertion of IUD's in parous women it is concluded that insertion of IUD's in nulligravidae should be performed only when other methods of contraception are unacceptable. The ratio between the lengyh of the uterine cavity and the length of the IUD seems to be of no significance for the clinical events following insertion of IUD's in nulligravidae.     

Uterine perforation by a Copper 7 intrauterine contraceptive device with subsequent penetration of the appendix. Case report

This case is presented of a 24-year old woman who came to an antenatal booking clinic following a 17-week period of amenorrhea and 10 months after her last pregnancy. A Copper 7 IUD had been inserted 8 weeks after the birth of her last child. Follow up visits after IUD insertion had shown no problems but an unplanned pregnancy followed and there was no evidence of an IUD within the uterus. When the infant was born no IUD was found although the uterine cavity was not explored. At laparoscopy the IUD was found to be embedded in omentum and apparently lying adjacent to the appendix but at laparotomy was seen to have penetrated the appendix wall. The appendix, IUD, and adherent omentum were removed and no site of uterine perforation was identified. Reported incidence of uterine perforation with IUDs varies from 1/350 to 1/2500 insertions. Copper containing devices are more often embedded in omentum than plastic devices and thus require laparotomy for removal. Intraperitoneal IUDs do not necessarily produce symptoms but may intrude on neighboring viscera such as the bladder or intestinal tract. Copper containing IUDs are known to cause irritation and although translocation may have occured at the time of insertion, appendiceal penetration was almost certainly a later event.     

Crystaline mineral deposits on copper intrauterine devices. Study involving diffraction by X-rays on whole IUDs

The crystallized mineral deposits on 91 copper IUDs removed by normal procedures were analyzed using x-ray diffraction. 50 Nova-T, 27 Multiload 375, and 14 Gravigard devices were divided into a group of 32 in place for 10-36 months and a group of 59 in place for over 36 months. Studies were performed by x-ray diffraction on whole IUDs in the fresh or dry state and by using classic x-ray, infrared, and atomic absorption spectrometry methods on deposits. Coils of all the IUDs were covered with a layer of cuprous oxide adherent to the metal that flaked over time. Crystals or coatings formed white deposits on 63% of all IUDs, especially when cuprous oxide adhered to the metal. The deposits covered 65-85% of adherent oxides and only 33-38% of flaked oxides for the 1st and 2nd durations of use respectively. Deposits were more abundant on Nova T and Gravigard than on Multiload devices. For the short and long periods of use, the respective frequencies were 67 and 74% on Nova Ts, 25 and 47% on Multiloads, and 88 and 67% on Gravigard. Calcium carbonate (CaCO3) was the only crystalline inorganic compound found, and was present with or without white deposit on 80% of IUDs. It was in the form of calcite, accompanied by vaterite in 40% of cases and rarely by aragonite. Calcium was substituted by magnesium, with an average of 3.7 atoms. Sodium, potassium, and excess magnesium were not in the organic crystalline phase.     

Copper in the menstrual and physiological cycle cervical mucus of copper IUD users (author's transl)

The article studies the concentration of copper in the cervical mucus of users and nonusers of copper IUDs. Of the 170 samples taken 90 were basal, i.e. taken from nonusers, and 80 were taken from users of No-Gravid, Dalkon Shield, Gravigard, Copper T, and Progestasert. Concentration of copper was much higher in IUD wearers than in nonwearers, even after 2 years from insertion, except in wearers of Dalkon Shield and of Progestasert. Copper concentration in wearers of Gravigard and Copper T were lower than concentrations found in wearers of No-Gravid.     

Translocation of the Dalkon Shield into the broad ligament.

Perforation of the uterus is a serious complication in users of intrauterine devices for contraception. The incidence varies with the type of device. The perforation can occur in different parts of the uterine wall. Perforation into the broad ligament is rare; only 4 cases have been described. Two additional cases, both occurring with the Dalkon Shield, are reported here.     

A comparative study of the various organisms causing salpingitis and their potential presence in IUD wearers

A prospective study was undertaken to compare the enbdometrial and vaginal bacteria of a continuous series of 283 patients who had IUDs removed between June 1, 1979 and June 1, 1983, by the same clinician. Measures were taken to avoid contamination of the IUD upon removal by the vaginal bacteria, but as a practical matter it was impossible to avoid all contact. The IUDs involved were Multiload copper 250 or 375, Gyne T and T 200, Nova T, and Dimelys. The number of positive cultures from the IUD and the vagina respectively were 1 and 3 of Trichomonas, 82 and 142 Doederlein, 17 and 47 Candida, 131 and 141 white Staphylococcus, 77 an 71 enterococci, 97 and 132 Coli bacilli, 41 abd 54 Lancedfield streptococci, 15 and 58 Hemophilus vaginalis, 13 and 24 Proteus, 1 and 1 Veillonella alcalescens, 3 and 11 Vibrions, 2 and 3 staphylococci dores, 1 and 2 Klebsiella, 1 and 1 Clostridium, 9 and 6 Peptostreptococcus putridus, 1 and 1 Peptococcus prevoti, 6 and 6 Bacteroides fragilis, 2 and 2 Peptococcus intermedius, 0 and 1 Peptococcus aerogenes, and 1 and 1 Citobacter diverous. In almost all cases the concentrartion of bacteria was much greater in the vagina. The rarity of sterile IUDs was not surprising considering the method or removal and the almost inevitable contact with the vagina. The number of organisms declined significantly with parity, but when non-pathogenic bacteria were excluded, the number of sterile IUDs was greatest among nulliparas and primaparas. The Nova T and Dimelys had less contamination by all types of organisms than did the Gravigarde, Multiload copper, or Gyne T. The greatly reduced quantity of bacteria in the uterine cavity relative to the vagina indicates that the cervix is still an effective filter even when it is traversed by the IUD thread.     

Iron deficiency in women using modern copper intrauterine devices

To evaluate the risk of iron deficiency and anemia connected with the use of modern copper intrauterine devices, serum ferritin, transferrin, iron, hemoglobin and hematocrit levels, red cell counts, and morphology, as well as red cell indexes were determined in 40 women and in 19 controls. Follow-up was for one year. Mean hemoglobin, hematocrit, serum iron, and serum ferritin levels decreased and serum transferrin levels increased significantly in the study population. About 20% of intrauterine device users but none of the controls showed signs of iron deficiency, and 10% had clinical anemia at 12 months of use. No differences were found between the three different copper intrauterine devices tested (Nova T, Multiload and Fincoid). Because the risk of anemia did not correlate with subjective evaluation of the amount of bleeding, it is recommended that hemoglobin levels should be determined for all intrauterine device users before its insertion and at six and 12 months of use. In those with decreased hemoglobin levels, serum ferritin should be measured and iron replacement instituted or the device removed.     

Perforation of the uterus by the copper-t and copper-7 intrauterine contraceptive devices.

Uterine perforation in patients wearing the Copper-T and the Copper-7 intrauterine contraceptive devices has been studied. In Bolln?s, Sweden, three perforations occurred in 1 156 insertions of the Copper-7, and in New York, USA, six perforations occurred in 1 153 insertions of the Copper-T. Cervical perforation seems to be a special feature of the Copper-T, while the Copper-7 tends to perforate through the uterine wall. The perforations can be divided into "primary" perforations, related to the insertion procedure, and "secondary" perforations, caused by uterine contractions. The diagnosis and treatment of uterine perforations by intrauterine devices is discussed.     

The role of copper-releasing intrauterine device or levonorgestrel-releasing intrauterine system on uterine bleeding and iron status (prospective study of 8 years)

BACKGROUND: The aims of this study were the effects of copper intrauterine device (Cu-IUD) compared to progesterone (PRG-IUS) or levonorgestrel releasing intrauterine system (LNg-IUS) on menstrual bleeding, menorrhagia and dysfunctional uterine bleeding. The authors evaluated the effect of copper surface area on uterine bleeding. METHODS: Between March 1992 and November 1999, 223 women, referred to I Institute of Obstetrics and Gynaecology University of Rome, were recruited in a prospective study with follow up at 3, 6 and 12 months to evaluate the incidence of endometrial pathology. The study includes 38 fertile women with regular menstruations and without intrauterine devices, as control group, and 185 patients with intrauterine devices, divides as follows: - 117 copper-releasing intrauterine devices: 30 with a copper (Cu) surface area =200 mm2, releasing 45 microgram Cu/24h (Nova T (R)); 27 with a copper surface area =250 mm2, releasing 50 microgram Cu/24h (Multiload 250 (R)); 25 with a copper surface area =375 mm2, releasing 65 microgram Cu/24h (Multiload 375 (R)); 20 with a copper surface area =384 mm2, releasing 100 microgram Cu/24h (No Gravid M (R)); 15 with a copper surface area =440 mm2, releasing 120 microgram Cu/24h (No Gravid 0,5 (R)). - 68 progesterone/levonorgestrel-releasing intrauterine devices: 40 progesterone-releasing intrauterine systems (Progestasert(R)); 28 levonorgestrel-releasing intrauterine systems 20 mg/24h (Mirena (R)). A total of 211 subjects had data that were valid for analysis: 12 women out of 223 (5,4%) were excluded from the prospective study lost to follow-up. A venous blood sample for serum ferritin (mg/l), iron (mg/dl), hemoglobin (g/dl), hematocrit (%), blood cell count, MCHC and MCV was taken during follow-up. RESULTS: PRG or LNg-IUSs determined a significant reduction in menstrual blood loss and in irregular bleeding by gradually reducing endometrial fitness and vascularisation. Serum ferritin significantly increased in women inserted with LNg- IUSs already after 6 months (26+/-22 e 28+/-14 microgram/l versus 32.5+/-19 e 34.5+/-25 microgram/l). Hemoglobin significantly increased (p>0.05) 6 months after insertion. On the contrary this did not occur with the insertion of Cu-IUDs. We observed that the increased amount of copper, released by IUD, causes increasing of bleeding. CONCLUSIONS: The LNg-IUS is a new contraceptive method combining the advantages of both hormonal and intrauterine contraception. In addition, it can be considered an alternative method in the treatment of menorrhagia and dysfunctional uterine bleeding. On the contrary, in women inserted with Cu-IUDs, the main reason of menorrhagia probably is due both to the shape of device and to copper surface area.     

Migration of an intrauterine contraceptive device to the sigmoid colon: a case report.

BACKGROUND: Copper T intrauterine devices (IUDs) remain the mainstay of family planning measures in developing countries, but have been associated with serious complications such as bleeding, perforation and migration to adjacent organs or omentum. Although perforation of the uterus by an IUD is not uncommon, migration to the sigmoid colon is extremely rare. Here, we report a case of migration of an IUD to the sigmoid colon. CASE REPORT: A 40-year-old woman who had an IUD (Copper T), inserted 1 month after delivery, presented, 7 months later, with secondary amenorrhea and transient pelvic cramps. Clinical findings and ultrasonographic examinations of the patient revealed an 8-week pregnancy, while laboratory tests were normal. Transvaginal ultrasonography also visualized the IUD located outside the uterus, near the sigmoid colon, as if it were attached to the bowel. The pregnancy was terminated at the patient's wish; a diagnostic laparoscopy was performed concomitantly, which showed bowel perforation owing to the migration of the IUD. The device, which was partially embedded in the sigmoid colon, was removed via laparoscopy; however, because of bowel perforation, laparotomy was performed to open colostomy. CONCLUSIONS: This case report highlights the continuing need for intra- and postinsertion vigilance, since even recent advances in IUD technique and technology do not guarantee risk-free insertion.     

Post-termination contraception: use of the Multiload Cu250

Summary. During a period of 27 months Multiload intrauterine devices were inserted immediately after suction evacuation of the uterus into 125 patients in two hospitals. Sixty-one patients were lost to follow-up despite careful explanation of the need to attend. The remaining 64 patients provided a total of 630 women months for analysis. Eleven patients requested removal of the Multiloads for various personal reasons. Four devices were spontaneously expelled, three in the first 2 months. Eight devices were removed on account of pain or bleeding and one because of infection. Five other patients were considered to have less severe uterine infection not requiring removal of the devices. These complications have to be viewed against those inherent in the procedure of termination: 4·4% pain or bleeding 3·6% uterine infection. Forty women are known to be continuing to wear the devices. They show no differences in terms of parity, gestation at the time of termination or degree of dilatation of the cervix at the time of termination from the other groups. One pregnancy occurred after 10 months of use. While acknowledging the deficiency of the study due to the high defaulter rate the immediate insertion of a Multiload at the time of termination of pregnancy can be considered as an acceptable method of contraception.     

The new IUDs

This brief review mentions 3-dimensional IUDs and large surface IUDs and discusses progesterone and copper-containing IUDs. The 3-dimensional IUDs (Corolle, Basquet, and Majzlin spring) were expelled easily and were poorly tolerated. The large area Dalkon shield was difficult to insert and remove but permitted few expulsions; the failure rate of less than 1% claimed by its inventors has not been confirmed in French and British studies. IUDs with progesterone capsules or with auxiliary daily pills are on trial. Copper T and 7 shaped IUDs have proved to be more effective, seldom expelled, and rarely responsible for severe bleeding. The IUDs with 300 sq. mm copper release about 50 mcg copper /day, not enough to affect blood levels. They seem to prevent implantation by attracting leukocytes and macrophages, by modifying mucosa enzymes such as acid phosphatase, and by preventing sperm from penetrating cervical mucus.     

Analysis of minor complications in copper IUD wearers

Minor complications occuring after insertion of 3216 copper IUDs between October 1976 and December 1980 were studied. 1813 of the device were Cu 7 200s, 176 were Cu T 200s, 237 were ML Cu 250s, and 990 were Nova Ts. 133 partial and 71 total expulsions, 21 removals for bleeding, 24 for pain, 10 for bleeding and pain, and 115 for other causes were studied. 5.23% of Cu 7 200, 4.54% of Cu T 200, 2.53% of ML Cu 250, and 2.42% of Nova T devices were partially expelled, while 3.23% of Nova T, 1.87% of Cu T 200, 1.68% of ML Cu 250, and .56% of Cu T 200 devices were totally expelled. Considering all types of IUD, the frequency of expulsions declined with age, but great differences were not observed in relation to parity. 67.6% of total and 48.9% of partial expulsions occurred in the 1st 6 months of use. All total expulsions in the ML Cu 250 and the Cu T 200 occurred in the 1st 3 months. 58.14% of partially expelled IUDs which were reinserted presented no further problems. 16 of 21 IUDs removed for bleeding were Cu 7 200s, 2 each were ML Cu 250s and Nova Ts, and 1 was a Cu T 200. Slightly over 1/2 were removed in the 1st year of use. 20 fo the 24 IUDs removed for pain were Cu 7 200s, and 37.5% of them were used by nilliparas. 9 of the 10 removed for pain and bleeding wer Cu 7 200s, 40% of them in nulliparas. Psychological intolerance of the method (63.35%) and removal by other doctors (18.26%) were the other causes of removal. For the Cu 7 200, Cu T 200, ML Cu 250 and Nova T respectively, the Pearl indices of expulsion were 1.97, 2.22, 2.76, and 4.89, while for pain and/or bleeding they were 1.39, 1.33, 1.18, and .29.     

Modification of the cervical flora by IUCD

The study objective was to examine the cervical flora during the insertion of an IUD and to determine whether the presence of the device in utero modified this flora. A secondary objective was to determine whether the colonization of the cervix with (occasionally) pathogenic bacteria warrants a prophylactic antibiotic treatment. IUDs were inserted in a group of 20 women, ranging in age from 23-40 years, at the Family Planning Clinic of Meir Hospital in Kfar Saba, Israel. The cervical bacterial flora was examined during insertion and again after a period of 3-12 months with the IUD in situ. None of the women received antibiotic or antifungal treatment for 3 months prior to or 12 months after insertion. The women were divided into 2 groups according to the type of IUD used. Group A consisted of 22 women with nonmedicated IUDs and Group B included 28 women with IUDs medicated with copper. A cervical swab was collected during insertion of the IUD and at 3-12 months afterwards. Of the 50 cervical cultures collected during the insertion, 48 (84%) were sterile, but only 27 of the cultures collected after 3-12 months with the IUD in utero were sterile. The medicated IUD had a more intense bacteriostatic effect on the bacterial cervical flora than the other devices. Among the copper IUDs the best results were obtained with the Nova T type and secondly with the Copper 7 (Gravigard). It is possible that the pathogenic organisms enter the uterine cavity and tubes from the cervix during insertion of the IUD. It may be concluded that during IUD insertion prophylactic treatment with a broad spectrum antibiotic would be indicated, but the study showed that this was not the case. The organisms isolated in the women studied were those normally found in the upper vagina and cervix and only occasionally became pathogenic. Medicated IUDs are preferable because of the bacteriostatic activity of the copper and to the fact that they are normally left in utero for a shorter time than the unmedicated IUDs.     

Analysis of risk factors associated with uterine perforation by intrauterine devices.

OBJECTIVE: To determine the risk factors for intrauterine devices (IUDs) being displaced into the abdominal cavity. METHODS: This prospective follow-up study was conducted between 1996 and 2002, at the family planning clinic of a referral hospital. All 8343 women who had a copper T-380A IUD inserted underwent ultrasound examination after 1 year. Relative risk estimates and logistic regression analyses were performed to determine the risk factors associated with uterine perforation by intrauterine devices. RESULTS: Eighteen uterine perforations occurred during the study, giving an incidence of 2.2 per 1000 insertions. When the time elapsed after the last delivery until IUD insertion is considered, postplacental insertion and insertion after 6 months postpartum were found not to increase the risk of uterine perforation. However, IUD insertion 0-3 months postpartum increased the risk of uterine perforation (odds ratio (OR) 11.7, 95% confidence interval (CI) 2.8-49.2) as did insertions at 3-6 months postpartum (OR 13.2, CI 2.8-62). Increasing parity decreased the risk (OR 0.04, CI 0.01-0.1) and increasing number of abortions increased the risk (OR 2.1, CI 1.2-3.6). CONCLUSION: It is safer to postpone IUD insertion until 6 months after delivery.     

The efficacy of immediate post-abortion intrauterine device insertion

Ovulation returns soon after abortion, with half of the women ovulating by 21 days after the procedure. Immediate post-abortion insertion provides immediate contraceptive protection. Clinicians have feared that rates of uterine perforation due to intrauterine devices (IUDs) and expulsion of IUDs may be higher in the post-abortal uterus due to its softness and enlargement. This study was carried out to assess the safety and efficacy of IUD insertion immediately after induced abortion compared with insertion during the first menstrual cycle after abortion. All women were counseled about a method of contraception, particularly copper T-380A, and divided into two groups: Group 1 included 226 women who preferred immediate IUD insertion, and Group 2 included 100 women who opted for interval-IUD insertion during the first menstrual cycle after abortion. All women were followed-up at two and eight weeks after insertion of the IUDs. Severe bleeding was observed 10.62% in Group 1 and 6% in Group 2. Expulsion rate was 7.08% and 8% in Groups 1 and 2, respectively, which was not statistically significant. Pelvic inflammatory disease (PID) was observed in one case in Group 1. However uterine perforation was not noted in either group. In conclusion, insertion of an IUD immediately after an induced abortion is safe and if a woman asks for a modern contraceptive method it could be offered.     

Factors affecting the clinical performance of Nova T and Copper T 200

In a randomized comparative use-effectiveness study of the copper-releasing intrauterine devices (IUDs), Nova T and Copper T 200, an analysis was made of the differences in women between the participating countries and of the influence of various factors on pregnancy rate and rates of terminations. In a cohort of 1865 women the five-year gross cumulative pregnancy rates were 3.4 per 100 women for Nova T and 8.7 per 100 women for Copper T 200. The rate of unwanted pregnancy was significantly related to the type of IUD, the country, and the age of the women. Prognostic factors for expulsion or removal of the device were age, country, parity, previous use of IUD, previous vaginal delivery, and previous abortion. The differences among the results for the participating countries may reflect the effects of different policies in clinics.