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.     

Intrauterine contraception (author's trans)

Biological and technical research findings have helped to increase the number of acceptors of the IUD in France to nearly 1.5 million in 1983. The endometrial effects of IUDs are better understood at the morphological level through the use of electron microscopy and at the functional level through use of doses of metabolites or hormonal receptors. More precise evaluation of modifications of the composition and biological properties of the uterine environment allow a better understanding of local physiological repercussions of the IUD. Copper IUDs, the most common type in use at present, are produced with numerous variations in size, shape, method of insertion, and other features. Factors conditioning the liberations of copper have not been studied until recently, but appear to depend on the woman herself as well as the quantity, quality, mode of incorporation and location of the device of the copper. There is no consensus as yet as to the optimal amount of copper, duration of the IUD, or role of the copper. Progesterone-freeing IUDs are on the point of being commercialized in France. Unlike copper IUDs, they release the substance at a constant rate over a determined period. The effects include diminution of fibrinolytic activity and liberation of prostaglandins, with consequent reductions in blood loss and menstrual pain. Because the properties of an IUD are modified by such conditions of use as the experience of the inserting physician and patient characteristics, comparison between different devices is difficult. The most important factor affecting performance of the IUD appears to be good adaptation of the device to the configuration of the uterine cavity. Complications are not always avoidable but they can be reduced by better patient selection and good technique of insertion, and their consequences can be limited by early identification and treatment.     

Insertion forces with intrauterine devices: implications for uterine perforation

The force required to insert a Copper 7, Multiload Copper or Nova T IUD was measured in 197 successful and 25 unsuccessful insertion attempts. These forces were compared with the forces required to perforate freshly obtained uterine specimens with a metal uterine sound and Dalkon shield device, as well as with the clinically tested devices. The mean insertion forces for the Copper 7, Nova T and Multiload Copper devices were 1.502 N, 2.134 N and 4.041 N respectively, while the mean insertion pressures (N/mm2) were 0.203, 0.209 and 0.122 respectively. The mean in vitro fundal perforation forces with metal sounds was 20.7 N and with the Dalkon shield 31.6 N. The Copper 7, Multiload Copper and Nova T IUDs achieved mean in vitro forces of 5.75 N, 9.2 and 8.1 N respectively, without causing perforation. Primary uterine perforation at the time of insertion of these devices appears unlikely.     

Immediate postplacental insertion of intrauterine contraceptive devices (author's transl)

Copper 250 IUDs were inserted post-partum in 600 women, who were observed for a total of 9843 women-months. The pregnancy rate after 6, 12, and 30 months was .6, 1.0, and 1.3, respectively. The rate of expulsion was 3.7, 5.0, and 6.0 after 6, 12, and 30 months, respectively. The rate of removals due to pain and bleeding was inversely proportional to the age of the patient. Interval insertions of the Copper T 200 were performed on 269 women: the pregnancy rate was .5 and 1.2 after 12 and 24 months, respectively; the expulsion rate was constant at 11.2. Interval insertions of the Copper T 250 were performed on 293 women: the pregnancy rate was 2.4 and the expulsion rate was 9.9 after 12 and 24 months. The technique for post-partum insertion of IUDs is described step by step. The position of the IUD is ascertained by radiographic examination or vaginal exploration just prior to release from the hospital. Post-partum insertion is technically simple, safe, and easily accepted. Research is now being done to improve the retention, effectiveness, and life span of IUDs, especially for post-partum insertion.     

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.     

Physiology of IUDs and their secondary effects

There are about 17 million IUD users in the world, excluding China. Tolerance and effectiveness of the device depends very much on its size, and on its proper adaptation into the uterine cavity. Copper potentiated IUDs have practically supplanted inert IUDs; their mode of action is at an endometrial level, but they also exert a spermatotoxic action. Prostaglandins seem to play an important role in the mechanism of action of copper IUDs. Side effects are bleeding, due to an increase in capillary permeability, and pain. Complications include infection and uterine perforation. Progesterone-releasing IUDs help reduce excessive menstrual bleeding, but they cannot be used for longer than 1 year.     

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.     

Copper in the uterus

Copper-releasing IUDs seem to have a greater antifertility effect due to their continuous releasing of copper. This release results from an interaction between the copper and uterine secretions. Several agents in the uterine secretions, the amount of surface area of the copper, and the quantity of the solvent all influence the copper release rate. Microscopic photographs illustrate the progress of copper corrosion. The process of corrosion involves the replacement of copper atoms by other atoms from the uterine secretions on the corroded areas. Only a cross-sectional picture of the wire will indicate the amount of corrosion which has occurred. The corrosion occurs in variable locations, indicating that increasing the wire dimensions will not increase the lifetime of the devices. Studies with a copper IUD having a noncorrodable silver core--the Nova T--have shown this device to have significantly lower pregnancy rates than the Copper T 200 and a functional lifetime of up to 5 years.     

OMGA copper: prescribe or proscribe (author's transl) (letter)

The author, who helped develop the OMGA IUD in 1966, presents data on the effectiveness and tolerance of the OMGA copper IUD. From July 1980-February 1982, 180 insertions were done, yielding a total of 2302 months of use through May 1982. 26 OOT, 78 OT, 67 IT, and 9 2T devices were included. There were 19 expulsions, 1 removal for metrorragia, 4 pregnancies, 1 ectopic pregnancy, and 1 infection (bilateral salpingitis). Minor problems associated with IUD use were not considered. The Pearl index of 2.08% was higher than that obtained in 1970 with inert OMGA IUDs. The same findings were noted at endometrial biopsies after 1 year of use of OMGA copper devices as had been found with the inert devices. The number of expulsions (10.55% on average for the 4 models) was significant, despite precautions to adjust IUDs to the uterine cavity. The proportion of expulsions varied from 3.84% for the OOT and OT, 16.66% for the IT, to 22.22% for the 2T. In addition, 2 2T IUDs rotated 90 degrees 6 months after insertion, but without requiring removal. No pregnancies occurred with the OOT, 2 with the OT, 1 in a 36-year old women after 15 months and 1 in a 39-year old woman after 7 months; 2 with the IT, 1 in a 36-year old after 7 months and 1 in a 43-year old after 16 months. No uterine pregnancies occurred with the 2T but ectopic pregnancy occurred in a 45-year old woman after 4 months. It is hazardous to predict the in vivo experience of OMGA copper devices based on in vitro experiments, but it appears that after the disappearance of the copper the device becomes an inert OMGA and may be left in place for several years without problems for women over 40.     

Copper-silver T: The classic T resuscitated

Tests of the contraceptive efficacy of different amounts of copper have indicated that effectiveness is proportional to surface area, but the improvement achieved with more than 200 sq mm of copper is minimal. Rates of release of copper vary considerably in different women. IUDs removed because of bleeding had a significantly higher release of copper. 1 consequence of variations in release of copper is unequal dissolution of copper leading to fragmentation of the copper thread. The Nova-T IUD has 200 sq mm of copper and a flexible body which is able to maintain correct placement in the uterus. A new device with a wire of silver coated with copper was designed to avoid the fragmentation of the copper and thus increase the duration of use. The new copper silver T was compared to the Nova-T in a randomized study in Scandinavia. The pregnancy rate after 1 year was under 1% in users aged 30 and over. Cumulative rates after 5 years of use of the Nova-T and copper silver T respectively for women under 25 were 3.0 and 7.1 for pregnancy, 8.2 and 12.5 for expulsion, 27.1 and 30.2 for removal for pain and bleeding, 42.7 and women 25-29 the cumulative rates were 2.6 and 9.0 for pregnancy, 12.3 and 5.8 for expulsion, 26.1 and 21.8 for removal for pain and bleeding, 25.3 and 29.1 for removal for other reasons, and 33.6 and 34.2 for continuation. For women 30-34 cumulative rates were 1.1 and 2.2 for pregnancy, 5.9 and 3.4 f expulsion, 27.4 and 20.6 for removal for pain and bleeding, 17.5 and 22.0 for removal for other reasons, and 48.0 and 51.7 for continuation. Among women 35 and over cumulative rates were .8 and 2.1 for pregnancy, 10.9 and 3.7 for expulsions, 25.0 and 17.6 for removal for pain and bleeding, 18.8 and 12.0 for removal for other reasons, and 44.5 and 64.7 for continuation. Cumulative pregnancy rates were better for the Nova-T after 1, 3, and 5 years of use, but differences diminished with age and parity. After age 30 the pregnancy rate with the copper silver T is particularly appropriate for women whose cervical canals permit insertion of a larger device.     

A comparison of the delta copper T and the copper T 200 in Bologna, Italy

An analysis is presented of a comparative study of the Delta T and Copper T 200 IUDs. A total of 195 postabortion insertions was performed between March 1981 and August 1982. All insertions were performed with an inserter. Primary bleeding/pain complaints after insertion were largely related to intermenstrual problems, with spotting the most frequently reported. Nine women had their devices removed for PID. One pregnancy occurred at ten months in the Delta T group. Both groups had one expulsion/displacement. Eight devices in each group were removed for bleeding/pain. Two women in the TCu group had their devices removed for personal reasons. The 6-months continuation rates for the two groups were 85.5 for the Delta T group and 82.2 for the TCu group. The 6-months follow-up rate for the Delta T group was 39.4 and 38.8 for the TCu group.     

The first year of clinical experience with concurrent post abortal insertion of copper "T" 200

Immediate postabortion period is a strategic time for providing contraceptive protection, especially insertion of IUD concommitent with the abortion procedure. One can be reasonably safe in assuming that copper T 200 may be used with comparable degrees of clinical effectiveness in such situations. A higher incidence of IUD removals for bleeding and IUD displacements in the postabortal insertion is justifiable when it is considered that a greater number of women are reached and thus protected against the risks of an unwanted pregnancy. Major problems such as cervical or uterine perforations were not associated with this type of insertion. IUD removal was effected in 5.39% for bleeding, and in 4.69% of cases where there was either complete or incomplete expulsion of the device. Expulsion rate was high within the 1st week of insertion, and it is reasonable to believe that abortion complications were responsible for this high expulsion rate. Even though IUD removal was not required, about 15% of the patients had menstrual irregularities at the end of 1 year of use. Embedding of the copper device did not pose any problem for removal of the device after 1 year of use and no fragmentation of copper wire was found in the IUDs removed. In those who wanted, conception had occurred within 4 months of removal of the device. The follow-up data suggests that the use-effectiveness of the device gradually increase with the duration of use and is found to be highest after 1 year of use.     

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.     

Future of intrauterine contraception (IUDS)

Performance of IUDs has improved greatly in the past decade. The reasons for improvement include increased copper content and prevention of copper fragmentation, flexible frames that adapt to the endometrial cavity, better evaluation of the endometrial cavity before insertion, simplified insertion, selection of acceptors, and careful follow-up. NO significant modifications in IUD design have occurred since the use of copper was begun in the 1970s except for use of systems-releasing steroids. The use of copper improved efficacy and permitted use of smaller devices, reducing some side effects especially in small uteruses. The duration of use of copper IUDs has increased, and their efficacy has improved at the same time that modifications have permitted greater local tolerance with no increase in expulsion rate. Greater selectivity of IUD users has improved performance, taking into account known risks for major complications such as extrauterine pregnancy and infection. Prior use of IUD and conditions of follow-up should also be considered in candidate selection. The major weaknesses of IUDs at present are related to the introduction of a foreign body into the uterine cavity; IUD insertion entails potential risks of infection and perforation. However, the active substance should not cause damage to the endometrial mucus or induce cycle disturbances or diminished defenses against pain and infection. Research on IUD frames is oriented toward development of a device adaptable to specific conditions such as the postpartum. 1 new device would completely eliminate plastic and the related side effects. A new miniaturized device is under investigation along with a biodegradable device and an intracervical device. New substances under study for a better contraceptive effect include spermicides, immunological substances, and synthetic progestins. An intracervical device emitting a battery-driven weak electric field is intended to immobilize sperm. Most current research has as its goal the reduction of secondary effects of bleeding, pain, or risk of infection. Among the numerous substances utilized have been antifibrinolytics, prostaglandin inhibitors, sexual steroids, and antibiotics. These systems should provide constant release over a prolonged period, a goal not yet attainable for all these substances.     

Analysis of surface deposits on intrauterine contraceptive devices]

The surface deposits on stainless steel contraceptive devices removed from the uterus after various periods of insertion were examined and analyzed by means of scanning electron microscopy, X-ray energy dispersive analysis, Augar electron spectroscopy, X-ray photoelectron spectroscopy, transmission electron microscopy and atomic absorption spectrophotometer for microquantitative analysis. The data obtained were compared with those of copper-bearing IUDs (TCu 200) obtained by the same methods. The wire coils of stainless steel IUDs which had been in situ for 5 years showed on evident changes but the copper wire coils of the same duration showed varying degrees of erosion. The analysis clearly showed that the wire coils of both types of IUDs were encrusted with deposit. Deposition began on copper-bearing IUDs earlier than on stainless steel IUDs (27 days and 3 months after insertion, respectively). This process began earlier than was reported in other literature. The amount of deposits increased with the time of insertion, but there were great individual variations. Through the above mentioned microanalysis, it was found that the principal composition of the deposition both types of IUDs was calcium and existed in the crystal form of calcium carbonate. The substance attaching to the crystals were very likely nitrogenous organic compounds. Regarding the mechanism of the deposit formation, the authors suggest that it may be similar to that of calculus. The influence of the deposits on the complications of IUD insertion, such as uterine bleeding and unwanted pregnancy, is discussed briefly in this article should be studied for further details.     

宫内节育器表面沉积物的分析

本文对使用不同时期(20年内)后的不锈钢宫内节育器表面的沉积物采用了扫描电子显微镜、X 线能量色散分析、俄歇电子能谱和X 射线光电子能谱、透射电镜以及原子吸收光谱的定量分析,并与含铜宫内节育器加以比较,结果表明在宫腔内放置五年的不锈钢丝节育器的外观变化不明显,含铜宫内节育器的铜丝有溶蚀现象,二者表面均出现沉积物,含铜节育器表面出现沉积物比不锈钢环要早(分别为27天和3个月)。沉积物的多少虽随放置时间的延长而增加,但有很大的个体差异。沉积物的主要成分系碳酸钙结晶。本文还对沉积物与带器妊娠、子宫出血等的关系进行了初步讨论。     

Cupremy values in women bearing IUD medicated with various Copper quantities (authors transl)

Long experience with the IUD shows it to be a safe, effective method, without influence on hormonal equilibrium, easy to insert, and completely reversible. IUDs containing copper are seen as a significant step forward in method efficiency, but there has been concern over whether the addition of metal has some systemic effect, especially since the quantities of copper in current models may be double those in the 1st models. A number of studies are cited which indicate no association of copper IUDs with levels of copper in patients using them. The present study at the Family Planning Center of Rome University involved 150 women using No-Gravid, Gravigard and Copper T IUDs. blood samples, drawn before and after insertion (3-13 months) showed no pathological relation between hematic rate of copper and insertion of the copper IUD.     

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.     

A study of delta intrauterine devices in Ankara, Turkey

Delta devices, modifications of standard Lippes Loop D and TCu 220C IUDs, were designed for postpartum insertion. A study of the Delta T and the Delta Loop was conducted at Hacettepe University School of Medicine in Ankara, Turkey. The IUDs were randomly allocated to 246 immediately postpartum women (less than 10 min postplacenta). Twelve-month expulsion rates were low for both devices; 3.7 for Delta Loop users and 7.6 for Delta T users.     

Intrauterine devices. The optimal long-term contraceptive method?

OBJECTIVE: To review selected data on the effectiveness, safety, cost and technical ease of intrauterine device (IUD) use compared with Norplant and surgical sterilization. STUDY DESIGN: Literature review. RESULTS: IUDs are highly effective, safe and relatively inexpensive methods of contraception that may offer advantages for some women over other long-term methods, such as sterilization and Norplant. IUDs provide protection against pregnancy comparable to that provided by female sterilization, and they may be more effective than Norplant. IUDs have a long duration of effectiveness: the copper T 380A (TCu380A) is effective for at least 10 years, and the levonorgestrel (LNg) IUD appears to be effective for at least 7. Norplant is effective for only five years. Both types of IUD can disrupt menstrual bleeding patterns, although the patterns of bleeding are different. Copper IUDs often increase blood loss, whereas the LNg IUD, like Norplant, substantially reduces menstrual bleeding. The most important adverse outcome associated with IUD use is higher rates of pelvic inflammatory disease; careful attention to proper insertion techniques can reduce this risk substantially, and LNg IUDs may cause no increase in risk. IUDs, like both sterilization and Norplant, provide no protection against sexually transmitted disease. The TCu380A IUD is extremely cost-effective. There is as yet no public sector price for the LNg IUD, which has not been approved by the U.S. Food and Drug Administration and is not provided by family planning donor organizations. If it can be made available to the public sector at a price substantially less than its present market price, the LNg IUD would be a useful addition to the contraceptive armamentarium for developing countries. CONCLUSION: Providers, consumers and family planning program managers should begin to see IUDs as potential substitutes for both surgical sterilization and Norplant.