In support of a compensation plan for vaccine-associated injuries. Infectious Diseases and Immunization Committee,Canadian Paediatric Society.

Between 1971 and 1973, 200 Dalkon Shield and 142 Gyne-T 200 intrauterine devices (IUDs) were inserted at the department of obstetrics and gynecology in a large urban hospital. In 1984 retrospective analysis of events associated with the use of these IUDs was done. Hospital and clinic charts were reviewed, and the women were contacted to obtain information on infertility and the outcome of pregnancy after discontinuation of IUD use. The rates of events leading to discontinuation of IUD use 2 years after insertion were similar in the two groups except for that of planned pregnancy, which was higher in the Dalkon Shield users (p less than 0.05). The rates of accidental pregnancy per 100 women were 3.8 for the Dalkon Shield users and 1 for the Gyne-T 200 users. The rates of pelvic inflammatory disease (PID) based on all cases of PID and follow-up information were similar in the two groups. There were no differences between the two groups in outcome of pregnancy with the IUD in situ or after expulsion or removal of the IUD because of planned pregnancy or other reasons. Infertility rates after discontinuation of IUD use were similar for the Dalkon Shield and Gyne-T 200 users. The results confirm the authors'' opinion that the Dalkon Shield and Gyne-T 200 IUDs are safe and effective methods of intrauterine contraception.     

Clinical Experience with the Dalkon Shield Intrauterine Device

Preliminary acceptability and reliability tests of the Dalkon Shield were done in 377 women over 17 months, amounting to 3,028 months of use. There was a 98% follow-up. The pregnancy rate of 4·7 and expulsion rate of 6·3 do not meet the claims described in initial trials by the developers of the device. Nevertheless, the Dalkon Shield seems to be an advance in intrauterine contraception since it has the advantages of a lower expulsion rate than the “first generation” inert intrauterine devices.     

Comparing the effectiveness of copper intrauterine devices available in Canada. Is FlexiT non-inferior to NovaT when inserted immediately after first-trimester abortion? Study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: We describe the rationale and protocol for a randomized noninferiority controlled trial (RCT) to determine if the Flexi-T380(+) copper intrauterine contraceptive device (IUD) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use, NovaT-200, when placed immediately after a first-trimester abortion. METHODS: Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380(+) IUD, a device for which no current evidence on expulsion or effectiveness rates is available, or the Nova-T200 IUD, the only other brand of copper IUD available in Canada at the time of study initiation. The primary outcome measure is IUD expulsion rate at 1 year. Secondary outcomes include: pregnancy rate, method continuation rate, complication rates (infection, perforation), and satisfaction with contraceptive method. A non-intervention group of consenting women choosing a range of other post-abortion contraception methods, including no contraception, will be included for comparison of secondary outcomes. Web-based contraception satisfaction questionnaires, clinical records, and government-linked health administrative databases will be used to assess primary and secondary outcomes. DISCUSSION: The RCT design, combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry, and hospital records, offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada, in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options. We highlight considerations of design, implementation, and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion.Trial registrationClinicalTrials.gov Identifier NCT01174225.     

The copper-7 intrauterine contraceptive device: 5-year evaluation.

Over a 5-year period a family practitioner inserted copper-7 (Cu-7 intrauterine contraceptive devices (IUDs) in 134 women. The rates of continued use after 2 years, 53.0% for the women''s first IUD and 63.9% for all their IUDs, and of accidental pregnancy, 2.4%, are comparable to those in the literature. However, in this series the rate of expulsion was 0.8%, much lower than that in the literature. Fertility did not appear to be reduced in women who planned to have pregnancies after the device was removed. A carefully scrutinized technique of insertion and conscientious follow-up make the Cu-7 IUD an acceptable form of contraception for many patients in a family practice.     

Efficacy of a Y-Design Silastic Elastomer Intrauterine Device as a Horse Contraceptive

To successfully manage population growth rates of free-roaming horses (Equus ferus caballus), an effective, long-acting contraceptive could be beneficial. We evaluated the efficacy and safety of an intrauterine device (IUD) in a breeding trial using seasonal pasture assemblages of 2 males individually pastured in large enclosures (~81 ha) each with 10 females per male. The study took place at a large animal research facility at Oklahoma State University in Stillwater, Oklahoma, USA. Specific objectives of the study were to evaluate the effectiveness of IUDs in preventing pregnancy over 20.5 months with return to fertility assessed over the subsequent 6 months and to evaluate potential effects of this IUD on ovarian function and uterine health (e.g., endometrial inflammation, infection, fibrosis). We developed a Y-design IUD, made of silastic elastomer, and set the desired retention rate at 75%. After procurement of endometrial biopsies, we inserted IUDs into the uteri of 20 females and examined them via transrectal ultrasound every 2 weeks for detection of the device and assessment of uterine health. After 20.5 months we removed the remaining 15 IUDs, obtained a second endometrial biopsy for comparision, and returned the females to their respective males for continued breeding in efforts to assess uterine return to health as indicated by pregnancy rates. The Y-design IUD met the 75% retention rate goal, with 100% contraception in females that retained the device; 12 of 20 treated females became pregnant (i.e. returned to fertility) after removal of the IUD. Based on these results, we conclude that the Y-design IUD is a safe and effective device to control fertility in free-roaming horses. © 2021 The Wildlife Society.     

Comparison of use of the Dalkon Shield in Dublin and Southampton.

The results of fitting Dalkon Shield I.U.D.s in Southampton and Dublin were compared. At 12 months the continuation rates were 77.4% and 93.4% respectively. There were also differences between the two cities in the major complication rates associated with the use of the device. At 12 months these rates for Southampton and Dublin were: pregnancy 5.6% and 1.4%, expulsion 4.0% and 0.9%, and removal for pain and/or bleeding 12.1% and 3.0%, respectively. Possible reasons for the difference in performance may include the older average age of the users in Dublin, and the greater number and more varied experience of the medical staff responsible for fitting in Southampton. We recommend that population factors be taken into account when comparing data relating to fertility regulation.     

The intrauterine contraceptive device.

This presentation brings into perspective the most recent information on intrauterine contraceptive devices. A comprehensive review of the literature is presented in a manner meaningful to the clinician. The advantages and disadvantages of this method of contraception, the problems that arise and the recommended methods of management are discussed. An updated review of the literature with regard to bleeding, pain, expulsion of the device, infection, uterine perforation and pregnancy is also presented.     

Pelvic infection: a comparison of the Dalkon shield and three other intrauterine devices.

A detailed analysis was undertaken of reports of possible pelvic infection in relation to the use of four commonly fitted intrauterine contraceptive devices during 1971 to 1978 in the United Kingdom. The four devices were the Dalkon shield, Lippes loops 3C and 2D, and the Gravigard (copper 7), and data used were those collected systematically through the UK intrauterine device research network. Prospective reports that the Dalkon shield was uniquely related to high levels of infection when compared with other intrauterine devices were not substantiated in this prospective study among 13 349 users. Though some factors such as social class and previous experience of abortion appeared to influence the rate of infection, the type of intrauterine device being worn did not appear to be a significant factor. Various methods of analysis were used including life table, regression, and discriminant analysis, using information relating to the type of intrauterine device worn, the characteristics of the user, the fitting centre, and the pattern of diagnosis and treatment of reported or suspected pelvic infection. The results of this study suggest that fears that the Dalkon shield may be associated with a higher incidence of pelvic infection than other intrauterine devices may have been unjustified.     

Copper concentration in women endometrium and in peripheral blood after prolonged use of intrauterine devices (author's transl)]

66 women were examined to determine the copper concentration in their serum and endometrium after prolonged use of an IUD (Lippes Loop, Hall Ring, Birnberg, Saf-T-Coil, Tatum, and Copper 7). A control of 16 nonusers was included. The level of copper was found by atomic absorption spectrophotometry. In the control group, the copper concentration in the serum was a mean of 100 gamma/100 cc of serum and in the endometrial tissue, a mean of 251 gamma/100 gm/wet tissue. In women using IUDs with no copper, the concentration in the serum was in the normal range, but in endometrial tissue it was between 457-586 gamma/100 gm. Similar findings came with the examination of women using IUDs containing copper. The high concentration of copper in inflamed endometrial tissue led to the hypothesis that such a condition, ith accompanying hyperenemia and hyperkinesia of the uterus and tubes are the principle factors for the contraceptive action of IUDs.     

Continuous intrauterine copper contraception for 3 years: comparison of replacement at 2 years with continuation of use.

A total of 1245 women had a copper 7 intrauterine contraceptive device (IUD) inserted in 1971-3 were followed up for three years (22 761-5 women months of use). After 24 months 483 women elected to continue with the same copper 7 (continuation group), and 183 had their copper 7 replaced with a new one (replacement group). The subsequent pregnancy and expulsion rates were both significantly lower in the replacement group. The higher pregnancy rate among the women who continued to use their copper 7 device for a third year suggests that although the copper is still there, it is not available for contraceptive action. Replacing the device at 24 months did not seem to cause again the problems that usually occur in the first six months of IUD use.     

Effect of IUDs on uterine cyclic AMP rabbits.

IUDs were inserted into the uteri of 15 New Zealand White rabbits in order to observe the effect of IUDs on uterine cyclic AMP. Rabbits received either a plastic IUD, a plastic-copper IUD, or were untreated. After 1, 2, or 3 months, the uteri were removed and analyzed. In 3 animals, IUDs were removed after 2 months and uteri excised 1 month later. Cyclic AMP was measured in neutralized, acid-extracted supernatants by the radioimmunoassay procedure of Steiner et al. Cyclic AMP was significantly lower (p less than .04) in the uteri containing plastic or plastic-copper IUDs by 1 month and remained depressed for up to 3 months. Cyclic AMP levels returned to control values in animals in which the plastic IUD was removed at 2 months, but remained depressed after removal of the plastic-copper IUD. The delayed effect of Copper-containing IUDs on the return of fertility in the rabbit needs further study.     

Contraceptive efficacy of a novel intrauterine device (IUD) in white-tailed deer

Overabundant white-tailed deer (Odocoileus virginianus) pose risks to property, health, and safety of human beings. Public concerns about lethal management can impair efforts to address these issues, particularly in urban settings. Several techniques developed for reducing reproductive output of deer have limited utility because they require repeated dosing to achieve permanent effect and face uncertain regulatory approval for use beyond experimentation. From 10 August 2006 through 30 December 2007, we evaluated the contraceptive efficacy of copper-containing intrauterine devices (IUDs) implanted trans-cervically in white-tailed deer at the E.S. George Reserve in Pinckney, Michigan. Intrauterine devices were implanted before (n = 9) and shortly after (n = 10) the breeding season. Post-breeding season IUD treatment was in conjunction with a 5 cm³ dose of 5 mg/ml prostaglandin F_2α (PGF_2α), delivered subcutaneously. Intrauterine devices reduced pregnancy rates when administered prior to breeding (P < 0.001) and prevented pregnancy for up to 2 years (the duration of the study). Two of 8 does that received IUDs prior to the breeding season and survived to the end of the study became pregnant (due to loss of the implant) during the second year while all (n = 16) does without implants conceived. Cervical changes associated with early pregnancy made trans-cervical implantation after the breeding season challenging, and resulted in improperly placed IUDs in 2 treated does. The apparent expulsion of IUDs by pregnant does that received the combined treatment after breeding suggests IUD treatment should be limited to the pre-breeding season. Intrauterine devices show potential as a tool for small-scale deer population management via non-steroidal reproductive inhibition.     

Evaluation of intra-uterine contraception in selected mission hospitals in India

The follow-up records of the 4067 women accepting Lippes loops (27.5 and 30 mm) during 1967-1968 in 15 randomly selected member mission hospitals of the Family Planning Project of the Christian Medical Association of India were studied. 97.7% of the insertions were not postpartum. Median age was 29.8. The difference between the mean number of living children, 3.7, and the mean parity, 4.9, suggests that a relatively high rate of infant and child mortality is characteristic of IUD acceptors. Analysis of the responses of 1656 acceptors to 1 query showed attitude toward the loop was favorable by both husband and wife in 77.3% of these cases and by either husband or wife in 90.5% of these cases. Expulsions, removals, and pregnancies were unaffected in any significant way by age. Expulsion, removal, and pregnancy rates were higher, but nonsignificantly so, for the 27.5 mm than for the 30 mm loop. The 27.5 mm loop was associated with a significantly higher proportion (p less than .05) of prolonged and heavy bleeding than was the 30 mm loop. The average number of women months of use was 6.7 (very low in a follow-up study of 24 months) and more or less unrelated to age. Most removals were due to bleeding, symptoms associated with bleeding, or desire for planned pregnancy. Removal rate was more or less uniform for all parities. With increase in the duration of use up to 18 months the complaint rate appeared to decrease, but after 18 months it appeared to increase again suggesting that IUDs cause irritation of the endometrium after long periods of use. Women less than age 25 had a significantly greater (p less than .01) percentage of reinsertion than did women age 25 or greater. The cumulative net termination rate after 24 months was 53.9 (plus or minus 1.4) per 100 first insertions, a rate comparing well with similar Indian figures. Pregnancy rate was 2 per 100 first insertions. Of the 2 devices the 30 mm loop seems the more effective and ideally suited for fertility control.     

Pelvic inflammatory disease and the intrauterine device: findings in a large cohort study.

The incidence of pelvic inflammatory disease was investigated among parous women taking part in the Oxford-Family Planning Association contraceptive study. Hospital admission rates for "acute definite" disease were 1.51 per 1000 woman-years among those currently using an intrauterine device (IUD) and 0.14 per 1000 woman-years among those using other methods of birth control (age-standardised relative risk 10.5 to 1 with 95% confidence limits of 5.4 to 1 and 32 to 1). There was little evidence of an increased risk of such disease in ex-users of an IUD. Hospital admission for "chronic definite" disease, on the other hand, was commoner in ex-users of an IUD than in current users. Acute definite disease occurred somewhat more frequently during the early months of use of an IUD than during the later months. While the rate of such disease was increased in users of each type of device, the highest rate (8.1 per 1000 woman-years) was observed in users of the Dalkon shield. This rate, however, was based on only three affected women.     

Contraceptive choice in an urban clinic in Nigeria

Contraceptive choice in the 1st 1075 acceptors at an urban clinic in Lagos, Nigeria is studied using clinical notes of all patients who attended the clinic between September 1, 1980 and August 31, 1983. Details of previous and current contraception, age, parity and level of education are analyzed. The IUD was the most popular choice followed by the injectable contraceptive and the pill. Interval tubal ligation was chosen by some patients. Acceptors of injectables were older women of high parity and lower educational standard while pill acceptors were of lower parity and higher educational level. The IUD was acceptable to all ages and parities except those with only 1 child or none. Loss to follow-up and the wish to plan another pregnancy were the commonest reasons for discontinuing contraception. Medical reasons for discontinuing the IUD were pain, menstrual disorder, accidental pregnancy and expulsion/perforation; for discontinuing injectables the reasons were menstrual disorder, accidental pregnancy and raised blood pressure. Of acceptors of the 3 main methods, former pill and IUD users were more likely to choose the same method again. A strategy should be devised to encourage patients of lower parities and age to use contraceptives, while sterilization in patients of parity 3 and above should be even more actively advocated. Greater effort should be made to support patients through the 1st 6 months after starting any method as this is the time when a large number of discontinuations occur.     

Cytologic atypias in the uterine fluid of intrauterine contraceptive device users

A peculiar cell pattern, characterized as an atypical glandular cell cluster (AGCC), was found in the uterine fluid from women using intrauterine contraceptive devices (IUDs). This atypia can mimic adenocarcinoma. Since the atypical cells were present in much higher frequency in the uterine fluid than in the cervical mucus, it is suggested that they originated in the endometrium.     

Incidence of actinomycetes infection in women using intrauterine contraceptive devices

Pancervicovaginal smears taken from 350 women using an intrauterine contraceptive device (IUD) were screened for the presence of actinomycetes organisms. Of the 12 cases in which actinomycetes-like organisms were seen in Papanicolaou-stained smears, the presence of actinomycetes organisms was confirmed by immunofluorescence in 10 cases. The prevalence of actinomycetes infection was thus 2.8% (10 of 350 cases) in the IUD users. Eight (4.3%) of 173 symptomatic subjects had actinomycetes infections. Two of the positive cases were asymptomatic. Eight of the ten patients with confirmed actinomycetes infection were using the Cu T device while two were wearing the Lippes Loop IUD. Seven of the ten patients had been using an IUD for more than two years. The time of insertion of the IUD (postpuerperal, postmenstrual or after medical termination of pregnancy) did not show any correlation with the presence of actinomycetes infection. Actinomyces israelii was responsible for the infection in eight cases while Arachnia propionica was seen in two cases. The organisms could not be grown in culture.     

Effect of an intrauterine contraceptive on the state of fertilized ova in rats

47 pubescent rats were inserted with IUDs and then impregnated. Ova were removed at 2, 3, 4, 5, and 6 days after impregnation and examined microscopically. The IUD failed to interrupt the processes of fertilization and of cleavage of the ova during their passage along the oviduct or the rate of passage. When a blastocyst entered the uterine cornu with an IUD, degenerative changes appeared leading to its death be fore the development of decidual transformations in the endometrial stroma.     

Fertility control using intrauterine devices: an alternative for population control in wild horses

The purpose of this study was to develop a contraceptive method for feral horses. The feral horse population has increased significantly in recent years despite attempts to control numbers. As in most wild animal population control programs, contraceptive methods must be easy to apply, cause minimal disruption to the social structure and be fully reversible. In the present study, we tested the effectiveness of an intrauterine device (IUD) for fertility control in mares. Six mares were fitted with a silastic O-ring-shaped IUD on July 1 of Year 1. The IUD-treated mares were turned out with 12 nontreated mares and a fertile stallion in a large pasture until October 20 (112 d). None of the IUD-treated mares and all the nontreated mares became pregnant. The IUD-treated mares were maintained separately from the stallion during the winter. Following removal of the IUD on April 27 of Year 2, the mares were again introduced to the pasture with the stallion together with 6 nontreated mares. For the 6 mares previously treated with an IUD, the mean interval from introduction to the stallion to conception was 17.5 +/- 5 d or 1.3 cycles per pregnancy, and all mares produced a normal foal at term. Subsequently, 19 recorded mare breeding seasons resulted in 18 foals. Uterine cytology and histopathology indicate that the IUD causes mild chronic endometritis without permanent changes in the endometrium. We conclude that based on our observations, the O-ring-shaped IUD is an effective, safe and practical contraceptive method for mares.     

Copper levels in cervical mucus of women with copper-bearing and noncopper-bearing intrauterine devices

The copper content of individual cervical mucus samples from 50 women using conventional plastic intrauterine devices (IUDs) and from 50 women using copper-bearing IUDs containing 200 sq. mm copper wire were determined. Both groups of women showed the same pattern of copper levels as normal controls with the lowerst level of copper at ovulation. The women using the copper-bearing IUDs showed a significantly higher copper content in all phases of the cycle. Prolonged use of the copper IUD (7 weeks - 2 years) was associated with a drop in copper levels of the cervical mucus to approximately the levels in women wearing a plastic IUD. It is concluded that changes in cervical mucus copper content are due to local effects of the devices on the reproductive tract.