Intrauterine contraception in multiparas with the Dalkon Shield

The large Dalkon Shield was used for intrauterine contraception in a series of 2,370 multiparous women over a 24 month study period. The device is well tolerated and has low expulsion and medical removal rates. The pregnancy rate was 1.3 per cent at 12 months and increased to 1.5 per cent at 18 months; it remained constant thereafter. The multiparous model of the Dalkon Shield is an effective and extremely acceptable means of intrauterine contraception.     

Intrauterine contraception in nulliparas with the Dalkon shield

The small Dalkon Shield was used for intrauterine contraception in a series of 1,697 nulliparous women over a 2 year study period. Of these women 80 per cent were nulligravid. The device is well tolerated and has low expulsion and medical removal rates. The pregnancy rate of 1.2 per cent remained constant after 12 months of use. The nulliparous model Dalkon Shield is an effective and extremely acceptable means of intrauterine contraception in the nulliparous female.     

Was the Dalkon Shield a safe and effective intrauterine device? The conflict between case-control and clinical trial study findings.

OBJECTIVE: To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials. DATA IDENTIFICATION: All published reports on the Dalkon Shield were identified through MEDLARS system (United States National Library of Medicine) searches and by cross checking all references in these reports. The same approach was used to identify all case-control and cohort studies of the purported relationship between intrauterine devices (IUDs) and pelvic inflammatory disease (PID). STUDY SELECTION: Only studies of interval patients that included 50 or more women and 6 or more months of follow up that computed standard IUD event rates (rates of pregnancy and expulsion and removal for pain and bleeding) were selected for this study. All case-control and cohort studies identified were included except two case-control studies that included women with sterile chronic salpingitis. RESULTS: The 16 case-control and 2 cohort studies found or suggested that the Dalkon Shield increased the risk of PID. The 71 clinical trials of the Dalkon Shield show that when this device is inserted by an experienced clinician it is a safe and effective contraceptive method, comparable with other IUDs used at the time. There was no evidence of an increased risk of PID found in these clinical trials. CONCLUSIONS: This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.     

A Prospective Randomized Comparative Trial of the Gravigard, Latex Leaf, Dalkon Shield and Multiload Cu 250 IUDs

This prospective randomized trial in 843 patients compared the effectiveness and complications of 4 intrauterine devices. At 24 months the gross accidental pregnancy rate for the Dalkon Shield was higher than for the 7Cu200 (p less than 0.05) and the ML Cu250 (p less than 0.05). The 7Cu200 had a higher expulsion rate than the Dalkon Shield (p less than 0.01), Latex Leaf (p less than 0.001) and ML Cu250 (p less than 0.001). Use-related terminations were higher for the 7Cu200 than for the ML Cu250 (p less than 0.01). Removal for pelvic inflammatory disease was necessary in 8 women (2 for the Latex Leaf and 3 each for the 7Cu200 and Dalkon Shield). There was no significant difference in termination rates between the ML Cu250 and Latex Leaf but subsequently the Leaf has given problems with removal particularly in women who have defaulted follow-up for several years.     

Long-term use of intrauterine contraceptive devices in a private practice

Clinical experience with 1504 insertions of intrauterine contraceptive devices (Lippes Loop, Dalkon Shield, Cu-7) in a private practice is evaluated. Expulsion rates and removal rates for bleeding and/or pain and personal reasons differed for the three types of devices. Pregnancy rates associated with use of the three types of devices were similar. Pelvic inflammatory disease rates were similar for Dalkon Shield and Cu-7 users but were higher than the rate for Lippes Loop users. Use of intrauterine contraceptive devices did not appear to compromise future fertility based on the experience of women who had the devices removed. The study shows that long-term IUD use (up to 5 years) provides a safe and effective method of contraception.     

Efficacy of the Dalkon Shield in Contraception

Summary: The Dalkon Shield was inserted in 180 multiparous women. Altogether 162 women-years were available for study. In contrast to earlier studies, it was found that the pregnancy rate of 3.7 per 100 women-years was higher than that of the Lippes Loop and the Double Coil while the expulsion and medical removal rates were similar. The Dalkon Shield did not appear to have any significant advantage over the Lippes Loop.     

Unilateral tuboovarian abscess: A distinct entity

In a 30 month interval at the Los Angeles County-University of Southern California Medical Center, 85 patients had tuboovarian abscesses removed that were unrelated to complications of pregnancy. Thirty-seven patients (44 per cent) of the 85 had unilateral abscesses. Twenty patients (54 per cent) of the 37 patients with a unilateral abscess were using an intrauterine contraceptive device (IUD). In 13 (65 per cent) of the 20 women using an IUD, the foreign body was a Dalkon Shield. Unilateral pelvic abscesses can occur with or without the presence of an IUD.     

Sexually transmitted diseases and the risk of tubal pregnancy

Women who were hospitalized for tubal pregnancy in five hospitals in King County, Washington, between 1975 and 1979 were interviewed regarding a prior history of gonorrhea, genital herpes, genital warts and trichomoniasis. Their responses were compared to those of women who delivered a live-born child during the same period. Multiple logistic regression was used to control for the effects of race, gravidity, smoking, Dalkon Shield use, douching, number of sexual partners and history of additional sexually transmitted diseases. The risk of tubal pregnancy in women who reported a history of gonorrhea, relative to that in other women, was 5.1. As compared to controls, women with tubal pregnancy more often reported a history of genital herpes and a history of trichomoniasis.     

Pelvic pain associated with an unsuspected intraomental intrauterine device placed 30 years earlier: a case report

BACKGROUND: Recent-onset chronic pelvic pain thought to originate from an intraomental Dalkon Shield intrauterine device (IUD) (A. H. Robbins, Inc., Richmond, Virginia) that had remained asymptomatic for over 30 years is unusual. Case reports and patient series suggest that intraomental IUDs remain asymptomatic for long periods of time and are usually not associated with chronic pelvic pain. CASE: A 49-year-old woman with an unrecollected history of Dalkon Shield placement 30 years earlier was evaluated after 6 months of pelvic pain. A negative workup and failure of conservative management prompted an abdominal hysterectomy with bilateral salpingooophorectomy, which failed to relieve the symptoms. Revaluation identified a mobile, intraabdominal Dalkon Shield. Real-time x-ray fluoroscopy and reverse Trendelenburg positioning were used to laparoscopically retrieve the IUD from the patient's benign-appearing omentum. The pelvic pain remained resolved for over 1 year after removal of the IUD. CONCLUSION: An intraomental IUD that remained asymptomatic for 30 years was the most likely source of chronic pelvic pain in this perimenopausal patient. Increased intraabdominal fat deposition associated with the perimenopause may have contributed to this patient's change in clinical status.     

Early postpartum insertion of an intrauterine device

Over a 2-year period in London, Dalkon Shield IUDs were inserted in 162 patients during the postpartum period, usually on the 5th day. To insert the IUD, a sterile bivalve speculum was inserted in the vagina and the cervix swabbed with .5% aqueous chlorhexidine. The anterior lip of the cervix was grasped with a sponge holding forceps and the depth of the uterine cavity was assessed with uterine sound. A Dalkon Shield was inserted at the fundus of the uterine cavity using a standard type carrier. The device was correctly placed in 86.4% of the 162 patients at the 6-week postnatal examination. 22 patients expelled the device completely or partially, 3 patients were diagnosed as being pregnant with the device in situ, and 1 patient was pregnant due to expulsion. At the first menstrual period, 32 women noted heavier bleeding and 2 patients complained of increased discomfort; however, there was no undue discomfort at subsequent menses. This pilot study assessed the practicability of establishing an IUD during a woman's stay on the postnatal ward. however, the rate with Lippes Loop and Saf-T-Coil was unacceptably high. The Dalkon Shield is no longer in use, but this type of IUD with its low expulsion characteristics may successfully be applied to early puerperium. A clinical trial of the Multi-load 250, similar to the Dalkon Shield, is commencing in the near future.     

Epidemiology of pelvic inflammatory disease in parous women with special reference to intrauterine device use

Up to the end of 1989, 206 parous women in the Oxford Family Planning Association contraceptive study had been referred to hospital with a first episode of pelvic inflammatory disease. Of these, 65 suffered from definite disease described as acute, 81 from definite disease not described as acute and 60 from 'other disease'. Considering all forms of disease together, referral was less common in those aged 25-29 and in those aged 45 or more than in those aged 30-44. Referral was more common in those of low social class, in those who smoked and in those who married young. All these factors were taken into account in analyses considering the effects of contraceptive methods. In these analyses, women currently using the contraceptive pill, the diaphragm, the sheath, female sterilization or an intrauterine device (IUCD) were compared with those currently using other methods or no method of contraception. IUCD ex-users were, however, placed in a separate category, irrespective of their current method of contraception. The relative risks obtained in these analyses, with 95% CI, were as follows: contraceptive pill 0.5 (0.2-0.9), diaphragm 0.6 (0.3-1.2), sheath 1.2 (0.6-2.4), female sterilization 0.7 (0.3-1.5), non-medicated IUCD 3.3 (2.3-5.0), medicated IUCD 1.8 (0.8-4.0), IUCD ex-users 1.3 (0.7-2.3). These data suggest that oral contraceptives, the diaphragm and female sterilization protect against pelvic inflammatory disease and that IUCDs increase the risk. Medicated devices, however, appear to carry only about half the risk of non-medicated devices, and the elevation of risks in IUCD ex-users appears to be small. Special analyses examined the risk associated with use of a Dalkon Shield. Among women currently using an IUCD (of any kind), those who had used a Dalkon Shield (at any time) had nearly five times as great a risk of hospital referral for pelvic inflammatory disease as those who had never used a Dalkon Shield (relative risk 4.7, 95% CI 2.1-9.0).     

Postmenopausal bleeding secondary to a Dalkon Shield retained for 33 years: a case report

BACKGROUND: Although the Dalkon Shield intrauterine device (IUD) was removed from the market in the early 1970s, some women currently in their late 50s and early 60s may still have the Shield in their uteri. An IUD retained for a long time is very rare but can be a cause of postmenopausal bleeding. CASE: A 58-year-old, postmenopausal woman presented with vaginal bleeding and spotting of 8 months' duration. Careful investigation of her history revealed that she had undergone IUD placement 33 years earlier. She was not sure about the type and whether the IUD was removed or expelled subsequently. There was no string visualized in the vagina. An office endometrial biopsy revealed Actinomyces and an associated polymorphonuclear cell exudate. A retained Dalkon Shield was diagnosed and removed hysteroscopically. CONCLUSION: Providers should include "retained IUD" in the differential diagnosis of postmenopausal bleeding. In addition to endometrial biopsy, hysteroscopic evaluation of the uterine cavity is a valuable tool in the diagnosis and treatment of such bleeding. A retained IUD may cause postmenopausal bleeding secondary to chronic endometritis or migration into the uterine wall. Hysteroscopic dislodgement and removal may be challenging due to chronic embedding within the uterine wall.     

Unilateral tubo-ovarian abscess and intrauterine contraceptive devices.

The association of unilateral tubo-ovarian abscess and the presence or use of an intrauterine contraceptive device (IUD) appears to be a definite clinical entity. Four cases of unilateral tubo-ovarian abscess in patients using the IUD are presented. Three patients had a Dalkon Shield IUD and one had a Lippes Loop. Two patients had unilateral salpingo-oophorectomy while the other 2 had total abdominal hysterectomy and bilateral salpingo-oophorectomy. The differential diagnosis, possible etiology, route and mode of infection, and management are discussed.     

Earth, motherhood, and the intrauterine device.

Commentary is provided on the relationship between the use of the IUD and infertility from the development of pelvic inflammatory disease (PID), preventive behavior for those using an IUD, and recent reviews of the Dalkon Shield. Among IUD users who have never been pregnant, tubal infertility is increased 2-6 fold (200-600%), and most with tubal infertility will never bear a child. Tubal infertility develops in 11% of patients with PID, but most IUD users do not develop PID. The physicians responsibility is 1) to give formal and extensive recognition to the connection that IUD uses causes PID; 2) to inform patients of the potential risk of PID and sterility; 3) to develop proper patient selection for an IUD; 4) to identify and treat PID, which may appear initially as abnormal uterine bleeding and mild pain; 5) to recognize that the IUD facilitates the development of PID in patients with Neisseria gonorrhoea and Chlamydia trachomatis even though 25-50% of IUD patients have neither infection; 6) to recognize that the risk of PID is increased in the first 4-6 months of insertion and to research alternatives, e.g. the use of available antibiotics to treat selected patients to reduce infections, and 7) to realize that most PID occurs 6 months after insertion and indolent abscess formation is expected to increase among longterm copper IUD users. The reviews referred to in this article are ones claiming unfair removal of the Dalkon Shield in 1974 based on flawed study design and analysis of case control and the understanding that the Dalkon Shield is no worse than other IUDs and not related to PID. The author points out that neither review mentions that primary tubal infertility increased 6-fold among Dalkon Shield users who had used only 1 IUD in their life, and that infertility increased 3-fold among IUD users compared with the non-IUD using population. The case control studies provide enough evidence for the cause and effect relationship. The Kronmal et al. article did not present convincing new evidence even with reanalysis of the original Lee et al. data. In the Memford and Kessel review case controlled studies are excluded from consideration. Most PID goes unrecognized. The rate of PID cannot be determined. The goal is to protect patients and reduce population. The enemy is not physicians with opposing positions on this issue.     

Postpartum and postabortal insertion of intrauterine contraceptive devices.

One hundred forty-four patients are studied over an 18 month period. Postpartum and postabortal insertions of intrauterine contraceptive devices using the Lippes Loop and the Dalkon Shield are compared. The age, parity, previous methods of contraception, and marital status of the study group indicated a poorly motivated patient population. Although accidental pregnancy rates and expulsion rates are higher, the technique is considered worth-while in the population studied. Future research should be directed toward improved devices in order to decrease side effects and to increase appeal of the technique to those who will benefit most.     

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.     

Ovarian pregnancy with intrauterine device in situ

Introduction Since some reports have already suggested a higher rate of ovarian pregnancies in women using intrauterine device and some have not, an additional case report may be of interest for the literature purposes.Case report In this case report we present an ovarian pregnancy in a patient with an intrauterine device in situ.     

Hospitalizations among black women using contraceptives

We analyzed hospitalizations among 26,507 young black women who attended a large metropolitan family planning clinic between 1968 and 1976. Age-adjusted hospitalization rates were compared for women using oral contraceptives, intrauterine contraceptive devices, and depot medroxyprogesterone acetate. Overall, intrauterine contraceptive device and depot medroxyprogesterone acetate users were hospitalized at about the same rate, while women using oral contraceptives were hospitalized 30% less often. The oral contraceptive users were not hospitalized at a higher rate for circulatory disease. Compared to women using intrauterine contraceptive devices, users of oral contraceptives and depot medroxyprogesterone acetate were less likely to be hospitalized for benign breast disease (rate ratios = 0.5 and 0.2, respectively, with 95% confidence limits of 0.3 to 0.7 and 0.1 to 0.5) and for pelvic inflammatory disease. Women were four times as likely to be using depot medroxyprogesterone acetate when they were hospitalized with carcinoma in situ of the cervix, but depot medroxyprogesterone acetate users with at least 3 years of use were less likely to be hospitalized for carcinoma in situ than comparable groups of oral contraceptive and intrauterine contraceptive device users.     

For and against the IUD in diabetics

Studies of the relative efficacy of IUD use in diabetic women are few and are all retrospective. A study by Wiese in which the experience of 118 insulin-treated diabetic women using the inert IUD Antigone was compared with that of 914 nondiabetic women using the same device showed a cumulative pregnancy rate of 3.5/100 woman years at 2 years for the diabetic women, compared to 5.2 among the nondiabetic. Wiese concluded that the use of the Antigone is as satisfactory in diabetic women as in nondiabetic and is suitable for all diabetic women except those with vascular complications and those with 2-3 children among whom sterilization is preferrable. A study by Gosden et al. published in 1982 gave a pregnancy rate of 36.6/100 woman years among insulin dependent IUD users compared to 4 among nondiabetic women. 11 of the 30 diabetic women became pregnant, of whom 5 used Gravigardes, 5 used Saf-T-Coils, and 1 used a Dalkon Shield. The authors concluded that IUD use is inappropriate for diabetic women. A study by Skouby showed no differences at 12 months in rates of accidental pregnancy, expulsion, or infection among 105 insulin dependent diabetic women and 119 nondiabetic women using Copper T 200s. New results published by Lawless and Vessey on 13 diabetic women in the Oxford Family Planning Association study gave a pregnancy rate of 2/100 woman years, comparable to that found in nondiabetic women. Kurz reported no pregnancies after a total of 136 woman years of IUD use by 4 insulin dependent diabetic women, and Buchsenschutz reported a pregnancy rate of 1.7% among 56 diabetic women. In view of methodological criticisms of the Gosden study and confirmation by the remaining studies of the efficacy of IUDs in diabetic women, it is concluded that IUD use is appropriate for such patients provided that the disease is properly treated and constant close surveillance is provided.     

Incidence of infections associated with the intrauterine contraceptive device in an isolated community.

In an attempt to estimate more precisely the frequency of infections associated with the intrauterine contraceptive device (IUD), all gynecologic morbidity resulting from infection and occurring during a two-year period in an isolated community was reviewed. Ten septic abortions occurred, and all but one were associated with IUD use. In 26 gynecologic inpatients (41 per cent of all admissions for acute pelvic inflammatory disease), pelvic infection was associated with IUD use. In contradistinction to the septic abortion data, implicating only the Dalkon Shield, the gynecologic infections were associated with various types of devices.