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.     

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.     

A comparative study of the effectiveness of the Lippes Loop, the Copper-T-200, and the Nova-T intrauterine contraceptive devices in Lagos, Nigeria

Two hundred five women attending the Family Planning Clinic of the Department of Community Health were admitted into a nonrandomised study to compare the effectiveness of the Copper-T-200, Nova-T, and Lippes Loop intrauterine devices. Members of the study group of women were found to be older than their European counter-parts and also tended to have a higher parity (81.0% of the total group having more than three children). The expulsion rates and removal rates for bleeding and pain for Copper-T-200 and Nova-T users were respectively 6.5 and 3.8 and 5.0 and 1.5. These results were significantly lower than the rates for the Lippes Loop users which were 14.7 and 6.7, respectively. The continuation rates were higher for the Copper-T-200 (88.2) and the Nova-T (91.3) than for the Lippes Loop (75.5). These findings were essentially similar to those of other worldwide studies.     

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.     

Quantitative transcervical uterine cultures in asymptomatic women using an intrauterine contraceptive device

Quantitative transcervical uterine cultures were obtained in 100 asymptomatic women using intrauterine contraceptive devices for varying periods. Twenty women using barrier forms of contraception served as controls. Cultures were obtained safely and satisfactorily without trauma to either the endocervix or endometrium. It was found that normal uterine sterility was significantly compromised in women using an intrauterine contraceptive device. The number of intrauterine organisms cultured was associated with neither the type of intrauterine contraceptive device (Cu-7, Lippes Loop, Saf-T-Coil) nor the duration of use (less than one month to greater than five years).     

A comparison of the Lippes Loop and two copper-bearing intrauterine devices

A review of published studies and studies conducted through the International Fertility Research Program on the Lippes Loop D, TCu and Cu-7 shows that none of the three devices evaluated is better with respect to continuation and all types of event rates. There is a trend toward lower expulsion rates for the copper-bearing IUDs, but other factors such as the cost of devices and the need for replacement must be considered in determining the merits of the devices for large-scale programs.     

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.     

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.     

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 3-year evaluation of the TCu380Ag and the Cu-7

The TCu380Ag and the Cu-7 intrauterine devices (IUDs) were evaluated in a randomized comparative clinical trial. A total of 198 women who had not recently been pregnant entered the trial in Manila, Philippines and were followed-up through 3 years postinsertion. The 36-month follow-up rates were impressively high at 80.3 for TCu 380A users and 76.7 for users of the Cu-7. Although the two IUDs demonstrated statistically similar termination rates, the findings suggest a higher efficacy for the TCu380Ag. Gross cumulative life-table pregnancy rates were 0.0 and 4.5 for the TCu380Ag and Cu-7, respectively, at 3 years. Overall 3-year continuation rates were 74.3 and 64.9 for users of the respective devices.     

Immediate postpartum insertion of a sutured Lippes Loop

Use of the sutured Lippes Loop for immediate postpartum insertion was evaluated in 100 volunteers at the Kasr-el-Aini Hospital in Cairo. The intrauterine devices were inserted manually immediately after delivery of the placenta. There was an expulsion rate of 1.2 per 100 women at three months, one case of infection requiring treatment and one removal because of bleeding. One woman became pregnant and expelled the Loop. The two major problems associated with the use of an intrauterine device, high expulsion rate and perforation, were overcome by hand insertion of the Loop.     

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.     

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.     

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.     

An association between the Dalkon Shield and complicated pregnancies among women hospitalized for intrauterine contraceptive device--related disorders.

A nationwide mail survey of virtually all physicians likely to be involved with intrauterine contraception resulted in 3,502 unduplicated reports of intrauterine contraceptive device (IUD)--related hospitalizations during the first six months of 1973. Dalkon Shield use was significantly more frequent among women hospitalized for a complicated pregnancy than those hospitalized for a non-pregnancy-related disorder. Although the observed association was not substantially altered by stratifications of the mail survey reports by the patient's age, race, or geographical region, the association did not apply to those women whose IUD's were explicitly reported to be of the nulliparous size. Interviews conducted with a probability sample of physicians who had not responded to the survey confirmed that the association between the Dalkon Shield and complicated pregnancy also existed in their experience. An association between the standard Dalkon Shield and complicated pregnancies might reflect an increased rate of pregnancy with this device, an increased rate of complications occurring after zygotic implantation, or perhaps both. Whatever the explanation, the observed association is sufficiently widespread to require further investigations.     

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.     

Postpartum and postabortion use of the TCu-220C and Lippes Loop: A comparative study

The postinsertion experience of 274 women with the TCu-220C and 522 women with the Lippes Loop in a university hospital family planning program in Bogotá, Colombia, has been studied by a life-table method. Pregnancy and continuation rates are similar for both devices. Although the expulsion rate of the TCu-220C is significantly lower than that of the Loop up to 12 months, higher removal rates for the TCu-220C account for the similarity in overall continuation.     

The end of IUD marketing in the United States: what does it mean for American women?

The decision to suspend sale of the copper 7 and Copper T 200 IUDs and the Lippes loop in the US will eventually affect most of the US women using them. Although the Progestasert, a progesterone-containing device manufactured by the Alza Corp, will still be available, the Progestasert accounted for only 3% of IUD sales in 1984 compared to 66% for the 2 copper devices and 31% for the Lippes loops. Ortho Pharmaceutical and Searle, the manufacturers of the discontinued devices, were motivated largely by their difficulty in obtaining liability insurance and their desire to avoid excessive financial risk resulting from lawsuits, especially in view of the large judgements against the makers of the Dalkon Shield. Ortho was also influenced by declining sales of the Lippes loop. The 198 National Survey of Family Growth (NSFG) estimated that in that year some 2,152,900 American women used IUDs, representing 7.3% of the 29.5 million contraceptive users in the US and 10.8% of users of reversible methods. 30% of IUD users had stopped oral contraceptive (OC) use on the advice of their physicians. Slightly over 1/2 of IUD users were 30 years old or over. 63% were currently married. 12.8% had no children. 21.2% had already had an unwanted pregnancy and 54.7% said they wanted no more children. OCs were contraindicated for 56.4% of the IUD users because of age, smoking, or medical conditions. Most IUD users thus belonged to the group for whom the method is most suitable: older married women who have already had children. Lippes loops are inert and users can continue indefinitely with the method, but copper IUDs require periodic replacement, usually after 3 years. Some physicians and family planning programs have advised women using Lippes loops or copper IUDs to have them removed at once. It is difficult to predict what method will be utilized in the future by current IUD users; the near total disappearance of a contraceptive method is unprecedented. 3 estimates of the percentage of current IUD users who will have unwanted pregnancies in the next year under different assumptions about contraceptive choices were compared to the proportion risking unwanted pregnancies assuming continued availability of their IUDs: 4.2%. If all IUD users chose the next most effective method available to them--sterilization for those not wanting more children, OCs for those with no contraindications who might want more children, and condoms for the rest--the pregnancy rate would be 2.4%. The other estimates were 9.2% assuming less resort to sterilization and more to diaphragms and spermicides, and 13.0% assuming that 15% of the women would use no other contraceptive. Current users of IUDs are faced with a difficult choice about future method use, and need clear and reliable information from their physicians and the media on the risks and advantages of other methods.     

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.     

Pelvic adhesions in intrauterine device users

A thorough inspection of the pelvis for adhesions was made at the time of laparoscopic tubal sterilization in 2131 patients. Contraceptive use was then compared in women with adhesions (cases) and those without adhesions (controls). Current or previous intrauterine device (IUD) use was not associated with a statistically significant increased incidence of adhesions (odds ratio = 0.98, 95% confidence limits 0.58-1.64). This risk was reduced to 0.62 for current IUD users. The IUDs removed at the time of laparoscopy included the Lippes Loop, Copper 7, and the Saf-T-Coil. These findings support the use of the IUD in the appropriate patient by demonstrating no increased risk for the development of adhesions in multiparous IUD users.