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.     

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.     

Laparoscopic removal of an intraperitoneal translocated intrauterine contraceptive device.

The use of an intrauterine contraceptive device (IUD) is often accompanied by various complications, the perforation of the uterus constituting the most dangerous. Here we report the case of a patient who complained of abdominal pains. She had had an IUD inserted 15 months previously. Three months later, as she could no longer see the IUD strings at the external os of the cervix, she underwent pelvic ultrasonography, which did not show the IUD in the uterine cavity. A diagnosis of expulsion of the IUD was made. A few months later, the patient accidentally became pregnant, and decided to have an abortion. From that time on, she started to complain of the above-mentioned symptoms. She had an abdominal X-ray which revealed the IUD in the abdominal cavity. She then underwent a laparoscopic removal of the translocated IUD.     

Laparoscopic removal of an intraperitoneal translocated intrauterine contraceptive device

The use of an intrauterine contraceptive device (IUD) is often accompanied by various complications, the perforation of the uterus constituting the most dangerous. Here we report the case of a patient who complained of abdominal pains. She had had an IUD inserted 15 months previously. Three months later, as she could no longer see the IUD strings at the external os of the cervix, she underwent pelvic ultrasonography, which did not show the IUD in the uterine cavity. A diagnosis of expulsion of the IUD was made. A few months later, the patient accidentally became pregnant, and decided to have an abortion. From that time on, she started to complain of the above-mentioned symptoms. She had an abdominal X-ray which revealed the IUD in the abdominal cavity. She then underwent a laparoscopic removal of the translocated IUD.     

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.     

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.     

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.     

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.     

带钩软体Cu140宫内节育器的研制和试用

带钩软体Ｃｕ１４０ＩＵＤ的设计构思为：１．带钩的ＩＵＤ可固定在宫底肌层内；２ＩＵＤ体部柔软，能适应不同大小形态的宫腔和收缩时变形；３．铜套面积１４０ｍｍ２在环的体部分布合理，铜面积减少可获得同样满意的避孕效果。放置３９４例经一年随访按生命表法统计一年净累计带器妊娠率１．０３％，因症取出率１．０４％，脱落率３．３６％，副反应小。脱落与ＩＵＤ的质量和放置技术有关。未掌握放置技术时脱落率达１０．６９％，正确放置到位者脱落率低。提高ＩＵＤ质量和放置技术，钩铜１４０将成为一种理想的新颖ＩＵＤ。     

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.     

Uterine perforation by intrauterine contraceptive devices: diagnosis and treatment. Report of a case

The reported incidence of IUD perforation ranges from .05/1000-8.7/1000 insertions and probably occurs at the time of insertion. Perforation is more frequent in cases of extreme antiflexion or retroflexion of the cervical canal and is more likely to occur in the presence of a tight cervical os. In diagnosis it is necessary to distin guish between unnoticed expulsion, ascent of the tail into the cavity, and perforation. Pregnancy may exist in any of these conditions. Biman ual palpation may allow detection of the ectopic IUD. Exploration of the cavity with a uterine sound or electrical amplification is the next step. If the device is still undetected, radiography with a uterine sound in place following the instillation of radioopaque dyes, or following the insertion of a 2nd device, is recommended. Removal of the device may be done by colpotomy, laparotomy, or laparoscopy and may be accompanied by abortion or sterilization. A case report of a 30-year-old nulligravida inserted with a Lippes loop who had a subsequent pregnancy is reported. At the time of therapeutic abortion the IUD was absent from the uterine cavity. X-rays revealed the loop superior to the uterine corpus. Under general anesthesia a laparoscopy was performed and the IUD located lying on the fundus with the nylon tail buried in the myometrium.     

Giant chorioangioma

This paper presents three case reports of women whose gynecologic difficulties centered around the unsuspected presence of an IUD. A 42-year-old black woman complained of menorrhagia of 1-year duration following IUD insertion at the local Planned Parenthood Clinic. She also had fibroid tumors of 10-years duration. Examination revealed no loop thread. A uterine sound detected an IUD in place. X-ray showed both a plastic and a metallic IUD in the uterus. Under general anesthesia a Saf-T-coil and Majzlin spring were removed. Her menarrhagia continued and back pain developed. X-ray showed another IUD present. A Lippes loop, size D, was removed and symptoms subsided. Review of her history revealed that she had returned to the Planned Parenthood clinic on 2 occasions where it was assumed the previously inserted IUD had been expelled and without x-ray confirmation another and different device was inserted. A 35-year-old woman, para 1-0- 3-1, complained of infertility of 18 months. She had become pregnant 5 years previously while using a Birnberg bow. After abortion she had used oral contraceptives until 18 months previously. Hysterosalpingogram revealed a Birnberg bow in the uterus. After removal, pregnancy promptly followed. It is believed the Birnberg loop had not been removed at the time of abortion or had been replaced while the patient was under general anesthesia without informing her. A 26-year-old woman complained of infertility for 8-9 months. An abortion had been performed 4 years previously. Later she had used an IUD and then foam contraceptives. A metallic IUD in the uterine cavity was shown by hysterosalpingography, A Hall-Stone ring was deeply imbedded in the uterine wall and removed with difficulty. Her physician stated he had inserted a Hall-Stone ring after the abortion 4 years previously and later was unable to confirm its presence with a uterine probe. He therefore inserted another similar device. No x-rays were taken. He removed 1 device later. It is thought a communication gap may accur between the patient and the physician after an IUD is inserted during general anesthesia or while the patient has amnesia from analgesics. The hysician may assume an IUD has been expelled when no thread is visible at the cervix. Insertion of a probe into the uterus is an unreliable method of detecting an IUD. X-ray confirmation is needed. A hysterogram may be required for exact localization.     

宫形球囊和宫内节育器预防宫腔镜下子宫中隔切除术后宫腔粘连的比较

目的：探讨宫形球囊和宫内节育器（IUD）对预防宫腔镜下子宫中隔切除术（TCRS）术后宫腔粘连的临床效果。方法：收集2016年2月-2017年12月于首都医科大学附属北京妇产医院妇科微创中心行TCRS的65例患者的临床资料进行回顾性分析,A组（n=30）术后放置宫形球囊并给予人工周期治疗,B组（n=35）术后放置宫形IUD并给予人工周期治疗。术后3个月行宫腔镜检查,B组患者同时取出IUD。并记录患者月经情况、异常子宫出血情况、腰腹部不适情况。结果：2组均未发现宫腔粘连。术后3个月内A组患者未发生腰酸腹痛、异常子宫出血情况;B组患者发生IUD嵌顿2例（5.71%）,发生腰酸腹痛6例（17.14%）,子宫异常出血10例（28.57%）,取出IUD后症状均缓解。2组腰酸腹痛和子宫异常出血情况差异均有统计学意义（P=0.027;P=0.001）。结论:宫形球囊和IUD预防TCRS术后宫腔粘连的效果基本相同,但宫形球囊放置时间短、不良反应少、取出方便而更具优势。     

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.     

Ultrasonic observation on early pregnancy in patients using IUD]

The paper is a report of ultrasonic examinations of IUD positions in women who became pregnant with IUD in situ. 61 pregnant women aged 23 to 41 wearing stainless steel single ring IUD were examined between 1983 and 1985. The duration between the IUD insertion and pregnancy of these women ranged from one month to 5 years with 67.2% under 1 year. This indicated that the first year after IUD insertion is a critical period for method failure. Extra care should be taken in the follow-up of insertion. Among the cases studied, the IUD position of 42 women was below the embryo in the uterine cavity, including some around the cervix. The position change of IUD apparently lost its contraceptive effect. The declined position of IUD in the uterus could be associated with the skill of inserter, and the compatibility of the shape and the size of IUD with the uterine cavity. It was suggested that both the length and width of uterine cavity should be measured before the insertion, and IUD's of all sizes should be made available in the clinics where the insertions are conducted. IUD different shapes should also be kept too fit those women with irregularly shaped uteri.     

Factors affecting intrauterine contraceptive device performance: I. Endometrial cavity length

The relationship of endometrial cavity length to intrauterine contraceptive device (IUD) performance was evaluated in 319 patients wearing three types of devices. The rate of events, defined as pregnancy, expulsion, or medical removal, increased significantly when the length of the IUD was equal to, exceeded, or was shorter by two or more centimeters than the length of the endometrial cavity. Total uterine length was found to be a less accurate prognostic indicator of IUD performance than endometrial cavity length alone.     

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.     

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.     

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.     

在剖腹产时用缝合固定法放置宫内节育器的临床报告

利用剖腹产时子宫腔充分暴露这一的特定条件,本院对218例剖腹产妇女,在剖腹产同时,用铬制肠将宫内节育器固定在子宫后壁上。214例带器者作了产后42天、3个月和6个月的随访,相应的累积脱落率分别为0.46%、2%和2.3%,4例脱落均发生在子宫口开大的病例中。8例带器妊娠。6个月的继续存放率达91.77%。所有随访者无严重合并症和明显的副作用,恶露6～75天,平均32.8天,但均无月经血量过多。说明剖腹产时用缝合固定法放置节育器为一安全、有效和及时的方法。但存在带器妊娠率略高的问题有待进一步研究。