Elton Kessel

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

OBJECTIVEnTo 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.nnnDATA IDENTIFICATIONnAll 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).nnnSTUDY SELECTIONnOnly 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.nnnRESULTSnThe 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.nnnCONCLUSIONSnThis 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.

Potential demand for voluntary female sterilization in the 1980s: the compelling need for a nonsurgical method.

n The authors estimate the potential world demand for voluntary sterilization on the basis of U.S. data which shows that 31.3% of U.S. married women of reproductive age are sterilized. If sterilization were equally available elsewhere, they estimate that approximately 180 million procedures would be required during the 1980s, or a five-fold increase over the number now being performed. Of presently available methods colpotomy, culdoscopy, the tantalum clip, and hysteroscopy are not satisfactory. In the authors view, minilaparotomy is the safest procedure, especially when performed by less specialized junior physicians and in rural areas. The most promising new methods use chemicals instilled into the fallopian tubes. Quinacrine pellets inserted through an IUD inserter have an estimated lifetime failure rate of 3/100 women. The authors consider this a safe approach costing about 1/2 as much as surgical sterilization. The quinacrine method has the potential to meet estimated developing country needs and also to be widely used in developed countries. They urge priority for further research on this method.n

Sterilization needs in the 1990s: the case for quinacrine nonsurgical female sterilization.

Much evidence suggests that demand for sterilization is a function of supply of surgical sterilization services in less-developed countries. If such services were greatly expanded, the number of procedures performed would grow dramatically. While the prevalence of sterilization is estimated to increase from 23.5% to 28.8% of married women of reproductive age in the 1990s, there will actually be 106,432,000 more couples of reproductive age at the end of this decade than at its beginning who use either no method or a far less effective method with much lower continuation rates than sterilization--nearly a 20% increase. To achieve a mean sterilization prevalence of 47% of married women of reproductive age in the less-developed world, as now seen in the Republic of Korea and Puerto Rico, the number of sterilizations would need to be more than double the current projection for the 1990s: 328,429,000 rather than 159,000,000. The quinacrine pellet method for nonsurgical female sterilization offers hope that this enormous shortfall in sterilization services can be overcome in this decade.

Quinacrine nonsurgical female sterilization: a reassessment of safety and efficacy

The relative safety and efficacy of surgical methods and nonsurgical quinacrine pellet methods of female sterilization have been reassessed. Although experience with the quinacrine pellet method is limited it appears to have advantages for both developing and developed countries. Its failure rate at 3 years after 3 transcervical insertions of 250 mg of quinacrine in pellets is approximately 5% compared with 0.5% for surgical sterilization. But the method can be delivered in any clinical setting capable of performing an intrauterine device insertion. The absence of increased risk of ectopic pregnancy among quinacrine pellet method failures has been noted. It is estimated that ectopic pregnancy accounts for one third of surgical sterilization mortality in a country like Bangladesh whereas it accounts for <5% of sterilization mortality in the United States. The need for multiple insertions of quinacrine pellets for the achievement of acceptable efficacy has not been demonstrated clinically. A single insertion trial is a high priority for fertility research. (authors)

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.

International Maternity Care Monitoring: Results of a Pretest

This report gives the preliminary results of a pretest cosponsored by the International Fertility Research Program and the International Federation of Gynaecology and Obstetrics. It includes data on 33 116 deliveries in 20 maternity centers in Latin America, Europe, Africa and Asia. The findings are organized around four themes: (a) family formation and reproductive history, (b) family health, (c) management of this delivery and (d) desired family size and family planning practices.

Estrogen-progesterone withdrawal bleeding in diagnosis of early pregnancy.

This study was designed to evaluate the efficacy of an exogenous estrogen‐progesterone preparation for inducing “withdrawal bleeding” in non‐pregnant women, a procedure used in some areas for the diagnosis of early pregnancy. Three hundred patients not desiring to be pregnant and with no signs of pregnancy other than menses delayed by 14 days or less were randomly assigned to treatment or control groups. The treatment group received an intramuscular injection of 50 mg progesterone and 3 mg oestradiol benzoate in oil. The control group received no hormonal injection. There was no significant difference between the two groups in the incidence of uterine bleeding within 7 days. Thus, the hormonal preparation was ineffective in inducing “withdrawal bleeding”. Its use as a diagnostic test for pregnancy is not recommended.

Is wide availability of abortion essential to national population growth control programs? Experiences of 116 countries

No nation wanting to reduce its growth rate to less than or equal to 1% can expect to do so without the widespread use of abortion. This study, based on the experience of 116 of the worlds largest countries, supports the contention that abortion is essential to any national population growth control effort. Existing circumstances in developed countries have facilitated reduction of growth rates to less than 1%, with abortion rates generally in the range of 200 to 500 per 1000 live births. However, developing countries are faced with a different and more difficult set of circumstances that require even greater reliance on abortion. These obstacles include a young population with resultant rapidly growing numbers of young fertile women, poor contraceptive use-effectiveness, low prevalence of contraception, and poor or nonexistent systems for providing contraceptives. By virtue of their profession, physicians play a critical role in family planning and carry a special responsibility in ensuring that abortion services are available to all women who need them.

Professional responsibility in maternity care: Proceedings of a workshop in Rio de Janeiro, October 17–18, 1988

Maternity care is the most critical constituent of Primary Health Care on two counts: it acts as the major predictor of morbidity and mortality; and pregnancy and birth present the greatest opportunity for health education, even with intergenerational effect. It is clear that maternity care needs exist overwhelmingly in the Third World, where 90% of births will take place in the balance of this century. These very countries rely heavily on government health bureaucracies to provide such care, but as a general rule, those often large systems lack the motivation to do so. The central objective of this workshop was to explore the role of health practitioners in the field in creating an environment conducive to delivery of quality maternity care within existing resource constraints. The distinguishing characteristic of any professional is a sense of membership in a group offering similar services that meet a standard of performance based on consensus in each local area. The motivation for adherence to standards lies in the valued opinion of professional peers. Development of a professional attitude is accomplished through instruction, and especially in-service training, during which an opportunity is afforded to establish a reputation among one’s peers. The essence of this

Follow-up study of oral contraceptive acceptors in Howrah District in India.

In the Howrah District in India, three clinics—one in each of the urban, slum, and rural areas of the city—were initiated by the Humanity Association of Howrah in November of 1968 to supply oral contraceptives (OCs) to women from 15 to 45 years of age. The project was discontinued in September, 1972. Of the 1700 patients still active when the project ended, 1 527 were contacted for the follow‐up survey. Findings indicate that most women in this district were satisfied with OCs and would continue to use them if they were available. In corroboration of this, it was found that 43% of the women had used OCs obtained from other sources after the project was discontinued. While 35.5% of the women who used no contraceptive method after the project ended reported becoming pregnant or suspected that they were pregnant at the time of the interview, only 4.2% of those who reported using some form of contraception reported pregnancy or suspected pregnancy. The demographic impact of the project will be evaluated on the basis of data to be obtained in a subsequent survey of the same communities.