Stephen D. Mumford

THE INTRAUTERINE DEVICE AND PELVIC INFLAMMATORY DISEASE: THE WOMEN'S HEALTH STUDY REANALYZED

The Womens Health Study (WHS) was a large, widely accepted and influential case-control study of the relationship between the use of intrauterine contraceptive devices (IUDs) and pelvic inflammatory disease (PID). The data were collected at 16 hospitals in 9 cities across the U.S.A. from October 1976 through August 1978. The first paper on this research was published in 1981 and concluded that IUDs increase the risk of PID. The report cited an estimated RR (relative risk) of PID for current IUD users vs nonIUD users of 1.6 with a 95% confidence interval of (1.4, 1.9). However, careful examination of the report reveals that the data support conclusions antithetical to those at which the author arrived. When the second report on the WHS was published in 1983, it was anticipated that many of the shortcomings of the first report would be corrected, but they were not. In 1983 we undertook a complete reanalysis of the same WHS data using more appropriate criteria and the results were compared to the first two published reports. The reanalysis revealed an RR of 1.02 (0.86, 1.21) for current IUD users compared to noncontraceptors. The conclusion of the WHS should have been that IUDs do not increase the risk of PID.

A comparison of different laparoscopic sterilization occlusion techniques in 24,439 procedures

This investigation assessed the safety and efficacy of five laparoscopic tubal occlusion techniques for female sterilization: electrocoagulation, the tubal ring via conventional and open laparoscopy, the prototype spring-loaded clip, and the Rocket clip. The 24,439 cases make up a data set collected by collaborating staffs at 64 institutions in 27 countries. The five techniques were compared with respect to six commonly evaluated parameters. Rates of surgical difficulties ranged from 2.4% to 12.5% (5.1% overall); rates of surgical complications, from 0.7% to 2.7% (1.7% overall); and rates of technical failures, from 0.6% to 1.0% (0.8% overall). Twelve-month life-table pregnancy rates were less than one per 100 women years. Prospective data on six menstrual parameters revealed that the menstrual cycles of the majority of women were unchanged after sterilization; for those who reported a change, approximately half experienced a change in one direction and half in the other direction. For example, one half reported an increase in the amount of menstrual flow, and one half reported a decrease in the amount of flow. The reported incidence of subsequent pelvic operations was less than 1% at each long-term follow-up. These data indicate that laparoscopic sterilization is safe and effective and that none of the studied techniques has a distinct advantage.

Menstrual pattern changes following laparoscopic sterilization with different occlusion techniques: A review of 10,004 cases

A comparison is made of menstrual pattern changes reported by 10,004 women undergoing interval and postabortion sterilization by the laparoscopic occlusive techniques of unipolar electrocoagulation, the tubal ring, the prototype spring-loaded clip, and the Rocket clip. Controlling for prior contraceptive use, the menstrual patterns in these women sterilized by the four techniques were compared with respect to six parameters: cycle regularity, cycle length, menstrual flow duration, amount of flow, dysmenorrhea, and intermenstrual bleeding. The majority of women reported no menstrual changes subsequent to sterilization. When changes were experienced, they occurred in equal proportions in opposite directions. Depending on the parameter, from 15% to 79% of the menstrual pattern changes seen within 6 months after sterilization in women who were using oral contraceptives or intrauterine contraceptive devices at the time of sterilization could be attributed to the discontinuation of those methods of contraception. There were no significant differences between the several occlusion technique groups with respect to the proportion of women who reported changes in their menstrual patterns after sterilization.

Male attitudes towards family planning in Khartoum, Sudan

Knowledge of, attitudes toward, and use of contraception were investigated in a 1982 survey of 250 men living in Khartoum, Sudan. Interviews were conducted at mosques, marketplaces, a government office building, and a textile factory. 75% of respondents were ages 21-40. 92% of respondents expressed the belief that Khartoum is overcrowded, although this was attributed by 57% to rural-urban migration. Despite the fact that 85-95% linked overpopulation with social problems such as inflation, food shortages, and unemployment, 72% expressed a desire for 5 or more children. Only 30% of the men interviewed supported the concept of family size limitation, largely for economic reasons. The majority of those opposing family size limitation cited religious reasons. Attitudes toward child spacing were more favorable, with 80% indicating approval 59% of the men with wives at risk of pregnancy reported that they were using some form of contraception, but only 21% were using an effective method. Two-thirds of respondents reported that they do not discuss contraception with their spouse. 60% identified either the mass media or friends and relatives as their source of family planning information. Although 64% indicated an awarencess of where to obtain family planning services, only 2.8% had ever received services from a family planning clinic. 79% voiced an interest in more information on family planning, and 59% with wives of reproductive age wanted to use family planning services. Most respondents desired more information on sexual sterilization and, although surgical contraception is not available in Sudan, 10% said they would consider this method when they attained their desired family size. The belief that family size should be limited increased dramatically with education, from 9% among those with no formal schooling to 45% among men with 13 or more years of school. Men under 40 years of age had more favorable attitudes toward family planning than older men. Surprisingly, men interviewed at mosques had the most favorable attitudes whereas government employees were the most conservative. Overall, these fndings suggest that the present family planning clinic system in Sudan may be falling short of meeting the demand for information services.

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.

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

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.

Technical failures in tubal ring sterilization: Incidence, perceived reasons, outcome, and risk factors

Six centers participated in comparative studies of female sterilization conducted by the international Fertility Research Program. The incidence of technical failures (or failed attempts) was compared between patients sterilized with the tubal ring and those sterilized with other tubal occlusion techniques. The tubal ring was associated with a higher failure rate than electrocoagulation, the Rocket clip, or the modified Pomeroy technique. Of 1,035 tubal ring sterilizations, there were 38 technical failures. Reasons given by the operators for the failures, by frequency of occurrence, were surgical complications, conditions preexisting in the patients, and problems with the instruments. Most of these failures were remedied by changing to other techniques. In two patients, the procedure was completed by changing the approach from laparoscopy to laparotomy. In five others, sterilization was not completed. Case-control analysis was performed and three risk factors were delineated: obesity, prior use of an intrauterine contraceptive device and previous abdominal operations.

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)

Vasectomy: Efficacy of Placing the Cut Vas in Different Fascial Planes*

The inadvertent failure to achieve sterility in 8 to 40 vasectomy procedures afforded a rare opportunity to study the efficacy of placing the two cut ends of the vasa in different fascial planes. Interposition of the fascia was performed in 12 patients and was not performed in 28 others, with no significant difference in the failure rates of the two groups. Histologic examination of vasal tissue from one patient in each group revealed that a sperm granuloma can erode fascia and the wall of the vas.