True and false regarding the risk of infection in contraception

Contraception is certainly less responsible for the recrudescence of venereal diseases than are other social factors, such as the increased sexual freedom among adolescents. The condom and all topical spermicidal agents provide a valuable barrier against the risk of venereal infections. Genital infection, especially moniliasis, is more frequent among oral contraception (OC) users than among nonusers. The exact etiology of this phenomenon is not known; it is probable that OC exercises an influence on vaginal pH, which varies between 3-4.5 in OC users, and between 5.5-6.5 among nonusers. Risk of infection in IUD users is increased by prior genital and pelvic infections, which remain an absolute contraindication to IUD use. Copper IUDs have the lowest rate of infection, and the Dalkon Shield has the highest; rate of infection is 2 times higher in wearers for over 5 years. Since pelvic infection can have a negative influence on tubal permeability, IUD use is not recommended for nulliparous women.     

Selecting patients and inserting the Progestasert

In this article, the author discusses what is presently known about the Progestasert IUD, a progesterone delivery system. Progestasert delivers progesterone on a daily basis and in continuous fashion into the endometric cavity. It has no systemic effects, although there is increasing evidence of its effects on hypermenorrhea na dysmenorrhea. Evidence suggests that Progestasert may avoid one of the major problems associated with former IUDs (particularly the Dalkon Shield): salpingitis. More than 10 years ago, physicians observed during sterilization procedures that a large number of women wearing inert or copper IUDs had salpingitis. Data from 27 Progestasert users show that none had salpingitis at the time of sterilization. Progestasert may also carry a lower risk of pelvic inflammatory disease associated with IUD use. A study in Helsinki found only 3 cases of pelvic inflammatory disease in 20,000 women years use of progestin (Levonorgestrel) impregnated IUDs, compared to the expected incidence (according to the Center for Disease Control) of 1/100 woman years. Additionally, in a study involving over 300 patients, the use of prophylactic antibiotics after insertion twice a day for 5 days and inserting Progestasert during the time ovulation rather at the time of menstruation produced no cases of the pelvic inflammatory conditions usually associated with the insertion procedure. Concerning the risks of ectopic pregnancy, evidence suggests that progestasert tends towards more ectopics when compared to the copper IUDs, but towards less when compared to not using any contraception. Although Progestasert is not contraindicated in nulliparous patients, caution should be taken with such patients.     

Cupremy values in women bearing IUD medicated with various Copper quantities (authors transl)

Long experience with the IUD shows it to be a safe, effective method, without influence on hormonal equilibrium, easy to insert, and completely reversible. IUDs containing copper are seen as a significant step forward in method efficiency, but there has been concern over whether the addition of metal has some systemic effect, especially since the quantities of copper in current models may be double those in the 1st models. A number of studies are cited which indicate no association of copper IUDs with levels of copper in patients using them. The present study at the Family Planning Center of Rome University involved 150 women using No-Gravid, Gravigard and Copper T IUDs. blood samples, drawn before and after insertion (3-13 months) showed no pathological relation between hematic rate of copper and insertion of the copper IUD.     

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.     

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.     

Will progesterone save the IUD?

In 1971 we began studying pelvic inflammatory disease (PID) in IUD users by examining fallopian tube specimens obtained after elective female sterilization. We studied four groups: 175 nonhormonal-IUD users, 22 Progestasert users, 1,500 non-IUD users and 100 non-IUD users who had had IUDs in the past. We found histologically detectable salpingitis in 49% of the nonhormonal-IUD users, none of whom had symptoms of PID. Culture of 100 specimens from these nonhormonal-IUD specimens proved to be sterile. Viewing the inflammation as predisposing the tissues to bacterial infection would help explain the higher frequency of PID among IUD users than among nonusers. All the Progestasert users lacked histologically detectable salpingitis; the difference was statistically significant (p < 10(-6). This finding suggests that women using progesterone-releasing IUDs have a lower risk of developing PID than do users of other kinds of IUDs.     

Experience with intrauterine contraception. Survey of 600 IUD users at the S. Anna University Hospital in Rome

A group of 600 IUD users aged 26 to 35 were studied. 440 women were married; 434 were pluriparae and 166 nulliparae. 24 (5.5%) had undergone cesarean section, and 266 (44.3%) had had induced abortion. 23% of single women had opted for voluntary termination of pregnancy, while 72% had previous experience with IUDs or oral contraceptives. 273 (45.5%) relied on behavioral methods of contraception, 33 (5.5%) used the diaphragm, 279 (46.5%) used pills, 124 (20.6%) used condoms (50.6%) used ML-250 IUD, 144 (24%) used Progestasert, 87 (14.5%) used Gravigard, 42 (7%) used Minigravigard, 18 (3%) used Nova-T, 4 (0.6%) used Anticon, and 1 (0.1%) relied on No-Gravid. The IUD was removed prematurely in 119 cases, 339 were removed at the end of usefulness, dropout occurred in 51 cases, and expulsions in 14 cases. IUD failure was registered in 103 cases corresponding to 21.8% of the total. Bleeding caused 31 instances, 22 were due to dislocation, there were 15 intra -uterine pregnancies, 14 expulsions, 11 cases of pelvic pain, 4 cases of pelvic inflammatory disease, 3 cases of extrauterine pregnancy, and 3 other failures of IUDs. 31% of failures occurred in the 31-35 age group, and 40% of nulliparous women had IUD experience, but only 22.8% had a positive experience. 83.9% of those who used progesterone-containing pills had success with them, only 16.1% failed. Pluriparae over 30 used Progestasert most successfully. Nulliparous women did not represent the ideal candidates for IUD use, previous positive experience was an important element of success, while less important factors were age and abortion history.     

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.     

The rise and fall and rise of the IUD

The history of IUD use, from the ring used by Richter in 1909 to the present, is described as 3 surges of popularity. The 1st IUDs were catgut rings with or without tails, and the Pust stainless and Ota rings. A worldwide pandemic or gonorrhea, and the population policies before and during World War II ended the popularity of IUDs temporarily. In 1959 IUDs re-emerged, proliferating to over 100 models, most of which were barium impregnated polyethylene, such as the Lippes Loop. Other models that had lesser success were several stainless springs that predisposed to embedding and perforations and the Majzlin spring with a multifilament tail that caused pelvic infection. The Dalkon shield, also bearing a multifilament nylon tail, brought the second wave of IUDs to a rapid end in the 1980s, because its multifilament tail increased risk of infection, midtrimester amnionitis, ectopic pregnancy, tubo-ovarian abscess, infertility, hysterectomy, and death. Robbins Company eventually recalled the Dalkon shield, and later became bankrupt from lawsuits. Other IUD makers, such as Searle, manufacturer of the well-tolerated and popular Copper-7, and Ortho, were subject to litigation, and removed their IUDs from the market, even though their products were still approved by the FDA. During this interim, several new copper bearing IUDs were being developed and tested. The TCU380A, like a Tatum-T with twice as much copper, developed and brought through FDA approval by the Population Council, was licensed and marketed by GynoPharma Corporation as the ParaGard. ParaGard is the most effective IUD to date for U.S. women, with pregnancy rates 1/100 after 2 years of use. Simultaneously, the Alza Corporation released Progestasert, a progesterone-releasing IUD. Progestasert has a 1.3% failure rate, and must be replaced yearly, but is the IUD of choice and therapeutic for women with dysmenorrhea or heavy menstrual flow. Progestasert appears to lessen tubal inflammation, but consequently permits more ectopic pregnancies than other IUDs.     

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.     

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.     

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.     

Insertion forces with intrauterine devices: implications for uterine perforation

The force required to insert a Copper 7, Multiload Copper or Nova T IUD was measured in 197 successful and 25 unsuccessful insertion attempts. These forces were compared with the forces required to perforate freshly obtained uterine specimens with a metal uterine sound and Dalkon shield device, as well as with the clinically tested devices. The mean insertion forces for the Copper 7, Nova T and Multiload Copper devices were 1.502 N, 2.134 N and 4.041 N respectively, while the mean insertion pressures (N/mm2) were 0.203, 0.209 and 0.122 respectively. The mean in vitro fundal perforation forces with metal sounds was 20.7 N and with the Dalkon shield 31.6 N. The Copper 7, Multiload Copper and Nova T IUDs achieved mean in vitro forces of 5.75 N, 9.2 and 8.1 N respectively, without causing perforation. Primary uterine perforation at the time of insertion of these devices appears unlikely.     

Copper IUDs (author's transl)

Following initial development of the Grafenberg ring in the 1920's, IUDs fell into disuse until the late 1950s, when plastic devices inserted using new technology began to gain worldwide acceptance. Further research indicated that copper had a significant antifertility effect which increased with increasing surface area, and several copper IUDs were developed and adapted, including the Copper T 200, the Copper T 220C, and the Copper T 380 A, probably the most effective yet. The Gravigard and Multiload are 2 other copper devices developed according to somewhat different principles. Copper devices are widely used not so much because of their great effectiveness as because of their suitability for nulliparous patients and their ease of insertion, which minimizes risk of uterine perforation. Records of 2584 women using Copper IUDs for 7190 women-years and 956 women using devices without copper for 6059 women-years suggest that the copper devices were associated with greater effectiveness and fewer removals for complications. Research suggests that the advantages of copper IUDs become more significant with increased duration of use. Contraindications to copper devices include allergy to copper and hepatolenticular degeneration. No carcinogenic or teratogenic effect of copper devices has been found, but further studies are needed to rule out other undesirable effects. Significant modifications of copper devices in recent years have been developed to increase their effectiveness, prolong their duration of usefulness, facilitate insertion and permit insertion during abortion or delivery. The upper limit of the surface area of copper associated with increased effectiveness appears to be between 200-300 sq mm, and at some point increases in copper exposure may provoke expulsion of the IUD. The duration of fertility inhibition of copper IUDs is usually estimated at 2-3 years, but recent research indicates that it may be 6-8 years, and some devices may retain copper surface for as long as 20 years. Shorter and smaller versions of standard copper IUDs have been tested as they permit easier insertion, but high rates of pregnancy, expulsion, and removal have prevented their wider use. The discovery that the size of the uterine cavity is more important than its length has prompted the development of some promising uterine measuring instruments. Attempts to develop a device appropriate for postpartum use have been disappointing, and expulsion rates remain high. A few promising new forms of copper IUDs have been developed but not yet tested clinically.     

The new IUDs

This brief review mentions 3-dimensional IUDs and large surface IUDs and discusses progesterone and copper-containing IUDs. The 3-dimensional IUDs (Corolle, Basquet, and Majzlin spring) were expelled easily and were poorly tolerated. The large area Dalkon shield was difficult to insert and remove but permitted few expulsions; the failure rate of less than 1% claimed by its inventors has not been confirmed in French and British studies. IUDs with progesterone capsules or with auxiliary daily pills are on trial. Copper T and 7 shaped IUDs have proved to be more effective, seldom expelled, and rarely responsible for severe bleeding. The IUDs with 300 sq. mm copper release about 50 mcg copper /day, not enough to affect blood levels. They seem to prevent implantation by attracting leukocytes and macrophages, by modifying mucosa enzymes such as acid phosphatase, and by preventing sperm from penetrating cervical mucus.     

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.     

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.     

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.     

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.