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.     

Steroid intra-uterine contraception: progesterone-releasing devices. II. Insertion,clinical problems and contraceptive dependability

The advantages and disadvantages of the progesterone-releasing intrauterine device (IUD), Progestasert, are investigated, relying on the published literature and the authors' own experiences. Insertion of the Progestasert presents very few problems except in certain cases, particularly in nulliparous women. A complete gynecologic examination is indispensible before insertion to guarantee the absence of contraindications (e.g., pregnancy, anatomically abnormal uterus, tumors, pelvic inflammatory disease, acute cervicitis). Pain or discomfort at insertion appears infrequently, except among nulliparas. Similarly, pain after insertion is rare, but occurs most often in nulliparous women. Because of the insertion technique required for this IUD, cases of perforation of he uterus or cervix are virtually nonexistent. Expulsion of the Progestasert is very infrequent; it appears that incorrect insertion is the primary cause of expulsion. All studies verify a decrease in the expulsion rate after the 1st month of use. The incidence of pelvic inflammatory disease in Progestasert users is significantly lower than in users of other IUDs. This may be due, in part, to the shape of the device, which does not have wide surface areas and has no sharp or pointed edges which can become embedded in the endometrial wall. Additionally, the nature of the insertion device, guaranteeing lack of contact between the transverse arm of the IUD and the vagina, assures the sterility of the IUD even at the moment of introduction into the uterus, limiting the transport of bacteria into the cavity. Lack of sufficient data on ectopic pregnancies in Progestasert users impedes a complete evaluation and definition of the problem with this particular device. One of the most frequent reasons for discontinuing use of the IUD is distrubance of the menstrual cycle. Increase in menstrual blood loss, prolongation of the menstrual period, and intermenstrual bleeding are disturbances found in users of most IUDs. The Progestasert, however, appears to decrease menstrual bleeding and shorten the menstrual period in all cases. The advantages of the Progestasert are indisputable in treating dysmennorhea. All studies agree on the attributes of topical release of progesterone in treating this illness. Studies report disappearance of symptoms in 35% of dysmennorheic patients and a marked reduction of symptoms in 65%. Not enough data exist to draw any conclusions about the teratogenic action of the Progestasert. In normal pregnancies, however, natural progesterone is found in much higher levels than that released by the IUD. Theoretically, the hormone released by the IUD should not interfere with normal fetal development. The failure rate of Progestasert is equal to or lower than that of other IUDs. Overall, the Progestasert represents a remarkable improvement over conventional IUDs.     

Transmissible venereal neoplasia: A case report

The use of an intrauterine device (IUD) in 690 patients hospitalized for acute salpingitis (pelvic inflammatory disease) was compared with IUD use in a sexually active age-matched control group. Two hundred and twenty (31.9%) of the patients and 114 (16.5%) of the controls were wearing IUDs. Thus, the relative risk of developing acute salpingitis was 2 among IUD users. No significant difference was found in IUD use in the two groups between nulligravid women and women who had been pregnant. It was shown furthermore that the use of oral contraceptives decreases the risk of salpingitis by two thirds. A lower frequency of gonorrhea among PID patients who were IUD users was revealed also.     

Intrauterine devices. The optimal long-term contraceptive method?

OBJECTIVE: To review selected data on the effectiveness, safety, cost and technical ease of intrauterine device (IUD) use compared with Norplant and surgical sterilization. STUDY DESIGN: Literature review. RESULTS: IUDs are highly effective, safe and relatively inexpensive methods of contraception that may offer advantages for some women over other long-term methods, such as sterilization and Norplant. IUDs provide protection against pregnancy comparable to that provided by female sterilization, and they may be more effective than Norplant. IUDs have a long duration of effectiveness: the copper T 380A (TCu380A) is effective for at least 10 years, and the levonorgestrel (LNg) IUD appears to be effective for at least 7. Norplant is effective for only five years. Both types of IUD can disrupt menstrual bleeding patterns, although the patterns of bleeding are different. Copper IUDs often increase blood loss, whereas the LNg IUD, like Norplant, substantially reduces menstrual bleeding. The most important adverse outcome associated with IUD use is higher rates of pelvic inflammatory disease; careful attention to proper insertion techniques can reduce this risk substantially, and LNg IUDs may cause no increase in risk. IUDs, like both sterilization and Norplant, provide no protection against sexually transmitted disease. The TCu380A IUD is extremely cost-effective. There is as yet no public sector price for the LNg IUD, which has not been approved by the U.S. Food and Drug Administration and is not provided by family planning donor organizations. If it can be made available to the public sector at a price substantially less than its present market price, the LNg IUD would be a useful addition to the contraceptive armamentarium for developing countries. CONCLUSION: Providers, consumers and family planning program managers should begin to see IUDs as potential substitutes for both surgical sterilization and Norplant.     

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.     

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.     

Inserting IUDs safely

A comprehensive discussion of safe insertion of IUDs in the contemporary U.S. setting, when any IUD complication may provoke litigation, includes explanations of complications listed on package inserts, what to look for in the pelvic exam, now to handle the inserter, whether to give prophylactic antibiotics or a cervical block, follow-up management, and advice on safe sex and hygiene. The similarities and differences in listed contraindications for the ParaGard and Progestasert IUDs are analyzed. It is important to know these listed contraindications to avoid being the sole defendant in a court case. Neither explicitly rules out nulliparas, and some women who have completed childbearing may be willing to risk ectopic pregnancy. The physician must be sure to avoid any possible risks of pelvic infection, however. It is important to postpone IUD insertion if there is any suggestion of lower genital tract infection. Similarly, IUD insertion is intended to last for years, so a paracervical block is recommended if access is difficult. Tips for ensuring scrupulous asepsis are suggested. Women for whom prophylactic antibiotics are advised include diabetics, those with heart valve disease or transplants. IUD patients should be clearly identified when they call in with complaints, and seen urgently. Finally, a sexual history should be taken to avoid candidates who engage in anal sex practices.     

Copper in the menstrual and physiological cycle cervical mucus of copper IUD users (author's transl)

The article studies the concentration of copper in the cervical mucus of users and nonusers of copper IUDs. Of the 170 samples taken 90 were basal, i.e. taken from nonusers, and 80 were taken from users of No-Gravid, Dalkon Shield, Gravigard, Copper T, and Progestasert. Concentration of copper was much higher in IUD wearers than in nonwearers, even after 2 years from insertion, except in wearers of Dalkon Shield and of Progestasert. Copper concentration in wearers of Gravigard and Copper T were lower than concentrations found in wearers of No-Gravid.     

IUDs safe and effective at nine years of continuous use

The WHO Special Programme of Research, Development and Research Training in Human Reproduction has conducted long term studies on 2 copper releasing IUDs (TCu220C and TCu380A) in almost 2800 women which show that they are effective for 9 years. The pregnancy rates for TCu220C at 7 and 9 years are 4.9 and 5.4/1000 woman years respectively. Thus the annual risk of pregnancy is about 1%. The pregnancy rates for TCu380A are even lower (1.7 and 2.1 respectively), an annual rate of less than 0.5%. As a result of these studies, the US Food and Drug Administration sanctioned TCu380A use for 8 years up from 6 years. More than 80 million women worldwide, especially in developing countries (e.g., about 74 million in China), use the IUD. Researchers have analyzed data on 22,908 insertions from 12 trials to see whether IUD use is related to pelvic inflammatory disease (PID) and whether long term use causes more severe PID. They learned that the overall PID rate is 1.6/1000 woman years. The first 20 days after insertion carry a 7 times higher risk of PID, but the risk falls considerably thereafter and stays low for at least 8 years. Further, duration of IUD use does not increase the severity of PID. WHO is supporting research at 28 centers which are evaluating a new IUD which has copper sleeves hanging from a nylon suture (frameless IUD). During insertion, the clinician embeds the suture superficially into the top of the uterus so the IUD and the copper sleeves are suspended. WHO is also supporting research at up to 6 centers on 2 modified frameless IUDs designed to be inserted after delivery. The research want to determine whether the high expulsion rate of IUDs inserted during the postpartum period can be reduced.     

Intrauterine progesterone contraceptive system as an alternative in cases where conventional IUD's are unsuitable

A progesterone intrauterine device (IUD), Progestasert, was prescribed for 25 patients unable to use an ordinary non-hormonal IUD. Both the amount of menstrual bleeding and the discomfort was observed to decrease more often than increase during the period of use of the progesterone IUD. Hemoglobin, hematocrit and the serum iron levels either remained static or increased. Continuation rate was 76 per cent after one year. The authors consider Progestasert a suitable alternative to the ordinary non-hormonal IUD in women with dysmenorrhea or menorrhagia and those in whom a previous IUD had been associated with pain or increased menstruation.     

Compelling reasons for recommending IUDs to any woman of reproductive age

The intrauterine device (IUD) is a highly effective method of contraception that, as opposed to other countries around the world, is underutilized in the United States by women of all ages. Lingering concerns about the safety of IUDs are in large part responsible for their lack of adoption, but a systematic review published recently nullified some of the major safety concerns about IUD use. The author summarized the methodologically sound evidence regarding the risk of upper-genital-tract infection and infertility associated with IUD use and reported that a slightly increased risk of pelvic inflammatory disease (PID) exists only in the first month following IUD insertion; that the risk of PID in women with symptomless sexually transmitted diseases (STDs) having an IUD inserted is similar to the risk in women not having an IUD inserted; and that there appears to be no negative effect on fertility following IUD removal. In addition, Mirena provides noncontraceptive benefits, such as treatment for menorrhagia, dysmenorrhea, and anemia, and ParaGard may help protect against endometrial cancer. An IUD is also a safer alternative to sterilization for perimenopausal women seeking a long-term and also reversible method of contraception. While both IUDs are suitable for many women of all ages, there are differences in their mechanisms of action, physical characteristics, and clinical effects that make each more or less appropriate for certain women.     

In vitro sperm penetration tests and PCTs in fertile women wearing different medicated IUDs (Cu and progesterone)

In order to evaluate the sperm-cervical mucus interactions in women wearing different intrauterine devices (IUDs), a longitudinal study of over 27 months in 7 selected normally fertile couples was made. In vitro sperm penetration tests and PCTs, in the same woman, were carried out in basal conditions and after insertion of IUDs (copper IUD before and progesterone IUD after). The copper IUD induces little modification on the "in vitro" and "in vivo" sperm passage and on the characteristics of the cervical mucus. In contrast, the progesterone IUD is more effective than the copper IUD in inhibiting sperm penetration even with little modofication of the characteristics of the ovulatory cervical mucus. It appears, therefore, that the cervical mucus modifications are less relevant than the toxic effect on the spermatozoa in the mechanism of activity of progesterone IUDs.     

Intrauterine devices

The aim of this chapter is to review the worldwide use of intrauterine devices (IUDs) for contraception and the long-term contraceptive efficacy and safety of copper-bearing IUDs. The TCu380A and Multiload Cu375 have a very low failure rate (0.2-0.5%) over 10 years. The main concerns of the use of IUDs are risk of pelvic inflammatory diseases and increased menstrual blood loss and irregular bleeding. Factors associated with an increase in risk of pelvic inflammatory diseases are discussed. Preventive measures can be taken with careful screening of eligible IUD users, technical training and adequate service facilities for provision of IUDs. Levonorgestrel-releasing IUDs have the benefit of reducing menstrual blood loss in addition to high contraceptive efficacy. The copper IUD is the most effective method for emergency contraception. It can prevent over 95% of unwanted pregnancies within 5 days of unprotected intercourse.     

Intrauterine contraception

Approximately 60 million women worldwide use IUDs. Despite worldwide distribution, the total number of IUD carriers has barely increased since 1970. Due to its risks and side effects there is a retrograding tendency both in West Germany and the US. To generate positive development, 3 basic trends have emerged: 1) Restrictive usage of the pharmacologically inactive, 1st generation IUDs such as the Lippes Loop or the Saf-T-Coil, 2) the increasing usage of small plastic IUDs with bioactive alloys to decrease failure rates such as the copper (2nd generation) or hormone-releasing IUDs, and 3) improvements made by changing its design to reduce side effects without loss of contraceptive effectiveness. Almost all IUDs increase monthly blood loss by 50-100%. The risk of illness for women with IUDs is 2-3 times higher than for a woman without or with other contraceptive methods. About 20% of all expulsions occur unnoticed. There are 2 kinds of perforations: primary (iatrogenic), at time of insertion, and secondary, some time after insertion. The IUD failure rate is about 1-3 pregnancies/100 woman years. In case of pregnancy, the IUD must be removed immediately. IUD insertion requires consent of the woman and can be made to women from 16 years on, presupposing moral maturity. IUD insertion after a miscarriage or abortion does not lead to risks or complications. Due to its corrosive quality, the copper IUD can only remain inside the uterus for a limited time. IUDs could become an excellent contraceptive method if it were possible to decrease bleeding, design easily-removeable IUDs, and prolong their potential for duration in the body.     

The intrauterine device, pelvic inflammatory disease, and infertility: the confusion between hypothesis and knowledge.

An earlier editorial made many false claims against the IUD and women. In many cases, the author extrapolated experience from the Dalkon Shield to today's IUDs. He even said the modern contraception has not reduced fertility, but data from at least 7 developing countries clearly refute that statement. Moreover he claims that the most female ambition is motherhood. Thus he blamed women for high fertility rates without acknowledging that women in developing countries have little control over fertility. Husbands determine when and how often to have intercourse and whether to use contraceptives or not. Women do not always have access to contraceptives. The author boldly stated that the IUD poses a threat to future fertility because it causes pelvic infections. The real threat is intercourse by which upper genital tract infections are transmitted. It is these sexually transmitted diseases that cause pelvic infections. The studies the author quoted have been found to have considerable bias and/or methodologic flaws. Some studies used as the comparison group women using contraceptive which lower the pelvic infection risk. Contemporary studies find no increased risk of infertility in copper and hormone IUD users, but instead show increased risk for multiple sex partners. Some studies do indicate an increased risk shortly after insertion which is due to insertion instrumentation used. The author even claimed that a Swedish study concluded that IUDs promote pelvic infection in patients with gonorrhea and chlamydia. But the Swedish study found no difference in pelvic infection risk between IUD and non-IUD, nonhormonal contraceptive users. Based on hundreds of millions of woman-years of worldwide experience, WHO claims modern copper and hormone releasing IUDs, when used as directed, may be the most effective and reliable reversible contraceptive method. This editorial based on flawed conclusions and misinformation does an injustice to the IUD and to women.     

The effects of TCu-380A on cervicovaginal flora

Objective This study aims to identify the alterations in cervicovaginal flora after insertion of TCu 380A which is a popular type of copper IUD. Study design Among the women who visited the Department of Family Planning in our hospital during 1 month, 100 subjects who preferred IUDs for contraception and who had no history of local or systemic antibiotic use were considered eligible candidates. Results Anaerobic colonies, especially Gram-positive cocci and Gram-negative bacilli were isolated at significantly higher rates after the insertion of TCu-380A. Aerobic colonies were isolated relatively less. Conclusions It can be suggested that copper IUD causes the predominance of anaerobic species in the cervicovaginal flora, which is consistent with the literature. This clinically insignificant condition can be attributed to the copper content or threads of the IUDs. Yet there is no evidence that the prevalance of pelvic infections is influenced by the use of IUDs.     

Safety and efficacy of levonorgestrel implant, intrauterine device, and sterilization

OBJECTIVE: To evaluate safety and efficacy of levonorgestrel-releasing contraceptive implants (Norplant; Leiras Oy, Turku, Finland) in developing countries. METHODS: We used controlled cohort methodology. Women attending family planning clinics in eight developing countries selecting Norplant were enrolled, together with women of similar age choosing intrauterine devices (IUDs) or surgical sterilization. Participants were interviewed and examined at semi-annual visits and followed-up for 5 years regardless of change of contraceptive methods. Incidence rate ratios of health events were estimated for initial and current method use. RESULTS: Altogether, 7977 women initiated Norplant, 6625 IUD, and 1419 sterilization. The overall follow-up rate was 94.6% and 78,323 woman-years of observation were accumulated. Pregnancy rates for Norplant, copper IUDs, and sterilization each averaged less than 1 per 100 woman-years. With two exceptions, no significant excess risk of serious morbidity was detected for Norplant users compared with controls. The incidence of gallbladder disease was higher in women who initiated Norplant use than in controls (rate ratio 1.52, 95% confidence interval [CI] 1.02, 2.27), as was the incidence of hypertension and borderline hypertension in current implant users (rate ratio 1.81; CI 1.12, 2.92). Other new findings were increased risks of respiratory diseases and decreased risks of inflammatory disease of the genital tract in Norplant users compared with IUD users and sterilized women. CONCLUSION: The study confirms the safety with respect to serious disease and the high contraceptive efficacy of Norplant, copper IUDs, and sterilization.     

Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice

OBJECTIVE: To assess obstetrician-gynecologists' clinical use of the intrauterine device (IUD), their attitudes toward the IUD and how they select IUD candidates, and to test the hypotheses that limited residency training in IUDs, fear of litigation, and a belief that IUDs cause pelvic inflammatory disease decrease IUD use. METHODS: We performed a national mailed survey of 811 practicing obstetrician-gynecologists obtained from systematic sampling of ACOG membership listings to assess use of and attitudes toward the IUD. RESULTS: The survey response rate was 50%. Most respondents agreed that the copper IUD is safe (95%) and effective (98%). However, 20% of respondents had not inserted an IUD in the past year, and of those who had, most (79%) reported inserting 10 or fewer. Fear of litigation and a belief that IUDs cause pelvic inflammatory disease were associated with lower IUD use; the number of IUDs inserted during residency was not. In selecting IUD candidates, respondents were most restrictive about patient monogamy. Having less conservative criteria for selecting IUD candidates was associated with greater IUD use. Respondents with liberal criteria inserted a mean of nine IUDs in the past year, whereas those with conservative criteria inserted four. CONCLUSIONS: Because most obstetrician-gynecologists are inserting few IUDs, educational programs should target these physicians to expand their IUD use. Such programs should highlight modern IUD safety and the rarity of litigation. The number of IUDs inserted in residency may be less important than the development of less restrictive, more evidence-based criteria for selecting IUD candidates.