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.     

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.     

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.     

Postpartum and postabortal insertion of intrauterine contraceptive devices.

One hundred forty-four patients are studied over an 18 month period. Postpartum and postabortal insertions of intrauterine contraceptive devices using the Lippes Loop and the Dalkon Shield are compared. The age, parity, previous methods of contraception, and marital status of the study group indicated a poorly motivated patient population. Although accidental pregnancy rates and expulsion rates are higher, the technique is considered worth-while in the population studied. Future research should be directed toward improved devices in order to decrease side effects and to increase appeal of the technique to those who will benefit most.     

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.     

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.     

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.     

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.     

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.     

A comparative study of the effectiveness of the Lippes Loop, the Copper-T-200, and the Nova-T intrauterine contraceptive devices in Lagos, Nigeria

Two hundred five women attending the Family Planning Clinic of the Department of Community Health were admitted into a nonrandomised study to compare the effectiveness of the Copper-T-200, Nova-T, and Lippes Loop intrauterine devices. Members of the study group of women were found to be older than their European counter-parts and also tended to have a higher parity (81.0% of the total group having more than three children). The expulsion rates and removal rates for bleeding and pain for Copper-T-200 and Nova-T users were respectively 6.5 and 3.8 and 5.0 and 1.5. These results were significantly lower than the rates for the Lippes Loop users which were 14.7 and 6.7, respectively. The continuation rates were higher for the Copper-T-200 (88.2) and the Nova-T (91.3) than for the Lippes Loop (75.5). These findings were essentially similar to those of other worldwide studies.     

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.     

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.     

A study of delta intrauterine devices in Ankara, Turkey

Delta devices, modifications of standard Lippes Loop D and TCu 220C IUDs, were designed for postpartum insertion. A study of the Delta T and the Delta Loop was conducted at Hacettepe University School of Medicine in Ankara, Turkey. The IUDs were randomly allocated to 246 immediately postpartum women (less than 10 min postplacenta). Twelve-month expulsion rates were low for both devices; 3.7 for Delta Loop users and 7.6 for Delta T users.     

Abscessing salpingo-oophoritis caused by Actinomyces in a woman using an IUD

Recent studies have demonstrated that there is a connection between actinomycetic genital swelling and longterm use of the Lippes Loop. After a literature review, a case of actinomycetic abscessing salpingo-ovaritis in a woman who had worn the same Lippes Loop for 12 years is reported. It is concluded that Actinomyces must be always considered a potential etiological agent in all cases where genital swelling is found in patients fitted with such loops. (author's modified)     

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.     

Large bowel perforation by intrauterine contraceptive devices.

Two cases of large bowel perforation by intrauterine contraceptive devices are presented. Both the Lippes LoopTM and Dalkon ShieldTM have the potential of evoking omental adhesions and causing bowel perforation. These serious complications justify the immediate removal of a contraceptive device from the peritoneal cavity by either laparoscopy or laparatomy.     

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.     

Dr. Lippes and his loop. Four decades in perspective.

Forty years ago Jack Lippes, M.D., hand made the first models of his "Double-S" intrauterine contraceptive device (IUD). Subsequently the Lippes Loop became the standard against which other IUDs came to be compared. Though millions of loops have been used, they have mostly been supplanted by copper-bearing, T-shaped devices. Due to the implant nature of IUDs, on occasion a patient presents well into menopause still bearing a Lippes Loop or other early IUD. Although there is no established causal evidence linking IUDs retained after menopause and cancer or other significant problems, such retention does confuse the diagnosis of post-menopausal bleeding and makes difficult such procedures as endometrial biopsy and ultrasonic endometrial evaluation. When contraception is no longer an issue, it is prudent to remove IUDs since they may cloud future necessary evaluations.     

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.     

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.