David Grimes, MD, FACOG, FACPM, is a leading expert on intrauterine devices (IUD). Dr. Grimes is currently Principal Investigator for a National Institutes of Health T32 training grant (Training in Epidemiology and Clinical Trials), a consortium of the University of North Carolina, Duke Clinical Research Institute, and Family Health International. He also serves as Vice President of Biomedical Affairs at Family Health International and is a Clinical Professor in the Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill.
Dr. Grimes presented a session on new uses for IUDs at the recent ACOG 56th annual clinical meeting in New Orleans. Peggy Keen, PhD, FNP, Editorial Director, Medscape Women's Health, attending this session and spoke with Dr. Grimes about the expanding indications for IUD use.
Medscape: It seems like the [intrauterine device] IUD is experiencing a resurgence -- and is now considered an acceptable method for many women who were never considered "candidates" for the method before. What's contributed to the recent resurgence?
David A. Grimes, MD: The IUD is indeed enjoying a well-deserved renaissance in the United States. Worldwide, the IUD is the most popular reversible method of contraception. However, the United States has lagged behind most industrialized nations in IUD use for decades. This problem stemmed from the confluence of bad science, bad tort law, and bad press concerning intrauterine during the 1970s and 1980s. The IUD nearly disappeared from the US market in the late 1980s as a result.
Since then, a sea change has occurred in thinking about IUDs. Better-quality research, able to avoid the flaws of earlier studies, has given the IUD a clean bill of health regarding infection. Moreover, the noncontraceptive benefits of intrauterine contraception are beginning to attract attention as well. The epidemic of lawsuits has subsided, and the media today are providing more accurate and balanced coverage of all methods of contraception.
Guidelines about appropriate candidates for IUDs were overly restrictive in the past. These obsolete recommendations reflected concerns about infection and resultant infertility. This cloud of suspicion concerning infection has now been lifted from the IUD by data from both cohort and case-control studies. A landmark case-control study from Mexico City showed that among nulligravid women, use of a copper IUD was not associated with tubal infertility; in contrast, prior exposure to Chlamydia trachomatis was associated with a significant increase in risk. Cohort studies from Norway and New Zealand have found that upon discontinuation of an IUD, women had problems with unwanted fertility, not involuntary infertility.
Medscape: Why the increased popularity among both clinicians and patients?
Dr. Grimes: The IUD is a prototype of "forgettable" contraception. Forgettable contraception (eg, IUD, implant, sterilization) is a method a woman can begin, then forget. The default option is excellent protection against pregnancy. Indeed, a conscious act is required to discontinue the protection. Stated alternatively, the IUD is simple and convenient.
Today's IUDs are so effective that one can consider them a reversible form of sterilization. The publication in 1996 of the landmark CREST study (Collaborative Review of Sterilization) of tubal sterilization from the CDC [Centers for Disease Control] was an epiphany for me. It revealed that the 10-year pregnancy rates after tubal sterilization were much higher than had been reported in earlier studies with poorer follow-up. For all methods combined, the overall 10-year failure rate was about 2%. I immediately recognized that a woman could achieve the same contraceptive effectiveness with an IUD, which obviates the inconvenience, expense, risk, and irreversibility of tubal sterilization.
Both IUDs currently available on the US market are "top tier" methods in terms of efficacy. This reflects the high inherent efficacy of the method, elimination of concerns about compliance, and high long-term continuation rates. For example, although oral contraceptives have high inherent efficacy, compliance is a common problem, and a large proportion of women quit the pill within a year of starting.
Medscape: Who can now safely use this method of birth control?
Dr. Grimes: Almost any woman interested in highly effective contraception can use an IUD. IUDs today are appropriate for women who have never been pregnant as well as for those who have had upper genital tract infection or a prior ectopic pregnancy. For example, the World Health Organization Medical Eligibility Criteria give nulliparity a category 2 rating, meaning that, in general, the benefits of IUDs for such women outweigh the potential harms. A few contraindications exist, such as an established pregnancy, undiagnosed uterine bleeding that might represent cancer, mucopurulent cervicitis, etc.
Medscape: Other than pregnancy, what other preventive aspects have been associated with use of contemporary IUDs?
Dr. Grimes: On a global basis, the most important public health benefit of IUDs may be the association with a reduced risk of endometrial cancer. My Family Health International colleague David Hubacher, PhD, first introduced me to this literature. Then, in the summer of 2007, Kate Curtis, PhD, and colleagues from the Centers for Disease Control (CDC) published a meta-analysis of the world's observational studies of this relationship. Nonmedicated (just plastic) and copper IUDs were associated with a 40% reduction in the risk of this cancer, which was statistically significant. This is nearly the degree of protection conferred by use of oral contraceptives or depo-medroxyprogesterone acetate. Given the frequency of endometrial cancer and the extensive use of IUDs worldwide, this contraceptive may have averted many cases of cancer.
The mechanism responsible remains unknown. The sterile inflammatory response in the endometrium may kill neoplastic cells, similar to its spermicidal effect. Regardless of the mechanism, the literature is strong and consistent, so I do discuss this feature with women considering an IUD. Most of this epidemiological literature relates to non-medicated and copper IUDs. However, I anticipate that future studies will document powerful protection against endometrial cancer with the levonorgestrel device. Indeed, small case-series reports have documented use of the levonorgestrel intrauterine system to treat complex endometrial hyperplasia or as a temporizing measure for women with early endometrial cancer who are poor surgical candidates.
The marked reduction in uterine bleeding among women using the levonorgestrel device can prevent iron deficiency anemia. Overall, bleeding is reduced by about 90%, and a substantial proportion of women stop bleeding altogether. An early cross-sectional study from Brazil examined hematocrit and ferritin levels in women using a plastic (nonmedicated), a copper, and a levonorgestrel IUD. Hematological indices were least favorable with the nonmedicated device, intermediate with copper, and most favorable with the levonorgestrel device.
Another prevention strategy with the levonorgestrel device is protection of the endometrium with estrogen therapy in the menopause. In more than 80 countries, the levonorgestrel device is approved for this purpose. Rather than taking oral progestins (with their systemic effects, including mood), women take progestin topically -- in the endometrial cavity. An attractive feature of this approach is the high proportion of women who are free from bleeding altogether, which both women and clinicians like.
Two reports[7,8] have examined the use of the levonorgestrel device to protect the endometrium in breast cancer patients taking tamoxifen. These studies found fewer endometrial polyps and a higher proportion of women with a decidualized endometrium than in women on tamoxifen but without the device.
Medscape: What treatment indications have been associated with contemporary IUDs?
Dr. Grimes: The best-established treatment option is management of heavy menstrual bleeding with the levonorgestrel system. Again, this indication has been approved by the regulatory agencies in more than 80 countries. Insertion of this device has been found to rival endometrial ablation techniques; although the operations yielded better bleeding control at 1 year; by 2 to 3 years, the distinction blurred. Women found both approaches equally satisfactory over the long run. Two randomized controlled trials from Finland[10,11] have shown this device to be an acceptable short- and long-term alternative to hysterectomy for some women with uterine bleeding refractory to usual medications, such as oral progestins. Some evidence suggests that the levonorgestrel device can be used to treat heavy bleeding associated with either leiomyomas or adenomyosis.
Another emerging indication is management of the pain associated with endometriosis. Two randomized controlled trials[12,13] have examined use of the device in women with endometriosis confirmed by laparoscopy. One trial randomized women to the levonorgestrel device or watchful waiting over a year; pain was much less in those who received the IUD. The other trial randomized women to the device or to leuprolide acetate. Pain improvement was similar with both treatments, but the cost of the device was far less than the GnRH [gonadotropin-releasing hormone].
Medscape: What "clinical pearls" about IUD use do you believe are most important for clinicians to know?
The IUD today is as effective as tubal sterilization, but less expensive, more convenient, safer, and immediately reversible;
An IUD should be considered an alternative to interval tubal sterilization, especially for young women, who are at increased risk for later sterilization regret;
Today's IUDs are not associated with a significantly increased risk of pelvic inflammatory disease or resultant tubal infertility;
Indeed, some tantalizing evidence from a randomized controlled trial in Scandinavia and Hungary suggests that the levonorgestrel device might lower the risk of infection, compared with a woman using a similar copper IUD;
IUDs need not be limited to women wanting long-term contraception; short-term use is also appropriate, although the costs per month of protection will be correspondingly higher with shorter use;
When amortized over the lifespan of the device, today's IUDs are among the least expensive forms of contraception;
Women who have their first levonorgestrel device removed and a second one inserted often have no uterine bleeding; the risk of pregnancy is negligible in the second 5-year interval of use;
Women have been studied for up to 20 years with the same copper T 380A device; no pregnancies occurred in the second decade of use, though data became sparse after many years of observation; and
A 25-year-old woman can have a copper T380A inserted and possibly never again have to think about contraception.
Medscape: Thank you for taking the time today to talk with us about IUDs.
Medscape Ob/Gyn © 2008 Medscape
Cite this: Contemporary IUDs: Contraception and More. An Expert Interview with Dr. David Grimes - Medscape - Jul 07, 2008.