Rediscovering the benefits of the IUD
Contemporary intrauterine devices (IUDs) rival tubal sterilization in efficacy and are much safer than previously thought, so why aren’t more American women using them for birth control?
The IUD remains the best-kept contraceptive secret in the United States, contends Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. First-year probability of pregnancy in women using the ParaGard T380A IUD (Ortho-McNeil Pharmaceutical, Raritan, NJ), the most widely used IUD in the United States, is 0.8% in typical use and 0.6% in perfect use. Rates for the Progestasert IUD (Alza Corp., Palo Alto, CA), the only other IUD available in the United States, is 2% in typical use and 1.5% in perfect use.1 However, fewer than 1% of contracepting American women choose to use an IUD.2
More women may become interested in the IUD with the advent of a new device under review by the Food and Drug Administration. The Mirena levonorgestrel intrauterine system, used by more than 1.4 million women in Europe, Asia, and Latin America, has been submitted for marketing approval in the United States by Berlex Laboratories in Wayne, NJ. (Contraceptive Technology Update reported on Berlex’s New Drug Application filing in the April 2000 issue.)
The company began enrolling women in the Phase IIIB study in early 2000, states company spokeswoman Julie Mandell. The study is designed to evaluate the insertion procedure, patient counseling, product satisfaction, and clinical performance for Mirena, she says.
"We also are collaborating with the Association of Reproductive Health Professionals [of Washington, DC] to organize training programs on the appropriate insertion technique for OB/GYNs and other health care practitioners," states Mandell.
Why has use of the IUD remained low?
Results from an international mail survey, sent to national institutions providing family planning services in 75 countries, show that inaccurate information about IUDs is a leading barrier to their use.3 Patients might mistakenly believe that IUDs cause an abortion, result in cancer use, or can move outside the uterus and travel as far as the heart or brain, survey results reveal.
Women who do have the correct information about IUD might be more inclined to use it. Kaunitz points to recently analyzed data from the Women Physicians’ Health Study, a large national study, which examined characteristics of female physicians in the United States.4 "The fact that more than 5% of female physicians use IUDs reminds us of the important role education plays in determining contraceptive choice," states Kaunitz.
Look at infection data
Concern about upper-genital-tract infection also has played a part in limiting the IUD’s use. A new review of research studies into IUD use, infection, and subsequent infertility indicates that such risks might have been exaggerated.5
The review, conducted by David Grimes, MD, vice president of biomedical affairs at Family Health International, a reproductive health research firm based in Research Triangle Park, NC, concludes that many previous studies were unreliable because of inappropriate use of comparison groups (such as women using contraceptives that lower the risk of pelvic inflammatory disease), systematic overdiagnosis of salpingitis among IUD users, and inability to control for confounding factors.
Uncritical thinking, poor early studies of the question of upper-genital-tract infection related to IUDs, and the lingering memory of the Dalkon Shield saga of the 1970s continue to hamper the IUD’s use, says Grimes. The IUD offers exceptional, compliance-free contraception, which Grimes sees as a "huge" advantage. While substantial upfront costs might present an initial economic disadvantage, the cost disappears when amortized over the life span of the device, he notes.
A 1998 report from the World Health Organization found the Copper T380A IUD, which is marketed in the United States as a 10-year device, remains effective 12 years after insertion.6 Even though it offers such long-term effectiveness, don’t limit the IUD’s use just to women who have completed their families and are looking for long-acting contraception, says Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care clinic and nurse practitioner training program at Harbor-UCLA Medical Center in Torrance.
"I think one thing that we really want to make clear in people’s minds is that this is an interval method," Nelson says of the IUD. "We tend to sequester it, because it is so long term, for women who have completed in their families, and that’s just not the only group."
The T380A is the most cost-effective reversible contraceptive on the market today, provided that it is used for at least two years.7 Since it breaks even in cost-effectiveness in just a few years, women don’t have to "sign up for a lifetime contract" when selecting the method, notes Nelson. Cost of the device is $184 in managed care settings and $109 in the public sector; insertion costs, including screening, counseling, and testing, are estimated at $207 in the managed care sector and $64 in the public sector.8
The recommended patient profile includes parous women in stable mutually monogamous relationships who are at low risk for sexually transmitted infections (STIs) with no history of pelvic inflammatory disease (PID); however, nulliparous women at low risk for STIs also might be candidates.8 Women with a history of PID might be candidates if they currently are in stable mutually monogamous relationships and have had a pregnancy since the PID episode.8
The IUD represents a good option for women who cannot use hormonal contraception, those at risk for thrombosis, smokers over age 35, and breast-feeding mothers.8 Despite its availability, though, many women are not using the method, says Nelson. "The astonishing thing is that if you go straight by the labeling, it shows that 10 million women perfectly fit the bill, and we’re certainly not using 10 million IUDs," she notes. "I think there are several things that are going to refocus our attention on the IUD and hopefully bring a lot more enthusiasm."
References
1. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York: Ardent Media; 1998.
2. Abma JC, Chandra A, Mosher WD, et al. Fertility, family planning, and women’s health: New data from the 1995 National Survey of Family Growth. Vit Health Stat 12 1997; No. 19.
3. Barnett B. Copper T IUD: Safe, effective, reversible. Network 2000; 20:4-9.
4. Frank E. Contraceptive use by female physicians in the United States. Obstet Gynecol 1999; 94(5 Pt 1):666-671.
5. Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet 2000; 356:1,013-1,019.
6. Long-term reversible contraception. Twelve years of experience with the TCu380A and TCu220C. Contraception 1997; 56:341-352.
7. Trussell J, Leveque JA, Koenig JD, et al. The economic value of contraception: A comparison of 15 methods. Am J Public Health 1995; 85:494-503.
8. Nelson AL, Hatcher RA, Zieman M, et al. A Pocket Guide to Managing Contraception. Tiger, GA: Bridging the Gap Foundation; 2000.
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