IUD update signals renaissance for long-term contraceptive method
February 1, 1998
IUD update signals renaissance for long-term contraceptive method
Careful client screening minimizes pelvic inflammatory disease risks
When a 1974 article in Morbidity and Mortality Weekly Report (MMWR)1 questioned the safety of the Dalkon Shield intrauterine device (IUD), it set the wheels in motion for the eventual recall of the device. A recent update of the groundbreaking article, however, now asserts the safety of currently marketed IUDs2 and sets the stage for what some family planners see as a renaissance for the long-term contraceptive method.
"I believe that the Copper T 380A IUD, as well as the levonorgestrel-releasing IUD in Europe, are among the most effective and best options for reversible contraception," remarks Allan Rosenfield, MD, dean of the School of Public Health at Columbia University in New York City and one of the co-authors of the MMWR update. (For more information on the levonorgestrel IUD, see Contraceptive Technology Update, January 1997, p. 4.) The new IUDs offer effectiveness equal to sterilization, Rosenfield says. They are easy to insert and remove, have minimal side effects, do not cause major menstrual problems as do depo-medroxyprogesterone acetate (DMPA) and Norplant, and allow a rapid return to fertility after removal, he notes.
Women who use IUDs are satisfied with them, Rosenfield says. Nonetheless, they are underutilized in the United States, due in part to the continued fallout from the Dalkon Shield. (A spate of lawsuits forced Dalkon Shield manufacturer A.H. Robins Co. of Richmond, VA, to declare bankruptcy in 1985 after more than 4,000 product liability cases had been filed against it.)
When IUDs began to disappear from the American marketplace, so did education surrounding their insertion and use, says Michael Rosenberg, MD, MPH, clinical associate professor of OB/GYN and Epidemiology at the University of North Carolina at Chapel Hill and president of Health Decisions, a private medical research firm based in Chapel Hill.
"In America, the dearth of recent research and commercial promotion of IUDs has produced a situation in which many practitioners’ concept of IUD safety reflects information from 20 or more years ago, such as the original MMWR article," Rosenberg says. "As a consequence, relatively few practitioners have been trained in basic methods of IUD insertion."
Family planners in the United States may be turning the corner when it comes to IUDs, though, observes Andrew Kaunitz, MD, prof-essor and assistant chair of OB/GYN at the University of Florida Health Sciences Center in Jacksonville.
"A generation of residents graduated from training programs with little or no experience or exposure to the IUD," he says. "We have to change that. Certainly at our program, and at many programs across the United States, we are changing that."
One of the chief concerns surrounding IUDs has been the risk of pelvic inflammatory disease (PID). Early studies showed a greater concentration of the disease in IUD users when compared with those using other contraceptives.3 These findings later were offset when studies revealed that the sexual behavior of women and their partners played a large part in PID risk.4 Women with IUDs who were at low risk for sexually transmitted diseases (STDs) were unlikely to develop PID, researchers found.
A further advancement came with the 1992 publication of clinical data on the incidence and patterns of PID risk with IUD use from the World Health Organization (WHO) in Geneva, Switzer-land.5 Researchers concluded that PID is an infrequent event beyond the first 20 days after insertion and that the IUD should remain in place to its maximum lifespan, provided there are no contraindications to continued use.
"As subsequent research refined the issue, we learned that it was not the IUD that caused these problems but the acquisition of STDs among IUD users" who tended to be sexually active and thus at risk for STDs, says Rosenberg, a coauthor of the 1992 WHO study. "We also now know that an STD present at the time of IUD insertion also increases the risk of infectious complications such as PID."
Risks of post-insertion PID nearly erased
Kaunitz points to two recent studies indicating that with modern approaches to IUD patient selection, risks for post-insertion PID are virtually eliminated.
One study examines the effect of prophylactic antibiotics on the risk of PID infection after insertion.6 A total of 3.6% of the women who received doxycycline prior to insertion had their IUDs removed for medical reasons three months following the procedure, compared with 4.5% who received a placebo, with only two cases of PID found in the 447-woman population. This initial study finding is due to be updated soon and may indicate that for women at low risk of the disease, prophylactic antibiotics are not indicated prior to insertion, Kaunitz says.
Another study, which looked at the use- effectiveness of two copper IUDs, found no cases of PID during the first three months following insertion.7
"I think when we look at current U.S. practice [where women are carefully screened for STDs and their risk factors prior to insertion], it’s not even clear there’s an increased risk post insertion in the first several weeks," Kaunitz notes. "In fact, when we look for post-insertion infections, we have a hard time finding them."
Who is the IUD candidate?
Which women are appropriate IUD candidates? Consider patients who are looking for long-term, reversible contraception and who are at low risk for STDs, Kaunitz suggests. For those women who have tentatively completed childbearing but would prefer to avoid the surgery involved with sterilization, IUDs are a good choice. Once patients learn there is a method that is as effective as sterilization yet is entirely and easily reversible, many of them may choose the IUD. (Informed consent is a top priority for any IUD insertion candidate. See story, at right.)
Today’s IUD candidate should be in a monogamous sexual relationship with a partner who is not at risk of STD acquisition, Rosenberg says. Since the IUD tends to be expensive initially but in the long run is one of the most cost-effective means of contraceptive protection, the method is particularly well-suited for couples who have completed their childbearing but are not certain about sterilization. (In an analysis of 15 methods of birth control, the copper-T IUD proved to be the most cost-effective in both managed care and publicly funded programs. See CTU, August 1997, p. 97.)
Women who want to space pregnancies
The IUD is a good method for women in a monogamous situation who want to space their pregnancies, he says. Although some providers may disagree, Rosenfield believes the data support the provision of IUDs for women in long-term relationships who want to delay their first pregnancy, particularly if prophylactic antibiotics are provided at time of insertion to decrease the chance of post-insertion infection.
For women who have heavy menstrual flow or heavy cramps, the copper T380A probably would not be the first choice for contraception, Kaunitz says. These patients may do better with oral contraceptives or DMPA injections, depending on their medical history and individual preference.
Which patients would benefit from the Progestasert progesterone IUD, manufactured by Alza Pharmaceuticals in Palo Alto, CA? Consider women who are interested in the IUD for its convenience but are concerned about having heavy periods or cramps often associated with the copper method, Kaunitz suggests. Women who choose the Progestasert IUD should be comfortable with the annual removal and insertion, which Kaunitz performs in the same visit.
Because the Progestasert requires annual removal and reinsertion, the device has not been widely used, Rosenfield says. The levonorgestrel IUD, developed jointly by the New York City-based Population Council and the Finnish pharmaceutical company Leiras Oy, has comparable effectiveness rates and fewer side effects than the copper T-380A, he notes. It is hoped that Leiras Oy will consider bringing the device to the United States.
References
1. Centers for Disease Control and Prevention. IUD safety: Report of a nationwide physician survey. MMWR 1974; 23:226, 231.
2. Rosenfield A, Peterson HB, Tyler CW. Current trends IUD safety: Report of a nationwide physician survey. MMWR 1997; 46:969-974.
3. Barnett B. Key precautions minimize PID risk. Network 1996; 16:12.
4. Lee NC, Rubin GL, Borucki R. The intrauterine device and pelvic inflammatory disease revisited: New results from the Women’s Health Study. Obstet Gynecol 1988; 72:1-6.
5. Farley TMM, Rosenberg MJ, Rowe PJ, et al. Intrauterine devices and pelvic inflammatory disease: An international perspective. Lancet 1992; 339:785-788.
6. Walsh TL, Bernstein GS, Grimes DA, et al. Effect of prophylactic antibiotics on morbidity associated with IUD use: Results of a pilot randomized controlled trial. IUD study group. Contraception 1994; 50:319-327.
7. Skjeldestad FA, Halvorsen LE, Kahn H, et al. IUD users in Norway are at low risk for genital C. trachomatis infection. Contraception 1996; 54:209-212.
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