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Elevated Risk of Pelvic Inflammatory Disease among Women Using the Dalkon Shield

Among women using intrauterine devices (IUDs), those using the Dalkon Shield have been found to have a 5-fold increased risk for pelvic inflammatory disease (PID), compared with those using other IUD types. Compared with women using no contraceptive method, current IUD users had a PID risk of 1.9 (95% confidence interval, 1.5 to 2.4), and users of specific IUD types* had the following PID risks: Dalkon Shield 8.3 (4.7-14.5); Progestasert 2.2 (1.0-5.0); Copper-7 1.9 (1.4-2.7); Saf-T-Coil 1.3 (0.5-2.9); and Lippes Loop 1.2 (0.9-1.8). These results indicate that women still using Dalkon Shields should have them removed. No change in use of other IUDs is recommended.

Excluding Dalkon Shield users, most of the increased PID risk among IUD users was seen among women who had been wearing their current IUD for 4 months or less. The highest risk occurred in the first month after IUD insertion (relative risk of 3.8 (2.1-6.8), compared with women currently using no contraception).

These data were derived from the Women's Health Study, a multicenter case-control study solicited and supported by the National among IUD users was seen among women who had been wearing their current IUD for 4 months or less. The highest risk occurred in the first month after IUD insertion (relative risk of 3.8 (2.1-6.8), compared with women currently using no contraception).

These data were derived from the Women's Health Study, a multicenter case-control study solicited and supported by the National Institute of Child Health and Human Development and conducted in the United States from 1976 to 1978 (1). Results were based on interviews of 622 women hospitalized with an initial episode of PID and 2,369 hospitalized women reporting no history of PID. An association between IUD use and PID has been previously documented (2). However, before this Women's Health Study, no study was of sufficient size to determine PID risks associated with different IUD types. Reported by RT Burkman, MD, Dept of Gynecology and Obstetrics, Johns Hopkins University; National Center for Devices and Radiological Health, Food and Drug Administration; Div of Reproductive Health, Center for Health Promotion and Education, CDC.

Editorial Note

Editorial Note: The Dalkon Shield was first marketed nationwide in January 1971. By June 1974, approximately 2.8 million had been distributed in the United States (3). In the summer of 1974, the manufacturer voluntarily halted further distribution of the Dalkon Shield in the United States because of its reported association with pregnancy-related complications. In 1980, the manufacturer advised physicians to remove the Dalkon Shield from asymptomatic women because of the risk of actinomyces infection (4). No currently available information provides reliable estimates of the number of women in the United States still using Dalkon Shields.

In this analysis, PID risk for current IUD users hospitalized for a first episode of the disease was almost twice that for women using no contraception. Although only a small proportion of IUD users in this study were using the Dalkon Shield, this device accounted for almost 20% of the excess PID risk occurring among all the IUD users. For users of other IUDs, most of the increased PID risk was confined to the first few months after IUD insertion.

Because risk estimates were adjusted for several confounding variables, it is unlikely that these findings could be explained by differences in age, race, parity, education, sexual practices, or medical history. Because the relative risk associated with the Dalkon Shield is large, it is unlikely to be completely explained by a bias or by some uncontrolled factor.

Previously published studies have not found a significantly increased PID risk among Dalkon Shield users. However, five studies found an elevated PID risk among women wearing the Dalkon Shield, compared with other IUD types, although these results were based on small numbers and were not statistically significant (5-9).

References

  1. Burkman RT. Association between intrauterine device and pelvic inflammatory disease. Obstet Gynecol 1981;57(3):269-76.

  2. Ory HW. A review of the association between intrauterine devices and acute pelvic inflammatory disease. J Reprod Med 1978;20(4):200-4.

  3. Levinson CJ, Richardson DC. The Dalkon shield story. Advances in Planned Parenthood 1976;11(2):53-63.

  4. AH Robins Company. Recommendations that the Dalkon Shield be removed from asymptomatic patients. (Letter from A. H. Robins Company to physicians). September 25, 1980.

  5. Faulkner WL, Ory HW. Intrauterine devices and acute pelvic inflammatory disease. JAMA 1976;235(17):1851-3.

  6. Flesh G, Weiner JM, Corlett RC Jr, Boice C, Mishell DR Jr, Wolf RM. The intrauterine contraceptive device and acute salpingitis: a multifactor analysis. Am J Obstet Gynecol 1979;135(3):402-8.

  7. Kaufman DW, Shapiro S, Rosenberg L, et al. Intrauterine contraceptive device use and pelvic inflammatory disease. Am J Obstet Gynecol 1980;136(2):159-62.

  8. Vessey MP, Yeates D, Flavel R, McPherson K. Pelvic inflammatory disease and the intrauterine device: findings in a large cohort study. Br Med J 1981;282(6267):855-7.

  9. Beerthuizen RJ, Van Wijck JA, Eskes TK, Vermeulen AH, Vooijs GP. IUD and salpingitis: a prospective study of pathomorphological changes in the oviducts in IUD-users. Eur J Obstet Gynecol Reprod Biol 1982;13(1):31-41.

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