Long Tail Strings: Impact of the Dalkon Shield 40 Years Later


Intrauterine devices (IUDs) are the most effective, reversible and longest acting birth control method. They require no effort for compliance and avoid systemic synthetic hormones. Evidence-based effectiveness and safety studies have demonstrated IUDs rival sterilization. IUDs low cost make them the most popular method worldwide. Despite these benefits, IUDs have minimal market penetration in the United States where they are expensive, disparaged by an older generation of physicians, and withheld from teenagers, nulliparous women, and women not in mutually monogamous relationships, i.e., those who would most benefit. This article reviews the nearly forgotten history of the IUD that resulted in broadening the Food and Drug Administration’s oversight of medical devices, brought needed transparency to physicians’ conflicts of interests, uncovered a corporate scandal with a whistleblower that led to a major pharmaceutical bankruptcy, and involved 327,000 women (though only 195,000 met strict criteria for claims) in the largest US personal injury case.

Share and Cite:

Roepke, C. and Schaff, E. (2014) Long Tail Strings: Impact of the Dalkon Shield 40 Years Later. Open Journal of Obstetrics and Gynecology, 4, 996-1005. doi: 10.4236/ojog.2014.416140.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] Spinelli, A., Talamanca, I.F. and Lauria, L. (2000) Patterns of Contraceptive Use in 5 European Countries. American Journal of Public Health, 90, 1403-1408.
[2] Finer, L.B. and Henshaw, S.K. (2006) Disparities in Rates of Unintended Pregnancy in the United States, 1994 and 2001. Perspectives on Sexual and Reproductive Health, 38, 90-96.
[3] Kooiker, C.H. and Scutchfield, F.D. (1990) Barriers to Prescribing the Copper T380A Intrauterine Device by Physicians. Western Journal of Medicine, 153, 279-282.
[4] Stanwood, N.L., Garrett, J.M. and Konrad, T.R. (2002) Obstetrician-Gynecologists and the Intrauterine Device: A Survey of Attitudes and Practice. Obstetrics and Gynecology, 99, 275-280. http://dx.doi.org/10.1016/S0029-7844(01)01726-4
[5] Stanwood, N.L. and Bradley, K.A. (2006) Young Pregnant Women’s Knowledge of Modern Intrauterine Devices. Obstetrics and Gynecology, 108, 1417-1422.
[6] Whitaker, A.K., Johnson, L.M., Harwood, B., Chiappetta, L., Creinin, M.D. and Gold, M.A. (2008) Adolescent and Young Adult Women’s Knowledge of and Attitudes toward the Intrauterine Device. Contraception, 78, 211-217. http://dx.doi.org/10.1016/j.contraception.2008.04.119
[7] Collier, A. (2007) The Humble Little Condom: A History. Prometheus Books, Amherst, New York, 273-274, 285.
[8] Davis, H.J. (1972) Intrauterine Contraceptive Devices: Present Status and Future Prospects. American Journal of Obstetrics Gynecology, 114, 134-151.
[9] Israel, R. and Davis, H.J. (1966) Effect of Intrauterine Contraceptive Devices on the Endometrium. JAMA, 195, 764-768. http://dx.doi.org/10.1001/jama.1966.03100090098021
[10] Davis, H.J. and Lesinski, J. (1970) Mechanism of Action of Intrauterine Contraceptives in Women. Obstetrics and Gynecology, 36, 350-358.
[11] Supramid (2009). http://www.supramid.com/homeinfo.htm
[12] Mintz, M. (1985) At Any Cost: Corporate Greed, Women and the Dalkon Shield. Pantheon Books, New York. At 27.
[13] Davis, H.J. (1970) The Shield Intrauterine Device. A Superior Modern Contraceptive. American Journal of Obstetrics and Gynecology, 106, 455-456.
[14] See Mintz, Supra Note 64-65, 176-177.
[15] Hicks, K.M. (1994) Surviving the Dalkon Shield: Women v. the Pharmaceutical Industry. Teachers College Press, New York. At 43.
[16] Hawkins, M.F. (1997) Unshielded: The Human Cost of the Dalkon Shield. University of Toronto Press, Toronto, Buffalo, London. At 17.
[17] See Mintz, Supra Note 99-100.
[18] Perry, S. and Dawson, J. (1985) Nightmare: Women and the Dalkon Shield. MacMillan Publishing Company, New York. At 75.
[19] Christian, C.D. (1974) Maternal Deaths Associated with an Intrauterine Device. American Journal of Obstetrics and Gynecology, 119, 441-444.
[20] Tatum, H.J., Schmidt, F.H., Phillips, D., McCarty, M. and O’Leary, W.M. (1975) The Dalkon Shield Controversy, Structural and Bacteriological Studies of IUD Tails. Journal of the American Medical Association, 231, 711-717. http://dx.doi.org/10.1001/jama.1975.03240190015009
[21] See Mintz, Supra Note 147.
[22] Cates, W., Ory, H.W., Rochat, R.W. and Tyler, Z.C.W. (1976) The Intrauterine Device and Deaths from Spontaneous Abortion. The New England Journal of Medicine, 295, 1155-1159.
[23] See Mintz, Supra Note 162-167.
[24] Lee, N.C., Rubin, G.L., Ory, H.W. and Burkman, R.T. (1983) Type of Intrauterine Device and the Risk of Pelvic Inflammatory Disease. Obstetrics and Gynecology, 62, 1-6.
[25] Burkman, R.T. (1981) Association between Intrauterine Device and Pelvic Inflammatory Disease. Obstetrics and Gynecology, 57, 269-276.
[26] Tatum, H.J. (1983) Milestones in Intrauterine Device Development. Fertility and Sterility, 39, 141-143.
[27] Bloss, R., Corneli, J., Moon, C. and Tomsich, L. (2010) The Dalkon Shield.
[28] See Perry and Dawson, Supra Note 36.
[29] Ibid at 133-134.
[30] Staff Manual Guide (2010) Chapter 53, Postmarketing Surveillance and Epidemiology: Human Drugs http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm129115.htm
[31] See Hawkins, Supra Note 30.
[32] “Dalkon Shield” CBS 60 Minutes. April 12, 1981.
[33] See Mintz, Supra Note 208-209, 235-238.
[34] Ibid at 267.
[35] See Hawkins, Supra Note 39.
[36] Ravishankar, L. (2010) Encouraging Internal Whistleblowing in Organizations.
[37] See Mintz, Supra Note 227.
[38] Ibid at 149-152.
[39] See Hicks, Supra Note 6.
[40] Ibid at 10.
[41] Sobol, R.B. (1991) Bending the Law: The Story of the Dalkon Shield Bankruptcy. University of Chicago Press, Chicago. At 286, 341.
[42] Ibid at 312,322.
[43] See Hicks, Supra Note 7.
[44] Faulkner, W.L. and Ory, H.W. (1976) Intrauterine Devices and Acute Pelvic Inflammatory Disease. Journal of the American Medical Association, 235, 1851-1853.
[45] Burkman, R.T. (1981) Association between Intrauterine Device and Pelvic Inflammatory Disease. Obstetrics and Gynecology, 57, 269-276.
[46] Cates Jr., W., op.cit., 1155-1159.
[47] Daling, J.R., Weiss, N.S., Metch, B.J., Chow, W.H., Soderstrom, R.M., Moore, D.E., Spadoni, L.R. and Stadel, B.V. (1985) Primary Tubal Infertility in Relation to the Use of an Intrauterine Device. The New England Journal of Medicine, 312, 937-941. http://dx.doi.org/10.1056/NEJM198504113121501
[48] Cramer, D.W., Schiff, I., Schoenbaum, S.C., Gibson, M., Belisle, S., Albrecht, B., et al. (1985) Tubal Infertility and the Intrauterine Device. The New England Journal of Medicine, 312, 941-947. http://dx.doi.org/10.1056/NEJM198504113121502
[49] Ory, H.W. (1978) A Review of the Association between Intrauterine Devices and Acute Pelvic Inflammatory Disease. Journal of Reproductive Medicine, 20, 200-204.
[50] Obituary “Hugh J. Davis,” New York Times, October 26, 1996.
[51] Trussell, J., Leveque, J.A., Koenig, J.D., London, R., Borden, S., Henneberry, J., LaGuardia, K.D., Stewart, F., Wilson, T.G., Sysocki, S., et al. (1995) The Economic Value of Contraception: A Comparison of 15 Methods. American Journal of Public Health, 85, 494-503.
[52] Darney, P.D. (2001) Time to Pardon the IUD? The New England Journal of Medicine, 345, 608-610. http://dx.doi.org/10.1056/NEJM200108233450810
[53] K4Health, IUD Toolkit, Frequently Asked Questions, 2010. http://www.k4health.org/node/974#5
[54] Ory, H.W. (1981) Ectopic Pregnancy and Intrauterine Contraceptive Devices: New Perspectives. The Women’s Health Study. Obstetrics and Gynecology, 57, 137-144.
[55] Sivin, I. (1999) Dose- and Age-Dependent Ectopic Pregnancy Risks with Intrauterine Contraception. Obstetrics and Gynecology, 78, 291-298.
[56] Anonymous (1990) The TCu380A, TCu220C, Multiload 250 and Nova T IUDS at 3,5 and 7 Years of Use—Results from Three Randomized Multicentre Trials. World Health Organization, Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on the Safety and Efficacy of Fertility Regulating Methods. Contraception, 42, 141-158.
[57] Lee, N.C., Rubin, G.L. and Borucki, R. (1988) The Intrauterine Device and Pelvic Inflammatory Disease Revisited: New Results from the Women’s Health Study. Obstetrics and Gynecology, 72, 1-6.
[58] Grimes, D.A. (2000) Intrauterine Device and Upper-Genital-Tract Infection. The Lancet, 356, 1013-1019. http://dx.doi.org/10.1016/S0140-6736(00)02699-4
[59] Sorbye, I.K., Jerve, F. and Staff, A.C. (2005) Reduction in Hospitalized Women with Pelvic Inflammatory Disease in Oslo over the Past Decade. Acta Obstetricia et Gynecologica Scandinavica, 84, 290-296. http://dx.doi.org/10.1080/j.0001-6349.2005.00509.x
[60] Odugbemi, T., McEntegart, M. and Hafiz, S. (1978) Effects of Various Divalent Cations on the Survival of Nesisseria Gonorrhoeae in Liquid Media. British Journal of Venereal Disease, 54, 239-242.
[61] Mehanna, M.T.R., Rizk, M.A., Ramadan, M. and Schachter, J. (1994) Chlamydia Serologic Characteristics among Intrauterine Contraceptive Device Users: Does Copper Inhibit Chlamydial Infection in the Female Genital Tract? American Journal of Obstetrics & Gynecology, 171, 691-693.
[62] Toivonen, J., Luukkainen, T. and Allonen, H. (1991) Protective Effect of Intrauterine Release of Levonorgestrel on Pelvic Infection: Three Years’ Comparative Experience of Levonorgestrel- and Copper Releasing Intrauterine Devices. Obstetrics and Gynecology, 77, 261-264.
[63] Ebi, K.L., Piziali, R.L., Rosenberg, M. and Wachob, H.F. (1996) Evidence against Tailstrings Increasing the Rate of Pelvic Inflammatory Disease among IUD Users. Contraception, 53, 25-32.
[64] Skjeldestad, F.E. (2008) The Impact of Intrauterine Devices on Subsequent Fertility. Current Opinion in Obstetrics and Gynecology, 20, 275-280. http://dx.doi.org/10.1097/GCO.0b013e3282fe7427
[65] Hubacher, D., Lara-Ricalde, R., Taylor, D.J., Guerra-Infante, F. and Guzman-Rodriquez, R. (2001) Use of Copper Intrauterine Devices and the Risk of Tubal Infertility among Nullagravid Women. The New England Journal of Medicine, 345, 561-567. http://dx.doi.org/10.1056/NEJMoa010438
[66] Wilson, J.C. (1989) A Prospective New Zealand Study of Fertility after Removal of Copper Intrauterine Contraceptive Devices for Conception and Because of Complications: A Four-Year Study. American Journal of Obstetrics and Gynecology, 160, 391-396.
[67] Hov, G.G., Skjeldestad, F.E. and Hilstad, T. (2007) Use of IUD and Subsequent Fertility-Follow-Up after Participation in a Randomized Clinical Trial. Contraception, 75, 88-92.
[68] Meyers, D., Wolff, T., Gregory, K., Marion, L., Moyer, V., Nelson, H., Petitti, D. and Sawaya, G.F. (2010) US Preventive Services Task Force Recommendations for STI Screening.
[69] Geisler, W.M., Chow, J.M., Schachter, J. and McCormack, W.M. (2007) Pelvic Examination Findings and Chlamydia Trachomatis Infection in Asymptomatic Young Women Screened with a Nucleic Acid Amplification Test. Sexually Transmitted Diseases, 34, 335-338.
[70] American College of Obstetricians and Gynecologists Committee (2007) Intrauterine Device and Adolescents, American College of Obstetricians and Gynecologists Committee Opinion No. 392. Obstetrics and Gynecology, 110, 1493-1495.
[71] American College of Obstetricians and Gynecologists Committee (2005) Intrauterine Device, American College of Obstetricians and Gynecologists Committee on Practice Bulletins-Gynecology No. 59. Obstetrics and Gynecology, 105, 223-232.
[72] World Health Organization (2004) Intrauterine Devices. In: Medical Eligibility Criteria for Contraceptive Use, 3rd Edition, WHO, Geneva, 1-17.
[73] Patient Package Insert (2010) Paragard T380 Intrauterine Copper Contraceptive. Duramed Pharmaceutical, Inc., Subsidiary of Barr Pharmaceuticals, New York.

Copyright © 2021 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.