Skip to main content
CMAJ : Canadian Medical Association Journal logoLink to CMAJ : Canadian Medical Association Journal
. 1986 Apr 1;134(7):747–751.

Long-term study of the safety of the Dalkon Shield and Gyne-T 200 intrauterine devices.

J E Rioux, D Cloutier, P Dupont, D Lamonde
PMCID: PMC1492461  PMID: 3948091

Abstract

Between 1971 and 1973, 200 Dalkon Shield and 142 Gyne-T 200 intrauterine devices (IUDs) were inserted at the department of obstetrics and gynecology in a large urban hospital. In 1984 retrospective analysis of events associated with the use of these IUDs was done. Hospital and clinic charts were reviewed, and the women were contacted to obtain information on infertility and the outcome of pregnancy after discontinuation of IUD use. The rates of events leading to discontinuation of IUD use 2 years after insertion were similar in the two groups except for that of planned pregnancy, which was higher in the Dalkon Shield users (p less than 0.05). The rates of accidental pregnancy per 100 women were 3.8 for the Dalkon Shield users and 1 for the Gyne-T 200 users. The rates of pelvic inflammatory disease (PID) based on all cases of PID and follow-up information were similar in the two groups. There were no differences between the two groups in outcome of pregnancy with the IUD in situ or after expulsion or removal of the IUD because of planned pregnancy or other reasons. Infertility rates after discontinuation of IUD use were similar for the Dalkon Shield and Gyne-T 200 users. The results confirm the authors' opinion that the Dalkon Shield and Gyne-T 200 IUDs are safe and effective methods of intrauterine contraception.

Full text

PDF
747

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Azen S. P., Roy S., Pike M. C., Casagrande J. Some suggested improvements to current statistical methods of analyzing contraceptive efficacy. J Chronic Dis. 1976 Oct;29(10):649–666. doi: 10.1016/0021-9681(76)90022-9. [DOI] [PubMed] [Google Scholar]
  2. Buchman M. I. A study of the intrauterine contraceptive device with and without an extracervical appendage or tail. Fertil Steril. 1970 Apr;21(4):348–355. doi: 10.1016/s0015-0282(16)37454-4. [DOI] [PubMed] [Google Scholar]
  3. Burkman R. T. Association between intrauterine device and pelvic inflammatory disease. Obstet Gynecol. 1981 Mar;57(3):269–276. [PubMed] [Google Scholar]
  4. Cooper D. L., Israel R., Mishell D. R., Jr Randomized comparative study of the copper T 300, Dalkon shield, and Shell Loop in parous women. Obstet Gynecol. 1975 May;45(5):569–573. [PubMed] [Google Scholar]
  5. Ditchik P. M., Ditchik J. M. A comparative evaluation of three IUDs. Contracept Deliv Syst. 1984 Apr;5(2):117–121. [PubMed] [Google Scholar]
  6. Edelman D. A., Berger G. S., Keith L. Pelvic inflammatory disease and the Dalkon Shield. Obstet Gynecol. 1984 Aug;64(2):297–300. [PubMed] [Google Scholar]
  7. Edelman D. A., Keith L., Berger G. S. Intrauterine devices and pelvic inflammatory disease. JAMA. 1984 Mar 9;251(10):1278–1279. [PubMed] [Google Scholar]
  8. Elstein M., Birnberg C., Mills W., Eckstein P. Pelvic inflammation and the intrauterine contraceptive device. Proc R Soc Med. 1967 Apr;60(4):397–398. doi: 10.1177/003591576706000428. [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Hasson H. M. Clinical experience with intrauterine devices in a private practice. Adv Contracept. 1985 Mar;1(1):51–61. doi: 10.1007/BF01849144. [DOI] [PubMed] [Google Scholar]
  10. Kaufman D. W., Shapiro S., Rosenberg L., Monson R. R., Miettinen O. S., Stolley P. D., Slone D. Intrauterine contraceptive device use and pelvic inflammatory disease. Am J Obstet Gynecol. 1980 Jan 15;136(2):159–162. doi: 10.1016/0002-9378(80)90589-x. [DOI] [PubMed] [Google Scholar]
  11. Kaufman D. W., Watson J., Rosenberg L., Helmrich S. P., Miller D. R., Miettinen O. S., Stolley P. D., Shapiro S. The effect of different types of intrauterine devices on the risk of pelvic inflammatory disease. JAMA. 1983 Aug 12;250(6):759–762. [PubMed] [Google Scholar]
  12. Keith L., Berger G. S. The etiology of pelvic inflammatory disease. Res Front Fertil Regul. 1984 May;3(1):1–16. [PubMed] [Google Scholar]
  13. Lee N. C., Rubin G. L., Ory H. W., Burkman R. T. Type of intrauterine device and the risk of pelvic inflammatory disease. Obstet Gynecol. 1983 Jul;62(1):1–6. [PubMed] [Google Scholar]
  14. Purrier B. G., Sparks R. A., Watt P. J., Elstein M. In vitro study of the possible role of the intrauterine contraceptive device tail in ascending infection of the genital tract. Br J Obstet Gynaecol. 1979 May;86(5):374–378. doi: 10.1111/j.1471-0528.1979.tb10613.x. [DOI] [PubMed] [Google Scholar]
  15. Sandmire H. F., Cavanaugh R. A. Long-term use of intrauterine contraceptive devices in a private practice. Am J Obstet Gynecol. 1985 May 15;152(2):169–175. doi: 10.1016/s0002-9378(85)80018-1. [DOI] [PubMed] [Google Scholar]
  16. Snowden R., Pearson B. Pelvic infection: a comparison of the Dalkon shield and three other intrauterine devices. Br Med J (Clin Res Ed) 1984 May 26;288(6430):1570–1573. doi: 10.1136/bmj.288.6430.1570. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Sparks R. A., Purrier B. G., Watt P. J., Elstein M. Bacteriological colonisation of uterine cavity: role of tailed intrauterine contraceptive device. Br Med J (Clin Res Ed) 1981 Apr 11;282(6271):1189–1191. doi: 10.1136/bmj.282.6271.1189. [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Tatum H. J., Schmidt F. H., Phillips D., McCarty M., O'Leary W. M. The Dalkon Shield controversy. Structural and bacteriological studies of IUD tails. JAMA. 1975 Feb 17;231(7):711–717. doi: 10.1001/jama.231.7.711. [DOI] [PubMed] [Google Scholar]
  19. Thomas W. O., Jr The Dalkon Shield, the TCu 200, and the TCu 380A in private practice. Trans Pac Coast Obstet Gynecol Soc. 1977;44:78–85. [PubMed] [Google Scholar]
  20. Tietze C. Evaluation of intrauterine devices: ninth progress report of the Cooperative Statistical Program. Stud Fam Plann. 1970 Jul;(55):1–40. [PubMed] [Google Scholar]
  21. WILLSON J. R., LEDGER W. J., BOLLINGER C. C., ANDROS G. J. THE MARGULIES INTRAUTERINE CONTRACEPTIVE DEVICE: EXPERIENCE WITH 623 WOMEN. Am J Obstet Gynecol. 1965 May 1;92:62–70. doi: 10.1016/0002-9378(65)90105-5. [DOI] [PubMed] [Google Scholar]

Articles from CMAJ: Canadian Medical Association Journal are provided here courtesy of Canadian Medical Association

RESOURCES