New label broadens IUD candidacy profile. History of some diseases now just a precaution

Contracept Technol Update. 1995 May;16(5):59-61.

Abstract

PIP: The Population Council recently reworded the package labeling for the copper T380A IUD as follows: pelvic inflammatory disease (PID) is related to a woman's sexual behavior and not to the device itself. Formerly contraindicated, histories of PID or ectopic pregnancy are now merely precautions. The labeling now warns that the Copper T is contraindicated in the presence of PID or in women with a history of PID since the last pregnancy. If a woman has been free of infection, there is no need not to give her an IUD. The former contraindication about ectopic pregnancy has been deleted, while contraindications in the section of the label on conditions associated with increased susceptibility to infections with microorganisms now include only leukemia and AIDS. IV drug use and conditions requiring chronic corticosteroid therapy have been dropped from the section, along with diabetes. Finally, the former contraindication of genital actinomycosis has been changed to address symptomatic genital actinomycosis with organism confirmed by culture. This latter change is due to the high number of false-positives seen with Pap smears alone. These changes are logical given recent research findings about IUDs. A brief overview is given of recent findings about IUDs with regard to pelvic inflammatory disease, ectopic pregnancy, and diabetes.

MeSH terms

  • Americas
  • Contraception
  • Contraception Behavior*
  • Developed Countries
  • Diabetes Mellitus*
  • Disease
  • Family Planning Services
  • Infections
  • Intrauterine Devices*
  • North America
  • Pelvic Inflammatory Disease*
  • Pregnancy Complications
  • Pregnancy, Ectopic*
  • United States