The Department of Health and Human Services yesterday warned women still using the Dalkon Shield intrauterine device to contact their physicians about its removal.
The warning is based on a new federal study showing that women using this birth control device have a risk of pelvic inflammatory disease (PID) five times greater than women using other types of IUDs.
This painful disease of the female reproductive organs can cause short-term, life-threatening infection as well as long-term risk of infertility.
Although the health hazards of the Dalkon Shield have been reported for the last decade, government spokesmen said that the new analysis by the federal Centers for Disease Control and the Food and Drug Administration is the first that is large enough to determine the risks of pelvic infection linked with various types of IUDs.
The Dalkon Shield, manufactured by the A.H. Robins Co., was voluntarily taken off the market in 1974 following reports of pregnancy-related complications. By then, about 2.8 million devices had been distributed in this country.
Both HHS and the Robins company said there is no reliable estimate of how many women in the United States are still using Dalkon Shields, but the number is thought to be small. The government said its warning did not apply to woman using other types of IUDs.
The finding of increased risk of pelvic infection is based on data derived from the Women's Health Study, a project supported by the National Institute of Child Health and Human Development. Conducted in the United States between 1976 and 1978, it included interviews with 622 women hospitalized with an initial episode of PID and 2,369 with no such history.
A summary published in today's issue of the CDC's Morbidity and Mortality report said the risk of PID for all current IUD users in the study was almost twice that for women using no contraception, with the risk of IUDs other than the Dalkon Shield largely confined to the first few months after insertion.
The risk for Dalkon Shield users was more than eight times as great as for women using no contraception, the report said.
Robins spokesman Roscoe E. Puckett Jr. said the company agreed with government advice that the Dalkon Shield should be removed from remaining users and had so advised doctors in 1980.
But the company disagreed with the study's finding of greater risk from its product, saying that other "studies do not show that the risks of PID associated the Dalkon Shield are greater than those associated with other IUDs." Robins and its insurance company are involved in extensive litigation with women alleging injury from the device.
Last week, the National Women's Health Network petitioned the FDA to order a worldwide recall of the Dalkon Shield, saying it had new evidence of deterioration of the shield's nylon string causing infection.