The National Women's Health Network said today that it is asking the Food and Drug Administration to order a worldwide recall of the Dalkon Shield, an intrauterine birth-control device suspected of causing serious infections that was taken off the domestic market in 1974.
The women's group said it has obtained evidence of "insidious and unknown" physical and chemical deterioration of the shield's unique nylon string which is intended, in part, to enable wearers to ascertain that the device is in place.
The petition said the deterioration allows bacteria through a barrier sheath and into the uterus, causing a "grave risk of infection and medical complications."
A.H. Robins Co. of Richmond sold an estimated 2.8 million shields between January, 1971, and June, 1974, when domestic sales were halted at the FDA's request after numerous reports of users who became pregnant and suffered infections and miscarriages.
The number of U.S. women still using the device is believed by the federal Centers for Disease Control in Atlanta to be small.
"These current wearers have received no public warning of this risk of deterioration-induced infection from any source including Robins or the FDA," the petition said.
By last Dec. 31, according to A.H. Robins' annual report, the company and its insurer had paid about $130 million in about 5,100 claims, with approximately 3,300 claims pending.
Robert Manchester, attorney for the women's group, said that Robins sold the device overseas after U.S. sales were suspended and that about 4.7 million shields were sent to 55 countries other than Canada, for which he said he has no figures.
The petition said a worldwide recall, paid for by A.H. Robins, is essential. Roscoe E. Puckett Jr., A.H. Robins' public information manager, said the company has not seen the petition but rejects its medical arguments as described by a reporter.
He said the company recommended in 1980, for reasons not connected with those stated in the petition, that women wearing Dalkon Shields should remove them.
"Robins has acted responsibly at all times in disclosing the risk associated with the Dalkon Shield," he said. "The company believes that the allegations contained in the petition do not warrant any new action by it or the FDA."
The women's group contends that the shield "has a propensity to become unsterile and contaminated" and that its labeling gave neither adequate directions nor warnings.
The FDA should rule the shield "a banned device" that "presents an unreasonable risk of substantial harm to the public health . . . not caused by the failure of anyone other than Robins," the petition said.
In addition to medical evidence, the petition includes charges, based on company documents, that the firm's management knew the shield suffered from serious defects.
The company began studying the problem of string deterioration as early as March, 1972, but did not disclose the study or its results to the FDA, physicians or users, according to the petition.
In the first of two studies commissioned by attorney Manchester, Aldo Crugnola, a professor of plastics engineering at the University of Lowell, examined devices supplied by A.H. Robins and found "obvious ruptures in the sheath" in 42 percent of shields in place for as long as six months and in 67 percent of those in place for 24 months or more.
A study by Dr. Paula Fives-Taylor, a professor at the University of Vermont Medical School, showed that bacteria tended increasingly to adhere to the string over time and that the string clearly provided bacteria a path to the uterus.
Fives-Taylor said her findings were consistent with an earlier study showing that risk of disease for women using Dalkon shields was 9.1 times greater than for women not using an IUD. The risk for users of other types of IUD was just 1.7 times greater, according to the study.
Today's petition is the second effort by the women's group to force recall of the Dalkon Shield. Last August, U.S. District Court Judge David S. Nelson in Boston dismissed the first request on grounds that it fell under FDA jurisdiction.
Manchester said the women's group hopes to test such issues as whether the FDA can order recall of a product sold overseas and whether agency regulations supersede rights of individual states to order a product recall.