Like every birth control method, the intra-uterine device (IUD) has its drawbacks. A piece of inert plastic—usually T-shaped and covered with copper—that is inserted in the uterus, it has been associated with menstrual cramps and infection that can lead to sterility. Still, between 30 and 40 million women worldwide currently use copper lUDs because they are relatively safe, effective and convenient. But few of the users are American. For the past two years IUDS have been almost impossible to obtain in the United States. And experts say that, as a result, an increasing number of American women are either turning to less reliable means of birth control or— despite the increased sales of condoms, which can be attributed more to concerns about acquired immune deficiency syndrome (aids)—they have stopped using contraceptive devices altogether.
Since early 1986 only one U.S. company, Alza Corp. of Palo Alto, Calif., has been distributing an IUD—Progestasert, which works in part by releasing the hormone progesterone and has to be replaced every year. During 1985 and 1986 the two major American IUD manufacturers—Ortho Pharmaceutical Corp. of Raritan, N.J., which made the Lippes Loop, and G.D. Searle & Co. of Skokie, 111., manufacturer of the Copper-7 and the Tatum-T—stopped making lUDs. Some family planning counsellors have attributed that turn of events to the negative publicity surrounding the Daikon Shield IUD, made by the A.H. Robins Co. of Richmond, Va., which medical experts say caused infection, sterility, miscarriages—and at least 15 deaths—before it was taken off the market in 1974. But spokesmen for Ortho and Searle say that their decision was based on market reasons rather than medical ones.
Still, some industry spokesmen say that the overriding factor has been the huge number of product liability lawsuits brought against the A.H. Robins Co. Although similar lawsuits launched against Ortho and Searle were largely unsuccessful, litigators “tried to tar their IUDS with the same brush as the Daikon Shield,” according to Dr. Louise Tyrer, vice-president of medical affairs of the New York-based Planned Parenthood Federation of America. In any event, American insurance companies have been reluctant to insure any IUD manufacturers or doctors who prescribe them. Indeed, Kay Bruno, Chicago-based spokesman for Searle, acknowledged that her company’s decision was based in part “on the lack of availability of product liability insurance.”
For her part, Sandra Waldman, spokesman for The Population Council, a New York-based nonprofit biomedical and social sciences research group, said that those developments were regrettable. Declared Waldman: “As a result of the scandal over the Daikon Shield, American women are being denied access to one of the best birth control methods around.” In the hope of turning that situation around, the council’s laboratories have developed a new IUD, the Copper T380A, which Waldman says is as safe as other governmentapproved lUDs. She added that the Tshaped plastic device is also more effective than earlier versions because more copper—the substance that impedes fertilization—is wrapped around it.
Approved by the U.S. Food and Drug Administration in 1984 and expected to reach consumers next year, the Copper T380A will be distributed by GynoMed Pharmaceutical Inc. of Somerville, N.J., through what chairman Roderick Mackenzie calls “conservative and educated marketing.” Mackenzie said that his company will ask physicians and clinic staff members to sign forms attesting that they have read all the background material packaged with the Copper T380A. Company officials will also suggest to doctors that they ask the women for whom they prescribe the IUD to sign similar forms. Among the precautions contained in the material is that the Copper T380A should not be used by women who have never been pregnant or who have had a history of pelvic inflammatory disease—an infection of the fallopian tubes and ovaries that can cause sterility—or “multiple sexual relations.”
On the other hand, the accompanying literature recommends the Copper T380A to women who have “a stable, mutually monogamous relationship,” who have had a child and who are over 25. According to Planned Parenthood’s Tyrer, those limitations are more stringent than they have to be. Declared Tyrer: “The company is trying to limit its liability so they can stay on the market.” For his part, Mackenzie denied that the company’s cautious approach is related to the liability issue. But he added that no IUD is totally safe—underscoring the frustrations facing researchers in their search for a birth control method that is at once completely effective and convenient and free of risk.
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