The copper intrauterine birth control device--not widely available since IUDs were withdrawn from the U.S. market in 1986--is to be reintroduced by the middle of next year.
An announcement of the reintroduction of an updated version of the Copper-7 was made at a New York press conference Wednesday.
A popular and relatively effective form of birth control, IUDs have not been generally available in the United States since early 1986, when manufacturers withdrew the products because of the fear of liability suits. An early intrauterine birth control device, the Dalkon Shield, triggered an onslaught of liability litigation over side effects, including pelvic inflammatory disease (PID).
Doctors' Offices and Clinics
The new IUD is expected to be available through private physicians' offices and birth control clinics by the middle of 1988. Some shipments could be made as early as January.
The new version--the Copper-T 380A--was approved for use in this country in 1984 by the U.S. Food and Drug Administration but was never sold here. The 380A has been available in Canada, however, where birth control experts have reported high success rates and few complications. Dr. Louise Tyrer, medical director of the Planned Parenthood Federation of America, said the announcement was "very good news (because) women have been disenfranchised from one of the most effective, long-term, reversible methods of contraception" since G.D. Searle & Co. stopped manufacturing IUDs in the United States in January, 1986.
Worldwide manufacturing rights to the new IUD are owned by the Population Council, a New York-based private international contraception agency, which had licensed Searle to market earlier versions in this country. When Searle withdrew from the American market, the Population Council reacquired the U.S. rights.
Under a new marketing agreement with the Council, GynoMed Pharmaceutical, Inc. of Somerville, N.J., will manufacture and distribute the updated Copper-T. Under terms of the agreement, the company had to furnish the Population Council with evidence of adequate product liability insurance and had to agree to make wholesale quantities available at a 50% discount to public sector birth control clinics, which usually charge less for standard gynecological procedures than private physicians.
Planned Parenthood officials noted that, because copper IUDs have a small chance of enhancing a woman's risk of getting PID, IUDs are appropriate for women who do not desire additional children, are monogamous, aren't at risk for PID and do not want to take birth control pills.
Searle has continued to manufacture and market various versions of the Copper-7 and Copper-T in Canada, Britain and elsewhere. And, since early last year, many American women have quietly traveled to Canada to obtain IUDs there.
A hybrid IUD, the Progestasert, made by Alza Corp. of Palo Alto, has continued to be available here, but it must be replaced annually because it inhibits conception by releasing small amounts of a birth control hormone. It is not widely regarded as a true IUD.
Despite Searle's withdrawal from the market, some women have been able to get copper IUDs from private physicians and public clinics that retained their existing stocks and have been rationing them carefully. The Los Angeles chapter of Planned Parenthood and the San Bernardino County Health Department have continued to make IUDs available.
But the announcement Wednesday, Tyrer said, apparently means that an unrestricted supply of copper IUDs will again be available to American women without the need to travel to another country or find a provider who, by chance, had retained small stocks.
Observers point out that the problem with IUDs has been availability. The IUDs in question were never the subject of a recall by the FDA and their use has continued to be completely legal nationwide.
George Zeidenstein, president of the Population Council, said his organization had been concerned about the IUD public relations climate ever since major problems were encountered with the Dalkon Shield, problems with which forced its manufacturer, A.H. Robins Co., into bankruptcy.
But Zeidenstein noted that recent copper-based IUDs never were the subject of safety concerns. He said the Population Council had been urged by many family planning organizations to negotiate another American licensing deal for its copper IUD, "so that American women can have the same range of contraceptive options as women in other countries."
And in a statement released at Wednesday's news conference, the American College of Obstetricians and Gynecologists said it was "encouraged" by the development.
The organization, which represents physicians, said "after a period of more than one and a half years in which the IUD was largely not available in the United States, American women once again will be able to choose a contraceptive that is appropriate and effective for a certain group of women."