Abstract

Over the course of 5 months in late 1985 and early 1986 Ortho Pharmaceutical Corporation ceased manufacturing their nonmedicated IUD the Lippes Loop and G.D. Searle and Company stopped US sales of their copper-bearing IUDs the TCu 200 and the Copper-7. Both companies cited reasons that were business-related not safet-related: In recent years the Lippes Loop had lost ground in sales to Copper-bearing IUDs; in addition since the late 1970s the number of lawsuits filed against Searle by women alleging that they had been injured by IUD use had mushroomed. Thus Ortho and Searle elected to remove their IUDs from the US market even though the FDA still considered them safe and effective methods of birth control. After this attention was turned to other IUDs as yet unlicensed in the US. 1 such IUD the TCu 380A was developed by the The Population Council in 1972 and has been used by many women around the world since 1982. But it was not until October 1987 that The Population Council was able to license the IUD. The TCu 380A represents an improvement over the TCu 200 in part because it carries 380 mm squared of copper instead of 200 mm squared. The copper on the TCu 380A comes both around the stem and fitted to the IUDs crossbar; as a result the device delivers more copper ions to the uterine fundus enhancing the contraceptive effect. A number of studies have shown the 4 year pregnancy rate associated with the TCu 380A to be less than 2 per 100 users. (authors modified)

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