CONTENTS
December 1995 |
The introduction of the TCu-380A in the US in 1988 filled a gap created in the mid-1980s when US manufacturers stopped selling the Saf-T-Coil (139), the Lippes Loop (246), and, in 1986, the TCu-200 and the Cu-7 (316). After the withdrawal of these devices from the market, the hormone-releasing Progestasert® was the only IUD available in the US for a number of years. This caused hardships for US women as well as concern in other countries (111). The reasons for this near absence of IUDs on the US market were unique and complex. They did not involve the safety or efficacy of these IUDs but instead involved business decisions. In the US, unlike many other countries, family planning services are provided largely through the private sector. As doctors switched to copper IUDs, sales of all-plastic devices declined, leading manufacturers of the Saf-T-Coil and the Lippes Loop to halt production (139, 246). The manufacturer took the copper Cu-7 and TCu-200 off the market in 1986 for a somewhat different reason. Over 800 lawsuits had been filed against the company, charging that the IUDs had injured their users. As a result, continuing liability insurance became unavailable (316). Although the company had won most of the cases that went to trial, the costs of defending against the lawsuits were so high that the company decided for financial reasons to stop marketing IUDs (457). The US FDA did not request that these IUDs be taken off the market, and the agency never recommended that women have these IUDs removed. Why were there so many lawsuits in the US over IUDs? This litigation is part of a larger US crisis in liability and liability insurance that is affecting many products and services in the health field as well as in other areas (3, 111, 292). IUDs became a particular target for US lawsuits because research in the mid 1970s linked one IUD, the Dalkon Shield, to spontaneous septic abortions and pelvic inflammatory disease (46). The Dalkon Shield was marketed nationwide between 1971 and 1974 (209). The extent of health risks with the Dalkon Shield may have been due to its particular design (372). Because of lawsuits and for other economic reasons, it has become more difficult and expensive for pharmaceutical companies and other institutions to obtain insurance (76, 111, 299, 338, 403). The temporary lack of IUDs in the US market was widely misunderstood and caused confusion. Some providers thought incorrectly that the government had declared IUDs unsafe (97). As IUDs became less available, IUD use in the US dropped. In 1987 a survey found that 3% of all women ages 15 to 44 were using IUDs. In 1992 the same survey found that only 1% of US women were using IUDs (594). US IUD users like the method, however. Among those who expressed an opinion, 96% of IUD users viewed their method of contraception favorably, topped only by users of implants, at 98%. By comparison, 94% of Pill users rated their method favorably, as did 93% of users of voluntary female sterilization and vasectomy, and 90% of condom users, while 76% of diaphragm users and 74% of rhythm method users had favorable views of their methods (594). |