Long Tail Strings: Impact of the Dalkon Shield 40 Years Later

Abstract

Intrauterine devices (IUDs) are the most effective, reversible and longest acting birth control method. They require no effort for compliance and avoid systemic synthetic hormones. Evidencebased effectiveness and safety studies have demonstrated IUDs rival sterilization. IUDs low cost make them the most popular method worldwide. Despite these benefits, IUDs have minimal market penetration in the United States where they are expensive, disparaged by an older generation of physicians, and withheld from teenagers, nulliparous women, and women not in mutually monogamous relationships, i.e., those who would most benefit. This article reviews the nearly forgotten history of the IUD that resulted in broadening the Food and Drug Administration's oversight of medical devices, brought needed transparency to physicians' conflicts of interests, uncovered a corporate scandal with a whistleblower that led to a major pharmaceutical bankruptcy, and involved 327,000 women (though only 195,000 met strict criteria for claims) in the largest US personal injury case.

Marketing and Public Policy Implications of Dobbs v. Jackson Women's Health Organization

“…First, many HCPs lack the training to insert LARCs (Durr et al 2021). Second, HCPs encounter resistance to IUDs, which may partially be attributed to negative word of mouth evoked by the Dalkon Shield, a beetle-shaped IUD popular in the early 1970s that was linked to IUD failures, infections, and maternal deaths (Roepke and Schaff 2014). In 1974, after a warning from the U.S. Department of Health, the company pulled the product from the market (see Sifferlin 2015).…”

FDA Device Oversight From 1906 to the Present

“…Lessons From the Dalkon Shield A contraceptive device inserted into a woman's uterus for pregnancy prevention, the Dalkon Shield was marketed to American women beginning in 1971 as a better alternative to contraceptive pills. 8 Its use skyrocketed, with approximately 2.2 million devices implanted in American women by 1974. 9 Due to limitations in regulatory requirements at that time, no federal oversight of the device's premarket assessment occurred.…”

Contraceptive Methods and the Subsequent Search for a Pregnancy

“…Despite some previous attempts and projects some decades earlier, it was not until the 1960s that commercial IUDs made their way into the market with the approval of the Lippes Loop and the Safe-t-coil by the FDA in 1966. The Dalkon shield, introduced in 1971, attempted to increase the surface of the endometrium in contact with the IUD and to increase retention rate; it included a multifilament tail string encased in Nylon [99]. Several reports associated this IUD with increased infection rates, septic abortions and deaths; apparently the multifilament string could allow vaginal bacteria to access the uterus.…”