Dalkon Shield
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Dalkon Shield was the name of a contraceptive intrauterine device (IUD) introduced by the Dalkon Corporation. Accusations of malfunction of this product led to a very famous lawsuit.
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History
The first modern IUDs were produced by Dr. Jack Lippes in the 1960s. They were made of plastic with an attached monofilament plastic tail. This tail had two purposes: By inserting a finger into the vagina and feeling the tail, a woman could be assured the IUD was in place, and it could be removed by a medical doctor when desired by the patient. Popular IUDs of the era include the Lippes Loop and the Saf-T-Coil.
In 1970 the A.H. Robins Company acquired the Dalkon Shield product from the Dalkon Corporation. In 1971, Dalkon Shields went to the market in the United States and Puerto Rico, spearheaded by a large marketing campaign. At its peak, about 2.8 million women used the Dalkon Shield.
Design
Like other IUDs, the Dalkon Shield was designed to be inserted into the uterus through the cervix. Like other IUDs, it had a trailing plastic "string" that reached through the cervix and into the vagina, providing users with tactile confirmation that the IUD was properly in place and medical practitioners with a means of removing the device. Rather than a single-strand string, the Dalkon Shield used a braided, multi-strand string encased in a sheath.
Soon after the product came into the market, the A.H. Robins Company began receiving complains of sick clients, who experienced pelvic inflammatory disease and tubal infertility. Some patients suffered ectopic pregnancies (indicating that the Dalkon Shield was not 100% effective against pregnancy). Other women underwent septic abortions and 12 died. Initial suspicions focused on the braided string. Critics, such as Dr. Howard J. Tatum argued that the string acted first as a breeding ground for bacteria and then as a conduit that allowed them to penetrate the uterus and fallopian tubes. The company's defenders countered that all the deaths occurred in women who used the larger model of the Dalkon Shield, despite the fact that both models used the same type of string. The product was removed from the market in June 1974.
Aftermath
The market for IUDs in the United States virtually collapsed after the withdrawal of the Dalkon Shield. Although new models of IUD began to appear in the late 1980s, the IUD remains one of the least popular types of contraception among US women. The popularity of IUDs worldwide was undiminished, and remains high.
Numerous lawsuits were filed against the A.H. Robins Company in the aftermath of the Dalkon Shield debacle. The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in 1985. Over 300,000 claims were filed against it in bankruptcy court. The threat and potential cost of litigation led to the abandonment of IUDs by other manufacturers.
Large-scale studies of IUD-related infections, carried out after the withdrawal of the Dalkon Shield, showed that early suspicions about the Dalkon Shield's string as a source of infection were incorrect. The current consensus among medical practitioners is that IUD-related infections occurring between three weeks and three months after insertion are most likely due to improper sterilization, and that the risk of subsequent infections increases substantially in women with multiple sexual partners (Mumford 1992).
The Dalkon Shield case helped to bring about regulatory changes that, in 1976, gave the U. S. Food and Drug Administration the authority to require testing and approval of medical devices.
References
- Story of Trial Lawyer [1]
- Speroff L, Glass RH, Kase NG. Clinical Gynecological Endocrinology and Infertility. 6th Edition, Lippincott, Williams & Wilkins, 1999, page 976.
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