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CLINICALCORNER [Medical Marketing and Media](Medical Marketing and Media Via Acquire Media NewsEdge) There are many reasons that women and physicians have warmed once again to the use of intrauterine devices (IUDs), among them educational efforts by the American College of Obstetricians and Gynecologists and the pervasive view that IUDs "are truly the most effective and economical type of birth control," according to Dr. Lisa Dietrich, executive vice president and director of medical affairs at ICC Lowe. But one factor that can't be dismissed is the age of the patients who are using them-they are too young to remember the notorious and tragic case of the Dalkon Shield. Developed by Dr. Hugh Davis of Johns Hopkins University, the Dalkon Shield was an intrauterine contraceptive device sold by the A.H. Robins Company in the 1970s. Owing to its unique shape-it had a crab-like design, with five prongs-the device was difficult to remove, which necessitated a multifilament tail string to aid with removal (by comparison, modern IUDs use monofilament strings). It was thought that the multifilament string allowed bacteria to climb into the vagina, causing pelvic infections that resulted in infertility or even death. As reports of these pelvic infections started to surge, the Food and Drug Administration advised A.H. Robins to withdraw the product from the market. In 1983, the FDA recommended that women using the Dalkon Shield should have it removed. Ultimately, the Dalkon Shield was found to have been responsible for 18 deaths and more than 200,000 infections and miscarriages. Bending beneath the weight of litigation, A.H. Robins abandoned the Dalkon Shield in the mid-1980s. The company was ultimately sold in bankruptcy to American Home Products (now Wyeth). It's no surprise, then, that the Dalkon Shield almost singlehandedly ended IUD usage in the US. "In another age, the term 'IUD' struck fear in people," Dietrich recalls. It was not until 1988 that IUDs began to reemerge as an option for many women, thanks to GynoPharma's release of a new copper IUD, ParaGard. Years later, the Dalkon Shield legacy extends beyond the damage it inflicted on the lives of women and their families, according to Wayne Pines, president of regulatory services and healthcare at APCO Worldwide and a former associate commissioner of the FDA. "The Dalkon Shield episode was a seminal example of where litigation became the predominant factor in driving medical decision-making," he says. "At the same time, the litigation caused IUDs to gain such a bad reputation that it became unfeasible for companies to develop and market the technology. It changed the dynamic of birth control for that generation." According to the Guttmacher Institute, a nonprofit group that works on reproductive health issues, 2.14 million US women used IUDs in 2010-5.6% of all US women who practice contraception. (c) 2014 Haymarket Media, Inc. |