Dalkon Shield - Design

Design

According to Ohio personal injury lawyer Jim Szaller:

On June 12, 1970, Robins purchased the Dalkon Shield from the Dalkon Corporation. (fn. 13) Within weeks of the purchase, some 30 high-ranking Robins officials, including E. Claiborne Robins, Sr., were informed in a memorandum stamped "confidential" of the Dalkon Shield tailstring's "tendency" to wick. The vagina is a wet cavity, normally inhabited by pathogenic bacteria. The uterus, on the other hand, is a sterile organ. If bacteria by some means gain entrance to the uterus, pelvic infection results. The infection can spread from the uterus to the fallopian tubes and ovaries, causing pelvic inflammatory disease (PID). PID, often evidenced by scars and adhesions on and around the pelvic organs, can cause occlusion of the fallopian tubes, resulting in ectopic pregnancies or sterility. Because the string was open at both ends (fn. 14) -- one in the bacteria-laden vagina, the other in the sterile uterus -- the wicking propensities of the Dalkon Shield tailstring portended disease. Of course, that didn't dampen Robins' enthusiasm, and irrespective of the warning it continued to march hastily toward production and sale.

National marketing began in January 1971, and Robins aggressively promoted the device as safe and effective. Insupportable, laudable claims were made while contraindications, side effects and cautions, contained in fine print on the next to last page of the "filecard" (the official labeling which accompanied the product) were seldom repeated in advertisements, even in diluted form. No warning was made in any promotional materials that the Dalkon Shield could cause widespread fulminating pelvic inflammatory disease, spontaneous or septic abortion, ectopic pregnancy, or infertility. The only warning given -- "sepsis may result from unclean technique" -- implied the treating physician's conduct, rather than the product, could harm the user.

Almost immediately after marketing began, Robins received complaints of severe pelvic infection. The tailstring was beginning to take its toll on users. Bacteria wicked from the vagina to the uterus was resulting in pelvic infection that caused PID, which in turn resulted in ectopic pregnancies and, for some, infertility. The longer the device remained in the body, the more bacteria could potentially enter the uterus, for the wicking process persisted. Compounding the situation was that the outer sheath of the Dalkon Shield tailstring, made of Nylon-6, underwent hydrolysis in the body. Wherever it disintegrated, holes in the sheath were created for bacteria to enter and exit. Finally, "fins" surrounding the body of the device dug into and often became embedded in the endometrium (the inner layer of the uterus), thus promoting the infectious process since the traumatized tissue was especially susceptible to bacteria. There was eventually reported in the medical literature (fn. 15) a unique and dire medical condition being suffered by some women who conceived while the Dalkon Shield was in situ. The condition was known as "septic spontaneous abortion," and occurred when the Dalkon Shield tailstring, filled with bacteria, was pulled upward as the pregnant uterus expanded. The bacteria attacked the placenta and the woman, ending in death of the fetus and, in some cases, the woman. Prior to reports of septic abortion in wearers of the Dalkon Shield, physicians had only seen this life-threatening medical condition in situations of criminal abortion with subsequent serious pelvic infection. When it was first reported that some women wearing the Dalkon Shield had occasioned septic spontaneous abortions, no one, including Robins, offered any explanation of how and why it occurred in Dalkon Shield wearers. Indeed, no one but Robins could have offered any explanation, because Robins had never disclosed to anyone that the tailstring was multifilament, and that it wicked. A physician in New York, Howard J. Tatum, M.D., Ph.D., was the first person who, outside of Robins, learned that the Dalkon Shield tailstring was multifilament, and that it had a propensity to wick. It was he who, in 1975, performed simple laboratory tests to evidence wicking and explain how the Dalkon Shield was the causative factor in septic spontaneous abortion. His results were published in the medical literature in January and February 1975, (fn. 16) but the information came too late to be of help to women considering which IUD to use. The Robins Company had "voluntarily" withdrawn the product from the market in June 1974 under pressure from the FDA.