Далкон Щиты: Трагедия внутриматочной спирали

Form of Intrauterine Device(IUD)

The Dalkon Shield was a contraceptive intrauterine device (IUD) developed by the Dalkon Corporation and marketed by the A. H. Robins Company. The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of women, which eventually led to numerous lawsuits, in which juries awarded millions of dollars in compensatory and punitive damages.

The Dalkon shield was developed by Hugh J. Davis, a physician, and Irwin Lerner, an electrical engineer. Davis was a physician working as a gynecologist with an interest in limiting the effects of overpopulation in the world, as part of the Zero population growth theory popular in the 1960s. He wrote: "While the upper socioeconomic tenth of the population can and does indulge in elaborate precoital rituals to control their fecundity the lowest socioeconomic tenth rejects such methods The birth rate in the city of Baltimore in 1960 reflects this fact. There were 73 births per 1,000 white females in the highest economic class aged fifteen to forty four, while in the lowest economic class there were 133 births. Thus, the segment of the population least able to discharge the responsibilities of parenthood was producing twice as many children per annum. The difference was nearly triple in the comparable non white group." He setup a family planning clinic for the Johns Hopkins Hospital in 1964, with the help of the Ortho Pharmaceutical Company, with many of his public patients being poor and black Baltimoreans. By the late 1960s, they were inserting up to 70 IUDs a month, some experimental, created by Johns Hopkins and Ortho. In 1964, he began working with Irwin Lerner, an electrical engineer, on various medical devices, and over Christmas 1967, they decided to work on an IUD together. The design they came up with had a closed center (so as to not pose a risk of strangling the intestines if it migrated to the abdomen), and increase its surface area (and perhaps effectiveness) made of EVA (which had been approved by the FDA for use in food packaging), and fins were added to make it less likely to dislodge. This, in turn, made it more difficult to remove, and necessitated a stronger string, for which they used Supramid, a multifilament string encased in a nylon sheath. Previous IUD designs had used a monofilament plastic string to reduce the chance of wicking bacteria from the non sterile vaginal canal to the sterile uterus. To manage this risk, they tied a knot at either end of the string and ran experiments to see if inky water would wick past the knot and up the string. It did not, and no further wick testing was done by the company.

Davis used the Johns Hopkins clinic to study the effects of his Dalkon shield on 640 women over a year long period between 1968 and 1969. He reported a pregnancy rate of 1.1%, an expulsion rate of 2.3%, a retention rate of 94%, and reduced bleeding complications. However, this was later found to have numerous flaws; in the five months after the study was concluded, pregnancy rates were at 3 5%, it didn't have enough participants to give statistically significant results, and the average woman was enrolled for 5 months of the 12 month study; women who dropped out were not included in the results; some women were included after they had found success with the IUD, and Davis had recommended using spermicide during the most fertile days of patients cycles. Lerner applied for a patent alone in 1968, and Lerner, Davis, and their attorney Robert Cohen formed the Dalkon Corporation. After testing, the membrane of the shield was thinned and softened to help with extraction; copper sulphate was added to increase its radiopacity; metallic powdered copper was added to improve the plastic's strength; and they created a smaller version for women who had not given birth. The addition of copper sulfate caused a problem for the company, since at the time the FDA was obliged to study and approve medical drugs and not devices, and although the IUD as a whole was a medical device, the copper was ruled to be a drug. To evade oversight, Robins claimed the copper sulphate was only there to help with imaging. The effectiveness of these changes were not studied before the device went on the market.

In February 1970, Davis's study on his Dalkon Shield was published in the American Journal of Obstetrics and Gynacology. It did not mention his status as a co inventor, or his financial interest in the device, nor was it peer reviewed before publication. In the time between the study's submission to the journal and its publication, several women had become pregnant, making the pregnancy rate 3 5%, and taking it from better than other IUDs and oral contraceptives on the market to worst. The Dalkon Corporation in 1970 gained another investor, J. Earl, M. D., a medical practitioner in Defiance, Ohio. The Dalkon Shield was promoted as a safer alternative compared to birth control pills, which at the time were the subject of many safety concerns. Dr. Davis himself was a participant in the 1970 Nelson hearings, which were congressional hearings led by Senator Gaylord Nelson regarding the safety of oral contraceptives. He asserted that oral contraceptives with high doses of hormones were dangerous and that the efficacy of the pill was "greatly overrated".

In January 1971, Dalkon Shield went into the market, beginning in the United States and Puerto Rico, spearheaded by a large marketing campaign. Initial reports in the medical literature raised questions about whether its efficacy in preventing pregnancy and expulsion rate were as good as those claimed by the manufacturer, but failed to detect the tendency of the device to cause septic abortion and other severe infections.

Physicians reported that the Dalkon Shield was more difficult to insert and painful than other types of IUDs, with a doctor writing to A. H. Robins in 1971 that "I have found the procedure to be the most traumatic manipulation ever perpetrated on womanhood, and I have inserted thousands of other varieties." By 1974, approximately 2.5 million women had received the Dalkon intrauterine device. In June of that year, the medical director of A. H. Robins published a letter to the editor of the British Medical Journal stating that the company was aware of an "apparent increase in the number of cases of septic abortions," including four fatalities, but stating that "there is no evidence of a direct cause and effect relationship between wearing of the Dalkon Shield and the occurrence of septicemia". The letter recommended precautions, including pregnancy tests for women who missed their period and the immediate removal of the device for women who were found to be pregnant. That same month, A. H. Robins suspended sales of the device in the United States at the urging of the Food and Drug Administration, but continued to sell it overseas. In October 1974, a series of four case reports of septic pregnancies were published in the journal Obstretics and Gynecology. In 1975, the CDC published a study associating the Dalkon Shield with a higher risk of spontaneous abortion related death compared to other IUDs. As many as 200,000 women made claims against the A. H. Robins company, mostly related to claims associated with pelvic inflammatory disease and loss of fertility. The company eventually filed for bankruptcy. The company's representatives argued that pelvic infections have a wide variety of causes, and that the Dalkon Shield was no more dangerous than other forms of birth control. Lawyers for the plaintiffs argued that the women they represented would be healthy and fertile today if not for the device. Scientists from the CDC stated that both arguments have merit.

In 1971, 5 months after the IUD was released, the string was found to wick bacteria into the vagina by a quality control supervisor, and the company chose to change nothing. In June 1974, at the urging of the US FDA, Robins removed the IUD from the US market, but it continued to be marketed and sold internationally. The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in August 1985. As part of the bankruptcy, they set up a 2.5 billion dollar trust fund for claimants. The share price went up following the bankruptcy, and the owners were later able to sell the A. H. Robins for a profit to American Home Products (now Wyeth) in 1989, with American Home Products receiving tax deductions up to about 1 billion dollars from the trust fund for victims and related to purchasing a company that has been in bankruptcy. More than half of the women in the class action suit were paid less than $1000, although some may have been paid out as much as $1 million in the cases of babies born with birth defects.

Overseas, the Dalkon shield continued to be marketed and sold for years after its withdrawal from the American market in 1974. In Australia, company memos informed their sales representatives of problems reported in the US, but this information was 'not to be used in doctor discussions'. It continued to be inserted as late as 1980.

In the US, IUDs remain unpopular despite their effectiveness, safety, and low cost. Pharmaceutical companies were discouraged from investing in IUDs after the bankruptcy of Robins and found them less profitable and more controversial than oral contraceptives. There were no IUDs on the market in the USA between 1983 and 1988, and modern IUDs (despite being well tested, effective, and impossible to misuse) are expensive and unpopular, which many attribute to memories of the Dalkon Shield amongst both physicians and the populace.