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.
48-535: 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
96-412: A Connecticut lawyer, and Professor Charles Lee Remington . In the long term, zero population growth can be achieved when the birth rate of a population equals the death rate . That is, the total fertility rate is at replacement level and birth and death rates are stable, a condition also called demographic equilibrium. Unstable rates can lead to drastic changes in population levels. This analysis
144-457: 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,
192-409: 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.,
240-527: A country occurs when the sum of these four numbers – births minus deaths plus immigration minus emigration - is zero. To illustrate, suppose a country begins the year with one million people and during the year experiences 85,000 births, 86,000 deaths, 1,500 immigrants and 500 emigrants. Change in population = 85,000 – 86,000 + 1,500 – 500 = 0 Population growth rate = (0 ÷ 1,000,000) x 100% = 0% For
288-476: A country's fertility is at replacement level, and has been that way for at least several decades (to stabilize its age distribution), then that country's population could still experience growth due to increasing life expectancy , even though the population growth is likely to be smaller than it would be from natural population increase. Zero population growth is often a goal of demographic planners and environmentalists who believe that reducing population growth
336-636: A given year equals the number of births minus the number of deaths plus immigration minus emigration expressed as a percentage of the population at the beginning of the given year. For example, suppose a country begins a year with one million people and during the year experiences one hundred thousand births, eighty thousand deaths, one thousand immigrants and two hundred emigrants. Change in population = 100,000 – 80,000 +1,000 – 200 = 20,800 Population growth rate = (20,800 ÷ 1,000,000) x 100% = 2.1% Zero population growth for
384-463: A medical practitioner in Defiance, Ohio . Looking for a large retailer with marketing experience to sell their product, Earl met with a representative from A.H. Robins Company and sold them ownership rights and royalties. Robins was a pharmaceutical company but had no previous experience with birth control, nor had it made a medical device, an unregulated area at the time. The Dalkon Shield was promoted as
432-399: 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
480-593: 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. In September 1980, Robins wrote a letter to physicians recommending they remove the Dalkon shield from women still wearing them. In 1984, 10 years after it was taken off the market in
528-404: 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
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#1732852373887576-425: A smooth nylon outer sheath that was commonly used to repair tears in the tendons of horses. In 1971, a quality control supervisor found that the strings were able to wick water and suggested heat-sealing the ends of the string to form a barrier against wicking, but management rejected the idea as cost prohibitive. In addition to the string's ability to wick bacteria, the string also had a propensity to deteriorate inside
624-503: 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 uterus by
672-427: Is a time lag between the point at which the fertility rate (mean total number of children each woman has) falls to the replacement level and the point at which the population stops growing. The reason for this is that even though the fertility rate has dropped to replacement level, people already continue to live for some time within a population. Therefore, equilibrium, with a static population, will not be reached until
720-430: Is as follows: A loosely defined goal of ZPG is to match the replacement fertility rate , which is the average number of children per woman which would hold the population constant. This replacement fertility will depend on mortality rates and the sex ratio at birth, and varies from around 2.1 in developed countries to over 3.0 in some developing countries. China and India are the largest countries by population in
768-550: Is essential for the health of the ecosystem . Achieving ZPG in the short run is difficult because a country's population growth is often determined by economic factors, incidence of poverty, natural disasters, disease, etc. Albert Bartlett , who was a professor of physics at the University of Colorado at Boulder , suggested that a population has the following choices to achieve ZPG: Similarly, Jason Brent argues that there are three ways to achieve zero population growth. His argument
816-431: Is valid for the planet as a whole, but not necessarily for a region or country as it ignores migration . Population momentum . Even when the total fertility rate of a population reaches replacement level, that population usually continues to grow because of population momentum . A population that has been growing in the past will have a higher proportion of young people. As it is younger people who have children, there
864-487: The birth control pill ("the Pill") in 1960 revolutionized the options for contraception, sparking vibrant discussion in the scientific and social science literature and in the media. Much attention focused on issues of women's rights , including ethics and personal choice. But the Pill also introduced new questions about risk. Two types of female oral contraceptive pill, taken once per day, are widely available: For perfect use
912-401: 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
960-473: 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
1008-473: The IUD as a whole was a medical device, the copper was ruled to be a drug. To evade oversight, Robins claimed the copper sulfate 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 Gynecology. It did not mention his status as
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#17328523738871056-437: The US, the company put out newspaper, magazine, and television ads warning people of the risks and offering to pay for the shield's removal. More than 327,000 lawsuits and claims were filed against the A.H. Robins Company – the largest tort liability case since asbestos . The federal judge, Miles W. Lord , attracted public commentary for his judgments, holding the corporate heads personally accountable, saying "Your company in
1104-487: 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,
1152-482: The bankruptcy of Robins, deciding that they were less profitable and more controversial than oral contraceptives. There were no IUDs on the market in the USA between 1983 and 1988, and newer IUDs remained unpopular through the 1990s, likely due to memories of the Dalkon Shield amongst both physicians and the populace. Only 1% of American women (aged 15-44) were using IUDs in 1995, but that number grew to 2.4% by 2004, and by 2017
1200-413: The body, adding additional risks and giving bacteria another avenue to enter the string. These properties allowed bacteria to pass through the cervix into the uterus, bypassing the cervical mucus, which normally acts as a barrier against infection. 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
1248-476: 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. By 1989, over 7,000 Australians were suing
1296-624: The company in relation to pregnancies, pelvic inflammatory disease, ectopic pregnancies , spontaneous septic abortions, and perforated uteri. In 1976, the Medical Device Amendments to the Food, Drug, and Cosmetic Act mandated the U.S. Food and Drug Administration, for the first time, to require testing and approval of not just medications, but also medical devices, including IUDs. Pharmaceutical companies were discouraged from investing in IUDs after
1344-478: The face of overwhelming evidence denies its guilt and continues its monstrous mischief. You have taken the bottom line as your guiding beacon and the low road as your route. This is corporate irresponsibility at its meanest." The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in August 1985. The bankruptcy was legal but controversial at
1392-412: The first "replacement level" birth cohorts reach old age and die. Aging populations . Conversely, with fertility below replacement, the fraction of elderly grows; but since that generation failed to replace itself during its fertile years, a subsequent "population bust", or decrease in population, will occur when the older generation dies off. This effect has been termed birth dearth . In addition, if
1440-480: The five was associated with the Dalkon Shield. Based on these data, the CDC estimated an IUD-related fatality rate of 3 per million users per year of use, which it compared favorably to the mortality risks associated with pregnancy and other forms of contraception. Importantly, the survey showed that the Dalkon Shield was associated with an increased rate of pregnancy-associated complications leading to hospitalization. By 1974, approximately 2.5 million women had received
1488-495: The forecast of a reduced labor pool and support for an aging population. India reached replacement level in 2021. However, the Indian population will keep growing for decades, given its relatively young population (see Mechanisms above). Birth control pills Oral contraceptives , abbreviated OCPs , also known as birth control pills , are medications taken by mouth for the purpose of birth control . The introduction of
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1536-463: The insertion stick was also flawed, with the stick protruding past the end of the IUD. Physicians reported that it was easy to accidentally perforate the uterus with this tip. In June 1973, the Centers for Disease Control and Prevention (CDC) conducted a survey of 34,544 physicians with practices in gynecology or obstetrics regarding women who had been hospitalized or had died with complications related to
1584-462: 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
1632-516: The late 1960s, ZPG became a prominent political movement in the U.S. and parts of Europe, with strong links to environmentalism and feminism . Yale University was a stronghold of the ZPG activists who believed "that a constantly increasing population is responsible for many of our problems: pollution, violence, loss of values and of individual privacy." Prominent advocates of the movement were Paul Ehrlich , author of The Population Bomb , Richard Bowers,
1680-441: 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
1728-447: 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." The design of
1776-489: The membrane of the shield was thinned and softened to help with extraction; copper sulfate 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
1824-411: The number had climbed to 14.0%, as a younger generation of women began embracing the newer IUDs as a safe, long-acting form of birth control. Zero population growth Zero population growth , sometimes abbreviated ZPG , is a condition of demographic balance where the number of people in a specified population neither grows nor declines ; that is, the number of births plus in-migrants equals
1872-405: The number of deaths plus out-migrants. ZPG has been a prominent political movement since the 1960s. As part of the concept of optimum population, the movement considers zero population growth to be an objective towards which countries and the whole world should strive in the interests of accomplishing long-term optimal standards and conditions of living. The growth rate of a population in
1920-520: 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
1968-410: The planet Earth as a whole, zero population growth occurs when the number of births equals the number of deaths. The American sociologist and demographer Kingsley Davis is credited with coining the term. However, it was used earlier by George J. Stolnitz, who stated that the concept of a stationary population dated back to 1693. A mathematical description was given by James Mirrlees . In
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2016-404: The time, as its assets were still sufficient to cover the current lawsuits and it was still making a profit, but by filing bankruptcy and creating a fixed-value trust fund for claimants, they were able to limit the damages paid. 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
2064-572: The use of an IUD in the previous 6 months. A total of 16,994 physicians responded, yielding 3,502 unique case reports of women hospitalized in the first 6 months of 1973. Based on the survey response rate, the CDC estimated that a total of 7,900 IUD-related hospitalizations occurred during this 6-month period. Based on an estimate of 3.2 million IUD users, the CDC estimated an annual device-related hospitalization rate of 5 per 1000 IUD users. The survey also provided five reports of device-related fatalities, with four of these related to severe infections. One of
2112-408: The use of contraceptives, and after 1980 limited most urban couples to one child and most rural couples to two children. According to government projections, the long-term effect of these policies will be a reduction of the working-age population to 700 million by 2050 vs 925 million in 2011, a decline of 24%. In November 2013, a relaxation of the one-child policy was announced amid unpopularity and
2160-451: The world, each having some 1.4 billion people (as of 2023). China reached a population plateau (zero growth) in 2022. China's population growth has slowed since the beginning of this century. This has been mostly the result of China's economic growth and increasing living standards. However, many demographers also credit China's family planning policy , formulated in the early 1970s, that encouraged late marriages, late childbearing, and
2208-491: 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. At its peak, about 2.8 million women used the Dalkon Shield in the U.S. While looking for a material for the tail string, Davis and Learner discovered Supramid. Supramid was a cable-like suture material made of hundreds of fine inner nylon fibers encased by
2256-562: 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
2304-701: 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
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