Exorcising the Dalkon Shield

Time to get over a bad (contraceptive) romance.
This post is 3 in the series: Twenty Times Better than the Pill

In 2002, 26 percent of Norwegian contraceptive users relied on a long acting method that they could simply fit and forget, the IUD. In the United States, that rate was 2 percent. Long acting reversible contraceptives (aka LARCs) such as IUDs and implants are rapidly growing in popularity, but the US and Canada lag behind many other countries in making these top tier methods widely available. Around the world, IUDs are the most popular form of reversible contraception, with rates of use as high as 40 percent  in China, and over 50 percent in seven smaller countries. By contrast, in the US, the rate of LARC use, while increasing, is still under 10 percent. That means we have a huge and largely untapped public health opportunity.

No one contraceptive works for everyone, but LARCs have a failure rate that is 1/10 to 1/50th of that for the most widely used American contraceptive, the Pill, and they are cheaper in the long run. More effective contraception means fewer unintended pregnancies, with all that implies: healthier babies, lower teen pregnancy rates, less abortion, less strain on public services and budgets, and more flourishing families. Giving women better tools to attain their pregnancy intentions has benefits that ripple through their communities.

Not only are LARCs more effective than the Pill at preventing unwanted pregnancy, they tend to have fewer side effects, higher continuation rates (over 80 percent at one year vs. under 40 percent for other hormonal methods), and higher rates of overall satisfaction. As one doctor put it, “If you ask any OB what they use or what their wives use, it’s an IUD.” So why haven’t American women had better access to these potentially life changing technologies?

A Bad Romance

More than forty years ago, at the end of the 1960s, IUD use was on the rise. Then, a defective IUD entered the market. The Dalkon Shield had a problematic shape and a multifilament string that carried bacteria from the vagina into the uterus, causing infections in up to seven percent of users, many serious, including a handful of deaths. The resulting firestorm was, as Dr. David Grimes of the University of North Carolina put it, a combination of bad science, bad press, and bad tort law. The flaws in the Dalkon Shield were specific to its unique design, not applicable to IUD’s in general, which are on average among the safest and most effective reversible contraceptives available. But by the mid 1980′s, IUDs largely disappeared from the US market, and an entire generation of American women who wanted modern contraception was forced to depend on methods with more downside, including unwanted pregnancies.

Inexperience and Misinformation

The trauma and drama of the Dalkon Shield meant that one cohort of medical providers had the experience of flawed 1970s technology and the next got no experience at all with long acting contraception. Many of those providers are still in practice, and many of them are still recommending the method that is most familiar and easiest to prescribe, the Pill. Studies in both the US and Canada have documented high levels of misinformation about LARCs among health providers including primary care physicians and nurses. Often they mention the Dalkon Shield by name. The result is that women may receive confusing information about LARC options or may not even know they exist.

Regulatory Delay

Because the controversy skewed American regulatory practices, even doctors who are in the know have not been able to provide their patients with the best methods available in other countries. For example, the US Food and Drug Administration didn’t approve a modern hormonal IUD in the US until 2000 — 19 years after it went on the market in Finland. The health consequences of these delays have been enormous. Hormonal IUDs are used in many countries to prevent the need for hysterectomy. They can eliminate menstrual symptoms like heavy bleeding and cramping, which cause over 100 million hours of lost work for American women and missed school for American girls. They reduce endometrial and cervical cancer. It is a peculiar irony that many women with these conditions have lost their ability to have children for lack of modern contraception.

Religious Misogyny

On top of barriers caused by bad history, American women face an active dis-information campaign propagated by the Catholic Church and a subset of Protestants who have incorporated competitive breeding into their theologies. Their primary false argument is that any effective contraceptive works via abortion—as we were informed recently, the wombs of pill-takers are embedded with dead babies. But on websites and in media they also repeat scientifically discredited allegations that contraceptives and abortion cause ills ranging from cancer to sterility to obesity to suicide. Disinformation drives up anxiety about contraception. For women who do not want to get pregnant but do want to stay healthy, it creates what psychologists call an approach-avoidance conflict. Such conflicts can derail rational decision-making, and as people do in such situations, women often respond by procrastinating, distracting themselves, or engaging in wishful thinking.

American Litigiousness

In the endeavor to raise safety fears, the Church has an unholy alliance with a class of personal injury attorneys who treat contraception as a cash cow through a process that has been called “trolling for torts.” Women start using contraceptives when they are at the prime of youth and health and continue using them as they age over the course of the next forty years. As a consequence, only carefully controlled research can separate side effects from the effects of time and aging. This makes it particularly easy to correlate contraceptive use with a variety of ailments and to persuade a jury that the relationship was causal. Scientifically unfounded litigation has all too often resulted in health losses for American women, as with the flurry of class action suits that forced Norplant (now Jadelle) out of the US market and discouraged subsequent contraceptive research. Note that almost twenty years later the same technology has an even more established safety record and is used by millions of women around the world.

Cost

Even a woman who has accurate information about her contraceptive options may face another obstacle: cost. In the long run, LARC methods are less expensive than hormonal contraceptives like the Pill, Patch, Ring, or the three month Depo Provera Shot. This is true even without considering the expense of contraceptive failure. However, the upfront cost is substantial, as much as $1,000 for the device and insertion. The result is that women who are living month to month often choose old technologies, and even middle class women with health insurance may balk at the deductible.

Canada has leveraged its role as single health-care payer to negotiate lower prices on contraceptive devices, and as a consequence both copper IUDs and hormonal IUDs are available to Canadian women at a fraction of the American cost. In the United States, President Obama’s Affordable Care Act, which mandates contraceptive access with no co-pay has the potential to finally eliminate what has been an insurmountable barrier standing between many women and top tier contraception.

In their fight against the contraceptive mandate, some conservatives argued that any woman who wants to prevent pregnancy can buy Pills for $10 a month at Walmart. One Seattle family-planning doctor finds their assertion galling. “When I hear people make that argument I want to say, ‘How’s that 1965 television working for you?’”

In Washington, the state Department of Health has begun to implement the Affordable Care Act’s contraceptive mandate. From Washington’s early legalization of abortion, to the state’s protection of reproductive health privacy for teens, to free contraceptive coverage for poor women under the Take Charge program, Washington has led the way on reproductive rights and health. As the “war on women” has heated up, Oregon is one of just three states that has managed to retain abortion access guided only by medical science and personal values. A core part of Northwest culture is a value on thoughtful childbearing—a belief that parenthood is too important to leave to chance and too personal to be decided by any institution—and that no woman should have a child simply because she has no choice.

Next time, in the closing piece of this series, I’ll examine how we can lower the remaining barriers to a technology revolution in contraception.

 

Valerie Tarico, Ph.D., a trustee of Sightline, is a psychologist and writer in Seattle. She is the author of Trusting Doubt and Deas and Other Imaginings and the founder of WisdomCommons.org. Her articles can be found at Awaypoint.Wordpress.com.

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Comments

  1. John Gear says:

    “American Litigiousness
    In the endeavor to raise safety fears, the Church has an unholy alliance with a class of personal injury attorneys who treat contraception as a cash cow through a process that has been called “trolling for torts.” Women start using contraceptives when they are at the prime of youth and health and continue using them as they age over the course of the next forty years. As a consequence, only carefully controlled research can separate side effects from the effects of time and aging. This makes it particularly easy to correlate contraceptive use with a variety of ailments and to persuade a jury that the relationship was causal. Scientifically unfounded litigation wins have all too often resulted in health losses for American women, as with the flurry of class action suits that forced Norplant (now Jadelle) out of the US market and discouraged subsequent contraceptive research. Note that almost twenty years later the same technology has an even more established safety record and is used by millions of women around the world.”

    Wow. For an article by a Sightline trustee (!) calling for scientific accuracy and reason to use such lurid insinuations, but and then back them up with absolutely nothing is shameful. Save that paragraph, you’ll be seeing it again — it’s one that the tobacco companies and fossil fuel and fracking boys have perfected. The coal lobby loves that paragraph, a perfect template of — dare I say “unholy” — disingenuousness.

    If Sightline wants to join Monsanto and Dow and all the others who hate the idea that everyday people should have access to the courts, even against powerful interests, make that clear. But know that you’re braiding the rope that they’ll use to hang us with.

  2. Jennie says:

    My IUD was covered at 100% starting on Jan 1, 2013. So, the cost will likely no longer be a barrier. Let’s hope that the word gets out to those who could really benefit from a reliable birth control method.

  3. Elaine livengood says:

    Save us the psychology and give us an actual MD to explain Medical devices, pro and con.
    The Dalkon Shield wasn’t the only bad IUD out there. Plenty of Copper 7 IUDs disintegrated inside the women who had them. Ovarian cyst the size of a small loaf of bread, anyone? Agonizing, tortured periods of 2 weeks duration? Hysterectomy?
    Yep. It happened to me.

  4. Valerie Tarico says:

    I am sorry to hear about your horrible experience. No contraceptive is risk free. Neither is pregnancy or abortion, with pregnancy being the highest risk of the three. But it is every woman’s nightmare to be trying to take care of herself and have things go wrong.

    The Copper 7 stopped being sold in the U.S. in 1986. With a modern copper IUD, menstrual flow and cramping do increase by an average of 50% for the first six months. One reason that hormonal IUDs were developed is that such an increase in cramping or bleeding, even if temporary, is not a good idea for women who already have heavy menstrual cramping and bleeding or who are at risk for anemia.

    All women are at risk for benign ovarian cysts. Copper IUDs do not alter ovarian function, and research does not show an increase in such cysts in women who use copper IUD’s. A hormonal IUD does increase the risk of benign ovarian cysts (most of which are small and which normally resolve on their own), but has the advantage of decreasing cramps and bleeding.

  5. Elaine Livengood says:

    Well put, but I must also add that the Copper 7 actually disintegrated and bits of copper wire were coming out over a period of time. I am sure this led to my further problems. Thank you for a well-written series on a topic that should be discussed.

  6. Valerie Tarico says:

    The United Nations reviews research on copper IUDs and maintains updated safety and efficacy information for their procurement process. One tool they rely on is Cochrane Reviews, like this one Kulier R, et al. Copper containing, framed intra-uterine devices
    for contraception (review). Cochrane Database of Systematic
    Reviews, 2006: Issue 3, July 2006, updated August 2007.

    The durability of the copper in an IUD depends on the diameter of the wire and the copper alloy used, and the FDA requires research to establish the length the wire can last before it needs to be replaced to prevent fragmentation.

    The Paragard IUD or TC380A is the only copper IUD currently available in the U.S. It is FDA approved for 10 years but approved in other countries for 12. One USAID employee told me that they now have data that would pass FDA standards at 14 years, but there is no economic incentive for the drug company to go through the process. Ongoing research suggests that the wire in this IUD is still stable at 16 years and counting.

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