By Maria Elena Garcia, Honeycomb Contributor
A note: throughout this post you will see me use the term “woman”. While the binary of gender is reductive to many people seeking contraceptive care for their uterus, I use the term “women” when citing research because that is the term used in the literature. We have a long way to go to de-gender reproductive care and I want to acknowledge that not all women have uteruses and not all people with uteruses are women.
Choosing a contraceptive is a lot like playing a game of Would You Rather. “Would you rather have to take a pill every day at the exact same time to avoid a pregnancy but risk major hormonal imbalance?” or “Would you rather not have to take any medication to avoid pregnancy but go through a surgical procedure with no anesthesia and fully conscious?” “oh and by the way none of these guarantee 100% success”.
Now, I am a data girlie, so I will browse, search, and advance search for the article that tells me matter-of-factly what is the best choice to make for my lifestyle. I’m also someone who has never had a child, can forget to take their medication on time, and tries to visit the doctor for “refills” as little as possible. Which meant no pill, patch, or shot.
That leaves the IUD. On paper, the IUD is great. It lasts up to 9 years depending on the type, only annual visits required, and no need to rely on the user. You just set it and forget it. BUT, the pain. I have read the horror stories and seen that painful video where the longest (and sharpest) forceps in history clamp at what looks like the human uterus. Needless to say, I was scared.
Then I came across this one study that talked about myths and barriers preventing the use of IUDs in nulliparous (those who have never given birth) people. This is where I first learned about an earlier version of the IUD, and the device “responsible for several cases of severe and potentially fatal pelvic sepsis… [and] still tarnishes the reputation of modern intrauterine contraceptives in certain countries”(1): the Dalkon Shield.
Take a look at this guy. If the thought of this going inside a uterus makes you clinch as hard as you humanly possible, you are certainly not alone. It came to the market in 1970 and was developed by the Dalkon Coorporation, which was later sold to A.H. Robins Company, the same company that developed Robutussin and chapstick… Very in line with their scope of work, Right? Right…
This was marketed as THE Contraceptive of the time given that the pill started to generate concerns about health risks. Robins sought this opportunity to have their device at the top of the market. It was heavily advertised for its effectiveness and safety, with research claiming the Dalkon Shield to have a 1-2% pregnancy rate in comparison to the 2-5% pregnancy rate of the pill.
With great marketing success, the Dalkon Shield was prescribed to over 2.2 million women across the United States. Things took a sharp turn when after only one year, women started to report painful symptoms and seeking serious medical attention over septic infections, pelvic inflammatory disease, infertility, and miscarriages. Some women died within 48 hours of the first symptoms.
The company swiftly attempted to shift the blame stating that the reason for bacteria traveling up the uterus through the string was the fault of “the doctors who improperly inserted the devices” and not its design that allowed the string filaments to disintegrate and collect bacteria.
Not only were they wrong, they were also lying.
Six months before the Shield went on the market, Robins officials were informed that the string had a wicking problem, yet they refused to make changes claiming manufacturing cost and fear of looking like they were wrong.
Are you angry yet? Palms feeling a little sweaty? Heart rate is bumping? Me too. Stay with me though, we are almost there. Knowledge is power.
Not only did the women endure great damage to their reproductive organs due to this device, but they did so for a contraceptive that was not as effective as promised. The earlier “low pregnancy rate” claims made by the company were manufactured by the inventor of the Shield who was also receiving royalties from the program. Hello? Conflict of interest, anyone?
The real rates were even higher than those for the pill, with an 5-10% pregnancy rate and added birth complications. When the CDC conducted a study in 1973 linking the increase in complications with the Dalkon Shield, it became harder for Robins to back their claims of user error. Yet, 2.5 million women were still using the Shield in 1974, gaining praise from organizations like the Department of Human Reproduction and Obstetrics in England for its “advancement in IUD technology”(2).
When does it stop? When the CDC continued to publish a series of studies that linked the Dalkon Shield to severe complications, abortion-related deaths, and many other serious medical consequences the company came under heavy pressure. Robins stopped producing the device, but refused to recall the ones that were still on the market. It took 10 years, over 300,000 lawsuits, and $245 million in settlements for the A.H. Robins Company to release a media campaign advising women to have the Dalkon Shield removed. They filed for bankruptcy in 1985.
If you asked yourself “how was this even approved?!” over and over, the answer is as painful as this story. The Dalkon Shield did not need FDA approval because the device was not a “drug” so it technically was not under the jurisdiction of the FDA. This offered an opportunity for a win in reproductive legislation. By 1976, the U.S. Congress passed federal law that mandates the FDA to require safety and efficacy testing of IUDs before they are approved.
There’s a lot to unpack here- but what are the key takeaways?
First off, the acknowledgement that our bodies have been experimented on for the sake of contraception is a difficult task, but one that is necessary. And most importantly (and probably for its own article in the future), while I did not explore in depth the demographic spread of these complications, history will tell us that marginalized bodies are the ones who suffer the most. Not only that, but they have also become the subject of regulation at the hands of those hungry for legislative power.