Recovering from the oddly male history of the intrauterine device.
Image: Nevit Dilman/Wikimedia
The Dalkon Shield looks more like a horseshoe crab than a contraception miracle.
Complete with spikes on the sides and an infection-spreading tail, the Dalkon Shield is now considered one of the worst designs of intrauterine devices (IUDs) in history. Released in 1971, it led to the deaths of at least 18 women and injured over 200,000 others before the FDA finally issued a recall on the 2.5 million devices that made it into uteri across the US over its four year run.
Just looking at this torture device, it's obvious that no one involved in its design and production actually possessed a uterus. Though the dozens of iterations of IUDs since have all but perfected the long-acting contraceptive device in terms of safety and efficacy, we were shocked to find that not a single IUD design in history has been credited to a woman.
"When I was in school, [women] were discriminated against. They weren't accepted," said Dr. Jack Lippes, designer of the Lippes Loop, a once-prominent player in the progression of better, safer IUDs. He listed off all the men who've historically made the IUDs. "They're all males, right."
Not a single IUD design in history has been credited to a woman
Inspired by the idea that "poor women needed a method that required less motivation than the Pill," Dr. Hugh Davis, a gynecologist, teamed up with Irwin Lerner, an electrical engineer to design the Dalkon Shield. They knew once it was in the uterus, it would do its job in preventing pregnancy, but they didn't give much consideration to the processes involved with putting it in or getting it out.
"I remember [The Dalkon Shield] very well," Lippes said. "I had one patient, the wife of a young intern who wanted to get pregnant. At the hospital, they pulled the string and they broke the string. They really had trouble removing it, so she was sent to me. The device was not designed for easy removal. It lacerated the cervix upon removal."
Considering that the whole concept of IUDs came about from the observation that if you put rocks inside the uterus of a camel, they wouldn't get pregnant, it's not surprising that the predecessors of the Dalkon shield were just as much of a horror show. One of the first IUDs to be published in a medical journal in 1909 was a ring made from the guts of a silkworm. Soon after in the 1920s, the guy (in)famous for "discovering" the G-spot invented a coiled ring IUD made out the kind of metal you'd find in a cheap accessory from Claire's: copper, nickel and zinc. It gave several women pelvic inflammatory disease which, in a pre-antibiotic era, was sometimes lethal.
The Population Council came onto the IUD scene in the 60s, tasked with preventing humanity from spawning out of control. In light of mounting concerns about the efficacy of the Pill, they held the first International Conference on Intrauterine Contraception in 1962, dismissing the horrors of early versions and clearing the way for the Dalkon Shield.
"We have to stop functioning like doctors, thinking about the one patient with pelvic inflammatory disease… Perhaps the individual patient is expendable in the general scheme of things," Dr. J. Robert Willson told the sausage fest of conference attendees in the opening statement.
That same year, Lippes introduced the Lippes Loop—arguably the first version of an IUD that was built with any real consideration for female anatomy. Despite opposition from colleagues and the fear of litigation, his soft, S-shaped device soon became the most popular IUD in the US.
"We have modern plastics now, we can make a better device," Lippes said of his thought process at the time. "That's where the idea of using injection molding techniques came in. I wanted one that would accommodate the anatomy of the uterus, and I came up with the design." He sought the help of Paul H. Bronnenkant, a World War II test pilot and engineer who managed Hallmark Plastics in Buffalo. Together, they created a loop made of polyethylene and barium sulfate.
Considering their dark history of development, new IUDs are really, really safe
Years after the Lippes Loop's success, Bronnenkant's son, Lance Bronnenkant, founded Finishing Enterprises. The company became the first to manufacture today's gold standard of safe IUDs, the Copper T380, after its approval in 1984. It still produces the device.
"That little plastics company probably prevented more pregnancies than any of the pharma companies combined," said David Sokal, co-founder of the Male Contraception Initiative and a former clinician.
Today, the Population Council is the primary force in global IUD research and development, and is responsible for inventing the Copper T380. Marketed in the US as ParaGard, it works by turning the uterus into a no-swim zone for sperm, making them incapable of passing through to the oviducts. Once inserted, copper ions from the device are released into the uterus which bind to the sperm, immobilizing them and… ripping off their heads.
"It creates an inflammatory reaction in the women, in the cavity of the uterus, and the toxic effect on the sperm makes it unable to fertilize the egg," said Dr. Régine Sitruk-Ware, a reproductive endocrinologist at their New York Center for Biomedical Research.
Unsurprisingly, the scene at the Population Council has shifted along with the advances in technology. In December of 2014, Julia Bunting was named president of the Council, making her the third woman to serve in this role since 1991. Its goal now is to address technology gaps in contraception—specifically, affordable solutions that wouldn't require women to return to a doctor each month for pills or an injection.
"More than 120 million people have used a contraceptive that was developed by the Population Council," Dr. Sitruk-Ware said.
ParaGard and the other approved IUDs used today are shaped like a T with rounded edges. They are about the size of a quarter when expanded, and are collapsible for safe insertion and removal through the slim, tubular opening of the cervix. In theory, by tugging a string that lingers outside of the cervix, the arms of the T fold upward, allowing it to slide harmlessly out of the uterus.
Hormonal IUDs go by the brand names Mirena, which lasts for five years, and Skyla, which lasts for three years; the Copper T380 lasts for 10 to 12 years. Obamacare has enabled most health insurance providers to cover IUD insertion, but some religiously-affiliated corporations like Hobby Lobby will make you foot the bill. (Despite the fact that some people are hopelessly confused when it comes to the science of abortion, IUDs are not used to this end.) Still, the out-of-pocket price for the top three IUDs works out to less than monthly birth control: Mirena ranges from $500-$927; Skyla from $650-$780; and ParaGard from $500-$932.
Most importantly, considering their dark history of development, new IUDs are really, really safe. According to the World Health Organization, the risk of uterine or cervical perforation or pelvic inflammatory disease with the Copper T-380 is only one in 1,000. According to their studies, about 5 percent of woman requested it be removed because of odd bleeding and pain, and three percent had the device expelled. If complications do occur, they are usually caught within in the first year of insertion and can be easily addressed.
It may be a long path to redemption for the IUD, as the horror stories seem to have lingered in our collective consciousness; rates of IUD use in the US are much lower than in other developed nations. Though at least 5 percent more women in the US are using IUDs today than they were 10 years ago, we still lag behind every European country. China has the highest IUD usage rate at 43 percent.
"I recognize... how panicked people are about them, despite IUDs being some of the most effective methods—in terms of both pregnancy prevention and financial cost savings—of them all," said Molly McLay, a 31-year-old social worker who decided to get a copper IUD six years ago when her body had complications with hormonal birth control.
Aside from the side effects of birth control pills, rings, and shots, which typically include nausea, weight gain and all kinds of mood changes, they are subject to human error. If we observed 100 women on the pill and 100 women with an IUD over the course of a year, we would expect nine of the women on the pill to become pregnant that year, but only one women with a copper IUD, based on past survey data. If an IUD is inserted properly, there's little room for failure.
Bonus: researchers also found that a copper IUD inserted up to five days after unprotected sex can also function as emergency contraception.
The most common side effects of either the hormonal or copper device include heavier periods and cramping. Aside from the one percent of users who have serious complications, insertion is the most painful part; it can make you feel dizzy or pass out. But for many, the benefits of having a reliable form of birth control for the next 10 to 12 years outweigh the pain of insertion.
"We see expulsions not much, less than 5 percent, but we see it," Sitruk-Ware said. She attributed this to improper insertion—not a malfunction of the device itself. If the physician doesn't clear the cervix and push the IUD all the way into the "triangle of the uterus," it can fall. "That was the big challenge, to train health providers to be comfortable, to know how to make it have no risk of perforation or expulsion or infection."
When asked whether women will design IUDs in the future, Sitruk-Ware was optimistic. "I hope so, and I hope the one I design," she said with a laugh. Though her device is currently in the prototype stage, Sitruk-Ware is determined to create a contraceptive device that will be even better than the last. Soon, women will be the ones creating their own empowering devices.
She also said that new research is being conducted on advancements to the current trio of IUDs that would include an anti-inflammatory drug that would lessen heavier periods associated with the copper-IUD.
There are myriad factors to consider when it comes to birth control, and obviously everyone is different. But considering all the benefits of new IUDs—the time saved not thinking about birth control, the incomparable cost effectiveness, and the lack of side effects it seems the IUD is slowly but surely pulling away from its gruesome, misogynist history. Perhaps it's time to put the fears inspired by the Dalkon Shield to bed; today, researchers have IUDs down to a T.