The Little-Known History of the IUD

It may seem like the most recently developed IUDs, such as the Paragard® copper IUD , are a relatively new development in the medical search for effective contraceptive methods. However, the concept of using intrauterine devices (IUDs) for birth control is more than a few centuries old!

Why haven’t IUDs become more widely prescribed until now? The answer is, in part, because it has taken many years to work out various kinks in the technology, which continues to produce serious side effects in women today.

The First IUD

The first known documentation of placing a foreign object, called a pessary, into a woman’s uterus to prevent pregnancy dates back to 1550 B.C. in the famous Egyptian medical document known as the Ebers Papyrus. Uncovered in the exploration of Ancient Egypt, the text describes how the devices were inserted into the vaginal canal after being soaked in everything from fermented leaves to feces, but the most popular contraceptive was a pessary soaked in donkey’s milk.

Over the centuries, the uterus remained fertile ground for experimentation in the hijacking of fertility. Pessaries took on various forms of cloth and sponge combined with chemical concoctions in an attempt to prevent pregnancy. By the 1800s, women were using cocoa butter and quinine to produce a thick fluid in the uterus that would create a barrier for sperm.

The Rise of Modern IUDs

In 1909, Dr. Richard Richter conceived the first version of what would become the modern IUD. He developed a ring made of coarse silkworm gut and topped it with a thin layer of plastic. Once it was positioned, he would cut off the two ends just outside the uterus to facilitate follow-up exams and the ultimate removal of the device.

Dr. Richter’s version never really took off, but it did seem to be a major influence in separate designs proposed by Dr. Karl Prust, who added a button to the ring in 1923, and Dr. Ernest Graefenberg, who introduced the “Graefenberg Ring” in 1930. Made of silver and silk, his ring would go on to become the industry standard. It was later discovered that the silver caused gum disease and major tooth decay in some women, and variations of the ring increased pelvic infection rates.

In 1962, just as questions began to swirl about the safety and efficacy of the different devices, Dr. Jack Lippes introduced the Lippes Loop. His plastic, descending, serpentine design broke away from the traditional ring in an attempt to more closely match the shape of the uterus. Although it was considered safer than previous generations, Lippes’ device produced higher failure rates. The increase in pregnancies among users left the device vulnerable to new competition.

A New Twist on the IUD

By the time the mid-1960s rolled around, IUDs had failed to inspire much confidence in women seeking reproductive freedom, and now these devices faced possible extinction with the introduction of a wildly popular new contraceptive option, known simply as The Pill.

As women clamored for these “magic pills,” a number of scientists and research physicians began to worry about the growing number of side effects they were witnessing with the new drug. One of these doctors, Hugh Davis from Johns Hopkins, knew that contraceptives would remain en vogue because of fervent overpopulation fears. Believing the time was right for a new and improved IUD, he went to work on an all-new design.

His creation resembled a petroglyphic interpretation of a trilobite—a sort of plastic badge with five legs and a long, flowing filament. By 1968, he and his partners were ready to start marketing their Dalkon Shield to potential investors in the pharmaceutical industry.

The Promising New Device

The new Dalkon Shield seemed to cover all the bases. It contained a small amount of copper to act as a spermicide. The five leg-like prongs prevented the uterus from expelling the IUD. And the strong multi-filament string provided a means for easy removal of the device.

Dr. Davis published results of a trial demonstrating an impressive 1.1 percent pregnancy rate. That was comparable to the Pill and a vast improvement over previous IUDs. Since the Dalkon Shield was a medical device and not a drug, the FDA of that era had no real regulatory say in allowing the product on the market. It wasn’t until much later that experts would learn that Davis’s sample size had been too small to be considered credible.

In 1970, Davis and his partners sold the rights to A.H. Robins Co., makers of ChapStick and Robitussin, for $750,000 plus 10 percent of net sales. vi The timing couldn’t have been more perfect. Earlier that year, Senator Gaylord Nelson held Congressional hearing that explored whether the birth-control pill had been proven safe before it was allowed on the market. The Nelson Pill Hearings, as they would come to be known, made the nightly news on TV networks and appeared above the fold in all the nation’s major newspapers. Women across the country began to panic as they saw leading physicians link the Pill to everything from depression to breast cancer.

As if on cue, the new owners began to market the Dalkon Shield as the safe alternative to the Pill.

A Colossal Failure

Like so many contraceptives before it, the Dalkon Shield was brought to market before sufficient testing could prove either its efficacy or its safety. And again, like so many other contraceptives, it didn’t take long for the drug to manifest numerous problems for the masses of women using it.
First, the prongs intended to keep the device from being ejected became embedded within the uterus of many women, causing great pain and sometimes perforating the uterus. What’s worse, the multi-filament string wasn’t sealed on the end, making it essentially a pipeline for germs to make their way into the uterus. After the first year on the market, large numbers of women were reporting problems with sepsis, Pelvic Inflammatory Disease, and some were starting to discover the Dalkon Shield had left them infertile.

As complaints continued to pile up, the FDA forced the company to suspend sales in 1974. They had distributed 4.5 million Dalkon Shields in 80 countries,vi but Dr. Davis’s dreams for the Shield disappeared into the shadow of its massive collapse. In only three years, the Dalkon Shield caused enough damage to produce the largest tort case in history. More than 200,000 claimants worldwide filed for damages caused by the IUD. Injuries included perforations, septic abortions, forced hysterectomies, and even 17 deaths in the United States. In 1976, estimating that 900,000 women were harmed by the Dalkon Shield, Congress passed the Medical Device Regulation Act requiring FDA approval and oversight for future medical devices.

In 1985, the A.H. Robins Company filed for bankruptcy. As of 1995, the trust fund established for victims of the Dalkon Shield had paid out $1.42 billion to resolve 185,000 cases.

A New Dawn for IUDs

While fears and backlash over the Dalkon Shield appeared to be killing the entire IUD industry, another pair of doctors, working in association with the Population Council, blazed a new trail.

Dr. Jamie Zipper and Dr. Howard Tatum teamed up to create a new concept for the IUD. In his work, Dr. Zipper had demonstrated that intrauterine copper in rabbits reduced their chances of getting pregnant. Dr. Tatum had designed a plastic, T-shaped IUD, which conformed more to the shape of the uterus and eliminated some of the side effects caused by the ring-shaped IUDs. Putting the two together, they wrapped a copper coil around the plastic T for a product they named, the Copper T 200. This first generation of the new copper IUD was approved by the FDA in 1976, the very same year the agency had been given regulatory power to try to correct the Dalkon Shield catastrophe.

IUDs in the Year 2000

The turn of the new millennium apparently motivated the drug companies to be more innovative with their birth-control options. In 2000, they introduced fourth-generation oral contraceptives featuring new progestins. Yaz® and Yasmin® would go on to become bestsellers. That first decade of the new millennium also saw a spate of new birth control devices and delivery methods, beginning with the Mirena® hormonal IUD, which also rolled out in 2000. Its design emulated the T-shaped copper IUD but it replaced copper with the powerful new progestogen, levonorgestrel, commonly known as Plan B. The drug companies continued to expand the line of LARC (Long-Acting Reversible Contraceptive) products like never before. Other products rolled out that decade, include the NuvaRing® insert in 2001, the Essure sterilization coil in 2002, and the Implanon rod implant in 2006.

This flurry of innovation and new options may sound exciting until you recall that the drug industry has a history of rushing contraceptive products to market before they have been properly tested. True to their heritage, these newest birth-control methods followed a similar pattern as their predecessors: in 2002, Norplant (an implant placed in the upper arm) was removed from the market; between 2009-2011, the FDA recalled Yaz® and Yasmin® because the new formulation of progestin had doubled the risk of blood clots over the already elevated risk in other forms of hormonal birth control (although an advisory panel narrowly voted to allow them to stay on the market); in 2014, Implanon (another version of the arm implant) was discontinued because of side effects; and in 2018, Essure (metal coils placed in the fallopian tubes for the purpose of sterilization) was removed from the market.

Today’s IUD Market

Currently, four of the five IUDs available in the United States are hormonal, meaning they release small doses of levonorgestrel as a sort of backup plan—literally a Plan B—should an egg become fertilized. While this adds an extra layer of protection from pregnancy, it also exposes the woman to the risks associated with synthetic hormones. Indeed, the most common complaints include moodiness, headaches, acne, and decreased sex drive. However, there are more serious side effects that also need to be considered.

It’s rare for complications to come to light to the point that a product is removed from the market as swiftly as the Dalkon Shield. It normally takes much longer for enough evidence to be presented to justify discontinuation. For example, it took 16 years to remove Essure from the shelves after the FDA received tens of thousands of adverse event and product problem reports. According to the FDA, adverse events associated with Essure included: “pain/abdominal pain, heavier menses/menstrual irregularities, headache, fatigue, weight fluctuations, depression/anxiety, hair loss, and hypersensitivity/rash.” Essure product problem reports included: “patient-device incompatibility (for example, possible nickel allergy), migration of the device or device component, dislodged or dislocated device, device breakage/material fragmentation/fracture, device operating differently than expected, for example, implant failure or pregnancy, malposition of the device, device difficult to remove, and device difficult to insert.” Most alarmingly, over 1,000 pregnancy losses and at least 49 deaths possibly related to use of the device have been reported to the FDA. So, the best way to gauge the safety record of these new hormonal IUDs would be to examine the one with the longest track record, which is Mirena®. Thousands of women have sued Bayer Pharmaceuticals saying Mirena® “perforated the uterus, damaged organs and caused pseudotumor cerebri—an abnormal fluid buildup in the skull,” which causes headaches and vision problems. Momentum seems to be building toward a class action lawsuit. For now, Bayer has offered to pay $12.2 million to settle some of the perforation lawsuits.

The next option for many women is the copper IUD, Paragard.®

Repeating History

Today, women are more aware of the dangers of hormonal birth control than at any point since the Nelson Pill Hearings. As in 1970, they are turning to the non-hormonal IUD thinking it is the safer alternative.

By comparison, today’s copper IUD is probably safer than the Dalkon Shield, but it is not flawless. By design, the copper IUD is meant to provoke the woman’s immune system. The copper ions inflame the uterus and increase the production of white blood cells. Just as they would with an infection, these blood cells go to work attacking any foreign cells, which include her partner’s sperm.

The inflammation, thickened mucus, and killer blood cells work to prevent pregnancy, but they also throw the woman’s immune system into a heightened state. Common side effects include Pelvic Inflammatory Disease, cramping, and heavier periods.

The consequences can broaden quickly when you begin playing with the immune system. The presence of inflammation or infection can cause the body to pull in even more copper in an effort to fight the infection. This vicious cycle can lead to copper toxicity or overload, which has been associated with everything from autism and ADHD to anxiety and depression.

As you might expect, the Copper IUD is also not recommended for women who have been diagnosed with an autoimmune disease. There is even evidence that it may actually trigger autoimmune diseases like rheumatoid arthritis in some patients.

Weighing the Options

When considering any birth control, it’s important to take into account the long-term ramifications. The large corporations making these devices have a history of overlooking patients’ health and safety in an eagerness to get their product on the market, and many patients have reported that their doctors ignored or belittled the concerns they expressed, often refusing to remove their IUDs.

It appears the words of Judge Miles Lord, as he reprimanded the executives who manufactured and marketed the Dalkon Shield, are as relevant of today’s IUDs as they were when he said them in 1984: “The only conceivable reasons you have not recalled this product are that it would hurt your balance sheet and alert women who already have been harmed that you may be liable for their injuries. You have taken the bottom line as your guiding beacon and the low road as your route. This is corporate irresponsibility at its meanest.”

Yaz®, Yasmin®, and Mirena® are registered trademarks of Bayer. NuvaRing® is a registered trademark of Merck & Co., Inc. Paragard® is a registered trademark of CooperSurgical, Inc.