“All right, let’s take it out,” I said, leaning forward in my chair and sighing heavily at the doctor. What a waste. For the past month, I’d had inside my body a gnawing little T-shaped device made out of plastic and copper, called ParaGard. It had seemed to me an ideal birth control solution: invisible, forgettable, long-lasting, highly effective and hormone-free.
ParaGard sits in the uterine cavity, where it changes the landscape significantly. Copper is annoying to sperm and can inhibit its mobility. It can also create an environment that is inhospitable to sperm and eggs, preventing implantation.
One aspect of ParaGard has always freaked me out: It’s an intrauterine device, meaning that it has to be inserted by a healthcare provider. (“Insert” is too simple a word, really). The uterus doesn’t particularly enjoy being violated, so it employs a gatekeeper, the cervix. The cervix is essentially a tunnel of muscle that leads from the upper portion of the vagina into the base of the uterus. Normally, the cervical opening is no bigger than the head of a pin.
Now imagine, if you will, a ship in a bottle. The ship has to fold flat in order to fit through the mouth of the bottle. Once it arrives in the more cavernous section, the ship springs back to its usual form. That same idea applies to ParaGard. The arms of the device collapse, making it more streamlined and acceptable to the cervix. Clinicians use a dilating tool to expand the cervix and move the IUD forward, into the uterus itself. Once it’s in, its arms pop open and voila, you’re 99 percent protected from getting pregnant. Or so the story goes.
***
After spending years on the fringe of the contraceptive market, the IUD seems to be everywhere lately. It’s fast becoming one of the most popular birth control methods in the United States. Two new hormonal models—Skyla and Liletta—have emerged in the last decade. Just last year, New York City’s Department of Health launched the #MaybetheIUD awareness campaign in the subway system, blanketing the city with ads for the contraceptive. The American College of Obstetricians and Gynecologists has even deemed IUDs safe for use by sexually active teenagers.
But, as I discovered, the IUD market isn’t hospitable to all women—especially those whose bodies can’t tolerate synthetic hormones. And the one non-hormonal IUD available in the U.S. today—ParaGard—hasn’t changed its design since the 1980s. So if a hormone-sensitive woman doesn’t react well to that model, she has no other options for long-acting, reversible contraception. Worse yet, the lack of non-hormonal IUD innovation has little to do with scientific limitations and more to do with profit margins, advertising campaigns and the forced primacy of the birth control pill.
***
My ParaGard insertion appointment had not gone smoothly. I’d taken a medication called Misoprostol to help relax my cervix and reduce pain during the procedure.
“Did you take the pill before you went to bed? The one I prescribed?” the gynecologist asked, shining her light at me.
“Mmhm. At 8pm.” I replied, staring up at the ceiling tiles.
“It didn’t open your cervix at all. It looks normal.”
Great.
The pain was intense, but only because the procedure lasted forever. After a few minutes, a monitor in some far corner of the room started beeping its concern about my lowering blood pressure.
“I need you to take some very deep breaths,” the attending nurse said. I complied.
Eventually, it was over. After a few minutes in recovery, I gingerly made my way to the ultrasound room. The doctor needed to make sure the IUD was situated properly. As I waited for the ultrasound tech, daggers of pain pierced the lower right side of my abdomen, causing me to suck in air. The ultrasound did not give the desired result. The IUD was sitting too low to give adequate protection.
“It might be OK. Let’s see how it looks in a month. If it hasn’t moved up by then, we’ll take it out,” the doctor said. Despite my discomfort, I resisted this.
“Is there any way to just adjust it while I’m here?” The doctor and the ultrasound tech looked at each other, silently debating whether I could handle another go-round. They agreed to try again. It hurt, but by that point I wanted to prove my own pain tolerance. I left the office with ParaGard in place.
For the next month, I suffered patiently with my new pet. I used a heating pad, slept a lot and tried to ignore the scrapes of pain that occasionally wracked my lower right side. I tolerated ParaGard’s misbehavior. After all, an adjustment period was to be expected.
But it was all for naught. At my follow-up appointment, the doctor discovered that the IUD had descended yet again. By then, the only real option was to remove it. The doctor explained that ParaGard sometimes doesn’t work well for women who haven’t had children yet, since their uteruses are smaller. It is the largest of the IUDs.
Seeing my crestfallen expression, she suggested that I look into Skyla or Mirena, which are smaller and, she added, “don’t contain a lot of hormones.” (It depends on what you mean by “a lot.” Many women using Skyla, Liletta and Mirena report that their periods cease completely.)
We’d been over this before. I had to stay far away from synthetic reproductive hormones. For me, they cause terrible swings of depression and anxiety. But, despite my hard line, doctors kept pushing me toward birth control devices and drugs that relied on man-made versions of estrogen and progesterone.
“All of this birth control business is a pain in the butt, isn’t it?” the doctor said, smiling. She moved to leave the exam room.
“Yeah, it’s almost like it’s unnatural,” I thought to myself.
***
Because of my sensitivity to synthetic hormones, my options for effective birth control are limited. The failure rates for condoms and diaphragms, two of my few options, are relatively high—around 12-18 percent of women will become pregnant after a year of typical use—and those numbers make me nervous. (By contrast, ParaGard boasts an impressive success rate—only 0.8 percent of women will get pregnant within a year of typical use.) Other options include contraceptive sponges, cervical caps and spermicide, but none of those have nearly the same success rate as the IUD.
Though I know I’m not alone, there is no hard data about women who have to rely on non-hormonal contraception. In other words, this is a blind spot in terms of scientific research. In fact, a recent article in The Journal of Family Planning and Reproductive Health concluded that research about why women discontinue contraceptive methods does not take into account women’s subjective experiences. And even though hormonal contraceptives are widely “accepted,” it’s not uncommon to hear women complain about mood swings, anxiety, irregular bleeding, decreased sex drive and other problems brought on by synthetic hormones.
Considering about half (51 percent) of the 6.6 million pregnancies in the United States each year (3.4 million) are unintended, and an estimated 4 in 10 of these end in abortion, I started to wonder why there aren’t more options for women like me. Why is ParaGard the only non-hormonal IUD on the market? Why does it seem like I’m dealing with forces outside the realm of women’s health? I started researching.
In the mid-1960s, ParaGard was born in the mind of Howard Tatum, a biomedical researcher for the Population Council. (The Population Council is a nonprofit organization with eugenicist roots; it was established by John D. Rockefeller III in the early 1950s). Tatum realized that previous IUD designs had been problematic because their size and shape did not agree with the musculature of women’s uteruses. In response, he created a smaller IUD frame that took its cues from uterine contours. Jaime Zipper, a Chilean doctor affiliated with the World Health Organization, added copper to that frame, increasing its effectiveness as a contraceptive.
After its FDA approval in 1984, ParaGard was marketed domestically by GynoPharma starting in 1988. Since then, it has been purchased, acquired or re-labeled at least 15 times. Yet, despite many years and many owners, the design of ParaGard has not changed. (TEVA Pharmaceutical Industries now owns the rights to the product.)
Dr. Chanelle Coble-Sadaphal specializes in adolescent medicine and long-acting contraceptives at NYU’s Langone Medical Center. She offered one explanation for why IUD innovation has been slow: “In any conversation about IUDs, you have to address the past, and what happened with one particular IUD in the 1970s—the Dalkon Shield,” she says. “It looked kind of scary, like a spider with little tentacles. Not something you’d want put in.”
Coble-Sadaphal explained that the Dalkon Shield emerged during the sexual revolution, a time when demand for non-hormonal birth control methods was high. The device got pushed to market quickly; FDA approval processes were much less stringent then.
The Dalkon Shield was used widely, but to the dismay of women and pharmaceutical companies it had a number of vicious side effects, ranging from pelvic inflammatory disease to infertility. Coble-Sadaphal says that even though the device was pulled from the market soon after it emerged, more than 300,000 women filed injury lawsuits, which created a long-lasting stigma around the IUD.
During the wave of medical injury lawsuits implicating the Dalkon Shield between 1971 and 1976, many drug manufacturers voluntarily removed their IUDs from the market. “Nobody wanted to get messy,” Coble-Sadaphal says. “You’re dealing with women and infertility—these are very sensitive issues. I think the pharmaceutical machine just kind of stopped and said, ‘We don’t need to devote any more resources to this—look what can happen.’”
But that’s not the only thing stopping pharmaceutical companies from investing in non-hormonal IUDs. According to Elizabeth Siegel Watkins, associate professor of social medicine at the University of California, San Francisco, pharmaceutical advertising campaigns in the 1990s situated the birth control pill as the dominant method of contraception. They created a wider market by touting the pills’ secondary effects, such as treatment for acne. With this shift in pharmaceutical focus, other contraceptive research slowed tremendously.
Dr. Watkins explains, “Although birth control has always been pitched in the United States as an individual solution rather than as a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians and consumers to be the prevention of pregnancy, a basic healthcare need for women of reproductive age. Since 1990, the content of that message has changed, reflecting a shift in the drug industry’s perception of the contraception business. This change was brought about by the industry’s move away from research and development in birth control and by the growth of the class of medications known as lifestyle drugs.”
Lifestyle drugs, according to Watkins, “generally describe medications that are designed to improve a person’s quality of life by treating less serious conditions; they have also been called cosmetic, life-enhancing, recreational or discretionary.” When you look at birth control pill marketing campaigns over the last 20 years, you’ll notice an increasing emphasis on the secondary effects of birth control pills: acne reduction, less frequent menstruation and treatment of premenstrual dysphoric disorder. This marketing strategy attracts a broader consumer population. Don’t need to prevent pregnancy? Well, you’ve got acne! No sex partners in your future? You’ve still got those annoying periods!
Watkins also notes that more stringent government regulation, the rise of birth control lawsuits and market saturation played a role in slowing contraceptive innovation.
Other experts say IUD innovation has been virtually nonexistent because the product just isn’t profitable. In fact, several major drug companies have stakes in both the pill and the IUD—arguably a conflict of interest. Bayer Pharmaceuticals, the maker of Skyla and Mirena, also offers Natazia, a combination birth control pill. TEVA Pharmaceuticals, maker of ParaGard, owns the Camrese, Apri 28, Aranelle and Aviane birth control pills—among others.
The pill is taken daily, its prescription renewed monthly, while the IUD is a single device installed once every three to 10 years. Whereas the IUD is only purchased once or twice, the pill is a long-term cash cow.
“I don’t think there’s any clinical obstacle to developing IUDs,” says Dr. Daniel Mishell, professor of obstetrics and gynecology at the University of Southern California’s Keek School of Medicine and an advisor at Population Council. “I just think that there wasn’t that much profit to be gained.”
Judy Norsigian, women’s health activist and co-author of Our Bodies, Ourselves explains that pharmaceutical companies will often buy up smaller companies whose products compete with their own. Then they’ll either nix the product at issue or fail to promote it.
I asked TEVA how it balances its competing stakes in ParaGard and the birth control pill. Michelle Larkin, TEVA’s associate director of communications, evaded my question, emphasizing in an email the need for “women to have access to a variety of contraceptive options.” When I asked whether the company had any plans to adapt ParaGard or make it smaller, Larkin responded, “At this time we have no updates to provide regarding any future adaptations of ParaGard which is indicated for intrauterine contraception for up to 10 years, and has no contraindications for use in nulliparous [never pregnant] women.”
Despite all this, Coble-Sadaphal says we’re experiencing an IUD renaissance thanks to younger consumers learning about the safety and effectiveness of the method. Healthcare providers are on board, too. “The American Congress of Obstetricians and Gynecologists … if you go to their website, there’s IUD info flashing everywhere,” she says. Likewise, the American Academy of Pediatrics recently released a policy statement saying the IUD should be offered to sexually active adolescents.
Coble-Sadaphal is optimistic about the future of the IUD. With continued awareness and greater research, she estimates that we will see between five and 10 new devices in the next decade, though it’s unclear how many will be non-hormonal.
For now, I’m stuck browsing the website of Pregna International Ltd.—which manufactures upwards of 11 copper-based IUD models, none of which have been approved for use in the U.S.—and wondering if I should risk purchasing one. The site’s banner proclaims, “Pregna contraceptive solutions can give you freedom to enjoy your life for a long time.” Pregna is based in India and has offices in 140 countries. It claims to be the world’s largest manufacturer of intrauterine contraceptives. Some of the IUDs it sells look a little hostile, admittedly. With its curved frame and plastic spines, the Inara Cu375 reminds me of a horseshoe crab. Other models look nearly identical to ParaGard, only smaller.
The Pregna website feels unsettlingly ramshackle. It has a loud disclaimer section and multiple instructional videos for providers; these demonstrate proper IUD insertion techniques to those who are unfamiliar. There’s no mention of regulatory bodies or safety standards.
But still, I’m curious. Could one of these work for me?
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Photo courtesy of Flickr user +mara licensed under Creative Commons 2.0
CORRECTION: Information on the functionality of the copper IUD has been updated to better reflect how the device interacts with the uterus and sperm.
