For Women Seeking Non-Hormonal Birth Control, an Exhausting Quest

4253230816_0e36b94e44_z (1)“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.

Carson Frame--Ms head shot

 

Carson Frame is a freelance journalist working toward her master’s in Literary Reportage at NYU. You can find more of her work in Souciant, Chronogram and Metroland: The Capital Region’s Alt-Weekly.


Comments

  1. Did it hurt when they removed it? I just got a copper IUD yesterday and so far I’m feeling ok, but I’m scared that the removal will be as painful as the insertion.

    • Michelle says:

      I know this is super late, but I recently had paragard removed. Removal was nothing like the insertion. For the insertion, they made sure that my cervix was dilated as much as possible, and that I had taken pain meds. They folded in the little wings and insertion just felt like a pinch. During removal, they do not dilate your cervix or fold in the wings, they just pull it out. I have a very high pain tolerance, but it was very painful. I don’t know why they take such care putting it in (I guess its to not damage the device rather than to minimize your pain) when they just yank it out in the end. I’m sure the wings scraped the sides of my cervix and had pain for weeks afterwards. Would recommend taking lots of pain meds beforehand.

  2. Vicki Messler says:

    Thank you so much for writing this, Ms. Frame. I am 40 years old and currently on my second copper IUD. In college, friends turned me on to the IUD and we had many discussions about the pharmaceutical disincentive to provide women with a “one and done” option for birth control. Another point we considered was that there was an oppressive control over women who had to think about birth control every morning when taking a pill- lnever allowing them to be sexually free. I used the copper IUD from age 20- age 27, but had it removed because of irregular bleeding that bordered on non-stop menstration. After 2 kids, I went back to the copper IUD since there was no WAY I wanted to resume the condoms, pill, ring cycle I’d been trapped in before I decided to have children. I also did not want to risk the mood swings associated with hormonal methods. I hope you find what you are looking for in the alternative choices abroad. Best of luck!

  3. Marianne Dietrich says:

    Interesting article. Some thoughts from a physician who performs IUD insertions. Sounds like you had a bit of a hellish experience that didn’t have to be so. Sounds like you were in an operating room for pete’s sake. Not every IUD is easy to insert, some do take longer than others. You had your blood pressure monitored during the procedure and an ultrasound was performed right afterwards?! That procedure must have cost a lot more money than it needed to. The cervical opening, or os, is not as small as the head of a pin. If it was how in the world would all that blood come out every month? Dilating tools are not always needed, actually the IUD can usually be inserted without dilating the cervix first. I personally don’t know any medical practitioners who prescribes misoprostol to dilate the cervix prior to IUD insertion, and it certainly will not reduce pain. You should have been given a hefty dose of ibuprofen for the cramping. I agree more research needs to be done to develop more types of acceptable non-hormonal IUDs. It really is a great method but unfortunately not tolerated by everyone. I hope your search is productive.

    • Thank you for clarifying some important things. I’ve seen my own cervix before childbirth during a gyn procedure, and it was definitely as “small as the head of a pin”. It’s large enough to easily accommodate those long q-tip swabs during Pap Smears.

  4. Yvonne says:

    Thank you for writing this! I have had the same struggles with hormonal birth control. Mirena was awful and lead to almost continual bacterial infection. The Paraguard was a nightmare! It migrated, embedded in the wrong place,caused an ectopic pregnancy which I had to terminate and have surgical procedure to remove the Iud. As a mother of two preemies who experienced premature labor combine multiple hospitalizations, and bed rest, I’m not looking to have any more children. There are no long-term options without hormones. The permanent Solutions include essure or tubal ligation. The first come with well documented horror stories of migrating Springs puncturing other organs and leading to internal bleeding while the other is a fairly invasive and requires going under anesthesia. There’s a serious lack of options the definite Gap in the research. More advocacy for this is needed.

  5. Dear Carson,

    I really liked your article and thought I would briefly explain my rather horrific experience with this seemingly fantastic long-term contraception device.

    A couple of months ago I went to see a doctor to have the hormonal model inserted to stop me from having the period (a have rather extreme period pains). The insertion was uncomfortable but nothing compared to what followed after. I was released from the clinic immoderately after even though my doctor noted that I was looking “a bit pale”. The clinic was a ten minute walk away from my flat. I called my mother as soon as I had left to tell her that I was ok. Only thing was my mother did not pick up and when she called me back (approximately one minute later) I was not fine anymore at all – in fact I was suffering from shock and intense pains. So much so that I was unable to answer the phone and tried to drag myself home holding on to fences and lampposts. Sure, I should have returned to the clinic right away but by then I was unable to make conscious decisions. All I could do was follow my instincts which were screening: “go home”. As soon as I arrived in my flat I stripped naked, the pressure of my panties on my skin was unbearable, ran to the bathroom, collapsed in front of the toilet and threw up. This was followed by hot and cold flushes and me lying in bed for 2 hours shaking until I could return my mother’s call. Thinking that it would get better I decided to stay in bed for a day. The next day however I was on so much pain that I was unable to walk further than from the bathroom to my bedroom. I called the clinic, took a taxi to see the doctor and was told that I was suffering from cervical shock – my implant had not been put in far enough and was constantly rubbing against my cervix. – cervical shock is a potential risk that may occur – my doctor never told me about it till after and I think that there is a lack of awareness among women of the dangers and risks of this seemingly fantastic contraceptive model.

    For me one thing is clear – never again!!!

  6. The Nova-T and Flexi-T are both used in Canada and neither have hormones. Might be worth looking into coming up here to have one of those put in…. I use the Nova-T and have had no issues past the first week of discomfort, and I too cannot use hormonal birth control.

  7. I would really like to talk more about this; this is a great article, but I didn’t feel like the author had a good grasp of diaphragm + condom + spermicide use. If you use them all together, you get GREAT protection from STDs and pregnancy.

  8. Great article!! I shared it on my page. I have never heard of the Dalkon Shield, super interesting! Thanks!!

  9. A great piece, thank you. There is, thankfully, a lot more innovation and investment happening in the world of technology (as opposed to pharmaceuticals). Tech-supported fertility awareness/natural family planning is very effective for preventing pregnancy. Fertility computers like Lady-Comp and Daysy are stepping into this gap to provide an effective, efficient, convenient alternative to a device or drug. I think Daysy is comparable to the copper IUD. You only have to take 30 seconds of your day to take your basal body temperature and you have your fertility status reading. I’ve been using this since early last year. The tech is making fertility awareness a more viable option for many, many more women. When I wrote my book, “Sweetening the Pill,” this was a growing sector – now it’s booming. The number of women asking for non-hormonal options is rising. The demand is definitely present. Although the IUD is being heralded as the next best thing, I have a lot of concerns about anything that is not woman-controlled, personally. There are issues with costs (might be free for insertion, but not removal) and with women finding it hard to convince their doctor they need to have their IUD out due to unwanted side effects. Carson – if you check out the tech side of all this, it’s very interesting. I’d be happy to talk with you about it too. My email is on my website – sweeteningthepill.com

  10. Vanessa Johnsonv says:

    I really love the Marquette method of Natural Family Planning. Unlike other methods of NFP, it doesn’t require observing one’s cervical mucus or taking daily temperatures. It utilizes the Clearblue Fertility monitor so you’re just taking a urine test to detect ovulation/fertility window. I’ve used it for several years and it’s been super easy even post-partum. I am always amazed that it’s not more widely known.

  11. Your experience seemed pretty horrific. I can’t imagine going through that much for reliable birth control and I agree that there should be more options for women who are seeing non-hormonal birth control. A couple of things stood out to me. I’ve had the Paragard for four years now and it has worked for me perfectly. Now, the insertion process was very painful and perhaps the most uncomfortable 30 minutes of my life. I also hadn’t had children so it made it a lot more painful than it would be for a parous woman. This is a big part of the reason that the IUD was not recommended for nulliparous women before. I definitely don’t regret getting it as it proved to be a fantastic option. A lot of women cannot tolerate it as it never quite seems to settle. I’m not sure if it is because of the shape of the uterus, inexperienced placement etc? I will say that the other IUDs such as Mirena and Skyla contain hormones that only act locally. This means that the hormones are not released throughout the whole body. They only affect the uterus and uterine lining. It’s unfortunate the Paragard IUD didn’t work for you as it is a fantastic choice for many women. Hopefully there will be further advancement in the nonhormonal contraceptive arena.

    • Chazzy35 says:

      E.R. …It is inaccurate to say “other IUD’s contain hormones that only act locally.” Whether that’s the way the manufacturers intended for them to work, or it’s a marketing scheme; it simply isn’t true. There is so much information available to the contrary I cannot fathom this could be a debatable issue.

  12. I used a copper 7 from the age of 23 through 53 when I began menopause. I was never pregnant and except for cramping at the first insertion and heavier periods which I adjusted to, I was fine and grateful not to have to rely on the pill which made me depressed and overweight or the diaphragm which I knew from family members pregnancies was not reliable. More copper models for people who have never been pregnant need to be made available. That IUD enabled me to get a degree, build a career and support myself.

    • How did your skin and weight react to getting off hormonal birth control? I’m looking to get this inserted but scared I may gain more weight from my hormones not being used to being on the pill…please email me at samiwelin@yahoo.com

  13. Thank you for continuing to spread the copper IUD gospel. I’m on my 2nd Paragard since I was 24, and have enjoyed 18 years of being baby-free with zero “accidents,” missed pills, or other concerns. I’m sorry it’s not working for you and it’s frustrating that non-hormonal options aren’t more widely available.

  14. C. Romano says:

    This is an important topic and I thank you for reporting on it. I am dissapointed that you brushed over the other methods of non hormonal birth control so quickly. Although not as effective, their success rate is closer to 98% when used correctly (especially with a male condom). They are sound options if, for any reason, a woman might wish to avoid an invasive medical procedure as well as hormonal birth control. But, it’s interesting to note that, at least in Texas, trying to get a diaphragm or a cervical cap is damn near impossible. Most young women I speak to don’t even know they exist. After making calls to many doctors and clinics, my daughter was able to find a Planned Parenthood that could fit her for a diaphragm that then had to be ordered from England and it wasn’t covered by insurance.

  15. Cynthia Bishoff says:

    I am glad to know that I am not the only one out there with this problem! I, too, wanted and needed to get off hormonal birth control. I tried the Paragard, but expelled it… TWICE! I have tried every pill combo out there and had to stop all of them for some reason or another. My gyno convinced me (against my better judgement) to get the Skyla, as it is a smaller IUD and that its minimal hormones were local and wouldn’t have any effect on my anxiety, migraines, or periods. I can tell you that this is false – I have been a moody, anxious, migrainous mess since having it put in 5 weeks ago. The size of the IUD is great, but I am thinking it is time for it to go! Condoms, it is…

    It would be so nice if we had more long term options available to us! We are not one-size-fits-all!

  16. Melanie Hodgins says:

    I had the Paragard for 9 months until they had to remove it yesterday. My body doesn’t respond well to synthetic hormones and I’ve been trying different methods of birth control since I was 16 (now 27). I had a previous miscarriage but no children so the doctor said it would be more painful to insert the Paragard. OH man did it hurt. The periods were MUCH heavier and the cramps were to debilitating, I would have to take Tylenol 3 and I have a high tolerance for pain. Anyway, they had to remove my IUD yesterday because it partially expelled itself and was starting to come out of my cervix.

    The doctor suggests I go with condoms from now on since I can’t do hormones and my last ditch effort (non hormonal IUD, Paragard) was a complete failure.

  17. Great article! I really hope a different form of non-hormonal birth control is developed soon… there is clearly a significant demand. Has anyone else heard that the “non-hormonal” Mirena Paragard copper IUD actually prompts the release of leukocytes and prostaglandins by the endometrium? The copper ions that are released by the copper IUD therefore DIRECTLY affect hormone production! And they call it “non-hormonal”? Does anyone have more information on this?

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