In Our Control (22 page)

Uncertainty about the patch has mounted since 2005, with prescriptions dropping from 9.9 million in 2004 to 2.7 million in 2007. The consumer advocacy group Public Citizen has petitioned the FDA to
remove the device from the market, citing blood-clotting dangers. Sidney Wolfe, the tireless face of that organization, added fuel to the fire by noting that patient lawsuits led to the discovery of two unpublished studies from 2001 that indicate that the manufacturer, Johnson & Johnson, was aware of the clotting problem before the patch received an FDA green light.
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The Web site for Ortho Evra now leads visitors to a stern warning about the possible side effects, and the future of the method is in many ways uncertain.
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As the patch struggles, the NuvaRing seems to be taking off. In my research I spoke to dozens of women who had used or were using the ring with varying degrees of satisfaction. The ring may have many of the same health concerns as the patch, but this remains to be shown as clearly in a laboratory. Because of this, despite individual reports of similar health problems, the ring has benefited from the patch’s disgrace: it may be in this case that “no news is good news” for drugmakers and very dangerous for consumers.

A combined estrogen/progestin contraceptive, the vaginal ring is a small 54 mm round tube made of a polymer. Each month, a patient inserts the ring into the vagina and leaves it for three weeks. On the fourth week, the device is removed and a withdrawal bleed occurs. The ring has 11,700 μg of etonogestrel (a progestin) and 2,700 μg of ethinyl estradiol, which it releases at a constant rate of 120 μg of etonogestrel and 15 μg of ethinyl estradiol per day over the course of a cycle.
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NuvaRing users may take out the ring for up to three hours for sex or other activities to prevent displacement.
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While more data is needed, research at this point holds that the ring doesn’t cause more blood clotting than traditional pills. According to one study, patients who switched from the patch to the ring have improved markers for thrombosis, meaning they seem less disposed to get a blood clot.
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Despite this, it is estimated that the FDA has had over three hundred reported serious events associated with (although not conclusively caused by) ring use, including strokes, blood clots, and even some deaths. In 2007, Jackie Bozicev, a thirty-two-year-old mother of a two-year-old son, collapsed after taking a shower.
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She was rushed to the hospital where she was declared dead. An autopsy determined that the cause was a blood clot that traveled from her pelvic area to her lungs.
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Bozicev’s
widower, Rob, also in his thirties, couldn’t believe his young wife had suffered this fate and was even more shocked to learn that the cause of the clot might be her birth control. Reading this tragic story, it is hard not to remember the story of Julie Macauley, the young mother who died on the early Pill, told so movingly by Barbara Seaman in the original 1969
The Doctors’ Case Against the Pill
. It is harder still to believe that so many years later we are still relearning some of the same lessons of the dangers of the original Pill.

It isn’t clear why either the patch or the ring might be less safe than pills. It could be because of the way the hormones are absorbed into the body or because they use third generation progestins that have been associated with greater clotting risk. While we wait for better information, over one hundred lawsuits claiming injury from the NuvaRing go forward,
⁷⁵
and women continue to use the method, unaware that it may pose greater clotting risk.

Women deserve to have all the information before they make a choice that could come with increased health risks, but arguing that we should learn more about these dangers is not calling for the ring to be pulled from the market. One ring user told me just how well the device works for her. A twenty-something artist living in Brooklyn, Lin had always used pills but had never been able to take them as reliably as necessary. The result was two unplanned pregnancies followed by two abortions. A switch to the ring has given her a sense of control over her fertility and solved her problems with remembering to take the drug. For teenagers who need hormonal contraception that doesn’t need to be taken every day, perhaps the ring provides a good alternative to Depo-Provera.

Ring users have less nausea, depression, and weight gain than pill users, but more breast tenderness. Local problems, such as vaginal infections, leukorrhea (thick discharge that can indicate problems in the vagina), and itching in the vaginal area are more common for ring users. Unlike a diaphragm, the ring doesn’t need to be fitted to an individual or placed over the cervix. It can, however, fall out as a result of sex, tampon removal, or straining.
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Most of the time, women are aware when this happens and can put the ring back in, but once in a while they aren’t so lucky. One young graduate student from Washington, DC, shares her story: “I had a bad experience with the NuvaRing. I did not realize that
it had fallen out. By the time I realized what had happened and switched to the Pill, it was too late to remedy the problem. This story ends in an abortion.”
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There are also very rare instances of the ring being displaced in the body; in one unusual instance, a twenty-five-year-old nurse put in her ring and experienced burning urinary symptoms within a day. At the end of the three-week period she went to remove the device, only to discover it wasn’t there. An ultrasound revealed that the device was in her bladder and was the source of her urinary infection.
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This sort of problem is exceedingly rare; expulsion of the ring is a far more common problem. Most women find the ring easy to both insert and remove.
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Bleeding on the ring, like the patch, seems to be more regular than what women experience on the traditional Pill,
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although the data is confusing. Because some women use the ring “off label” for extended use—that is, for menstrual suppression—it is important to remember that irregular bleeding is a reality of hormonally eliminating monthly bleeds, regardless of the way in which you take those compounds. While the ring may cause predictable bleeding when you take it out for a monthly bleed, this isn’t true when you are using the method continuously.

New methods can bring benefits, but they can also be unpredictable. Faye, a recently married woman in her thirties, switched to the ring five years ago. She had been with the man who is now her husband for several years and was having trouble on the Pill. Always the first of her friends to try something new, she decided to give the ring a try: “It was all right at first, but within two months it killed my sex drive. I mean killed it dead. I’d never just not wanted to have sex before, and I realized after a few months that the only thing different in my life was my birth control.”
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Faye went back to the Pill, despite other complications, and has found that things have returned to normal in the bedroom. Some studies show that women experience an increase in libido with the ring as compared to the Pill,
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but when it comes to hormones and new ways of taking them in, everyone’s body is different.

Some women—particularly younger folks—find that the ring can interfere with intercourse in a more immediate way. Some people’s partners can feel the device during sex, and a smaller group found that they or their partners dislike the sensation. One study found that “interference with intercourse” was the main reason women gave for stating that they
disliked the method.
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This was less likely to be a problem in older women and with continued use of the method.

Looking to the Future

While, clinically speaking, much remains to be seen about the safety of these methods, new contraceptive products are always exciting. Even as we temper our enthusiasm for recent “innovations” by realizing that they carry both some of the old problems of hormonal contraceptives as well as their own distinctive issues and a lack of long-term safety data, each new product gives us the hope that it will be a better way to manage our fertility. I invite you to start asking some hard questions about contraceptive innovation. Why have there been so few truly new methods? And what possibilities exist in the future for making a product worthy of the adjective “novel”?

Women face the unfortunate reality that protecting our safety often comes at the cost of discouraging drug and device innovation. How can we strike a balance between making sure that patients aren’t unnecessarily endangered by their birth control and ensuring that women have numerous and growing options? Finally, years of experience have taught us that trying something new usually means risking unanticipated side effects and dangers. Each woman must decide for herself the extent to which her need for something different outweighs her concerns about trying an untested method.

Chapter Five
Of Tides and Phases: Menstruation and Birth Control

Menstruation may not be important in itself, but it is highly symbolic of femaleness, and the ways in which people deal with it show us a lot about how women are viewed
.
—Sophie Laws

It may seem obvious to suggest that any conversation about contraception should necessarily involve one about women’s monthly hormonal cycle. After all, every birth control system, whether it involves popping a pill or charting your temperature, is based on understanding when and how ovulation happens and figuring out how to prevent conception.

Although we use the phrase “birth control,” and certainly we hope our chosen methods
prevent
pregnancy, what we are really controlling and manipulating is the monthly menstrual cycle. A woman should understand
how
her method works, in the long term and short term, in addition to understanding
how well
it works. Your doctor can give you statistics about efficacy in ten minutes: for example, the Pill is 99.9 percent effective. But comprehensively knowing how and what the Pill does is a process that involves true body knowledge.

Our contraceptive choices are largely informed by the cultural ideas we internalize about periods at young ages and the bodily metaphors we become conversant in when we are practically children. Early in our lives, most women receive some sort of information about what goes on in our bodies each month that causes us to bleed. The information is usually more or less scientific, and we receive it when we are relatively young (somewhere between ages ten and fifteen). For most of us, it stops there, and we have little reason over the years to go back and refresh or complicate the very basic details we learned in middle school health class or perhaps from a parent.

We’ll soon get into the reasons for the spectacular silence surrounding one of the most basic female bodily processes, but first, for those of us
who are more than a few years from health class, let’s remember together what makes up a monthly cycle.

When a female baby is born, she already has all the cells that will eventually become her eggs. This is different from men, who continuously produce new sperm throughout their lives. Women are born with all the necessary pieces to make a baby already in place in their bodies. In total, there are probably around 450,000 of these cells (although of course every person is different). That number decreases with age.

When a biologically female person begins to mature sexually, periods begin. It happens because enough hormones are running through the body to encourage the hypothalamus, a tiny gland in the brain, to begin a complicated chemical reaction that will eventually result in menstrual bleeding. Women are used to being told that perceptions about our bodies are “all in our heads,” but in the case of menstruation, it really does begin “up here” rather than “down there.”

The hypothalamus sits just above the brain stem and helps to coordinate bodily processes including hunger, thirst, libido, and sleepiness. At some point, it sends out a chemical message to the pituitary gland, a pea-sized protrusion immediately below the hypothalamus at the base of the brain. Like colleagues developing a new project together, the pituitary takes the initial idea sent by hypothalamus and expands on it, producing two chemicals, follicle-stimulating hormone (FSH) and leutinizing hormone (LH). At first the body makes much more FSH than LH. This hormone works on the ovarian follicles like water on seeds, causing several to begin sprouting—but only one will actually grow into a full-fledged egg. As the follicles grow and ripen, they release estrogen, which begins to thicken the lining of the uterus.

There are a lot of reasons for this thickening, including, of course, creating a space for a potential pregnancy. Rising estrogen levels cause other changes. First, they alter the cervical fluids (sometimes called cervical mucus), making them thicker and able to keep sperm alive for longer periods of time. Second, they send a message back to the hypothalamus, which, again in concert with the pituitary, leads to the release of a gush of LH.

Until this point, several follicles have been ripening and readying to make an egg. For reasons that aren’t entirely understood, when the surge
of LH reaches the ovaries, it causes one (and rarely, two) follicles to race ahead of the others and burst, producing an egg. The tiny egg will live only a short time—around twenty-four hours—and is carried along the fallopian tube by tiny hairlike projections called cilia.