Tuesday 16 January 2018

Why no one can design a better speculum

The gynecological device may have an ethically fraught history, but it's hard to improve on the design, writes Rose Eveleth in The Atlantic. Read on: 

Few women enjoy pelvic exams: the crinkly paper dress, the awkward questions, the stirrups, the vague fear that can comes with doctors’s visits of any kind (what if they find something abnormal, something bad, something cancerous?). But perhaps no piece of the pelvic exam is as reviled as the vaginal speculum—the cold, clicking, duck-billed apparatus that lifts and separates the vaginal walls so a near-stranger can peer inside.

The speculum’s history is, like many medical histories, full of dubious ethics. Versions of the speculum have been found in medical texts dating back to the Greek physician Galen in 130 A.D. and shown up in archaeological digs as far back as 79 A.D. amidst the dust of Pompeii. (The artifact from Pompeii is a bit of a nightmare: two blades that open and close via a corkscrew-like mechanism.)

But the speculum most women experience today is largely credited to a man named James Marion Sims, often heralded as the father of American gynecology. He was a controversial figure even in his day, and should probably remain one now.

Sims’s early gynecological experiments were done on slave women who, in many cases, he purchased and kept as property in the back of his private hospital. Along with this violent legacy, Sims left behind a few medical advances and inventions—one of them being the vaginal speculum. While the design has been refined, the speculum women see today isn’t all that different from the one Sims used on his captive patients.

One might expect our modern spirit of innovation and disruption to turn its eye on the speculum. Surely something invented so long ago, under such dubious circumstances, could use an update. And many have tried. In the past 10 years, new designs for the speculum have continuously cropped up, only to fade away again. But while medical manufacturers continue to improve the design in little ways, there has been no real contender to displace the duck-billed model. The speculum’s history is inextricably linked to extreme racism and misogyny. But for all that, it just may be the best design we’re ever likely to have.

* * *

In 1845, Sims opened up a private hospital for women in Montgomery, Alabama. Slave owners in the surrounding areas brought their ailing women to him, and one of the more common problems he saw was something called vesicovaginal fistulas—a condition often caused by prolonged childbirth, in which a hole forms in between the bladder or rectum and the vagina. The tear causes urine and feces to pool in the vagina, creating infections, pain, and incontinence. Fixing it required a doctor to be able to look into the vaginal canal and see the hole.
J. Marion Sims engraved by R. O'Brien, (National Library of Medicine)
Sims didn’t want to have to look at a woman’s genitals. “If there was anything I hated, it was investigating the organs of the female pelvis,” Sims wrote in the autobiography he half completed before he died. This was a time when men and women interacted in very strict, pre-determined ways. Early illustrations from medical textbooks show doctors examining women’s pelvic areas by reaching their arms up beneath the layers of skirts and feeling around, literally blindly. A doctor was specifically instructed to reassure a female patient that he was not looking at her private parts by doing one of two things: gazing off into the distance or maintaining eye contact with her the entire time.

But when a patient came to Sims with an especially painful fistula, he wrote, “this poor girl was in such a condition that I was obliged to find out what was the matter with her.” He was eager to figure out a way to surgically seal up the hole, and happy to use slave women as his test subjects.

The idea for the speculum came to Sims while treating a white patient who had been thrown from a horse. After he helped her “reposition her uterus,” he had an idea. He fetched a slave, had her lay on her back with her legs up, and inserted the bent handle of a silver gravy spoon into her vagina. That’s right, the very first modern speculum was made out of a bent gravy spoon.

This new access allowed Sims to start performing surgery on the fistulas. Eventually he came up with a method for sealing them. He performed many of his experimental procedures without the benefit of anesthesia, and some of these slave women were operated on up to 30 times. Even at the time he was working, there were concerns about the ethics of his experiments. “All kinds of whispers were beginning to circulate around town,” wrote Seal Harris in a biography published in the 1950s, “dark rumors that it was a terrible thing for Sims to be allowed to keep on using human beings as experimental animals for his unproven surgical theories.” There is still an ongoing debate over whether or not to celebrate Sims’s legacy.

Specula from 1847 (U.S. National Library of Medicine)
At the time, however, the larger question wasn’t about Sims’s ethical practices as much as it was about his device. The vaginal speculum set off a vigorous debate in the medical community. “Diseases of the vulva, vagina, and cervix might be better understood and more effectively treated if physicians could see these organs, but this greater understanding came at what many physicians considered to be too high a price,” Margarete Sandelowski, a women’s health expert, wrote in a paper on the history of the speculum. Doctors thought that opening up a woman’s body might corrupt those women and turn them into prostitutes or sex-crazed maniacs.

This was, after all, a time when vaginal exams were associated with prostitution and indecency. Prostitutes were often hired as model patients for doctors to practice on. “There’s this really interesting line between torture device, disciplinary device, sexual device,” says Terri Kapsalis, a professor at the School of the Art Institute of Chicago, and the author of the book Public Privates: Performing Gynecology from Both Ends of the Speculum. Police officers would even leverage pelvic exams as threats against sex workers when they were arrested. Some doctors worried that using the speculum even on proper women might somehow make them sex-crazed.

In 1850, the Royal Medicine and Chirurgical Society of London held a standing-room-only meeting in which the community heard arguments for and against the speculum. These doctors worried that women would mistake the exam for a sexual experience. The British physician Robert Brudenell Carter reinforced this fear in his 1853 book, On the Pathology and Treatment of Hysteria, writing that he had “seen young unmarried women, of the middle class of society, reduced by constant use of the speculum to the mental and moral condition of prostitutes; seeking to give themselves the same indulgence by the practice of solitary vice; and asking every medical practitioner ... to institute an examination of the sexual organs.”
Sims Speculum (Wikimedia)
The speculum caught on probably for a whole number of reasons. One of them, according to Brandy Schillace, a researcher at the Dittrick Medical History Center at Case Western Reserve University, was that medical devices like the speculum and their relative the forceps helped doctors take control of an entire field: childbirth. Until the 18th century, the care of pregnant women and the birth of the child was something practiced by midwives, who were women. “Male doctors looked around and thought, ‘Hey, that’s something we should be doing,’” said Schillace. “But they couldn’t do that if everybody saw birth as being this natural thing. You needed tools and devices.” The speculum and forceps, Schillace says, weren't just tools that helped doctors open up the female body, but also tools that helped them gain control over a whole new subspecialty.

By the late 1800s childbirth and pregnancy were firmly a realm where doctors reigned and women were no longer the experts. As with many developments in medical history, the results were mixed: Doctors eventually developed medical equipment and procedures that would save many lives. But in those early days, obstetrics wasn't necessarily an improvement on midwifery. In fact, hospital births produced a much higher maternal death rate than home births because of a disease called puerperal fever that was transmitted from doctor to patient.

* * *

Over the past 150 years, medicine has advanced and doctors have become comfortable with the idea of examining a woman’s genitals. But the idea that the speculum in some way subverts female delicacy has never really died. During second-wave feminism, the speculum again became a symbol of gender roles and power. Mary Daly’s book Gyn/Ecology describes how activists of the 1970s equated gynecology with genocide and torture, seeing it as a symbol of a male-dominated society that put women in vulnerable positions (in this case, literally on their backs, naked) and made decisions about their bodies. “Women activists saw the speculum as an instrument of power that physicians used against women but which women ultimately could wrest from men,” Sandelowski writes.

In 1971, Carol Downer tried to do just that. She bought a plastic speculum, pulled out a mirror, and performed a self-exam. Downer thought women deserved to see what their doctors did—and objected to the fact that the vast majority of women (then, as now) hadn’t ever seen their own cervix. Downer invited other women to do the same. And they did. Downer also encouraged them to use the speculum to self-diagnose their own yeast infections, and encouraged home remedies like inserting yogurt into their vaginas. The medical establishment was none too pleased, and in 1972, Downer was arrested and charged with “practicing medicine without a license.”

The jurors eventually acquitted Downer, saying that they didn’t think that encouraging women to self-treat with yogurt was equivalent to practicing medicine. But feminist scholars argue that the case wasn’t really about yogurt. It was about who was allowed to wield the speculum and who wasn’t. “As these women discovered, a speculum in the hand of a woman posed a serious challenge to gynecologists, who had succeeded in claiming exclusive rights to the instrument and to diagnosing women’s maladies,” Sandelowski wrote.

* * *

The speculum we see today—that duck billed apparatus that clicks open, giving doctors a line of sight to the cervix—is fundamentally quite similar to the one Sims used on his slave women. In 1870 a man named Thomas Graves updated the device slightly, and gave us the form we see today. “That’s the one that’s stuck with us,” says Dr. Anthony Tizzano, a gynecologist at the Cleveland Clinic and collector of antique specula. Tizzano has over 100 specula, from as far back as the 1500s. He says that before Sims, there were over 200 different types of specula made for a variety of specialized tasks: placing leeches on the cervix, bloodletting the cervix, cauterizing wounds, but these were largely about delivering some kind of object or treatment, not about looking at the vagina and cervix themselves. But since Sims and Graves, the basic design hasn’t changed.

During the past decade, there has been an ongoing stream of alternative designs for the specula. And why not? Some studies suggest that women avoid and dread the pelvic exam because they hate the speculum in particular.

But not everything old is broken, and it turns out there might be a good reason to stick with the duck bill. Many of the doctors and designers I spoke with actually think the speculum is just fine, and are skeptical of the newer designs for a whole variety of reasons.

Most recent variations on the speculum work with the same central idea: inflation. Rather than having a two-part system that pushes the vaginal walls apart like an opening hand, these new devices are actually small tubes about the size of a tampon. Doctors insert the speculum into the vagina and inflate it. The air opens up the vaginal canal and exerts pressure equally on all sides of the cavity. Imagine a blood-pressure cuff, but in reverse.

In 2005, a company called FemSuite designed an inflatable speculum called FemSpec, got it approved by the FDA, and announced it would be working with Planned Parenthood to test out its invention. At the time, the device got some press. In an interview with the Chicago Tribune, a patient named Maryanne Sheofsky said that the FemSpec was “the most wonderful thing in the world.” Dr. Gerald Feuer, an Atlanta-based gynecologist working with the company, told the Tribune that their device would eliminate pinching and discomfort by conforming to the natural contours of a woman’s body.

At the time, FemSuite wasn’t the only group attempting this kind of thing. A company called Doctors Research Group Inc. had created a similar device called SoftSpec and filed for a patent three years earlier. But FemSpec and SoftSpec met similar fates within just a year of each other. In 2008, Jennifer Stroud Rossmann reported in Ambidextrous Magazine that FemSpec hadn’t caught on and would no longer be available. Annie Legomsky, FemSuite’s director of marketing, told Rossmann that doctors simply didn’t want to use it. “Doctors and nurses would see it and praise it,” she said, “but then they didn’t want to take the time to learn something new.” In 2009, the rival product, SoftSpec, cancelled its own application.

When I tried to figure out if anything new had happened with either company or device during the past five years, I met with a series of bounced email addresses and research dead-ends. The patent attorney who represented a similar inflatable speculum no longer had the contact information for his client. In the end, I couldn’t find anybody associated with either SoftSpec or FemSpec to comment.

What I did find were gynecologists and medical-device designers who are working to improve pelvic exams and create better versions of the traditional speculum. They’re just not ready to ditch the fundamental, duck-billed setup just yet. “I’m not sure it’s such a badly designed device,” Kapsalis told me. “I actually think that the design is fairly simple and fairly straightforward.”

The medical establishment tends to resist change, but Kapsalis isn’t sure that was what killed the FemSpec and its competitors. “I have a feeling that if there was a design that clinicians thought was an improvement, and particularly that their patients would be happier with, that they would be willing to try it out.” She pointed out some immediate problems with the premise of an inflatable speculum. “I think, sonically, it could be kind of intense—you hear this thing that’s inflating. And from a sensory perspective, I think that it could feel really weird.”

Not only might it sound and feel weird, but the inflatable setup might actually hinder a gynecologist’s view because the tube, by definition, fills the entire canal. Being able to see the vaginal walls is important for doctors to be able to diagnose infections. Even if the tube were made of a transparent plastic, it might still conceal important symptoms.

Kapsalis also worried that an inflatable tool might not be able to stand up to the realities of a pelvic exam. “You need a device that has some guts,” she said. “It’s got to really be able to hold something open that there’s a great deal of pressure on.” The vaginal walls can exert a whole lot of force inward, and that force might be more than air can resist.

Of course, there have been improvements to Sims’s gravy spoon since the 1840s. But those improvements have built on the same basic design. Today’s specula come in a variety of sizes, for example. When the medical manufacturer Welch Allyn launched its line of specula in 1968 they came in just small and medium. In 1999, the company introduced the large. And in 2005, after hearing from doctors that sometimes even the small was a little too big, it introduced an extra small. Now it offers all four sizes in disposable, plastic form.

Otherwise, though, Welch Allyn hasn’t done much to alter the basic mechanism. Tracy Bennett, one of the company’s product managers, spends most of her time thinking about ways to improve the speculum. Her team has considered changing the duck-billed setup. “We’ve looked at different ways to maybe add a third bill, and make the two bills smaller,” she said. But these alternative designs had their own problems, and weren’t any better than the current model. “Really what we found when we got out into the market is that there really was nothing wrong. It is an old design, but there really is nothing wrong with the way it is, and with the third bill there was more chance of pinching the vaginal wall.”

Welch Allyn's current sizes. (Photo courtesy of Welch Allyn)
Unlike Sims’s device, about half the specula in use today are made of plastic—a material that is often more practical than metal. Reusing metal specula requires thoroughly cleaning them between each patient or running the risk of spreading disease. Besides, in Kapsalis’s view, patients tend to like the plastic specula better. “Part of the thing people like better about the plastic and the metal is the warmth, and it doesn’t have this feeling of like a torture device; it’s not this clanky metal thing.”

Another benefit of plastic is the ability to integrate a light. This is what Bennett currently spends much of her time working on. Rather than forcing physicians to position an external light source so they can peer into the vaginal canal, many of Welch Allyn’s models have a light source built right into the handle of the specula where it can shine directly onto the cervix. The company’s most recent creation is a cordless, fully disposable plastic speculum with built-in lighting. The whole thing can be turned on at the beginning by pulling some tabs and thrown away when the exam is over. (Physicians who feel a twinge of guilt for throwing away all those batteries and light bulbs can remove and recycle them if they choose.)

So it’s not like the specula dropped out of the antebellum period and into your ob-gyn’s office unchanged. But these modifications have been relatively minor; the basic product still works just fine. Our technological bias may tell us that old things should be thrown out and redesigned completely—particularly when an old thing was the brainchild of a violent and sexist inventor. In the case of the speculum, however, the old thing seems to work just fine. “As you can imagine,” Bennett reminded me, “the female anatomy hasn’t changed that much.”

* * *

If the speculum isn’t the problem, why do so many women dread the pelvic exam? Kapsalis said that women who have trouble with pelvic exams are probably not suffering from a badly designed device, but rather from a badly designed patient experience.

Bennett agrees. “It’s probably more dependent on the technique of the clinician,” she said. “Or they might not be using the right size.” Bennett points out that the size of the speculum doesn’t necessarily correspond to the size of the person: Both adolescents and post-menopausal women, for example, tend to need smaller specula than middle-aged women do. Figuring out the right size can be difficult, and as a 2011 review paper on pelvic exams notes, there are no real guidelines that help practitioners figure out which size to use.

“This clanky thing comes out of a drawer and is put in their vagina before they even know what’s going on.”
Tizzano, who uses specula every day in his work as a gynecologist, says that clinicians need to remember that while they may use a speculum regularly and see the procedure as routine, their patients often don’t. “We do this all the time,” he said, “and you tend to lose some sensitivity. So you have to try to go slow and easy.” And a bad first experience can set a woman up for a lifetime of worries about pelvic exams. Even in the best of cases, though, Tizanno concedes that the examination is an invasive procedure by nature, and it’s going to feel like one. “Any time you have to dilate a body orifice and it’s not done so willingly, in the throes of passion, it’s not pleasant.”

It also turns out that much of the trouble women have with the speculum does go back to the male-dominated history of gynecology. Most women don’t really understand how the speculum works, and not all doctors do a good job of explaining what the experience is going to be like. “This clanky thing comes out of a drawer and is put in their vagina before they even know what’s going on,” Kapsalis said.

The movement in the 1970s encouraging women to buy and use their own specula did help in this regard. Kapsalis works with the Chicago Women’s Health Center, where doctors always offer women the opportunity to insert their own speculum. “That can really shift things,” she said. “Sometimes people feel much more empowered inserting their own speculum and having control over that aspect of the design. In that case, it’s not really the design of the tool but how it’s used.”

Not every woman wants to insert her own speculum, or peer at her own cervix. Kapsalis actually said that far fewer women are taking her up on the offer to insert their own speculum than they used to. But for some women—particularly those with a history of sexual violence or bad experiences with pelvic exams in the past—it can be a huge help. “If we’re going to put energy into that exam, I think more energy needs to go into the communication and the context and the sharing of power,” Kapsalis said.

So the next time you visit the gynecologist, fear not the speculum. It’s actually a well-designed tool. And it might be time to learn how to use it yourself.

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