Does the vaginal speculum need a redesign?

Chloe Kent 10 September 2020 (Last Updated September 10th, 2020 13:52)

Over the past decade or so, new designs for the speculum have continuously cropped up, only to fade away again. A lot of the media coverage surrounding them has had one consistent message – a new design is urgently needed; however, many clinicians insist they work just fine as they are. So, are patients suffering from a poorly designed device, or is a bad patient experience to blame?

Does the vaginal speculum need a redesign?
Speculums are designed to dilate the vagina so that a clinician can have a clear view of the cervix. Credit: Shutterstock

A pelvic exam isn’t something anyone with a vagina particularly looks forward to, but the vaginal speculum can provoke a unique ire among patients, more so than any other aspect of gynaecological care.

Looking at one, it’s not hard to see why. The duck-billed apparatus is designed to dilate the vagina so that a clinician can have a clear view of the cervix, a cylinder-shaped ring of tissue, which separates the vagina from the uterus. It resembles an instrument of a bygone era, and the clicking and clanking noises it makes as its arms are opened does little to assure anybody that the device does indeed have a place in a modern doctor’s surgery.

Patients often report significant discomfort or even outright pain during speculum examinations, and much of the media conversation surrounding the device places a sense of urgency around redesigning the it entirely with headlines such as: ‘The speculum is getting an overdue redesign, and we cannot wait’, ‘Women Are Reinventing the Long-Despised Speculum’, and ‘The speculum gets a much-needed redesign after 150 years of using the same contraption which was designed for deliberately painful experiments on slaves’.

But is the oft-maligned device really that bad?

Dr Fox Online Pharmacy sexual and reproductive health specialist Dr Deborah Lee says: “I personally think the vaginal speculum is well designed for the job. What we can do is as health professionals, is develop a better technique of how to use it. It’s impossible to imagine an instrument which would do the job better.”

The history of the speculum

The speculum used in clinics world-over is largely credited to James Marion Sims, who in 1845 invented a prototype of the one we see used today. Like many other vast swathes of modern medicine, the ethics of the speculum’s invention are uncomfortable, and this alone can be enough to put patients off the device.

The device was initially invented to treat vesicovaginal fistulas, tears which form between the bladder or rectum and the vagina as a result of some kind of trauma, most often prolonged childbirth.

These tears cause waste to pool inside the vagina, leading to infections, pain and incontinence. To fix them, doctors need to be able to have a clear look into the vaginal canal, which pre-speculum could be incredibly difficult. Sims, eager to figure out a way to do so, was happy to use enslaved women as his test subjects.

Starting out by inserting a bent gravy spoon into the vagina of a slave to lift and separate the vaginal walls, Sims graduated to buying or borrowing enslaved women with fistulas and using them for surgery test subjects at the hospital he ran.

He didn’t use anaesthetics during surgery, even after they became widely available, and thought black women had a higher tolerance for pain than white women. He is believed to have operated on one woman named Anarcha up to 30 times.

Eventually, the bent spoon became a double-bladed surgical instrument used to retract the posterior vaginal wall which is still used today for certain surgical procedures. This design was then updated in 1870 by Thomas Graves, who gave us the duck-billed device we now see in everyday practice. Since then, the basics haven’t really changed that much.

The material to make everyday speculums has switched from metal to clear, disposable plastic, although metal devices are often still used during some surgeries. Many models now have a torch built-in to give clinicians a better view, and there are a variety of sizes available to accommodate differences in vaginal anatomy, but that’s about the extent of it.

FemSpec: using inflation to reach the destination

In 2005, a company called FemSuite designed an inflatable speculum dubbed the FemSpec which went on to receive US Food and Drug Administration (FDA) approval. The device was designed to slowly inflate once inserted into a patient’s vagina, like a blood pressure cuff in reverse, allowing clinicians to visualise the cervix while conforming to the natural contours of the body.

The company announced that it would be working with US sexual healthcare firm Planned Parenthood to roll out the device, but by 2008 FemSuite was forced to withdraw the FemSpec due to resistance from physicians. An inflatable mechanism may make sense in terms of patient comfort – although, the feeling of a ‘blood pressure cuff in reverse’ inside the vagina sounds more like a different kind of uncomfortable than anything else – but as Lee notes, it’s far from ideal for physicians.

Lee says: “You need a machine to inflate it – this may be difficult to transport to a community setting and risks not working. You would also need a large pressure to hold back the walls of the vagina. Inflating a tube, like a sort of larger-diameter-but-thinner-volume blood pressure cuff, would then obscure the entire vaginal walls.”

Pumping air into the vagina also carries the risk of an air embolism, a blood vessel blockage caused by bubbles of air making their way into the circulatory system, which can happen via abrasions inside the vagina. It’s uncommon but has been reported after sexual partners have blown air into the vagina during oral sex or after penetrative sex too soon after childbirth, and could have happened if the inflatable speculum malfunctioned.

Callascope: observing the inside from the outside

Inflation isn’t the only mechanism that’s been trialled as a novel means by which to replace the conventional speculum. While studying for her PhD at Duke University, Massachusetts Institute of Technology (MIT) post-doctoral fellow Mercy Asiedu spearheaded a new take on the device.

Asiedu designed a tampon-sized device with a two-megapixel camera attached to the end, known as the Callascope. It bypasses the dilation aspect of traditional speculums entirely, with the cervix visualised on-screen via a video stream from the camera rather than directly.

This live video can even be connected to a smartphone, allowing patients to self-assess at home rather than coming into a clinic. The Callascope’s supporting software also contains a clinical decision-supporting algorithm which assesses the texture and colour of the cervix to identify abnormalities.

The Callascope enabled cervical visualisation for 82% of participants in-clinic, and when self-inserted at home saw 83% success on the first try and 100% after multiple attempts. Participants all indicated greater comfort when the Callascope was used compared to the speculum.

The device is focused more on patient comfort than clinical ease of use, and Asiedu acknowledged in an interview with Wired magazine in 2017 that there may be some pushback from physicians due to the more intricate means by which it needs to be operated.

There’s also the cost factor. Calla Health Technology’s website states that the Callascope costs “about a tenth” of a traditional colposcope, which can range from £2,000 to $8,000.

Meanwhile, a disposable plastic speculum can cost less than a dollar, meaning the £200 to £800 Callascope begins to look more than a little pricey. A question mark hangs over how much private health insurers may be willing to pay for the device when a viable alternative is still readily available.

Nella and Yona: no need to reinvent the wheel

Ceek Women’s Health and design consultancy frog has taken a rather different approach to the speculum. Instead of attempting to invent an entirely novel device, it has made alterations to the existing design to make it more ergonomic.

The company’s Nella range is made of a strong, autoclavable polymer, which is smooth enough that the company says no lubricant is required for insertion. It’s also designed to operate more quietly to avoid the creaking sounds that can leave patients so on edge.

The fundamental difference, however, are its two integrated sidewall retractors. As well as the two duck bills of the traditional speculum, which push apart the anterior and posterior walls of the vagina, the Nella speculum comes with two smaller bills which can be deployed to push apart the left and right walls, giving clinicians improved cervical visibility.

Ceek Women’s Health also manufactures a speculum light, which can be fitted into most devices and a sleeve which can be placed around a speculum to achieve a similar effect to the sidewall retractors.

frog’s Yona concept also focuses on an improved field of view for clinicians, with a three-leafed design which pushes tissue out of the way without having to open the device as wide. The company have also relaxed the handle angle from 90° to 105°, which it says allows for more intuitive ad comfortable operating by leaving space between the healthcare provider’s hand and the exam table.

The device avoids clicking and clinking and has a thumb-press button, which can lock the device in place, so clinicians have a free hand instead of having to hold the device open. Yona is made of stainless steel but covered in autoclavable silicone, designed to make insertion less painful, and the designers say they plan to eventually add a built-in light to the device.

Does the speculum actually need redesigning?

A medical device, which was developed via experiments on enslaved women in the 1800s and has seen little change to its design since sounds like something that needs an urgent update, but this isn’t necessarily the case.

While physical issues can complicate pelvic examinations, many patients find speculum examinations so unpleasant due to anxiety about the procedure, which can make the whole thing seem much more uncomfortable than it needs to be.

This anxiety is often poorly managed by time-pressured clinicians, who must attempt to get their appointments over and done with as quickly as possible so they can see their next patient. Being too hasty with the physical aspect of the examination can also cause the speculum to pinch the patient, causing a sharp, breath-taking pain – and if they have a bad experience like this, they’re less likely to come back next time.

In a recent 2020 survey of women’s reasons for failing to attend for a cervical smear, 13.6% of those who had not attended didn’t show up for this reason.

Lee says: “Clinicians don’t blink an eyelid at yet another speculum examination, but for the patient who may never have had one before, or had a bad experience, it’s a very different issue. The vast majority of patients have a very poor understanding of their anatomy.

“The clinician should ask the patient if she’s had a speculum examination before. They should be shown either a good picture of the vagina and pelvis or a pelvic model. Give her a speculum and let her hold it and have a fiddle with the mechanism. Explain how the blades open inside the vagina to hold the vaginal walls out of the way.”

Even if a redesigned speculum were to become widely used, if examinations continue to be carried out in a rushed and impersonal way, little will improve in terms of patient experience. What really needs to change isn’t necessarily the duck-billed device, but our approach to it.