Page last updated August 2021

Outdated practices are causing preventable coil insertion pain

Outdated practices are causing preventable coil insertion pain

Before Lucy Cohen got her contraceptive coil inserted, her doctor said she would only need to take a couple of paracetamol to manage the pain.

“My insertion was horrendous,” Lucy says. “I was screaming in pain, and I felt violated because I didn’t consent to being in that amount of pain.”

Lucy set up a survey to see if others shared her experience and then launched a petition which eventually lead to the Faculty of Sexual Reproductive Healthcare (FSRH) changing their guidelines to state that patients should always be offered pain relief during coil insertions.

While this is a welcome development, it is just the tip of the iceberg. Many coil insertions are needlessly painful and uncomfortable due to outdated procedures and equipment choices — plus, the fact that the size of a standard coil is larger than most uteri.

Centuries-old equipment

The speculum is a device shaped like the bill of a duck which holds the vaginal walls apart, so that doctors can examine the cervix during coil insertions. The modern speculum was invented by James Marion Sims in the nineteenth century, over 150 years ago — although plastic speculums are more commonly available now which are thought to be somewhat more comfortable.

Tracy Bennett, Senior Vice President of Marketing & Sales at medical device company Ceek Women’s Health, says she’s heard the speculum be referred to as the “can opener of the cervix”. “Very little thought went into it, it was just designed for a functional purpose,” she says.

Using a smaller speculum can help to make the procedure less painful

Although most people do not find it painful when a speculum is being used to examine them — doctors say that those who can tolerate penetrative sex can tolerate a speculum — they are uncomfortable enough to make some people avoid routine cervical screenings. Additionally, for survivors of sexual assault, the use of a speculum can be triggering.

In 2020, Ceek released the Nella NuSpec, a speculum that is the width of a regular tampon and is designed to be “one-size-fits-most”. Using a smaller speculum can help to make the procedure less painful. “You’re most sensitive in the beginning of the vaginal canal where your nerve endings are,” Bennett explains. “Once NuSpec is inserted and opened, you feel a little pressure, but it’s not painful.”

Traditional speculums open vertically, but a patient’s vaginal walls can still obstruct the doctor’s view on each side. The NuSpec opens horizontally as well as vertically, allowing doctors better visibility which could lead to quicker coil insertions.

And then there’s the tenaculum, a device that looks like a pair of scissors with its pointed tips curved inwards, that can also be used during a coil insertion. It is used to pierce the cervix in order to hold it in place while the coil is being fitted, and was originally designed over a century ago to gouge bullets out of soldiers’ bodies during the American Civil War.

Gynaecologist Dr David Finci said that, in his experience, the tenaculum causes bleeding in over 80% of insertions

Gynaecologist Dr David Finci, the Chief Medical Officer of Swiss medical device startup Aspivix, said that in his experience, the tenaculum causes bleeding in over 80% of insertions. Other studies have recognised the tenaculum as a cause of pain and discomfort during IUD insertion.1

Aspivix is currently trialling Carevix, a new tenaculum which is scheduled to be released early next year. Carevix uses suction technology to grasp the cervix and showed promising results from its Phase I clinical trial of ten cisgender women, who reported lower pain scores compared to standards in published literature on IUD insertions and did not experience any bleeding or tissue tear.

Are coils too big?

When Ffion Lister, 24, got the hormonal Mirena coil inserted in 2018, she barely found the insertion painful at all. But her body rejected the coil almost immediately, and she fainted as soon as she stood up to leave the doctor’s office.

“Everyone was panicking,” she says. “I had this woman holding up my legs and the doctor was literally using a flashlight to get [the coil] out, it was horrific. It turns out my uterus is small, but they didn’t know that.”

The width of the uterus is best measured using a 3D ultrasound, a precaution which wouldn’t be feasible to provide to everyone and would be unnecessary for most patients, Dr Deborah Lee from Dr Fox Pharmacy explains.

If a coil is too large and it is left inside the patient, it can cause chafing — resulting in pain and sometimes bleeding

However, 82% of cisgender women who have never given birth have uteri less than 28mm wide2 — the Mirena is 32mm wide, and the T-safe copper 380A, which is the first-line copper coil prescribed by the NHS, is 31.8mm.3

If a coil is too large and it is left inside the patient, it can cause chafing — resulting in pain and sometimes bleeding, Dr Lee says. “This probably happens far more often than we have been aware of to date,” she adds.

Although two smaller hormonal coils, Jaydess and Kyleena, are available on the NHS, they still measure 28mm, which would be too large for many people with a uterus. Ffion says that while her friends had mentioned that there were different coil sizes available, her doctor failed to do so.

Many smaller coils have comparable rates of efficacy and longevity to the Mirena and T-Safe copper 380A, which are typically recommended as first-line options,4 yet patients are not routinely made aware that alternatives are available.

Smaller coils such as Kyleena and Jaydess can also minimise pain as they require a smaller insertion tube5 — which can cause pain when it is placed into the tiny opening of the cervix.

We need better data collection on the pain patients experience during and after coil insertion, and how this compares with different coils and other types of contraception

There are eight different types of copper coils currently available on the NHS.6 The IUB Ballerine, the first new coil design in nearly 50 years, is the tiniest. It comes in 12mm and 15mm sizes, and was supposed to be released on the NHS in 2020 before the rollout got delayed due to the pandemic.

Developed by Israeli femtech startup Ocon Medical, the Ballerine’s spherical shape is also designed to reduce the pain and bleeding caused by T-shaped coils which are badly positioned within the uterus.

Choices matter

While medical device innovation could significantly ease the pain and anxiety people feel during coil insertions, it is also important to empower patients by giving them a choice between different coils.

Patient experience should be considered alongside other factors, such as efficacy, when contraceptive methods are recommended. “You might decide that an extra 1% chance of pregnancy is worth taking if you can’t bear the idea of being in pain for six months,” says Lucy.

We also need better data collection on the pain patients experience during and after coil insertion, and how this compares with different coils and other types of contraception, Lucy adds. “We can rate airport toilets and we can’t rate coil fittings? Come on.”

Featured image is an illustration of a metal speculum and a tenaculum, done in the black-and-white style of a Victorian science illustration. They are drawn against a pale peach background

Page last updated August 2021

Before Lucy Cohen got her contraceptive coil inserted, her doctor said she would only need to take a couple of paracetamol to manage the pain.

“My insertion was horrendous,” Lucy says. “I was screaming in pain, and I felt violated because I didn’t consent to being in that amount of pain.”

Lucy set up a survey to see if others shared her experience and then launched a petition which eventually lead to the Faculty of Sexual Reproductive Healthcare (FSRH) changing their guidelines to state that patients should always be offered pain relief during coil insertions.

While this is a welcome development, it is just the tip of the iceberg. Many coil insertions are needlessly painful and uncomfortable due to outdated procedures and equipment choices — plus, the fact that the size of a standard coil is larger than most uteri.

Centuries-old equipment

The speculum is a device shaped like the bill of a duck which holds the vaginal walls apart, so that doctors can examine the cervix during coil insertions. The modern speculum was invented by James Marion Sims in the nineteenth century, over 150 years ago — although plastic speculums are more commonly available now which are thought to be somewhat more comfortable.

Tracy Bennett, Senior Vice President of Marketing & Sales at medical device company Ceek Women’s Health, says she’s heard the speculum be referred to as the “can opener of the cervix”. “Very little thought went into it, it was just designed for a functional purpose,” she says.

Using a smaller speculum can help to make the procedure less painful

Although most people do not find it painful when a speculum is being used to examine them — doctors say that those who can tolerate penetrative sex can tolerate a speculum — they are uncomfortable enough to make some people avoid routine cervical screenings. Additionally, for survivors of sexual assault, the use of a speculum can be triggering.

In 2020, Ceek released the Nella NuSpec, a speculum that is the width of a regular tampon and is designed to be “one-size-fits-most”. Using a smaller speculum can help to make the procedure less painful. “You’re most sensitive in the beginning of the vaginal canal where your nerve endings are,” Bennett explains. “Once NuSpec is inserted and opened, you feel a little pressure, but it’s not painful.”

Traditional speculums open vertically, but a patient’s vaginal walls can still obstruct the doctor’s view on each side. The NuSpec opens horizontally as well as vertically, allowing doctors better visibility which could lead to quicker coil insertions.

And then there’s the tenaculum, a device that looks like a pair of scissors with its pointed tips curved inwards, that can also be used during a coil insertion. It is used to pierce the cervix in order to hold it in place while the coil is being fitted, and was originally designed over a century ago to gouge bullets out of soldiers’ bodies during the American Civil War.

Gynaecologist Dr David Finci said that, in his experience, the tenaculum causes bleeding in over 80% of insertions

Gynaecologist Dr David Finci, the Chief Medical Officer of Swiss medical device startup Aspivix, said that in his experience, the tenaculum causes bleeding in over 80% of insertions. Other studies have recognised the tenaculum as a cause of pain and discomfort during IUD insertion.1

Aspivix is currently trialling Carevix, a new tenaculum which is scheduled to be released early next year. Carevix uses suction technology to grasp the cervix and showed promising results from its Phase I clinical trial of ten cisgender women, who reported lower pain scores compared to standards in published literature on IUD insertions and did not experience any bleeding or tissue tear.

Are coils too big?

When Ffion Lister, 24, got the hormonal Mirena coil inserted in 2018, she barely found the insertion painful at all. But her body rejected the coil almost immediately, and she fainted as soon as she stood up to leave the doctor’s office.

“Everyone was panicking,” she says. “I had this woman holding up my legs and the doctor was literally using a flashlight to get [the coil] out, it was horrific. It turns out my uterus is small, but they didn’t know that.”

The width of the uterus is best measured using a 3D ultrasound, a precaution which wouldn’t be feasible to provide to everyone and would be unnecessary for most patients, Dr Deborah Lee from Dr Fox Pharmacy explains.

If a coil is too large and it is left inside the patient, it can cause chafing — resulting in pain and sometimes bleeding

However, 82% of cisgender women who have never given birth have uteri less than 28mm wide2 — the Mirena is 32mm wide, and the T-safe copper 380A, which is the first-line copper coil prescribed by the NHS, is 31.8mm.3

If a coil is too large and it is left inside the patient, it can cause chafing — resulting in pain and sometimes bleeding, Dr Lee says. “This probably happens far more often than we have been aware of to date,” she adds.

Although two smaller hormonal coils, Jaydess and Kyleena, are available on the NHS, they still measure 28mm, which would be too large for many people with a uterus. Ffion says that while her friends had mentioned that there were different coil sizes available, her doctor failed to do so.

Many smaller coils have comparable rates of efficacy and longevity to the Mirena and T-Safe copper 380A, which are typically recommended as first-line options,4 yet patients are not routinely made aware that alternatives are available.

Smaller coils such as Kyleena and Jaydess can also minimise pain as they require a smaller insertion tube5 — which can cause pain when it is placed into the tiny opening of the cervix.

We need better data collection on the pain patients experience during and after coil insertion, and how this compares with different coils and other types of contraception

There are eight different types of copper coils currently available on the NHS.6 The IUB Ballerine, the first new coil design in nearly 50 years, is the tiniest. It comes in 12mm and 15mm sizes, and was supposed to be released on the NHS in 2020 before the rollout got delayed due to the pandemic.

Developed by Israeli femtech startup Ocon Medical, the Ballerine’s spherical shape is also designed to reduce the pain and bleeding caused by T-shaped coils which are badly positioned within the uterus.

Choices matter

While medical device innovation could significantly ease the pain and anxiety people feel during coil insertions, it is also important to empower patients by giving them a choice between different coils.

Patient experience should be considered alongside other factors, such as efficacy, when contraceptive methods are recommended. “You might decide that an extra 1% chance of pregnancy is worth taking if you can’t bear the idea of being in pain for six months,” says Lucy.

We also need better data collection on the pain patients experience during and after coil insertion, and how this compares with different coils and other types of contraception, Lucy adds. “We can rate airport toilets and we can’t rate coil fittings? Come on.”

Featured image is an illustration of a metal speculum and a tenaculum, done in the black-and-white style of a Victorian science illustration. They are drawn against a pale peach background

Page last updated August 2021

Helen Gonzalez Brown

Helen Gonzalez Brown is a freelance journalist focusing on art, design, and health. She is particularly interested in medical device design, chronic illness, and women’s health activism.

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References

  1. Bahamondes, L., et al., Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives, The Journal of Family Planning and Reproductive Health Care, January 2014, vol 40, no 1, pp 54-60
  2. Wildemeersch, D., Uterine cavities are much smaller than what most gynecologists think. Journal of the Turkish German Gynecological Association. 2016; 17(3): 127. PubMed
  3. Gleser, H. Characteristics of IUD available in the UK and prescribable on the NHS. Tayside Sexual & Reproductive Health Service [online] https://www.nhstaysideadtc.scot.nhs.uk/approved/guidance/IUD%20IUS%20device%20characteristics.pdf (accessed 13 July 2021)
  4. ibid
  5. ibid
  6. ibid