A growing number of women have opted to get an intrauterine device in recent years, but the pain of the insertion and removal remains a barrier for many. While some clinicians have tried pain killers or numbing agents, the pain-relief options most commonly offered are often insufficient.
A new device, described in a presentation this week at the annual meeting of the American College of Obstetricians and Gynecologists, attempts to reduce the pain of IUD placement.
The tool uses suction to grasp the cervix during the IUD insertion procedure. It was designed as an alternative to a widely used device, called a tenaculum, which looks like a pair of scissors tipped with hooks. Versions of the tenaculum date back to before the Civil War, when it was most likely used to extract bullets from wounds.
The new device, called Carevix, is still being tested, and it’s not yet clear just how effective it is. But it’s an attempt to answer a question that gynecologists and patients have long wondered: Is there a way to make getting an IUD, a highly reliable form of contraception, more bearable?
IUD insertion consists of two main components: grabbing and pulling the cervix to straighten out the uterus, and then inserting the device. The tenaculum is used to grab the cervix and is so sharp that it can “literally poke holes,” said Dr. Alissa Conklin, an assistant professor of clinical obstetrics and gynecology at Indiana University School of Medicine, contributing to the pain of an IUD procedure. The holes it makes in the cervix are small and they occasionally bleed, she added.
Dr. Conklin is working on a clinical trial, funded by Aspivix, the medical device company that made the Carevix. She is studying the device’s effectiveness and whether it reduced perceived pain among patients at her clinic.
Doctors have long tried to reduce the discomfort associated with that grasping action by implementing certain practices, said Dr. Beverly Gray, an associate professor of obstetrics and gynecology at Duke University, who was not involved with Aspivix’s trials. “Some providers feel very strongly that having patients cough and then grasping the cervix quickly is less painful, and then other people are taught that placing the tenaculum more slowly is less jarring and less uncomfortable,” Dr. Gray said. In a 2019 study, Dr. Gray compared the “cough” and the “slow” techniques and found little difference in pain perception between the two.
But, she added, researchers did find that patients who have higher anxiety have a greater pain experience overall during an IUD insertion.
Two versions of the suction device have been studied in small preliminary trials funded by Aspivix. In one, published last year, 100 patients getting IUDs at two clinics in Switzerland were randomly assigned to either a traditional tenaculum or the suction device.
When the Aspivix device was used, some patients reported less pain at the moment the cervix was grabbed and pulled than when the tenaculum was used. There was a more notable reduction in pain for women who had never given birth (a group that is more likely to report greater pain with IUD insertion than women who have given birth).
But eight people in the Aspivix group were switched to the traditional tenaculum because the IUD couldn’t be inserted with the new device. One of the subjects fainted and, in another case, difficulty with removing the suction cup resulted in bruising and bleeding. Out of the 64 devices used in the study, 21 had defects.
The company has since designed a new version of the device. Last fall, 11 clinics across Europe and in the U.S. started using it among their own patients, including at Columbia University and in Dr. Conklin’s practice. A majority of patients surveyed at the clinics reported that the procedure was “more comfortable” or “less painful” than they expected, according to preliminary research that was presented at the ACOG summit but hasn’t been peer-reviewed. That study also found that patients shown the device before the procedure reported feeling reassured.
Last year, the Food and Drug Administration cleared the company’s newest model, though it did so through a regulatory pathway that involves less scrutiny than is given to higher-risk medical devices and medications.
Another limitation, Dr. Conklin said, is that it can’t be used for all patients. Sometimes “the cervix is too small or there’s an irregularity that won’t allow a suction cup to compress against the cervix well,” she said. Also it might not work as well among some women who’ve given birth, since labor and delivery can change the shape and opening of the cervix.
And, for many people, the most painful part of the procedure tends to be the insertion of the IUD itself, not the grabbing or the pulling of the cervix, Dr. Gray said. It’s unclear if this device would reduce pain during that part of the process.
