Although intrauterine devices have become a popular method of birth control, it is common for women to report pain during the insertion process, and many people still avoid them out of fear. Now, a company called Aspivix has manufactured a new device designed to make IUD insertion less painful.
Before inserting an IUD, a healthcare provider typically uses a long, scissors-like instrument called a tenaculum to pinch the cervix. Experts say this tool can puncture the cervix and cause painful uterine contractions. A new device called Carevix offers an alternative to the tenaculum by using suction to pinch the cervix. According to Aspivix, this “eliminates unnecessary pain and bleeding.”
The device was cleared by the Food and Drug Administration (FDA) last year, and Aspivix said the device “will soon be commercially available in the United States.”
“Pain during IUD insertion is caused by several factors, mainly related to manipulation of the cervix and uterus,” said Dr. Michal Yaron, an obstetrician and gynecologist at the University Hospital of Geneva, who led the study on Carevix presented at the American College of Obstetrics and Gynecology. (ACOG) Annual Clinical and Scientific Meeting, May.
Carevix “addresses an important barrier to IUD adoption” by potentially reducing pain during IUD insertion, Yaron said. health.
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The new tool is still being tested, but some studies have shown promising results.
In a study published in May that has not yet been peer-reviewed, Yaron and her colleagues collected data from nearly 300 procedures performed at 11 medical centers in Europe and the United States, 88 percent of which involved IUD insertion.
Approximately 76% of health care providers reported using Carevix successfully the first time, and 89% reported success after using it for 10 procedures.
Regarding pain, most patients surveyed said it was manageable and the procedure was “easy.”
In another study led by Yaron and funded by Aspivix last July, researchers randomly assigned 100 women who were eligible for IUD insertion to receive the procedure using either a suction device or a tenaculum. Overall, participants who received the suction procedure reported less pain than those in the other group.
The research team saw the biggest difference in pain reduction among patients who had never given birth. This group tends to experience more pain when inserting an IUD because their cervix has never been dilated. (One study found that 80% of women who had never had children reported severe pain when the IUD was inserted.)
Yaron says using suction instead of clamps can reduce the risk of uterine contractions due to cervical manipulation.
Carevix may also help minimize ectropia, said Dr. Katrina Heyrana, an obstetrician-gynecologist at Cedars-Sinai in Los Angeles who was not involved in the study. health. “In my experience, most patients feel the most intense pain when the tenaculum penetrates the cervix,” she said.
The device has some limitations, said Dr. Lisa Bayer, assistant professor of obstetrics and gynecology at Oregon Health & Science University School of Medicine, who was not involved in the Carevix study. health.
It does not address the pain that occurs when your doctor measures the length of your cervix. A measuring device must be inserted to stretch the cervix and feel the bottom of the uterus. “Any time something passes through the cervix, it can be painful,” she said. “Then you touch the top of the uterus, which has a lot of nerves that can cause pain.”
This is often the most significant source of pain for patients, Heyrana added.
It is possible that some patients may not be able to use the tool. Approximately 5% of participants in published studies were excluded from the study because the instrument was too large for use on the cervix.
Carevix is also a single-use device, Bayer added, so it will contribute to the already significant medical waste problem.
“I don't think it's a complete replacement for tenaculum,” she said.
According to a report released by the Centers for Disease Control and Prevention (CDC) in 2023, about a quarter of American women ages 15 to 49 who have ever had sex with a man use long-acting reversible contraception that does not include condoms or surgical sterilization. I found that using . Such as hysterectomy. More than 80% of them used an IUD.
Bayer says that as IUDs become more popular among women who have never had children, more people are likely to report pain when the IUD is inserted.
“IUD users have changed over the last 10 to 20 years,” Bayer said. “Traditionally, women would get them after they had a baby. But that has changed. They are now common in younger women and in people who have never been pregnant.”
A major problem contributing to this problem is “ignoring women’s pain during gynecological procedures,” Bayer said, adding that the American College of Obstetricians and Gynecologists, the organization that governs gynecology, does not have guidelines on how best to manage pain during IUD insertion.
“They acknowledge that research has not proven effective strategies to alleviate this discomfort, but instead tell people what to do.” she said “That led many people to think there was no effective intervention.”
Bayer said that despite having options, many women are not provided with anything to reduce pain during the procedure.
“Studies have shown that ibuprofen is not the best drug for these conditions, but other NSAIDs have been shown to be effective,” she said.
Bayer adds that cervical blocks, which involve administering a local anesthetic to the cervix and uterus, may also be helpful.
For some people, it may also be necessary to have an IUD inserted under general anesthesia. “A lot of people haven’t thought about it, because traditional thinking is just a little twitch,” she said.