Innovation

Fibroids treatment without the fuss

Designed to provide a less invasive alternative to hysterectomies and myomectomies, Gynesonics’s Sonata System uses radiofrequency energy to remove fibroids. Natalie Healey speaks to Gynesonics’ medical director David Toub about what the tech could mean for women who experience heavy menstrual bleeding.

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new emoji prompted much excitement last year. Women’s health organisations hoped the long-awaited ‘drop of blood’ symbol approved by the Unicode Consortium would help people talk more freely about menstruation - a historically taboo subject. The icon’s launch coincided with news about a UK inquiry into endometriosis, a condition that causes debilitating period pain, after 13,500 women took part in a BBC study exploring how the disease impacts their life. But although awareness-raising efforts for endometriosis are gaining traction, other menstrual disorders remain overlooked.


For instance, uterine fibroids are a rarely mentioned but extremely common condition. These non-cancerous growths found in the womb typically develop between the ages of 30 and 50. They can vary in diameter enormously - ranging from the size of a pea up to a melon in rare cases.


Experts believe at least half of all women experience fibroids at some point in their lives; they are thought to be even more prevalent in Black women. For some individuals, they cause no symptoms at all. But for others, fibroids lead to devastatingly heavy periods and abdominal pain.


The chance of a fibroid turning cancerous is extremely rare (about one in 10,000). But although the condition does not generally cause mortality, it can significantly impact a woman’s quality of life.


“Fibroids can mean anything from some unexpectedly heavy bleeding here and there to something that absolutely destroys a women’s confidence to go out in public or go to work,” says David Toub, a gynaecologist and medical director of women’s health tech company Gynesonics in Philadelphia, US. “Women often refer to the bleeding as ‘flooding’ where they almost can’t keep up in terms of the number of sanitary products they’re using.”


When periods are abnormally heavy it can even lead to dangerous amounts of blood loss for some women. Toub has had patients who have required blood transfusions. “I even once had a patient who came into hospital with right-sided heart failure, she was so anaemic.”

Gynesonics’s Sonata System treatment device. Image: Gynesonics

Treatment options for uterine fibroids

Luckily, there are a few ways of treating fibroids. Toub says there are far more options now than when he started practising as a gynaecologist in the 1990s. “Back then, the only choice was to put women on birth control pills. But that generally doesn't work because fibroids tend to grow in response to hormones such as oestrogen and progesterone.”


The most effective way to treat fibroids and prevent them from coming back is surgery. A hysterectomy (removing the womb) is often recommended for women who don’t want to get pregnant in the future. After a hysterectomy, the patient will usually need to spend a few days in the hospital and the recovery from the procedure is a gruelling six to eight weeks. Fibroids are the most likely benign reason for a woman to undergo a hysterectomy.


For women who do want to preserve their fertility, an alternative surgical option called myomectomy is often offered where the uterus is spared.

“Fibroids are the most likely benign reason for a woman to undergo a hysterectomy.”

“It can be done through a big incision the old-fashioned way or you can do it laparoscopically, which in many cases is absolutely possible and absolutely preferable,” says Toub, who believes a myomectomy should be offered to all women who are suitable for it, even if they’re not hoping to get pregnant in future. “It’s rarely absolutely necessary to do a hysterectomy for fibroids,” he says. “You can almost always at least do a myomectomy, if not something else, to treat it.”


But most myomectomies also require a few days in hospital and several weeks of recovery time. And there's a high chance the growths will return and further surgery will be needed. Around a third of women will need to come back in five years for a repeat procedure.


Other surgical treatments include uterine artery embolization where fibroids are not removed but the blood vessels feeding them are blocked causing the growths to shrink. This is effective but can be very painful. And some cases can be treated by passing a hysteroscope inside the womb through the cervix. This is a much less invasive procedure, but hysteroscopy can’t reach fibroids buried deep inside the wall of the uterus.

The Sonata System treatment device in use. Image: Gynesonics

On the radio(frequency)

Gynesonics has developed an alternative way of treating fibroids in the form of the Sonata System device. Radiofrequency energy is delivered to the fibroids via a probe inserted into the cervix. But it also has a built-in ultrasound camera which shows the gynaecologist exactly where to target the energy.


Sonata is approved for sale in the EU and the US; it’s already used in a handful of clinics in the UK. Toub says it can treat 80% of all fibroids and a general aesthetic is not required unless the patient requests it. What’s more, patients can go straight home after treatment. In a recent clinical trial, women treated with Sonata left hospital within two and a half hours on average – and that included the procedure time.


“Half the patients returned to normal activity within 24 hours,” says Toub of the results published in Obstetrics and Gynecology, the official journal of the American College of Obstetricians and Gynecologists. “Even with the laparoscopic myomectomy we usually don’t keep patients overnight and they do recover reasonably fast - but not that fast.”


The therapeutic effects can also be seen relatively quickly. Toub says Sonata can provide symptom relief two to three months after the procedure and most women experience a significant reduction in menstrual bleeding.

“It wouldn't really be as attractive to me as a gynaecologist if it weren't safe.”

While it’s suitable for many women with fibroids, as with any procedure, there are some risks such as the possibility of infection. And if the fibroids are too large or too close to other organs outside of the uterus, the Sonata treatment might have to be halted. There’s a small risk (one in 200) of piercing the uterus. Even rarer (one in 1,000) is the risk of a burn injury to the bladder or bowel. Some women also experience period-like bleeding for a short while as the uterus heals after surgery.


“The symptom relief is great, but it wouldn't really be as attractive to me as a gynaecologist if it weren't safe,” reassures Toub. “The reality is it is a very safe procedure when used correctly. We take great pains to make sure people use it correctly.”


While the Gynesonics team is always interested in other potential applications of the Sonata device, the focus is firmly on fibroids for now. Toub hopes we’re going to get much better at talking about the condition in future, expressing his delight that US Senator Kamala Harris recently introduced a bill to provide $30m a year to fund research and public awareness campaigns on uterine fibroids.


“We live and breathe fibroids,” he says. “We’re trying to get this technology to as many women who are appropriate candidates for it as possible. And that really means most women with fibroids.”