In 2004, the director of our MRI centers heard of this
new technology coming out of a company in Israel called Insightec and invited
them to give us a lecture on focused ultrasound. I sat in the lecture and
couldn’t believe that in my lifetime this would be possible. Our center
purchased the system, and we performed the first commercial treatment for
uterine fibroids after FDA approval in 2004. Although the director, Dr. Fred
Steinberg, was supposed to do the first case, I filled in at the last minute.
The treatment was successful, and I was hooked after I saw how the patient
walked out of the MRI center one hour after the procedure as if I had done
nothing to her!
We have participated in several clinical research
projects. We were part of the multicenter trials using focused ultrasound for
African American women with fibroids, and I have also completed some of my own
clinical research with fibroids. We also participated in the clinical trial
that led to the Insightec system being approved by the FDA to reduce pain from
bone metastases.
From 2004 to 2008, there was a lot of buzz around
focused ultrasound for fibroids. We had many women wanting to participate in
the early research studies, partly because there was no cost, and because women
wanted a non-surgical option.
Treatment volume began to slow during the start of the
recession in 2008. We also did not have insurance coverage then, which
continues to be a challenge today. Despite FDA approval and many clinical
studies demonstrating the efficacy of focused ultrasound for fibroids, payers
still want a long term comparative study before they will reimburse for the
procedure. A study to generate this data is prohibitively expensive and hasn’t
been conducted, so we don’t have widespread insurance coverage in the US.
Without this coverage, only a few sites across the country have been offering
the procedure.
Despite these challenges, we recognize that the
benefits of focused ultrasound are so compelling for patients that they would
be willing to pay for the treatment. So the Fibroid Education Center was
created to empower women to make informed decisions and make the procedure more
accessible. We are aiming to turn the tide by generating awareness of focused
ultrasound, increasing the number of sites offering the procedure, and
ultimately, leading insurance companies to recognize the incredible value of
this option for women. I am hopeful because some payers have recently changed
their policies to cover focused ultrasound for fibroids.
When I think of the millions of women suffering from
their fibroids, I know that many of them want a solution that doesn’t involve
surgery such as a hysterectomy or myomectomy. As a non-surgical alternative,
focused ultrasound can improve their symptoms, minimize complications often
associated with other fibroid treatments, and enable them to return to work and
their activities of daily living much faster. In 2015, the FDA changed the labeling
so Curawave can also be used in women who wish to maintain their uterus for
future fertility. Over the past few months, I have treated many women in their
early 30’s who are so grateful to have a nonsurgical treatment that keeps their
uterus and retains the ability to have future children!
Autor:
Fibroid Education Center, Boca Raton, FL
