2/20/2017

Non surgical treatment that keeps their uterus and retains the ability to have future children…


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.

HIFU Treatment in Bulgaria
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:
Dr. Suzanne Leblang, MD, Medical Director
Fibroid Education Center, Boca Raton, FL