July 21, 2020

July is Fibroid Awareness Month and the perfect time to shed light on this critical women’s health condition that impacts a vast majority of women at some point in their lifetime. Uterine fibroids are non-cancerous tumors of the uterine muscle that can cause heavy menstrual bleeding, pain, bowel and/or bladder problems and infertility. This is a topic of personal interest to  staff within the Office of Women’s Health who have experienced firsthand the challenges of living with uterine fibroids. This month we are highlighting FDA’s efforts to help expand the treatment options for women with fibroids. We also invite you to read about the personal journeys of two women whose experiences inspired them to bring broader awareness to this important topic.

 
The Division of Urology, Obstetrics and Gynecology (DUOG), Center for Drug Evaluation and Research (CDER), joins OWH in recognizing July as Fibroid Awareness Month. Fibroids are the most common benign tumors in women of reproductive age. When fibroid-related symptoms become severe, women often resort to surgical treatments, such as hysterectomy and myomectomy (removal of the uterus and removal of the fibroids while leaving the uterus in place, respectively). However, surgical treatments are invasive procedures and may not be the appropriate option for all women. Until earlier this year, the only medical therapy for fibroid-related condition was injections (gonadotropin-release hormone agonists [GnRH agonists]) to improve anemia prior to fibroid surgery. Such use was limited to a maximum of 3 months due to side effects. In May, we approved the first medical option – an oral medication with the brand name Oriahnn – specifically for reducing heavy menstrual bleeding caused by uterine fibroids. Oriahnn is approved for use for up to two years because of concerns of possible bone thinning. We will continue to support the development of medical treatments in this therapeutic area to expand the medical armamentarium.

There is a growing demand for better, faster and less costly evidence generation to evaluate the technologies in women’s health that reflect the patient experience and outcomes during routine health care. Our colleagues in FDA’s Center for Devices and Radiological Health (CDRH) manage FDA’s Coordinated Registry Network (CRN). Based on the recommendation of the National Medical Device Registry Task Force (NMDRF), FDA in collaboration with  Medical Device Epidemiology Network (MDEpiNet) pursued development of the concept of Coordinated Registry Networks (CRNs) that link various real-world data sources such as claims, electronic health records (EHRs), patient generated data, among other data sources. Following successful pilot projects, a CRN for women’s health technologies (WHT) has been established.  In the uterine fibroid space, the Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) Registry joined the WHT-CRN partnership as a multi-center registry funded by PCORI and administered by the Agency for Healthcare Research and Quality (AHRQ). The COMPARE -UF registry has enrolled over 3000 women at 8 clinical centers around the country, with a primary goal of conducting comparative effectiveness research of currently available procedural treatments for fibroids. The WHT-CRN  including COMPARE UF, will enable the development of a framework for clinical studies to help better evaluate different treatment options for conditions uniquely affecting women’s health. 

Stakeholder Insights 

Can you share a brief summary of your fibroid journey and when you were diagnosed?
My fibroid symptoms started for me around the age of 14. Heavy menstrual bleeding, bloating, painful cramping. In 2013, I had my first myomectomy to remove 27 fibroids and a second myomectomy in 2018. I am still currently living with fibroids and created this organization while recovering from my first surgery and in an effort to ramp up the conversation on uterine fibroids. 

How have fibroids impacted your daily living?
Starting The White Dress Project organization and hearing the impact of fibroids on so many women has allowed me to realize how deeply a woman's quality of life can be impacted by fibroids and the psychological impact can be equally as burdensome. The White Dress Project team are the authors of Fibroid Awareness Month legislation. When we created this observance, we knew that we wanted to have the stories of women with fibroids recognized because too often, people suffer in silence with uterine fibroids.

What do you think could change the trajectory for women suffering from fibroids in the next 5 years?
Addressing the deficiency and lack of advocacy efforts, policies that impact change, appropriations to address the research gaps, addressing health disparities as they specifically relate to Black women and education for underserved communities. Change is also going to be revealed by women speaking out boldly and transparently about their fibroid journey and the impact fibroids have on their lives.

Learn more about The White Dress Project today. 

Can you share a brief summary of your fibroid journey and when you were diagnosed?
My fibroid journey started at 26 when I was diagnosed.  A hysterectomy was immediately recommended which I thought was odd given my age and the fact that I did not have children.  After my 2nd of 4 fibroid surgeries, I started to wonder if I was the only one having this horrendous experience and started The Fibroid Foundation.

How have fibroids impacted your daily living?
When I was symptomatic my days were very difficult.  Flying coast to coast for work was agonizing.  Sometimes on flights you're not allowed to leave your seat.  Oftentimes, fibroids patients need access to a restroom every hour or even more frequently.  Also the heavy menstrual bleeding and severe anemia made just breathing a challenge.

What do you think could change the trajectory for women suffering from fibroids in the next 5 years?
I'm encouraged by the progress that I've seen over the last 13 years of advocacy.  The fibroid and menstrual health conversations have increased. Our community is mobilized, vocal and becoming more informed. Over the next 5 years, I hope to have an even larger global footprint which will allow us to educate women about the full spectrum of treatment options.  At the moment, hysterectomies are still performed far too frequently to address fibroids.

Learn more about The Fibroid Foundation today.