Good morning. Ladies and gentlemen of the Panel, please bear with me as my first language is French.
My name is Julie Elliott, and I’m from Quebec, Canada. I have Mentor smooth cohesive gel implants for 10 years.
When I decided to get breast implants, I knew every surgery has its risks and that implants could rupture or cause contracture.
But my surgeon said that the newest generation of implants were impossible to rupture, and the cohesive gel would never leak.
Implants transformed me from an athlete with a full-time job, to a full-time patient.
Three weeks after getting my implants, I noticed the first changes in my health. I experienced extreme exhaustion, rapid weight gain, paralyzing brain fog, intolerance to sun and heat.
Nine months after getting my implants I was diagnosed with Hashimoto disease.
Later on, I experienced muscle pain so severe I had to stop exercising. My hair was falling out, and I was always thirsty. I was also diagnosed with asthma. I then developed food allergies, my throat was closing after each bite, and my gastrointestinal issues became so severe that I had to stop working.
In 2016, I read about breast implant illness. I had been searching for the cause of my health problems for 10 years, and it was right in front of me. I have two polymer bags inside of me. I had my implants removed in January 2018.
A month after my surgery I sent my implants and capsule to be analyzed by Dr. Pierre Blais in Ottawa. My capsules were a hundred times thicker than what he usually sees and were covered with granulomas.
But the most shocking was the fact that one of my implants had a micro-rupture of longstanding origin that had leaked silicone oil into my body for years. After my explant surgery, several of my long-term symptoms disappeared almost immediately.
Today marks my 14 months since my implant [explant] surgery. While some of my symptoms still remain, I am healthier than I’ve been in years. My implants greatly compromised my health, and it may take years, it may take years to recover.
I decided to create the first French Canadian support group for women affected with breast implants. The group immediately got to over 800 members and [is] growing every day, and these members are actually 800 patients.
I stand in front of you because women are literally dying from their implants and no one believes them. We need more long-term research studies on the complications from breast implants that focus on symptoms and not just diagnosis.
I stand in front of you because I see women fighting every day to get proper testing for BIA-ALCL. Healthcare providers need awareness on the latest developments about diagnosis, pathology, and treatments for this cancer.
I stand in front of you because every day I see women who have no clue what kind of implants they have inside their bodies. We need national registries that tracks all complications and not just reoperations.
I stand before you because I know the FDA can lead the way and be the role model we need. This meeting is FDA’s opportunity to listen to what patients are saying about their experiences with implants so that public health agencies make decisions that will help shape the future health of millions of women around the globe.
Thank you for this opportunity.
(Applause)
[Open public comment given by breast implant recipient Julie Elliott at the General and Plastic Surgery Devices Panel on March 25, 2019. The title of this article does not constitute part of the speaker’s comment to the FDA and any hyperlinks or text appearing in brackets were added for clarity or ease of use by editors.]