Hi, my name is Raylene Hollrah, and I traveled from Missouri on my own expense, and I have no conflict of interest.
I was diagnosed with breast cancer at the age of 33. I had a bilateral mastectomy without immediate reconstruction followed by chemotherapy. After the following year of treatment, I was very concerned about not having a chest and I was struggling.
I went to three different plastic surgeons for consults on my reconstruction options. All three were united, and it was a safe choice to use textured implants as a reconstruction.
Upon this, I was part of the 10-year mandated study to follow my reconstruction path. Ironically, I was dropped from that study at the same time I was diagnosed with my second cancer, with no reason or notification why.
I was diagnosed with BIA-ALCL on June 21st, 2013.
Yes, a man made cancer from my breast implants.
I was never warned, I was never notified of the risk, and my life was forever changed again from another cancer diagnosis.
When I was diagnosed, I picked up my whole life and moved to Houston, Texas, MD Anderson.
On there, you can see in 2018 Allergan came out with the ConfidencePlus warranty program. They’ll pay up to a thousand dollars for diagnostic testing and up to $7,500 for out-of-pocket surgical costs.
My costs to date at MD Anderson since my diagnosis is $288,133.50.
That does not include my lost time working, traveling, or lodging, and I never had to have chemotherapy because of my ALCL. That number would be a lot higher.
I also stand here today in honor of my daughter. She’s 15 years old, and when she turns 18, she will be tested for the BRCA mutation.
She couldn’t be here today because I said studies come first and she should be at school right now. But in this letter to the FDA, she talks about how thankful she is to be here. Memories, her prom, her first one’s coming up, I’m going to be there to help her get ready, take photos, and I know I’ll cry. But at the end she says, “My mom is one of the lucky ones, and I was wondering if you’re willing to admit that you could’ve taken this all away from me. Are you willing to keep these cancer-causing implants on the market and put other kids’ mothers at risk?”
This is the fourth time today that I’m testifying before the FDA in the past couple years.
Thank you for taking the time to listen, but I’ve been clear and concise every time I’ve come:
We need mandated patient informed consent, we need a mandated black box warning, we need a mandated patient checklist, and most importantly, 19 women have died.
You have the power and the authority to remove this cancer-causing implant from the market.
[Open public comment given by breast implant recipient Raylene Hollrah, at the General and Plastic Surgery Devices Panel, FDA White Oak Campus, Building #31, Great Room, on March 25, 2019. The title of this article does not constitute part of the speaker’s presentation to the FDA Panel, and any hyperlinks within the text or text appearing in brackets were added for clarity or ease of use by editors.]