Hello, my name is Jennifer Cook, and I’m from Georgia, and here is a photo of me, my husband, and 4-year-old son on vacation days before my diagnosis of BIA-ALCL in 2017.
As most of you know, the reports linking ALCL and breast implants began in the 1990s.
In 2008, JAMA published an article recognizing that link.
In 2010, a panel of experts looked at this long history and documented their agreement that the established scientific evidence is that a positive association does exist between breast implants and developing ALCL.
But sadly, in the latter half of that same year, my plastic surgeon and the manufacturer communicated to me the exact opposite.
Here is what my consent form said: “There is presently no established scientific evidence that links either silicone or saline breast implants with cancer.” I was given that informed consent because I was part of a study for an implant that was not yet FDA approved.
Because I wasn’t followed [up with, in the study] because I had a revision surgery shortly thereafter, I have concerns that my complications were never documented.
Years went by after my surgery, and don’t you think my surgeon, or the implant manufacturer, should’ve made sure that I was directly aware that there was established evidence linking implants to cancer?
But, instead, I remained in the dark.
And do you know how I eventually learned the truth?
I learned it randomly from middle school students in an inner-city school where I taught. The middle school students had written a play that made reference to media reports of implants causing cancer.
Of course, I was shocked because I had been told just the opposite, and so I thought I was going to need to reprimand the students for making false, reckless statements.
But before I did that, I Googled it, and that’s when I learned the horrifying truth. I read a lot about the BIA-ALCL, and shortly thereafter, I started to recognize that I actually did have symptoms of the disease, and I went to the doctor.
Even though I was informed, none of the doctors that I saw were, including radiologists and breast surgeons, and so I was unable to recognize and get a diagnosis until actually a year later, and by that time I had developed masses around my implant and, as a result, I had to have targeted chemotherapy as well as surgery.
I was blindsided. I was deceived. I don’t want anyone else to go through what I am having to go through.
One way to stop it is with mandatory standardized informed consent. Patients should not have to rely on their plastic surgeon, who may fail to stay up-to-date or may want to actually hide the facts.
In recognition of the FDA’s desire for the patient perspective, I sent a document to Mr. Garcia1 suggesting what I think should be in part of a standardized informed consent on BIA-ALCL. Everything in that document I believe to be true, and patients have the right to know it.
Thank you.
(Applause)
1 Patricio Garcia, the Designated Federal Officer for the FDA Panel.
[Open public comment given by breast implant recipient Jennifer Cook, 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.]