Good morning, my name is Terri McGregor. I traveled from Ontario, Canada, at my own expense.
Four years ago, I was diagnosed with ALCL from breast implants that were 6 years old. My diagnosis was Stage IV.
The joy of life was cut short by a profit-driven man-made cancer. Life as I knew it ceased to exist.
Clinic appointments, tests, exams, chemotherapy, debilitating side effects, and excruciating procedures drained my reserves.
I failed six rounds of CHOP, I failed relapse chemotherapy, and my prognosis changed to terminal with 4 to 6 months to live. I received rituximab under clinical trial through our national healthcare system in Canada, and after four rounds I was NED, no evidence of disease.
I underwent a stem cell transplant as my best hope for long-term survival.
I have recently been given my second cancer diagnosis, a complication from transplant. Being a vanguard in round two for a club I never wanted to join is unbelievable.
Our patients are facing reoccurrence and complications from this cancer. I have never been asked to participate in a study for BIA-ALCL. In my deepest thoughts and most private moments, I ask myself if I can endure a repeat of the excruciating effects of treatment.
Well, I did my best to put on a brave face as a mom, a wife, and a daughter. I watched my loved ones struggle as I became a typical cancer patient, and they were helpless. My health declined. The isolation, betrayal, loneliness of our cancer is compounded by the dismissive public relations campaign by industry.
While patients and clinicians called out on the emerging evidence, the industry stayed silent. When our existence could no longer be denied, we were merely portrayed as an anomaly.
Our disease status was to be reported to the FDA by the manufacturers who created our cancer. Allergan took 19 months to send a follow-up from my reporting physician.
With FDA annual reporting, Allergan was able to avoid confirming my case for 3 years. Underreporting and undiagnosed are common and unacceptable.
I collaborated with Dr. Peter Lennox at the CSBS in Canada to assist collecting our 28 Canadian cases. The five cases reported by the manufacturers to Health Canada did not include me. Our advocacy team helps thousands of women every day with awareness and education.
We want clinicians to be the experts, not patients. The presence of an implant has become a detriment to oncology investigation.
We patient advocates request a seat at the table. We ask surgeons to contact their past patients with or without FDA recommendation.
Lastly, please vote your full authority to withdraw all textured implants and expanders from the market and end the suffering of tomorrow’s families.
Thank you.
(Applause)
[Open public comment given by breast implant recipient Terri McGregor 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.]