My name is Jennifer Robb. I’m a clinician advocate and [the] third generation of my family harmed by breast implants. My son, the fourth: His lifelong battle began in utero.
Devan was born at 32 weeks. My four-pound baby boy was placed on a ventilator, fighting to survive. Besides respiratory complications, he had food intolerances, failure to thrive, allergies, eye infections, dermatitis, asthma, testing for cystic fibrosis.
We both spent our lives in and out of hospitals, doctors’ and specialists’ offices. We’ve become dependent on the government to provide financial and medical assistance. I felt so helpless and frightened.
Devan, please stand. Before you is the strongest, most courageous young man I am blessed to call my son.
Ladies with BII, cancer, and all mothers with implants, please stand. Today I request, today I speak for the unaccounted children left orphaned, decades of complaints globally, 19 reported deaths from BIA-ALCL, lack of proper testing for those with systemic symptoms now and prior to established guidelines; also, to remind you of the genetic variants thought to increase the risk of developing autoimmune diseases caused by silicone exposure.
For us, the first casualty in our family was my grandmother, who died in 1993 after her disintegrated breast implants were removed. My mother’s health [was] wrecked for over 40 years with three different brands of breast implants. Three.
In 1993 my breasts were augmented. A rupture went undetected for an unknown period of time, never picked up on imaging. Ultrasound reported floating debris in my implants. The textured shell was severely eroded and adherence [adhered] to the chest wall making proper removal impossible. Could mesh not do the same?
I have symptoms of BIA-ALCL, rashes, lung disease, weight loss, masses, enlarged lymph nodes, brown watery fluid in my chest, and the implant and blood tested positive for a rare fungus.
However, the fluid was discarded, and specimens never tested appropriately to rule out BIA-ALCL.
I was often misdiagnosed, did not return to my plastic surgeon, but instead had several life-threatening emergencies and hospitalizations, including a three-week stint at Mayo Clinic, and Devan finding me unresponsive after being dismissed by an uninformed physician.
It was 2 years after surgery I had pleural effusions, pneumonia, infections, preterm birth, cardiac arrest, stroke; masses began around the implant at five years, my first seroma at eight years. By 24-years-old, I had the first of many visits with a surgical oncologist for concerning breast issues and lists of specialists.
Familiar with rare, I did not know I had Ehlers-Danlos syndrome, a rare connective tissue disorder, or the genetic variants thought to increase the risk of developing cancer or autoimmune diseases caused by silicone exposure.
Please immediately recall textured breast implants. Ban the manufacturing, production, distribution, and sale of all breast implants. Demand manufacturer accountability and action.
How long does history have to repeat itself? How many lives have to be lost before action takes place? Isn’t one life enough?
Banning this lethal product is not to limit choice. I repeat, it is not to limit choice. But instead do no more harm. Save lives, prevent disease, inspire the creation of new innovative ideas with healthier options. Is not the definition of insanity, doing the same thing expecting different results?
Thank you. I urge you to please listen to our plea.
[Open public comment given by breast implant recipient Ms. Jennifer Robb, at the General and Plastic Surgery Devices Panel, FDA White Oak Campus, Building #31, Great Room, on March 26, 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.]