Thank you for the opportunity to speak.
My name is Nicole Daruda. In 2005 I got Mentor’s silicone cohesive gel breast implants. I was perfectly healthy before breast implants, and in the first couple years with implants, very marked symptoms appeared, and by 5 years, my declining health was so bad I had to leave my 25-year career.
I’m not going to list all the symptoms because you’re going to hear from many women about their systemic symptoms and our stories are mostly identical. Suffice it to say, I had serious autoimmune symptoms and diseases, endocrine gland damage, and kidney damage.
I, along with multitudes of other women, feel duped into believing breast implants are safe, by plastic surgeons and manufacturers of implants.
After experiencing breast implant illness and researching, I found that silicone is not safe or biologically inert, as described by my plastic surgeon, but rather it is made of an array of toxic chemicals and heavy metals that leak from early on and interact with our body glands, organs, and immune system, causing profound illness.
After experiencing this illness first hand, I realized that four generations of women and their families have been harmed over several decades, and due to the current trend of breast implants, there would be many, many more sick women.
I felt a deep responsibility to do something, and so in February 2013 I published a website called healingbreastimplantillness.com. Quickly, this website turned into a forum which is now 70,000, because my hunch was correct: there are multitudes of women that are profoundly ill from their implants.
Several hundreds of women arrive each day to our forum with the same story of symptoms, the same loss of health.
We have all been repeatedly told our breast implants were safe or are safe and our symptoms are not from our implants, by both plastic surgeons and by family doctors who are misinformed.
All of this illness and suffering could have been avoided if we had just been properly informed about the toxic chemicals and heavy metals of silicone and their real-world effects in our body and how breast implants leak much earlier than anyone expects and documented in your own data. I cannot emphasize this enough.
The crux of the issue is proper informed consent about the real failure rates of breast implants, the real-world effects of toxic chemicals and heavy metals of silicone, and the real health consequences of these ingredients in our body as not occurring. If women knew up front of the toxic chemicals and heavy metals in silicone and the real failure rates, they would never buy breast implants and this issue would disappear.
If doctors knew the truth, they would not be misdiagnosing their patients.
Proper informed consent is the only moral, ethical, and commonsense solution to decades of profound harm to women.
FDA, stop the manufacturers from hiding the truth that should be available to anyone considering breast implants.
It’s no longer possible for you or anyone to minimize breast implant illness. We are not going away. These issues are not going away.
Please do the right thing by enforcing proper informed consent in respect to saline and silicone breast implants.
[Open public comment given by breast implant recipient and breast implant illness support group founder Nicole Daruda at the General and Plastic Surgery Devices Panel on March 25, 2019. Article title 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.]