Hi, my name is Danielle Valoras. I’m a physician assistant, and I’ve worked in the medical device research industry for over 20 years. I love innovation.
I’m also a BII survivor.
Thus far, breast implants have cost me over three years of my life and over $100,000.
FDA, I’m asking for you to hold the device manufacturers accountable to conduct the appropriate long-term safety studies and ask the appropriate questions.
Two: Initiate a patient checklist providing full disclosure on the surgical and biomedical risk of breast implants.
Three: A declaration from you, the FDA, recognizing that breast implant illness is real so those affected can get the support they need.
My breast augmentation was in December 2015. I was 48-years-old, and I [had] lost 40 pounds. I was in the best shape of my life, and I wanted to look as good as I felt. I met with my plastic surgeon, and he recommended breast augmentation, saying it would be a perfect fit for me and the only real risk would be that of anesthesia. There was no mention of the associated risks for those of us with a history of autoimmune disease.
Fast forward almost two years, I was in and out of hospitals and doctors’ offices with migraines, swelling, muscle pain, fatigue, common symptoms that we BII people have. I kept looking for answers, and I soon realized I needed to remove my implants. It took multiple visits and over a year before I can [could] convince a plastic surgeon that the implants were a problem.
When my lymph nodes started to swell, the doctor finally became concerned and agreed to explant. I became extremely ill, and surgery seemed unwise until I got better. I never got better, but I knew I needed to explant, so I did [in] October 2017.
Immediately after the explant, the swelling, migraines, joint pain, were all gone. My inflammation markers and my heavy metal levels also went down.
Please note, my implants did not rupture.
There’s a slide to go with my presentation, and it’s not here. Is there—there we go. And one more. This is a picture of me, and on the left you can see a thermography with implants and depicting the red and the yellow is inflammation. Two weeks post-explant, I wanted to see if the inflammation was still present, and you can see it is greatly diminished.
I was told that these could not cause any physiological issues, and obviously, that’s not true.
I’ve worked on many Class III clinical trials, and it is mind-blowing that the FDA did not require better safety data and did not hold the companies accountable.
When I look through the MAUDE [Manufacturer and User Facility Device Experience] evidence online, through February 2019, there have been over 51,000 adverse events. Over 43,000 were injury-related, and 116 were death-related regarding breast implants.
There are life-saving devices that are worth the risk of serious harm. Breast implants are not one of them.
The FDA is a public health agency. The taxpayers should be your most important customers, not the device companies.
Please require that the manufacturers boldly display potential risks for cancer and autoimmune issues and hold them accountable. We need more longitudinal studies on how to best treat implant victims, so they can regain their health.
The first and most important step for the FDA is to acknowledge that breast implant illness is real, and until that happens, thousands more will be harmed.
[Open public comment given by breast implant recipient Danielle Valoras, MPAS, PA-C, 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.]