
Myrl Jeffcoat
myrlj@jps.net1 mai, 2005 09:29
Lisa Hickey Testimony - FDA Panel Hearings - April 2005
MS. HICKEY: Good morning. I am Lisa Hickey, and I am from Phoenix. I have no conflicts of interest.
I am here to tell you I experienced four surgeries in four years due to complications with implants. My experience involved three manufacturers and new and improved products. Two of the surgeries were back to back after a rupture occurred.
Concurrent with the implant exposures, I experienced serious systemic illness and visual and motor impairment, which improved considerably after the implants and capsules were removed.
After the rupture diagnosis, I was required to sign a Mentor informed consent document in order to receive replacements. That occurred after a moratorium had been placed on the implants that I knew nothing about.
During prep for the rupture removal, I was sedated and negotiated with for my rupture evidence. My baseline mammogram and evidence were taken away from me around the same time as that surgery.
If implants are so safe, why are there gag orders and sealed documents regarding silicone implants from an historical perspective? Now I understand that the Justice Department has entered a settlement agreement with manufacturers for recovery of enormous expenses paid out to Health and Human Services claims for breast implant complications.
Aren't Social Security and Medicare in enough trouble already? How is it that the Justice Department can recover its losses with the Daubert rule in place, not allowing important evidence from expensive medical testing, while at the same time there is a law in place requiring insurance to cover breast cancer reconstruction with implants?
And I have been told the Navy Department is conducting a large breast cancer study. I am a furloughed flight attendant for a struggling airline that is required to pay for products with high complication rates for reconstructions when the Justice Department is trying to recover U.S. losses incurred by enormous claims from complication.
Now, I do not have a fancy degree or knowledge about rocket science, but my grandparents were educators. And they taught me to read the road signs on the highway of life. I can read that things just don't add up to safety when it comes to silicone gel.
Many of my fellow flight attendant friends and acquaintances with implant exposures have been ill. And some have passed on in the prime of their lives.
Is silicone research taking place in the morgue? In your approval process, please consider what this research does not tell you. Breast implant exposures altered my health forever. Believe me, experiencing illness serious enough to have my implants cut out in hopes of feeling better did not improve my self-esteem.
I implore you to help ensure that what happened to me and my friends with silicone exposures never happens to anyone else, especially young women in childbearing years, single mothers with limited financial resources, and vulnerable cancer patients.
Thank you.