2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
FDA Comment Number : EC9
Submitter : Ms. Carolyn Greer Date & Time: 06/29/2006 02:06:57
Organization : Ms. Carolyn Greer
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I have a 19-yr. old daughter who tells me how many of her friends are getting silicone implants. I am 55 yrs. old and remember how past studies (carefully controlled) raised issues as to the safety of these implants. I am seriously ill and had a chin implant and wonder if this plays a role..and I am shocked that no independent agencies are doing studies now to determine the safety BEFORE the FDA approves this!!

I am truly shocked..Carolyn C. Greer