| 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 | ||||||||||||||||||||||||