2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
FDA Comment Number : EC16
Submitter : Ms. Catherine Critz Date & Time: 06/29/2006 02:06:33
Organization : Ms. Catherine Critz
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Please do further research before silicone breast gel implants are approved for general distribution to young females. We do not know if they are safe for the children of women who breast feed, nor do we know if they are safe for the women.