| 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. | ||||||||||||||||||||||||